Labor VR × analgesic use, cesarean birth and instrumental delivery: precise effects and power unverified

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich outcome-reduction claim is selected?Required	The selection is the existing subclaim of reduced analgesic use, cesarean birth or instrumental delivery. Distinguish immediate parent-trial pain and the separate persistence question, retaining direct-material gaps for the three selected outcomes separately.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Existing subclaim versus parent pain and persistence questions	Material needed: Original definitions, reports, registration and protocols for these outcomes are needed. Create no new claim or independence certification. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow do subclaim grade and parent score differ?Required	The subclaim grade is ?; preserve the original note that precise outcome effects and adequate power were not established. Subclaim score/status are absent; parent C with 50 points and Caution is historical pain-question context.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Subclaim ?, original note, absent score/status and parent record	Material needed: A changed original verdict requires complete before/after records. Do not fill absent subclaim score/status with parent values. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWho is eligible for each outcome question?Required	The parent key pain trial involved 40 term nulliparous women before pharmacologic or neuraxial analgesia. Eligibility, exclusions, planned surgery, at-risk populations and denominators for other reports and each outcome are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Labor stage, parity, term status, analgesia and outcome eligibility	Material needed: Recruitment, exclusions, labor stage, obstetric risk and outcome-specific analysis tables are needed. Do not copy representative populations/samples to every report. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhich VR components are recorded?Required	The key trial combined VR, nature scenes, distraction and labor-specific audio. Content, exposure, headsets and epidural status differ across reports; component contributions to outcome reduction are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Device, content, audio, actual exposure and discontinuation	Material needed: Intervention specifications, versions, actual use/adherence and discontinuation records are needed. Create no new device-use instructions. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat care is the reduction compared with?Required	Distinguish no added intervention/standard care in the key trial from non-VR contractions in Frey. This does not mean absence of clinical care. Concurrent/rescue analgesia, obstetric decisions and attention controls for each outcome are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Standard care, no added intervention, non-VR contractions and decisions	Material needed: Comparator care, concurrent/rescue medication, epidural use, contact/audio and obstetric decision criteria are needed. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre outcome observation periods verified?Required	Up to 30 minutes in the key trial, about 10 minutes in the crossover, and Correia pain during use/30 minutes later are original records. Whole-labor/discharge collection and observation periods for the selected outcomes are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Exposure/pain assessments versus outcome collection/follow-up	Material needed: Outcome-specific start/end, labor completion and discharge/later follow-up records are needed. Do not turn exposure duration into outcome follow-up. This records needed materials; no new research was executed.
7	Unverified	Full text not readStored summary read	N07 · Evidence conditionWhat defines reduced analgesic use?Required	The original question includes reduced analgesic use; the parent also says reduced epidural use is unproven. The stored summary lacks definitions for specific drugs, totals and rescue/neuraxial-use outcomes. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset	Material needed: Drug categories, outcome definitions, original administration records, registration/SAP, doses, frequency and onset times are needed. This records needed materials; no new research was executed.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionIs there a direct between-group analgesic effect?Required	Original records leave precise medication-outcome effects unverified. The four reports summarize pain, anxiety, satisfaction and persistence; between-group analgesic effects/CIs are not preserved. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Arm-specific use/dose, direct effects, adjustment and CIs	Material needed: Original arm-specific counts/doses, tables, models, adjustment, CIs and analysis units are needed. Symptom values do not substitute for outcome effects. This records needed materials; no new research was executed.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionWhat are analgesic denominators and missingness?Required	The key trial records all 40 participants analyzed. Denominators, missingness, handling of unmedicated/already-medicated women and repeat-dose units for analgesic outcomes are separately unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing	Material needed: Outcome flow diagrams, missingness, ITT/PP and crossover exposure/dosing rules are needed. Calculate no new event or attrition counts from original samples. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionAre direct comparative cesarean results available?Required	The original question and parent records preserve the boundary that cesarean/operative reduction is unproven. Arm-specific cesarean counts, direct effects, CIs and time windows are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Arm-specific events/denominators, effects/CIs and observation windows	Material needed: Original surgery tables, birth types, denominators, effects/CIs, registration and analysis plans are needed. Unverified findings do not establish exact no effect. This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre planned/emergency surgery and decision criteria distinguished?Required	The parent provides context that studies were not powered for major clinical outcomes. Planned/emergency surgery, decision-makers, indications and whether VR preceded events are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Indications, decision-makers, baseline risk and exposure/decision timing	Material needed: Surgical indications, decision records, baseline obstetric risk and allocation/exposure/decision timelines are needed. This records needed materials; no new research was executed.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionAre direct instrumental-delivery results available?Required	The original question includes instrumental delivery, but the four reports contain no instrumental-delivery numbers. Precise effects and adequate power for these outcomes are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Types, arm-specific events/denominators and effects/CIs	Material needed: Original instrumental-delivery tables, types, prespecified definitions, denominators and effects/CIs are needed. Do not transfer other-endpoint values. This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionWhat population and unit define instrumental delivery?Required	The stored material does not verify vaginal-birth risk-set denominators, analysis of all allocated women, instrument types, repeated attempts or final-outcome units. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	All allocated/vaginal-birth risk sets, attempts/completion, types and missingness	Material needed: Birth-pathway flow diagrams, risk sets, instrument types, attempts/completion, denominators, missingness and analysis plans are needed. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionHow were the selected outcomes prespecified?Required	The key trial concerns between-group pre-post pain change; Carus concerns primary satisfaction and secondary pain. Prespecified endpoint hierarchy, times, denominators, analyses and power for the selected outcomes are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Registration/protocol/SAP hierarchy, times, denominators and power	Material needed: Registration, protocols, SAPs and outcome-specific original reports are needed. An identifier alone does not verify prespecified plans. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre Wong pain values outcome effects?Required	Preserve Wong control +0.58, VR -0.52, original change difference -1.10, P=.03. The 95% CI is unverified. These are between-group pre-post pain changes, not the selected outcome effects. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original pain change/CIs versus medication and birth outcomes	Material needed: Original pain/outcome tables, direct CIs, denominators and models are needed. Do not back-calculate new CIs/SEs from changes/P. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionDoes complete analysis establish each outcome denominator?Required	Wong records 40 participants, 21 VR/19 control, with all analyzed. Observation/analysis denominators and missingness for analgesic use, cesarean birth and instrumental delivery are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Allocated samples versus outcome-specific observation/analysis denominators	Material needed: Key-trial flow diagrams, outcome-specific denominators and original tables are needed. Do not extend all analyzed to complete data for every outcome/harm. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionIs MCID pain response an outcome reduction?Required	Original MCID response was 0% versus 23.8%, P=.049. Preserve the original interpretation that it was not added as a separate strength because external threshold validation and CIs were unverified. These are not medication/birth event rates. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original proportions, threshold and intervals versus event rates	Material needed: Threshold definitions, external validation, original response tables, exact denominators and intervals are needed. Calculate no new responder or event counts. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionIs Wong linked to official registration?Required	Wong records that the paper-official-registration link could not be verified. Preserve PMID 32485759 and DOI 10.1055/s-0040-1708851; infer no new registration linkage or reading. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original bibliography, official registration identity, dates and outcome plans	Material needed: Official registration linked to the paper, protocols, prespecified endpoints, dates and change histories are needed. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat is the scope of Frey pain/anxiety findings?Required	Preserve sensory pain -1.5 (95% CI -2.2 to -0.8) and anxiety -1.5 (-2.3 to -0.8). Original independent acute support is pain context, not outcome-replication certification. Do not newly assign an interval level to anxiety. R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original sensory-pain/anxiety effects/intervals versus outcomes	Material needed: Original crossover pain/anxiety tables and outcome-specific direct effects, denominators and CIs are needed. Do not inherit intervals from another endpoint. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionHow do crossover samples differ from repeated contractions?Required	Frey is an order-randomized acute crossover with 27 participants comparing VR/non-VR contractions for about 10 minutes. Details of order, carryover, repeated contractions and birth-outcome analyses are unverified. R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Order, periods, carryover information and within-person analysis	Material needed: Crossover protocols, order/periods, carryover, paired denominators, within-person models and outcome tables are needed. Do not count contractions as new independent participants. This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionWhat is the satisfaction/pain hierarchy?Required	Carus has primary satisfaction and secondary pain; original results are satisfaction P=.04, within-group early-pain reduction and no post-epidural change. Outcome hierarchy, effects, denominators and intervals are unverified. R03	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Carus primary satisfaction, secondary pain and outcome plans	Material needed: Registration, SAP, endpoint hierarchy and original satisfaction/pain/outcome tables are needed. Satisfaction P or within-group reduction is not a between-group outcome effect. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionDoes post-epidural pain answer reduced medication use?Required	Carus records 42 participants, 21 versus 21, with no post-epidural pain change. Who selected epidural use, timing, rates, doses, onset and medication-outcome denominators are unverified. R03	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Epidural selection/timing, use/dose and denominators	Material needed: Pre/post-epidural population flow, original medication-use records, outcome tables and outcome-specific denominators are needed. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre Correia persistence findings outcome effects?Required	Correia records 61 participants, 32 versus 29, in pain contexts during use and 30 minutes later. The during-use signal was not sustained 30 minutes later; exact CIs and registration are unverified. Effects on the selected outcomes are unverified. R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	During/follow-up pain, total allocation and outcomes	Material needed: Original during/post-use pain and birth-outcome tables, direct effects/CIs, denominators and registration are needed. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionCan different reports be combined as outcome replication?Required	Content, exposure, headsets and epidural status differ across reports. Pain, anxiety, satisfaction and post-use pain are distinct contexts; common definitions of medication, operative and instrumental-delivery effects are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Content, populations, scales, epidural status, times and outcome definitions	Material needed: Report-specific conditions, outcome tables, common definitions, inclusion relationships, family identity and participant overlap are needed. Create no unique-trial/participant totals. This records needed materials; no new research was executed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat is verified about randomization and concealment?Required	Preserve original designs: open randomization for Wong, order-randomized acute crossover for Frey, and randomized controlled trials for Carus/Correia. Actual generation, concealment, selection procedures and effects on outcome analyses are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Sequence generation/concealment, recruitment order and analysis units	Material needed: Allocation procedures, flow diagrams, recruitment order and baseline obstetric-risk/arm-balance tables are needed. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWho recorded and decided outcomes?Required	The parent describes limitations of unblinded patient-reported pain. Data sources, extractors, adjudicators, clinicians' allocation awareness and decision procedures for the selected outcomes are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Medication/birth records, extractors, adjudicators and allocation awareness	Material needed: Medication/birth-record collection, extraction, adjudication, masking and decision criteria are needed. Do not turn pain-bias explanations into a confirmed magnitude of outcome bias. This records needed materials; no new research was executed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre attention effects separated from concurrent care?Required	The parent states that active controls separating attention effects were absent. Detailed material separating audio/contact from rescue analgesia and obstetric-care differences is unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Active controls, contact/audio, rescue analgesia and concurrent procedures	Material needed: Active-control, contact/audio, common-care, rescue-analgesia and concurrent-procedure records are needed. This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionDo original samples differ from missing outcome data?Required	Outcome-specific missingness/follow-up beyond Wong's all-analyzed statement is unverified. Frey 27, Carus 42 and Correia 61 are original samples, not outcome-specific analysis samples or exclusion reasons. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions	Material needed: Outcome flow diagrams, denominators, missingness, analysis exclusions, discontinuation reasons and missing-data rules are needed. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhich effect do outcome analyses estimate?Required	Report summaries concern acute symptoms, satisfaction and persistence. Allocation/actual-use effects, analgesic/surgical selection, baseline-risk/epidural adjustment, repeated-data handling and models for the selected outcomes are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	ITT/PP, actual use, baseline-risk adjustment and models	Material needed: Outcome-specific SAPs, estimands, ITT/PP, denominators, actual use, covariates, models and estimates are needed. This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre outcome-specific CIs and power available?Required	The original subclaim note says precise outcome effects and adequate power were not established. The parent also describes studies not powered for major clinical outcomes or medication sparing. Outcome-specific CIs and sample-size planning are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Effects/CIs, event counts, sample-size planning, importance and follow-up	Material needed: Outcome-specific effects/CIs, planned effects, event counts, sample-size/power plans and importance thresholds are needed. Calculate no new power. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionHow are same-cohort related reports counted?Required	A same-cohort Wong report describes AppliedVR support. The original verdict did not double-count same-cohort qualitative research as replication. Separate bibliographies, registration and overlap scope of related reports are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Primary, qualitative/support reports, registration and cohort identity	Material needed: Detailed primary/qualitative/support-report identities, registration, recruitment dates and outcome links are needed. Do not add new independent trials. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionAre registration identifiers separated from content verification?Required	Preserve Frey NCT02926469 and Carus NCT05032456 strings. Retain unverified Wong linkage and Correia registration. Original registration content was not read in this work. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original identifiers, official content, dates, changes and outcome links	Material needed: Official registration, protocols, change histories and links to prespecified outcome endpoints/dates for each report are needed. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWhat funding and interests are recorded?Required	Preserve same-cohort Wong AppliedVR device/software support and reported no analysis role; Frey NIH AR054115/GM042725; Carus reported funding not applicable/no COI; and Correia unverified. This is no new independence verdict. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Funding, devices, roles, COI and related reports	Material needed: Original funding, device, COI, design/analysis/publication-role and investigator-role documents and related reports are needed. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionWhich materials were actually read?Required	Preserve the complete parent stored JSON and the four reports' original bibliographies/summaries. The summary was read; external papers, abstracts, registration and plans remain unread. External access was not attempted. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Stored summary versus external abstracts/full texts/registration/plans	Material needed: Needed original abstracts/full texts, registration, protocols and SAPs are required. Do not turn unattempted access into access failure or full-text reading. This records needed materials; no new research was executed.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionHow do historical verification and production dates differ?Required	The original evidence date is 2026-09-07; correction and deliberation records are empty. Historical parent cross-checking/grade decisions do not establish completed content review in this production.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original evidence date, empty change history and current scope	Material needed: New corrections/evidence updates require complete originals, events, before/after values and reasons. Do not fill an unrecorded review date with the production date. This records needed materials; no new research was executed.
36	Partly verified	Full text not readStored summary read	N36 · Evidence conditionAre Korean/English question boundaries preserved?Required	The original English claim concerns reduced analgesic use, cesarean birth or instrumental delivery, with a note that precise effects/adequate power were not established. Parent English separately describes immediate pain and whole-labor/epidural/cesarean limitations.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original subclaim wording/notes versus parent pain/safety wording	Material needed: Detailed comparison with external originals/corrections remains unverified. Preserve complete relevant originals and comparison records when needed. This records needed materials; no new research was executed.
37	Partly verified	Full text not readStored summary read	N37 · Evidence conditionAre parent axes inherited as a subclaim verdict?Required	The parent records B/P/R1/I1/E+/B2 with unrecorded precision and all four Boolean flags false. Preserve derived grade C and empty override reasons. Subclaim score, status and axes are absent.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original axes, unrecorded precision/override and absent subclaim fields	Material needed: Changed axes/subclaim records require complete change events. Do not fill parent values or empty fields as new outcome verdicts/certification. This records needed materials; no new research was executed.
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionHow were harms collected?Supplementary; required for extending safety conclusions	Original caution wording describes possible dizziness, motion sickness, discomfort and visual obstruction. These are not counts/rates or direct comparative harm tables; definitions, collection methods and assessors are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Symptoms, maternal/neonatal definitions and active/passive collection	Material needed: Harm definitions, active/passive collection, assessors, discontinuation/symptom records and original maternal/neonatal tables are needed. This records needed materials; no new research was executed.
39	Unverified	Full text not readStored summary read	N39 · Evidence conditionWhen did harms, discontinuation and follow-up occur?Supplementary; required for extending safety conclusions	Preserve maximum 30-minute key-trial exposure and acute-assessment context, but harm onset, discontinuation times and maternal/neonatal follow-up windows are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Exposure start/end, symptoms and post-birth/discharge follow-up	Material needed: Exposure, symptom, discontinuation, clinical-event, birth/discharge/later follow-up timelines are needed. This records needed materials; no new research was executed.
40	Unverified	Full text not readStored summary read	N40 · Evidence conditionWere harms compared under equivalent observation conditions?Supplementary; required for extending safety conclusions	The parent includes standard-care/non-VR comparisons. Whether harms were collected identically over the same periods in both conditions, and direct comparative results, are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Comparator care, common collection/observation and occurrence/discontinuation tables	Material needed: Comparator harm-collection, observation-period, discontinuation and original-table records and common procedures are needed. This records needed materials; no new research was executed.
41	Unverified	Full text not readStored summary read	N41 · Evidence conditionAre event counts and denominators available for harm frequency?Supplementary; required for extending safety conclusions	Preserve the original limitation that all 40 key-trial participants were analyzed but the trial was too small for rare maternal/neonatal harms. Harm counts, exposure/follow-up denominators, maternal/neonatal units and missingness are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness	Material needed: Original harm tables, exposure/follow-up flow, maternal/neonatal units and discontinuation reasons are needed. Do not newly calculate/certify event counts, rates or absence of harm. This records needed materials; no new research was executed.
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionAre concurrent care and alternative causes distinguished?Supplementary; required for extending safety conclusions	The parent describes visual obstruction, clinical monitoring/communication and small-study limitations. Actual monitoring-interference events, contributions from other care, obstetric-risk adjustment and causal assessments are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation	Material needed: Event timing, concurrent drugs/procedures, baseline risk, actual interference records and independent adjudication material are needed. This records needed materials; no new research was executed.
43	Unverified	Full text not readStored summary read	N43 · Evidence conditionWere discomfort, discontinuation or follow-up losses omitted?Supplementary; required for extending safety conclusions	The key trial records all analyzed, but details of device discontinuation, discomfort, missing harm reports and maternal/neonatal follow-up loss are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Device refusal/discontinuation, reporting omissions and post-birth follow-up	Material needed: Refusal/discontinuation reasons, harm logs, outcome-publication scope and post-birth/discharge follow-up losses are needed. This records needed materials; no new research was executed.
44	Partly verified	Full text not readStored summary read	N44 · Evidence conditionHave rare maternal/neonatal harms been excluded?Supplementary; required for extending safety conclusions	Original records state that small trials cannot adequately assess/exclude rare maternal/neonatal harms. Independent recurrence of the same harms, vulnerable groups and post-birth material are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Independent related harms, vulnerable groups and follow-up beyond brief observation	Material needed: Related harm reports, unique-event/family links, exposure/follow-up and vulnerable-group results are needed. Do not extend brief observation to overall safety. This records needed materials; no new research was executed.
45	Partly verified	Full text not readStored summary read	N45 · Evidence conditionHow are conditions and new materials updated?Required	Connect preserved methods and application conditions. Retain the original sequence of recording observations separately after conditions were frozen; existing content/boundary review remains incomplete. No new external material was applied and no official-method certification occurred now.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Originals, criterion versions, creation/application order and update events	Material needed: New reports, registration, outcome tables or corrections require complete originals linked to events, versions, before/after values and reasons. Distinguish criterion revisions from verdict changes. This records needed materials; no new research was executed.
46	Partly verified	Full text not readStored summary read	N46 · Evidence conditionIs pain extrapolated to medication/surgery replacement?Required	The parent describes how VR instead of epidural or surgery-free birth claims extend momentary pain signals to medication replacement/obstetric-event prevention. Record direct outcome gaps here without new use, labor, analgesic or treatment instructions.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original advertising boundary, outcome gaps and use/treatment guidance	Material needed: Link added original direct-outcome results in separate records. Do not establish unverified outcome reduction, whole-labor effects or replacement comparisons. This records needed materials; no new research was executed.

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46 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: The population is women in labor. The parent key pain trial involved 40 term nulliparous women before pharmacologic or neuraxial analgesia. Eligibility, at-risk populations and observation/analysis denominators for analgesic use, cesarean birth and instrumental delivery are unverified. Do not copy the representative trial population and sample to every outcome.
Ingredient, formulation and route: The original key trial combined immersive VR, nature scenes, distraction and labor-specific audio. Content, devices and epidural status differ across reports; component contributions to the selected outcomes, actual use and discontinuation are unverified. Do not newly establish a device-only effect or use instructions.
Dose: Up to 30 minutes in the key trial and about 10 minutes in the acute crossover are original exposure records. Actual use, discontinuation, repeat exposure and observation periods for the selected outcomes are unverified. Do not turn exposure duration into outcome follow-up or create new VR, labor, analgesic or treatment instructions.
Comparator: Distinguish no added intervention/standard care in the original key trial from non-VR contractions in the crossover. This does not mean absence of clinical care. Concurrent/rescue analgesia, obstetric decision criteria, contact/audio and actual between-group comparisons for each outcome are unverified.
Measured outcome: The selection is the existing subclaim of reduced analgesic use, cesarean birth or instrumental delivery. Preserve original grade ? and the note that precise effects and adequate power were not established. Definitions, original event counts, denominators and direct between-group effects/CIs are unverified. Immediate pain, MCID, anxiety, satisfaction and persistence do not substitute for these outcomes.
Duration: Maximum 30-minute parent-trial exposure, about 10 minutes in the crossover, and pain during use/30 minutes later are distinct contexts. Occurrence, decisions, collection times and whole-labor/discharge/later follow-up windows for the selected outcomes are unverified. Do not extend brief pain windows to outcome observation or long-term safety.
Questions outside this scope: Back-calculating CI/SE or standardized effects from original change differences/P, or calculating new MCID responder counts; Combining primary pain with secondary pain, satisfaction, anxiety or medication/obstetric events as one effect; Interchanging within-group reduction, pre/post-epidural and during/immediately-after/30-minutes-later results; Using representative populations, maximum exposure, standard care or total samples as every report/endpoint’s conditions or denominators; Counting same-cohort qualitative reports, shared bibliography or the three questions as new independent trials or participant totals; Certifying in-kind support, reported noninvolvement in analysis or public funding as complete independence/support verification; Inheriting parent C with 50 points, Caution or historical verification as subclaim scores or new clinical/safety certification; Creating new VR use/setup, labor, analgesic or treatment instructions, or medication/surgery replacement recommendations

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021;38(S01):e167-e172. PMID: 32485759. DOI: 10.1055/s-0040-1708851.

PubMed

Material type: Open randomized controlled trial
Materials actually read: Stored summary read; external materials unread
Findings recorded in the stored summary: Control +0.58, VR -0.52; difference in change -1.10, P=.03
Record level: Primary between-group pre-post pain change from 40 participants, 21 VR/19 control. Direct intervals, scales/models and endpoint-specific denominators are unverified. All analyzed and MCID-response statements do not establish complete data at all times/for harms or separate confirmation. Do not promote this context to a direct effect or replication for the selected medication/birth outcomes.
Study overlap and independent replication: The parent and three subclaims share the four Wong, Frey, Carus and Correia references. Preserve the original rule against adding same-cohort qualitative material as replication. Do not count reports, years, repeated contractions or separate sheets as new unique trials or independent participant totals; unique-trial/participant totals are unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 32485759, DOI 10.1055/s-0040-1708851 and unverified paper–official-registration linkage. PMCID and case/citation registration annotations are unrecorded. Same-cohort in-kind-support/noninvolvement-in-analysis statements do not become new reading or independence certification.

R02 · Frey DP, et al. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019;128:e93-e96. PMID: 31094789. DOI: 10.1213/ANE.0000000000003649.

PubMed

Material type: Order-randomized acute crossover trial
Materials actually read: Stored summary read; external materials unread
Findings recorded in the stored summary: Sensory pain -1.5 (95% CI -2.2 to -0.8); anxiety -1.5 (-2.3 to -0.8)
Record level: Order-randomized acute crossover context with 27 participants. Keep original sensory-pain and anxiety values separate without newly assigning an interval level to anxiety. Order, periods, carryover, paired denominators and differing content/scales are unverified. Do not promote this context to a direct effect or replication for the selected medication/birth outcomes.
Study overlap and independent replication: The parent and three subclaims share the four Wong, Frey, Carus and Correia references. Preserve the original rule against adding same-cohort qualitative material as replication. Do not count reports, years, repeated contractions or separate sheets as new unique trials or independent participant totals; unique-trial/participant totals are unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 31094789, DOI 10.1213/ANE.0000000000003649 and NCT02926469. PMCID is unrecorded. The identifier and original funding wording do not establish current registration/full-text reading, prospective status or complete support verification.

R03 · Carus EG, Albayrak N, Bildirici HM, Gur Ozmen S. Immersive virtual reality on childbirth experience for women: a randomized controlled trial. BMC Pregnancy Childbirth. 2022;22:354. PMID: 35461248. PMCID: PMC9034564. DOI: 10.1186/s12884-022-04598-y.

PubMed

Material type: Randomized controlled trial
Materials actually read: Stored summary read; external materials unread
Findings recorded in the stored summary: Satisfaction P=.04; within-group early-pain reduction and no post-epidural change
Record level: 42 participants, 21 versus 21, distinguishing primary satisfaction from secondary pain. Do not turn early within-group reduction or no post-epidural change into a direct between-group primary pain effect. Exact intervals, time-specific denominators and medication status are unverified. Do not promote this context to a direct effect or replication for the selected medication/birth outcomes.
Study overlap and independent replication: The parent and three subclaims share the four Wong, Frey, Carus and Correia references. Preserve the original rule against adding same-cohort qualitative material as replication. Do not count reports, years, repeated contractions or separate sheets as new unique trials or independent participant totals; unique-trial/participant totals are unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. Identifiers/PMCID do not establish current registration/full-text reading or verification of prespecified endpoints/analyses. Outcome effects, denominators and power remain unverified separately from the original bibliography.

R04 · Correia MCG, et al. Virtual Reality in Labor Pain Management: A Randomized Controlled Trial. Pain Manag Nurs. 2026;27:e708-e714. PMID: 41896140. DOI: 10.1016/j.pmn.2026.02.005.

PubMed

Material type: Randomized controlled trial
Materials actually read: Stored summary read; external materials unread
Findings recorded in the stored summary: The during-use signal was not sustained 30 minutes later
Record level: Pain-persistence context during use/30 minutes later from 61 participants, 32 versus 29. Exact pain effects/CIs, time-specific denominators, registration and support are unverified. Do not transfer this to direct effects or denominators for analgesic use, cesarean birth or instrumental delivery.
Study overlap and independent replication: The parent and three subclaims share the four Wong, Frey, Carus and Correia references. Preserve the original rule against adding same-cohort qualitative material as replication. Do not count reports, years, repeated contractions or separate sheets as new unique trials or independent participant totals; unique-trial/participant totals are unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Preserve original PMID 41896140, DOI 10.1016/j.pmn.2026.02.005 and unverified registration/support. PMCID and case/citation registration annotations are unrecorded. Retain the original bibliographic year and evidence date; infer no new URLs or original-material acquisition.

Report counts versus independent study counts

The parent and three subclaims share the four Wong, Frey, Carus and Correia references. Preserve the original rule against adding same-cohort qualitative material as replication. Do not count reports, years, repeated contractions or separate sheets as new unique trials or independent participant totals; unique-trial/participant totals are unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which outcome-reduction claim is selected?

Required materials and conditions: Existing subclaim versus parent pain and persistence questions
Conditions for verification: Material for Existing subclaim versus parent pain and persistence questions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Existing subclaim versus parent pain and persistence questions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N02 · How do subclaim grade and parent score differ?

Required materials and conditions: Subclaim ?, original note, absent score/status and parent record
Conditions for verification: Material for Subclaim ?, original note, absent score/status and parent record must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Subclaim ?, original note, absent score/status and parent record with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N03 · Who is eligible for each outcome question?

Required materials and conditions: Labor stage, parity, term status, analgesia and outcome eligibility
Conditions for verification: Material for Labor stage, parity, term status, analgesia and outcome eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Labor stage, parity, term status, analgesia and outcome eligibility with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N04 · Which VR components are recorded?

Required materials and conditions: Device, content, audio, actual exposure and discontinuation
Conditions for verification: Material for Device, content, audio, actual exposure and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Device, content, audio, actual exposure and discontinuation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N05 · What care is the reduction compared with?

Required materials and conditions: Standard care, no added intervention, non-VR contractions and decisions
Conditions for verification: Material for Standard care, no added intervention, non-VR contractions and decisions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Standard care, no added intervention, non-VR contractions and decisions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N06 · Are outcome observation periods verified?

Required materials and conditions: Exposure/pain assessments versus outcome collection/follow-up
Conditions for verification: Material for Exposure/pain assessments versus outcome collection/follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Exposure/pain assessments versus outcome collection/follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N07 · What defines reduced analgesic use?

Required materials and conditions: Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset
Conditions for verification: Material for Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N08 · Is there a direct between-group analgesic effect?

Required materials and conditions: Arm-specific use/dose, direct effects, adjustment and CIs
Conditions for verification: Material for Arm-specific use/dose, direct effects, adjustment and CIs must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Arm-specific use/dose, direct effects, adjustment and CIs with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N09 · What are analgesic denominators and missingness?

Required materials and conditions: At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing
Conditions for verification: Material for At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N10 · Are direct comparative cesarean results available?

Required materials and conditions: Arm-specific events/denominators, effects/CIs and observation windows
Conditions for verification: Material for Arm-specific events/denominators, effects/CIs and observation windows must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Arm-specific events/denominators, effects/CIs and observation windows with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N11 · Are planned/emergency surgery and decision criteria distinguished?

Required materials and conditions: Indications, decision-makers, baseline risk and exposure/decision timing
Conditions for verification: Material for Indications, decision-makers, baseline risk and exposure/decision timing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Indications, decision-makers, baseline risk and exposure/decision timing with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N12 · Are direct instrumental-delivery results available?

Required materials and conditions: Types, arm-specific events/denominators and effects/CIs
Conditions for verification: Material for Types, arm-specific events/denominators and effects/CIs must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Types, arm-specific events/denominators and effects/CIs with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N13 · What population and unit define instrumental delivery?

Required materials and conditions: All allocated/vaginal-birth risk sets, attempts/completion, types and missingness
Conditions for verification: Material for All allocated/vaginal-birth risk sets, attempts/completion, types and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects All allocated/vaginal-birth risk sets, attempts/completion, types and missingness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N14 · How were the selected outcomes prespecified?

Required materials and conditions: Registration/protocol/SAP hierarchy, times, denominators and power
Conditions for verification: Material for Registration/protocol/SAP hierarchy, times, denominators and power must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Registration/protocol/SAP hierarchy, times, denominators and power with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N15 · Are Wong pain values outcome effects?

Required materials and conditions: Original pain change/CIs versus medication and birth outcomes
Conditions for verification: Material for Original pain change/CIs versus medication and birth outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original pain change/CIs versus medication and birth outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N16 · Does complete analysis establish each outcome denominator?

Required materials and conditions: Allocated samples versus outcome-specific observation/analysis denominators
Conditions for verification: Material for Allocated samples versus outcome-specific observation/analysis denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Allocated samples versus outcome-specific observation/analysis denominators with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N17 · Is MCID pain response an outcome reduction?

Required materials and conditions: Original proportions, threshold and intervals versus event rates
Conditions for verification: Material for Original proportions, threshold and intervals versus event rates must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original proportions, threshold and intervals versus event rates with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N18 · Is Wong linked to official registration?

Required materials and conditions: Original bibliography, official registration identity, dates and outcome plans
Conditions for verification: Material for Original bibliography, official registration identity, dates and outcome plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original bibliography, official registration identity, dates and outcome plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N19 · What is the scope of Frey pain/anxiety findings?

Required materials and conditions: Original sensory-pain/anxiety effects/intervals versus outcomes
Conditions for verification: Material for Original sensory-pain/anxiety effects/intervals versus outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original sensory-pain/anxiety effects/intervals versus outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N20 · How do crossover samples differ from repeated contractions?

Required materials and conditions: Order, periods, carryover information and within-person analysis
Conditions for verification: Material for Order, periods, carryover information and within-person analysis must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Order, periods, carryover information and within-person analysis with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N21 · What is the satisfaction/pain hierarchy?

Required materials and conditions: Carus primary satisfaction, secondary pain and outcome plans
Conditions for verification: Material for Carus primary satisfaction, secondary pain and outcome plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Carus primary satisfaction, secondary pain and outcome plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N22 · Does post-epidural pain answer reduced medication use?

Required materials and conditions: Epidural selection/timing, use/dose and denominators
Conditions for verification: Material for Epidural selection/timing, use/dose and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Epidural selection/timing, use/dose and denominators with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N23 · Are Correia persistence findings outcome effects?

Required materials and conditions: During/follow-up pain, total allocation and outcomes
Conditions for verification: Material for During/follow-up pain, total allocation and outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects During/follow-up pain, total allocation and outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N24 · Can different reports be combined as outcome replication?

Required materials and conditions: Content, populations, scales, epidural status, times and outcome definitions
Conditions for verification: Material for Content, populations, scales, epidural status, times and outcome definitions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Content, populations, scales, epidural status, times and outcome definitions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N25 · What is verified about randomization and concealment?

Required materials and conditions: Sequence generation/concealment, recruitment order and analysis units
Conditions for verification: Material for Sequence generation/concealment, recruitment order and analysis units must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Sequence generation/concealment, recruitment order and analysis units with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N26 · Who recorded and decided outcomes?

Required materials and conditions: Medication/birth records, extractors, adjudicators and allocation awareness
Conditions for verification: Material for Medication/birth records, extractors, adjudicators and allocation awareness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Medication/birth records, extractors, adjudicators and allocation awareness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N27 · Are attention effects separated from concurrent care?

Required materials and conditions: Active controls, contact/audio, rescue analgesia and concurrent procedures
Conditions for verification: Material for Active controls, contact/audio, rescue analgesia and concurrent procedures must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Active controls, contact/audio, rescue analgesia and concurrent procedures with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N28 · Do original samples differ from missing outcome data?

Required materials and conditions: Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions
Conditions for verification: Material for Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N29 · Which effect do outcome analyses estimate?

Required materials and conditions: ITT/PP, actual use, baseline-risk adjustment and models
Conditions for verification: Material for ITT/PP, actual use, baseline-risk adjustment and models must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects ITT/PP, actual use, baseline-risk adjustment and models with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N30 · Are outcome-specific CIs and power available?

Required materials and conditions: Effects/CIs, event counts, sample-size planning, importance and follow-up
Conditions for verification: Material for Effects/CIs, event counts, sample-size planning, importance and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Effects/CIs, event counts, sample-size planning, importance and follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N31 · How are same-cohort related reports counted?

Required materials and conditions: Primary, qualitative/support reports, registration and cohort identity
Conditions for verification: Material for Primary, qualitative/support reports, registration and cohort identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Primary, qualitative/support reports, registration and cohort identity with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N32 · Are registration identifiers separated from content verification?

Required materials and conditions: Original identifiers, official content, dates, changes and outcome links
Conditions for verification: Material for Original identifiers, official content, dates, changes and outcome links must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original identifiers, official content, dates, changes and outcome links with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N33 · What funding and interests are recorded?

Required materials and conditions: Funding, devices, roles, COI and related reports
Conditions for verification: Material for Funding, devices, roles, COI and related reports must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Funding, devices, roles, COI and related reports with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N34 · Which materials were actually read?

Required materials and conditions: Stored summary versus external abstracts/full texts/registration/plans
Conditions for verification: Material for Stored summary versus external abstracts/full texts/registration/plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Stored summary versus external abstracts/full texts/registration/plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N35 · How do historical verification and production dates differ?

Required materials and conditions: Original evidence date, empty change history and current scope
Conditions for verification: Material for Original evidence date, empty change history and current scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original evidence date, empty change history and current scope with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N36 · Are Korean/English question boundaries preserved?

Required materials and conditions: Original subclaim wording/notes versus parent pain/safety wording
Conditions for verification: Material for Original subclaim wording/notes versus parent pain/safety wording must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original subclaim wording/notes versus parent pain/safety wording with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N37 · Are parent axes inherited as a subclaim verdict?

Required materials and conditions: Original axes, unrecorded precision/override and absent subclaim fields
Conditions for verification: Material for Original axes, unrecorded precision/override and absent subclaim fields must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original axes, unrecorded precision/override and absent subclaim fields with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N38 · How were harms collected?

Required materials and conditions: Symptoms, maternal/neonatal definitions and active/passive collection
Conditions for verification: Material for Symptoms, maternal/neonatal definitions and active/passive collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Symptoms, maternal/neonatal definitions and active/passive collection with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N39 · When did harms, discontinuation and follow-up occur?

Required materials and conditions: Exposure start/end, symptoms and post-birth/discharge follow-up
Conditions for verification: Material for Exposure start/end, symptoms and post-birth/discharge follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Exposure start/end, symptoms and post-birth/discharge follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N40 · Were harms compared under equivalent observation conditions?

Required materials and conditions: Comparator care, common collection/observation and occurrence/discontinuation tables
Conditions for verification: Material for Comparator care, common collection/observation and occurrence/discontinuation tables must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Comparator care, common collection/observation and occurrence/discontinuation tables with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N41 · Are event counts and denominators available for harm frequency?

Required materials and conditions: Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness
Conditions for verification: Material for Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N42 · Are concurrent care and alternative causes distinguished?

Required materials and conditions: Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation
Conditions for verification: Material for Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N43 · Were discomfort, discontinuation or follow-up losses omitted?

Required materials and conditions: Device refusal/discontinuation, reporting omissions and post-birth follow-up
Conditions for verification: Material for Device refusal/discontinuation, reporting omissions and post-birth follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Device refusal/discontinuation, reporting omissions and post-birth follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N44 · Have rare maternal/neonatal harms been excluded?

Required materials and conditions: Independent related harms, vulnerable groups and follow-up beyond brief observation
Conditions for verification: Material for Independent related harms, vulnerable groups and follow-up beyond brief observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Independent related harms, vulnerable groups and follow-up beyond brief observation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N45 · How are conditions and new materials updated?

Required materials and conditions: Originals, criterion versions, creation/application order and update events
Conditions for verification: Material for Originals, criterion versions, creation/application order and update events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Originals, criterion versions, creation/application order and update events with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N46 · Is pain extrapolated to medication/surgery replacement?

Required materials and conditions: Original advertising boundary, outcome gaps and use/treatment guidance
Conditions for verification: Material for Original advertising boundary, outcome gaps and use/treatment guidance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Why this condition is needed: This condition connects Original advertising boundary, outcome gaps and use/treatment guidance with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Awaiting user review, or actual review remains incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-19 · Public page/material version 1.0

Public-facing views and materials were prepared from the existing 46 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which outcome-reduction claim is selected?

Current findings: The selection is the existing subclaim of reduced analgesic use, cesarean birth or instrumental delivery. Distinguish immediate parent-trial pain and the separate persistence question, retaining direct-material gaps for the three selected outcomes separately.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original definitions, reports, registration and protocols for these outcomes are needed. Create no new claim or independence certification.
Required materials and conditions: Existing subclaim versus parent pain and persistence questions
Materials to obtain first: Original definitions, reports, registration and protocols for these outcomes are needed. Create no new claim or independence certification.
Further research: Material needed: Original definitions, reports, registration and protocols for these outcomes are needed. Create no new claim or independence certification. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Existing subclaim versus parent pain and persistence questions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Existing subclaim versus parent pain and persistence questions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N02 · How do subclaim grade and parent score differ?

Current findings: The subclaim grade is ?; preserve the original note that precise outcome effects and adequate power were not established. Subclaim score/status are absent; parent C with 50 points and Caution is historical pain-question context.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: A changed original verdict requires complete before/after records. Do not fill absent subclaim score/status with parent values.
Required materials and conditions: Subclaim ?, original note, absent score/status and parent record
Materials to obtain first: A changed original verdict requires complete before/after records. Do not fill absent subclaim score/status with parent values.
Further research: Material needed: A changed original verdict requires complete before/after records. Do not fill absent subclaim score/status with parent values. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Subclaim ?, original note, absent score/status and parent record must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Subclaim ?, original note, absent score/status and parent record with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N03 · Who is eligible for each outcome question?

Current findings: The parent key pain trial involved 40 term nulliparous women before pharmacologic or neuraxial analgesia. Eligibility, exclusions, planned surgery, at-risk populations and denominators for other reports and each outcome are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Recruitment, exclusions, labor stage, obstetric risk and outcome-specific analysis tables are needed. Do not copy representative populations/samples to every report.
Required materials and conditions: Labor stage, parity, term status, analgesia and outcome eligibility
Materials to obtain first: Recruitment, exclusions, labor stage, obstetric risk and outcome-specific analysis tables are needed. Do not copy representative populations/samples to every report.
Further research: Material needed: Recruitment, exclusions, labor stage, obstetric risk and outcome-specific analysis tables are needed. Do not copy representative populations/samples to every report. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Labor stage, parity, term status, analgesia and outcome eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Labor stage, parity, term status, analgesia and outcome eligibility with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N04 · Which VR components are recorded?

Current findings: The key trial combined VR, nature scenes, distraction and labor-specific audio. Content, exposure, headsets and epidural status differ across reports; component contributions to outcome reduction are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Intervention specifications, versions, actual use/adherence and discontinuation records are needed. Create no new device-use instructions.
Required materials and conditions: Device, content, audio, actual exposure and discontinuation
Materials to obtain first: Intervention specifications, versions, actual use/adherence and discontinuation records are needed. Create no new device-use instructions.
Further research: Material needed: Intervention specifications, versions, actual use/adherence and discontinuation records are needed. Create no new device-use instructions. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Device, content, audio, actual exposure and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Device, content, audio, actual exposure and discontinuation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N05 · What care is the reduction compared with?

Current findings: Distinguish no added intervention/standard care in the key trial from non-VR contractions in Frey. This does not mean absence of clinical care. Concurrent/rescue analgesia, obstetric decisions and attention controls for each outcome are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Comparator care, concurrent/rescue medication, epidural use, contact/audio and obstetric decision criteria are needed.
Required materials and conditions: Standard care, no added intervention, non-VR contractions and decisions
Materials to obtain first: Comparator care, concurrent/rescue medication, epidural use, contact/audio and obstetric decision criteria are needed.
Further research: Material needed: Comparator care, concurrent/rescue medication, epidural use, contact/audio and obstetric decision criteria are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Standard care, no added intervention, non-VR contractions and decisions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Standard care, no added intervention, non-VR contractions and decisions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N06 · Are outcome observation periods verified?

Current findings: Up to 30 minutes in the key trial, about 10 minutes in the crossover, and Correia pain during use/30 minutes later are original records. Whole-labor/discharge collection and observation periods for the selected outcomes are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Outcome-specific start/end, labor completion and discharge/later follow-up records are needed. Do not turn exposure duration into outcome follow-up.
Required materials and conditions: Exposure/pain assessments versus outcome collection/follow-up
Materials to obtain first: Outcome-specific start/end, labor completion and discharge/later follow-up records are needed. Do not turn exposure duration into outcome follow-up.
Further research: Material needed: Outcome-specific start/end, labor completion and discharge/later follow-up records are needed. Do not turn exposure duration into outcome follow-up. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Exposure/pain assessments versus outcome collection/follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Exposure/pain assessments versus outcome collection/follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N07 · What defines reduced analgesic use?

Current findings: The original question includes reduced analgesic use; the parent also says reduced epidural use is unproven. The stored summary lacks definitions for specific drugs, totals and rescue/neuraxial-use outcomes.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Drug categories, outcome definitions, original administration records, registration/SAP, doses, frequency and onset times are needed.
Required materials and conditions: Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset
Materials to obtain first: Drug categories, outcome definitions, original administration records, registration/SAP, doses, frequency and onset times are needed.
Further research: Material needed: Drug categories, outcome definitions, original administration records, registration/SAP, doses, frequency and onset times are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N08 · Is there a direct between-group analgesic effect?

Current findings: Original records leave precise medication-outcome effects unverified. The four reports summarize pain, anxiety, satisfaction and persistence; between-group analgesic effects/CIs are not preserved.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original arm-specific counts/doses, tables, models, adjustment, CIs and analysis units are needed. Symptom values do not substitute for outcome effects.
Required materials and conditions: Arm-specific use/dose, direct effects, adjustment and CIs
Materials to obtain first: Original arm-specific counts/doses, tables, models, adjustment, CIs and analysis units are needed. Symptom values do not substitute for outcome effects.
Further research: Material needed: Original arm-specific counts/doses, tables, models, adjustment, CIs and analysis units are needed. Symptom values do not substitute for outcome effects. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Arm-specific use/dose, direct effects, adjustment and CIs must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Arm-specific use/dose, direct effects, adjustment and CIs with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N09 · What are analgesic denominators and missingness?

Current findings: The key trial records all 40 participants analyzed. Denominators, missingness, handling of unmedicated/already-medicated women and repeat-dose units for analgesic outcomes are separately unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Outcome flow diagrams, missingness, ITT/PP and crossover exposure/dosing rules are needed. Calculate no new event or attrition counts from original samples.
Required materials and conditions: At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing
Materials to obtain first: Outcome flow diagrams, missingness, ITT/PP and crossover exposure/dosing rules are needed. Calculate no new event or attrition counts from original samples.
Further research: Material needed: Outcome flow diagrams, missingness, ITT/PP and crossover exposure/dosing rules are needed. Calculate no new event or attrition counts from original samples. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N10 · Are direct comparative cesarean results available?

Current findings: The original question and parent records preserve the boundary that cesarean/operative reduction is unproven. Arm-specific cesarean counts, direct effects, CIs and time windows are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original surgery tables, birth types, denominators, effects/CIs, registration and analysis plans are needed. Unverified findings do not establish exact no effect.
Required materials and conditions: Arm-specific events/denominators, effects/CIs and observation windows
Materials to obtain first: Original surgery tables, birth types, denominators, effects/CIs, registration and analysis plans are needed. Unverified findings do not establish exact no effect.
Further research: Material needed: Original surgery tables, birth types, denominators, effects/CIs, registration and analysis plans are needed. Unverified findings do not establish exact no effect. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Arm-specific events/denominators, effects/CIs and observation windows must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Arm-specific events/denominators, effects/CIs and observation windows with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N11 · Are planned/emergency surgery and decision criteria distinguished?

Current findings: The parent provides context that studies were not powered for major clinical outcomes. Planned/emergency surgery, decision-makers, indications and whether VR preceded events are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Surgical indications, decision records, baseline obstetric risk and allocation/exposure/decision timelines are needed.
Required materials and conditions: Indications, decision-makers, baseline risk and exposure/decision timing
Materials to obtain first: Surgical indications, decision records, baseline obstetric risk and allocation/exposure/decision timelines are needed.
Further research: Material needed: Surgical indications, decision records, baseline obstetric risk and allocation/exposure/decision timelines are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Indications, decision-makers, baseline risk and exposure/decision timing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Indications, decision-makers, baseline risk and exposure/decision timing with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N12 · Are direct instrumental-delivery results available?

Current findings: The original question includes instrumental delivery, but the four reports contain no instrumental-delivery numbers. Precise effects and adequate power for these outcomes are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original instrumental-delivery tables, types, prespecified definitions, denominators and effects/CIs are needed. Do not transfer other-endpoint values.
Required materials and conditions: Types, arm-specific events/denominators and effects/CIs
Materials to obtain first: Original instrumental-delivery tables, types, prespecified definitions, denominators and effects/CIs are needed. Do not transfer other-endpoint values.
Further research: Material needed: Original instrumental-delivery tables, types, prespecified definitions, denominators and effects/CIs are needed. Do not transfer other-endpoint values. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Types, arm-specific events/denominators and effects/CIs must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Types, arm-specific events/denominators and effects/CIs with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N13 · What population and unit define instrumental delivery?

Current findings: The stored material does not verify vaginal-birth risk-set denominators, analysis of all allocated women, instrument types, repeated attempts or final-outcome units.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Birth-pathway flow diagrams, risk sets, instrument types, attempts/completion, denominators, missingness and analysis plans are needed.
Required materials and conditions: All allocated/vaginal-birth risk sets, attempts/completion, types and missingness
Materials to obtain first: Birth-pathway flow diagrams, risk sets, instrument types, attempts/completion, denominators, missingness and analysis plans are needed.
Further research: Material needed: Birth-pathway flow diagrams, risk sets, instrument types, attempts/completion, denominators, missingness and analysis plans are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for All allocated/vaginal-birth risk sets, attempts/completion, types and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects All allocated/vaginal-birth risk sets, attempts/completion, types and missingness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N14 · How were the selected outcomes prespecified?

Current findings: The key trial concerns between-group pre-post pain change; Carus concerns primary satisfaction and secondary pain. Prespecified endpoint hierarchy, times, denominators, analyses and power for the selected outcomes are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Registration, protocols, SAPs and outcome-specific original reports are needed. An identifier alone does not verify prespecified plans.
Required materials and conditions: Registration/protocol/SAP hierarchy, times, denominators and power
Materials to obtain first: Registration, protocols, SAPs and outcome-specific original reports are needed. An identifier alone does not verify prespecified plans.
Further research: Material needed: Registration, protocols, SAPs and outcome-specific original reports are needed. An identifier alone does not verify prespecified plans. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Registration/protocol/SAP hierarchy, times, denominators and power must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Registration/protocol/SAP hierarchy, times, denominators and power with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N15 · Are Wong pain values outcome effects?

Current findings: Preserve Wong control +0.58, VR -0.52, original change difference -1.10, P=.03. The 95% CI is unverified. These are between-group pre-post pain changes, not the selected outcome effects.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original pain/outcome tables, direct CIs, denominators and models are needed. Do not back-calculate new CIs/SEs from changes/P.
Required materials and conditions: Original pain change/CIs versus medication and birth outcomes
Materials to obtain first: Original pain/outcome tables, direct CIs, denominators and models are needed. Do not back-calculate new CIs/SEs from changes/P.
Further research: Material needed: Original pain/outcome tables, direct CIs, denominators and models are needed. Do not back-calculate new CIs/SEs from changes/P. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original pain change/CIs versus medication and birth outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original pain change/CIs versus medication and birth outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N16 · Does complete analysis establish each outcome denominator?

Current findings: Wong records 40 participants, 21 VR/19 control, with all analyzed. Observation/analysis denominators and missingness for analgesic use, cesarean birth and instrumental delivery are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Key-trial flow diagrams, outcome-specific denominators and original tables are needed. Do not extend all analyzed to complete data for every outcome/harm.
Required materials and conditions: Allocated samples versus outcome-specific observation/analysis denominators
Materials to obtain first: Key-trial flow diagrams, outcome-specific denominators and original tables are needed. Do not extend all analyzed to complete data for every outcome/harm.
Further research: Material needed: Key-trial flow diagrams, outcome-specific denominators and original tables are needed. Do not extend all analyzed to complete data for every outcome/harm. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Allocated samples versus outcome-specific observation/analysis denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Allocated samples versus outcome-specific observation/analysis denominators with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N17 · Is MCID pain response an outcome reduction?

Current findings: Original MCID response was 0% versus 23.8%, P=.049. Preserve the original interpretation that it was not added as a separate strength because external threshold validation and CIs were unverified. These are not medication/birth event rates.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Threshold definitions, external validation, original response tables, exact denominators and intervals are needed. Calculate no new responder or event counts.
Required materials and conditions: Original proportions, threshold and intervals versus event rates
Materials to obtain first: Threshold definitions, external validation, original response tables, exact denominators and intervals are needed. Calculate no new responder or event counts.
Further research: Material needed: Threshold definitions, external validation, original response tables, exact denominators and intervals are needed. Calculate no new responder or event counts. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original proportions, threshold and intervals versus event rates must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original proportions, threshold and intervals versus event rates with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N18 · Is Wong linked to official registration?

Current findings: Wong records that the paper-official-registration link could not be verified. Preserve PMID 32485759 and DOI 10.1055/s-0040-1708851; infer no new registration linkage or reading.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Official registration linked to the paper, protocols, prespecified endpoints, dates and change histories are needed.
Required materials and conditions: Original bibliography, official registration identity, dates and outcome plans
Materials to obtain first: Official registration linked to the paper, protocols, prespecified endpoints, dates and change histories are needed.
Further research: Material needed: Official registration linked to the paper, protocols, prespecified endpoints, dates and change histories are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original bibliography, official registration identity, dates and outcome plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original bibliography, official registration identity, dates and outcome plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N19 · What is the scope of Frey pain/anxiety findings?

Current findings: Preserve sensory pain -1.5 (95% CI -2.2 to -0.8) and anxiety -1.5 (-2.3 to -0.8). Original independent acute support is pain context, not outcome-replication certification. Do not newly assign an interval level to anxiety.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original crossover pain/anxiety tables and outcome-specific direct effects, denominators and CIs are needed. Do not inherit intervals from another endpoint.
Required materials and conditions: Original sensory-pain/anxiety effects/intervals versus outcomes
Materials to obtain first: Original crossover pain/anxiety tables and outcome-specific direct effects, denominators and CIs are needed. Do not inherit intervals from another endpoint.
Further research: Material needed: Original crossover pain/anxiety tables and outcome-specific direct effects, denominators and CIs are needed. Do not inherit intervals from another endpoint. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original sensory-pain/anxiety effects/intervals versus outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original sensory-pain/anxiety effects/intervals versus outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R02

N20 · How do crossover samples differ from repeated contractions?

Current findings: Frey is an order-randomized acute crossover with 27 participants comparing VR/non-VR contractions for about 10 minutes. Details of order, carryover, repeated contractions and birth-outcome analyses are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Crossover protocols, order/periods, carryover, paired denominators, within-person models and outcome tables are needed. Do not count contractions as new independent participants.
Required materials and conditions: Order, periods, carryover information and within-person analysis
Materials to obtain first: Crossover protocols, order/periods, carryover, paired denominators, within-person models and outcome tables are needed. Do not count contractions as new independent participants.
Further research: Material needed: Crossover protocols, order/periods, carryover, paired denominators, within-person models and outcome tables are needed. Do not count contractions as new independent participants. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Order, periods, carryover information and within-person analysis must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Order, periods, carryover information and within-person analysis with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R02

N21 · What is the satisfaction/pain hierarchy?

Current findings: Carus has primary satisfaction and secondary pain; original results are satisfaction P=.04, within-group early-pain reduction and no post-epidural change. Outcome hierarchy, effects, denominators and intervals are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Registration, SAP, endpoint hierarchy and original satisfaction/pain/outcome tables are needed. Satisfaction P or within-group reduction is not a between-group outcome effect.
Required materials and conditions: Carus primary satisfaction, secondary pain and outcome plans
Materials to obtain first: Registration, SAP, endpoint hierarchy and original satisfaction/pain/outcome tables are needed. Satisfaction P or within-group reduction is not a between-group outcome effect.
Further research: Material needed: Registration, SAP, endpoint hierarchy and original satisfaction/pain/outcome tables are needed. Satisfaction P or within-group reduction is not a between-group outcome effect. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Carus primary satisfaction, secondary pain and outcome plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Carus primary satisfaction, secondary pain and outcome plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R03

N22 · Does post-epidural pain answer reduced medication use?

Current findings: Carus records 42 participants, 21 versus 21, with no post-epidural pain change. Who selected epidural use, timing, rates, doses, onset and medication-outcome denominators are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Pre/post-epidural population flow, original medication-use records, outcome tables and outcome-specific denominators are needed.
Required materials and conditions: Epidural selection/timing, use/dose and denominators
Materials to obtain first: Pre/post-epidural population flow, original medication-use records, outcome tables and outcome-specific denominators are needed.
Further research: Material needed: Pre/post-epidural population flow, original medication-use records, outcome tables and outcome-specific denominators are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Epidural selection/timing, use/dose and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Epidural selection/timing, use/dose and denominators with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R03

N23 · Are Correia persistence findings outcome effects?

Current findings: Correia records 61 participants, 32 versus 29, in pain contexts during use and 30 minutes later. The during-use signal was not sustained 30 minutes later; exact CIs and registration are unverified. Effects on the selected outcomes are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original during/post-use pain and birth-outcome tables, direct effects/CIs, denominators and registration are needed.
Required materials and conditions: During/follow-up pain, total allocation and outcomes
Materials to obtain first: Original during/post-use pain and birth-outcome tables, direct effects/CIs, denominators and registration are needed.
Further research: Material needed: Original during/post-use pain and birth-outcome tables, direct effects/CIs, denominators and registration are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for During/follow-up pain, total allocation and outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects During/follow-up pain, total allocation and outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R04

N24 · Can different reports be combined as outcome replication?

Current findings: Content, exposure, headsets and epidural status differ across reports. Pain, anxiety, satisfaction and post-use pain are distinct contexts; common definitions of medication, operative and instrumental-delivery effects are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific conditions, outcome tables, common definitions, inclusion relationships, family identity and participant overlap are needed. Create no unique-trial/participant totals.
Required materials and conditions: Content, populations, scales, epidural status, times and outcome definitions
Materials to obtain first: Report-specific conditions, outcome tables, common definitions, inclusion relationships, family identity and participant overlap are needed. Create no unique-trial/participant totals.
Further research: Material needed: Report-specific conditions, outcome tables, common definitions, inclusion relationships, family identity and participant overlap are needed. Create no unique-trial/participant totals. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Content, populations, scales, epidural status, times and outcome definitions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Content, populations, scales, epidural status, times and outcome definitions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N25 · What is verified about randomization and concealment?

Current findings: Preserve original designs: open randomization for Wong, order-randomized acute crossover for Frey, and randomized controlled trials for Carus/Correia. Actual generation, concealment, selection procedures and effects on outcome analyses are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Allocation procedures, flow diagrams, recruitment order and baseline obstetric-risk/arm-balance tables are needed.
Required materials and conditions: Sequence generation/concealment, recruitment order and analysis units
Materials to obtain first: Allocation procedures, flow diagrams, recruitment order and baseline obstetric-risk/arm-balance tables are needed.
Further research: Material needed: Allocation procedures, flow diagrams, recruitment order and baseline obstetric-risk/arm-balance tables are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Sequence generation/concealment, recruitment order and analysis units must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Sequence generation/concealment, recruitment order and analysis units with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N26 · Who recorded and decided outcomes?

Current findings: The parent describes limitations of unblinded patient-reported pain. Data sources, extractors, adjudicators, clinicians' allocation awareness and decision procedures for the selected outcomes are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Medication/birth-record collection, extraction, adjudication, masking and decision criteria are needed. Do not turn pain-bias explanations into a confirmed magnitude of outcome bias.
Required materials and conditions: Medication/birth records, extractors, adjudicators and allocation awareness
Materials to obtain first: Medication/birth-record collection, extraction, adjudication, masking and decision criteria are needed. Do not turn pain-bias explanations into a confirmed magnitude of outcome bias.
Further research: Material needed: Medication/birth-record collection, extraction, adjudication, masking and decision criteria are needed. Do not turn pain-bias explanations into a confirmed magnitude of outcome bias. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Medication/birth records, extractors, adjudicators and allocation awareness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Medication/birth records, extractors, adjudicators and allocation awareness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N27 · Are attention effects separated from concurrent care?

Current findings: The parent states that active controls separating attention effects were absent. Detailed material separating audio/contact from rescue analgesia and obstetric-care differences is unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Active-control, contact/audio, common-care, rescue-analgesia and concurrent-procedure records are needed.
Required materials and conditions: Active controls, contact/audio, rescue analgesia and concurrent procedures
Materials to obtain first: Active-control, contact/audio, common-care, rescue-analgesia and concurrent-procedure records are needed.
Further research: Material needed: Active-control, contact/audio, common-care, rescue-analgesia and concurrent-procedure records are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Active controls, contact/audio, rescue analgesia and concurrent procedures must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Active controls, contact/audio, rescue analgesia and concurrent procedures with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N28 · Do original samples differ from missing outcome data?

Current findings: Outcome-specific missingness/follow-up beyond Wong's all-analyzed statement is unverified. Frey 27, Carus 42 and Correia 61 are original samples, not outcome-specific analysis samples or exclusion reasons.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Outcome flow diagrams, denominators, missingness, analysis exclusions, discontinuation reasons and missing-data rules are needed.
Required materials and conditions: Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions
Materials to obtain first: Outcome flow diagrams, denominators, missingness, analysis exclusions, discontinuation reasons and missing-data rules are needed.
Further research: Material needed: Outcome flow diagrams, denominators, missingness, analysis exclusions, discontinuation reasons and missing-data rules are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N29 · Which effect do outcome analyses estimate?

Current findings: Report summaries concern acute symptoms, satisfaction and persistence. Allocation/actual-use effects, analgesic/surgical selection, baseline-risk/epidural adjustment, repeated-data handling and models for the selected outcomes are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Outcome-specific SAPs, estimands, ITT/PP, denominators, actual use, covariates, models and estimates are needed.
Required materials and conditions: ITT/PP, actual use, baseline-risk adjustment and models
Materials to obtain first: Outcome-specific SAPs, estimands, ITT/PP, denominators, actual use, covariates, models and estimates are needed.
Further research: Material needed: Outcome-specific SAPs, estimands, ITT/PP, denominators, actual use, covariates, models and estimates are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for ITT/PP, actual use, baseline-risk adjustment and models must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects ITT/PP, actual use, baseline-risk adjustment and models with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N30 · Are outcome-specific CIs and power available?

Current findings: The original subclaim note says precise outcome effects and adequate power were not established. The parent also describes studies not powered for major clinical outcomes or medication sparing. Outcome-specific CIs and sample-size planning are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Outcome-specific effects/CIs, planned effects, event counts, sample-size/power plans and importance thresholds are needed. Calculate no new power.
Required materials and conditions: Effects/CIs, event counts, sample-size planning, importance and follow-up
Materials to obtain first: Outcome-specific effects/CIs, planned effects, event counts, sample-size/power plans and importance thresholds are needed. Calculate no new power.
Further research: Material needed: Outcome-specific effects/CIs, planned effects, event counts, sample-size/power plans and importance thresholds are needed. Calculate no new power. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Effects/CIs, event counts, sample-size planning, importance and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Effects/CIs, event counts, sample-size planning, importance and follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N31 · How are same-cohort related reports counted?

Current findings: A same-cohort Wong report describes AppliedVR support. The original verdict did not double-count same-cohort qualitative research as replication. Separate bibliographies, registration and overlap scope of related reports are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Detailed primary/qualitative/support-report identities, registration, recruitment dates and outcome links are needed. Do not add new independent trials.
Required materials and conditions: Primary, qualitative/support reports, registration and cohort identity
Materials to obtain first: Detailed primary/qualitative/support-report identities, registration, recruitment dates and outcome links are needed. Do not add new independent trials.
Further research: Material needed: Detailed primary/qualitative/support-report identities, registration, recruitment dates and outcome links are needed. Do not add new independent trials. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Primary, qualitative/support reports, registration and cohort identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Primary, qualitative/support reports, registration and cohort identity with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N32 · Are registration identifiers separated from content verification?

Current findings: Preserve Frey NCT02926469 and Carus NCT05032456 strings. Retain unverified Wong linkage and Correia registration. Original registration content was not read in this work.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Official registration, protocols, change histories and links to prespecified outcome endpoints/dates for each report are needed.
Required materials and conditions: Original identifiers, official content, dates, changes and outcome links
Materials to obtain first: Official registration, protocols, change histories and links to prespecified outcome endpoints/dates for each report are needed.
Further research: Material needed: Official registration, protocols, change histories and links to prespecified outcome endpoints/dates for each report are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original identifiers, official content, dates, changes and outcome links must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original identifiers, official content, dates, changes and outcome links with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N33 · What funding and interests are recorded?

Current findings: Preserve same-cohort Wong AppliedVR device/software support and reported no analysis role; Frey NIH AR054115/GM042725; Carus reported funding not applicable/no COI; and Correia unverified. This is no new independence verdict.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original funding, device, COI, design/analysis/publication-role and investigator-role documents and related reports are needed.
Required materials and conditions: Funding, devices, roles, COI and related reports
Materials to obtain first: Original funding, device, COI, design/analysis/publication-role and investigator-role documents and related reports are needed.
Further research: Material needed: Original funding, device, COI, design/analysis/publication-role and investigator-role documents and related reports are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Funding, devices, roles, COI and related reports must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Funding, devices, roles, COI and related reports with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N34 · Which materials were actually read?

Current findings: Preserve the complete parent stored JSON and the four reports' original bibliographies/summaries. The summary was read; external papers, abstracts, registration and plans remain unread. External access was not attempted.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Needed original abstracts/full texts, registration, protocols and SAPs are required. Do not turn unattempted access into access failure or full-text reading.
Required materials and conditions: Stored summary versus external abstracts/full texts/registration/plans
Materials to obtain first: Needed original abstracts/full texts, registration, protocols and SAPs are required. Do not turn unattempted access into access failure or full-text reading.
Further research: Material needed: Needed original abstracts/full texts, registration, protocols and SAPs are required. Do not turn unattempted access into access failure or full-text reading. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Stored summary versus external abstracts/full texts/registration/plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Stored summary versus external abstracts/full texts/registration/plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N35 · How do historical verification and production dates differ?

Current findings: The original evidence date is 2026-09-07; correction and deliberation records are empty. Historical parent cross-checking/grade decisions do not establish completed content review in this production.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: New corrections/evidence updates require complete originals, events, before/after values and reasons. Do not fill an unrecorded review date with the production date.
Required materials and conditions: Original evidence date, empty change history and current scope
Materials to obtain first: New corrections/evidence updates require complete originals, events, before/after values and reasons. Do not fill an unrecorded review date with the production date.
Further research: Material needed: New corrections/evidence updates require complete originals, events, before/after values and reasons. Do not fill an unrecorded review date with the production date. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original evidence date, empty change history and current scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original evidence date, empty change history and current scope with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N36 · Are Korean/English question boundaries preserved?

Current findings: The original English claim concerns reduced analgesic use, cesarean birth or instrumental delivery, with a note that precise effects/adequate power were not established. Parent English separately describes immediate pain and whole-labor/epidural/cesarean limitations.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Detailed comparison with external originals/corrections remains unverified. Preserve complete relevant originals and comparison records when needed.
Required materials and conditions: Original subclaim wording/notes versus parent pain/safety wording
Materials to obtain first: Detailed comparison with external originals/corrections remains unverified. Preserve complete relevant originals and comparison records when needed.
Further research: Material needed: Detailed comparison with external originals/corrections remains unverified. Preserve complete relevant originals and comparison records when needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original subclaim wording/notes versus parent pain/safety wording must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original subclaim wording/notes versus parent pain/safety wording with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N37 · Are parent axes inherited as a subclaim verdict?

Current findings: The parent records B/P/R1/I1/E+/B2 with unrecorded precision and all four Boolean flags false. Preserve derived grade C and empty override reasons. Subclaim score, status and axes are absent.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Changed axes/subclaim records require complete change events. Do not fill parent values or empty fields as new outcome verdicts/certification.
Required materials and conditions: Original axes, unrecorded precision/override and absent subclaim fields
Materials to obtain first: Changed axes/subclaim records require complete change events. Do not fill parent values or empty fields as new outcome verdicts/certification.
Further research: Material needed: Changed axes/subclaim records require complete change events. Do not fill parent values or empty fields as new outcome verdicts/certification. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original axes, unrecorded precision/override and absent subclaim fields must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original axes, unrecorded precision/override and absent subclaim fields with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N38 · How were harms collected?

Current findings: Original caution wording describes possible dizziness, motion sickness, discomfort and visual obstruction. These are not counts/rates or direct comparative harm tables; definitions, collection methods and assessors are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Harm definitions, active/passive collection, assessors, discontinuation/symptom records and original maternal/neonatal tables are needed.
Required materials and conditions: Symptoms, maternal/neonatal definitions and active/passive collection
Materials to obtain first: Harm definitions, active/passive collection, assessors, discontinuation/symptom records and original maternal/neonatal tables are needed.
Further research: Material needed: Harm definitions, active/passive collection, assessors, discontinuation/symptom records and original maternal/neonatal tables are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Symptoms, maternal/neonatal definitions and active/passive collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Symptoms, maternal/neonatal definitions and active/passive collection with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N39 · When did harms, discontinuation and follow-up occur?

Current findings: Preserve maximum 30-minute key-trial exposure and acute-assessment context, but harm onset, discontinuation times and maternal/neonatal follow-up windows are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Exposure, symptom, discontinuation, clinical-event, birth/discharge/later follow-up timelines are needed.
Required materials and conditions: Exposure start/end, symptoms and post-birth/discharge follow-up
Materials to obtain first: Exposure, symptom, discontinuation, clinical-event, birth/discharge/later follow-up timelines are needed.
Further research: Material needed: Exposure, symptom, discontinuation, clinical-event, birth/discharge/later follow-up timelines are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Exposure start/end, symptoms and post-birth/discharge follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Exposure start/end, symptoms and post-birth/discharge follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N40 · Were harms compared under equivalent observation conditions?

Current findings: The parent includes standard-care/non-VR comparisons. Whether harms were collected identically over the same periods in both conditions, and direct comparative results, are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Comparator harm-collection, observation-period, discontinuation and original-table records and common procedures are needed.
Required materials and conditions: Comparator care, common collection/observation and occurrence/discontinuation tables
Materials to obtain first: Comparator harm-collection, observation-period, discontinuation and original-table records and common procedures are needed.
Further research: Material needed: Comparator harm-collection, observation-period, discontinuation and original-table records and common procedures are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Comparator care, common collection/observation and occurrence/discontinuation tables must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Comparator care, common collection/observation and occurrence/discontinuation tables with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N41 · Are event counts and denominators available for harm frequency?

Current findings: Preserve the original limitation that all 40 key-trial participants were analyzed but the trial was too small for rare maternal/neonatal harms. Harm counts, exposure/follow-up denominators, maternal/neonatal units and missingness are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original harm tables, exposure/follow-up flow, maternal/neonatal units and discontinuation reasons are needed. Do not newly calculate/certify event counts, rates or absence of harm.
Required materials and conditions: Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness
Materials to obtain first: Original harm tables, exposure/follow-up flow, maternal/neonatal units and discontinuation reasons are needed. Do not newly calculate/certify event counts, rates or absence of harm.
Further research: Material needed: Original harm tables, exposure/follow-up flow, maternal/neonatal units and discontinuation reasons are needed. Do not newly calculate/certify event counts, rates or absence of harm. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N42 · Are concurrent care and alternative causes distinguished?

Current findings: The parent describes visual obstruction, clinical monitoring/communication and small-study limitations. Actual monitoring-interference events, contributions from other care, obstetric-risk adjustment and causal assessments are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Event timing, concurrent drugs/procedures, baseline risk, actual interference records and independent adjudication material are needed.
Required materials and conditions: Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation
Materials to obtain first: Event timing, concurrent drugs/procedures, baseline risk, actual interference records and independent adjudication material are needed.
Further research: Material needed: Event timing, concurrent drugs/procedures, baseline risk, actual interference records and independent adjudication material are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N43 · Were discomfort, discontinuation or follow-up losses omitted?

Current findings: The key trial records all analyzed, but details of device discontinuation, discomfort, missing harm reports and maternal/neonatal follow-up loss are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Refusal/discontinuation reasons, harm logs, outcome-publication scope and post-birth/discharge follow-up losses are needed.
Required materials and conditions: Device refusal/discontinuation, reporting omissions and post-birth follow-up
Materials to obtain first: Refusal/discontinuation reasons, harm logs, outcome-publication scope and post-birth/discharge follow-up losses are needed.
Further research: Material needed: Refusal/discontinuation reasons, harm logs, outcome-publication scope and post-birth/discharge follow-up losses are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Device refusal/discontinuation, reporting omissions and post-birth follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Device refusal/discontinuation, reporting omissions and post-birth follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N44 · Have rare maternal/neonatal harms been excluded?

Current findings: Original records state that small trials cannot adequately assess/exclude rare maternal/neonatal harms. Independent recurrence of the same harms, vulnerable groups and post-birth material are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Related harm reports, unique-event/family links, exposure/follow-up and vulnerable-group results are needed. Do not extend brief observation to overall safety.
Required materials and conditions: Independent related harms, vulnerable groups and follow-up beyond brief observation
Materials to obtain first: Related harm reports, unique-event/family links, exposure/follow-up and vulnerable-group results are needed. Do not extend brief observation to overall safety.
Further research: Material needed: Related harm reports, unique-event/family links, exposure/follow-up and vulnerable-group results are needed. Do not extend brief observation to overall safety. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Independent related harms, vulnerable groups and follow-up beyond brief observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Independent related harms, vulnerable groups and follow-up beyond brief observation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N45 · How are conditions and new materials updated?

Current findings: Connect preserved methods and application conditions. Retain the original sequence of recording observations separately after conditions were frozen; existing content/boundary review remains incomplete. No new external material was applied and no official-method certification occurred now.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: New reports, registration, outcome tables or corrections require complete originals linked to events, versions, before/after values and reasons. Distinguish criterion revisions from verdict changes.
Required materials and conditions: Originals, criterion versions, creation/application order and update events
Materials to obtain first: New reports, registration, outcome tables or corrections require complete originals linked to events, versions, before/after values and reasons. Distinguish criterion revisions from verdict changes.
Further research: Material needed: New reports, registration, outcome tables or corrections require complete originals linked to events, versions, before/after values and reasons. Distinguish criterion revisions from verdict changes. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Originals, criterion versions, creation/application order and update events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Originals, criterion versions, creation/application order and update events with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N46 · Is pain extrapolated to medication/surgery replacement?

Current findings: The parent describes how VR instead of epidural or surgery-free birth claims extend momentary pain signals to medication replacement/obstetric-event prevention. Record direct outcome gaps here without new use, labor, analgesic or treatment instructions.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Link added original direct-outcome results in separate records. Do not establish unverified outcome reduction, whole-labor effects or replacement comparisons.
Required materials and conditions: Original advertising boundary, outcome gaps and use/treatment guidance
Materials to obtain first: Link added original direct-outcome results in separate records. Do not establish unverified outcome reduction, whole-labor effects or replacement comparisons.
Further research: Material needed: Link added original direct-outcome results in separate records. Do not establish unverified outcome reduction, whole-labor effects or replacement comparisons. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original advertising boundary, outcome gaps and use/treatment guidance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original advertising boundary, outcome gaps and use/treatment guidance with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.
Application exceptions: Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources