# Labor VR × analgesic use, cesarean birth and instrumental delivery: precise effects and power unverified Verdict 3004 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-07 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-19 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · Which outcome-reduction claim is selected? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread - 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. - 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. - 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. - 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. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: ## Evidence and sources ### 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](https://pubmed.ncbi.nlm.nih.gov/32485759/) Materials actually read: Stored summary read; external materials unread Findings recorded in the 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. 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. | 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](https://pubmed.ncbi.nlm.nih.gov/31094789/) Materials actually read: Stored summary read; external materials unread Findings recorded in the 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. 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. | 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](https://pubmed.ncbi.nlm.nih.gov/35461248/) Materials actually read: Stored summary read; external materials unread Findings recorded in the 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. 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. | 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](https://pubmed.ncbi.nlm.nih.gov/41896140/) Materials actually read: Stored summary read; external materials unread Findings recorded in the 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.