{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3004-s1", "verdict_number": "3004", "title": "Labor VR × persistent pain relief: during-use signal not sustained at 30 minutes", "view_version": "1.0", "view_created_date": "2026-10-19", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Correia records 61 participants, 32 versus 29. Time-specific analysis populations, completion, missingness, labor progression and analgesia status are unverified. Do not substitute the parent Wong trial’s 40 term nulliparous women or pre-pharmacologic/neuraxial conditions for the persistence trial’s population or denominators.", "intervention": "Preserve the parent VR context of combined nature scenes, distraction and labor-specific audio. Correia’s exact devices, content, audio, exposure and actual delivery are unverified. Do not fill persistent-effect conditions using another report’s content or medication status.", "dose": "The parent’s up to 30 minutes and acute crossover’s about 10 minutes are study-specific exposure records. Do not transfer them into post-exposure observation time or Correia’s actual dose. Create no new VR use/setup, labor, analgesic or treatment timing instructions, or total-exposure calculation.", "comparator": "The parent no-added-intervention/standard-care comparison and absence of an active attention control are original trial context. Exact arm mapping, shared care, guidance, contact, expectancy and concurrent analgesia in Correia’s persistence comparison are unverified. Do not establish an identical comparator across reports.", "endpoint": "The selection is pain relief lasting beyond 30 minutes; the original grade D note says the during-use signal was not sustained 30 minutes later. Exact between-group persistent effects, CIs, P, scales and denominators are unverified. Do not transfer immediate change differences or other endpoints, or turn nonpersistence into precise no effect or equivalence.", "duration": "Distinguish Correia’s during-use pain from the result 30 minutes later. Exact time origin, exposure end, stopping/repetition, follow-up window and concurrent labor/analgesia changes are unverified. Do not extend this point to effects at every period beyond 30 minutes or throughout labor.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which persistent-pain claim is selected?", "needed": "Existing subclaim, grade and nonpersistence note", "role": "Required", "role_reason": "This condition connects Existing subclaim, grade and nonpersistence note with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Existing subclaim, grade and nonpersistence note must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact during/post-exposure times, denominators, between-group persistent effects/CIs and concurrent analgesia are needed. Create no new question or independence certification. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The selection is pain relief lasting beyond 30 minutes; the original grade D note says the during-use signal was not sustained 30 minutes later. Immediate-pain C and medication/operative-event ? are separate.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact during/post-exposure times, denominators, between-group persistent effects/CIs and concurrent analgesia are needed. Create no new question or independence certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact during/post-exposure times, denominators, between-group persistent effects/CIs and concurrent analgesia are needed. Create no new question or independence certification." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What are the original Correia persistence results?", "needed": "Trial sizes, during-use/follow-up pain and nonpersistence", "role": "Required", "role_reason": "This condition connects Trial sizes, during-use/follow-up pain and nonpersistence with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Trial sizes, during-use/follow-up pain and nonpersistence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original times, scales, arm values/effects/CIs, endpoint denominators, prespecified plans and concurrent analgesia/labor changes are needed. Invent no missing numbers or P. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Correia records a randomized trial of 61 participants, 32 versus 29, with a during-use signal not maintained 30 minutes later. Exact effects/CIs and registration are unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original times, scales, arm values/effects/CIs, endpoint denominators, prespecified plans and concurrent analgesia/labor changes are needed. Invent no missing numbers or P.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original times, scales, arm values/effects/CIs, endpoint denominators, prespecified plans and concurrent analgesia/labor changes are needed. Invent no missing numbers or P." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are maximum exposure and follow-up the same time?", "needed": "Exposure duration versus post-exposure observation", "role": "Required", "role_reason": "This condition connects Exposure duration versus post-exposure observation with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Exposure duration versus post-exposure observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exposure start/end, assessment times, stopping/repeated exposure, original analysis windows and denominators are needed. Create no new VR timing or use instructions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The parent’s up to 30 minutes is VR exposure. Correia records pain during use and 30 minutes later. Do not turn duration of use into post-exposure persistence or establish a time origin beyond the summary.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exposure start/end, assessment times, stopping/repeated exposure, original analysis windows and denominators are needed. Create no new VR timing or use instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure start/end, assessment times, stopping/repeated exposure, original analysis windows and denominators are needed. Create no new VR timing or use instructions." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Does nonpersistence establish exact no effect or long-term null effects?", "needed": "Persistent results, precision and temporal extrapolation", "role": "Required", "role_reason": "This condition connects Persistent results, precision and temporal extrapolation with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Persistent results, precision and temporal extrapolation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Time-specific direct effects/CIs, scales/denominators, labor stage/analgesia, clinical-importance criteria and follow-up are needed. Calculate no new CIs, P or effects. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The original record retains nonpersistence without an exact between-group effect/CI. Do not establish exact effect 0 or equivalence at all periods beyond 30 minutes or throughout labor.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Time-specific direct effects/CIs, scales/denominators, labor stage/analgesia, clinical-importance criteria and follow-up are needed. Calculate no new CIs, P or effects.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific direct effects/CIs, scales/denominators, labor stage/analgesia, clinical-importance criteria and follow-up are needed. Calculate no new CIs, P or effects." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are total sizes the denominators at each time?", "needed": "Allocation, completion, during/follow-up missingness and stopping", "role": "Required", "role_reason": "This condition connects Allocation, completion, during/follow-up missingness and stopping with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Allocation, completion, during/follow-up missingness and stopping must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original flow, time/arm-specific denominators, missingness/stopping reasons, ITT/analysis and sensitivity are needed. Calculate no new participant differences or attrition counts. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Correia’s 61 participants, 32 versus 29, are total trial/arm sizes. The summary lacks denominators for time-specific completion/analysis, post-analgesia exclusions, labor progression/stopping and missed follow-up.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original flow, time/arm-specific denominators, missingness/stopping reasons, ITT/analysis and sensitivity are needed. Calculate no new participant differences or attrition counts.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original flow, time/arm-specific denominators, missingness/stopping reasons, ITT/analysis and sensitivity are needed. Calculate no new participant differences or attrition counts." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Is Wong’s immediate change difference a persistent effect?", "needed": "Immediate between-group pre-post change versus follow-up", "role": "Required", "role_reason": "This condition connects Immediate between-group pre-post change versus follow-up with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Immediate between-group pre-post change versus 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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Baseline, assessment/exposure times, post-exposure values/effects/CIs, denominators and follow-up are needed. Preserve the original change difference without new calculations. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Wong’s control +0.58, VR -0.52 and change difference -1.10, P=.03 concern immediate pre-post between-group pain. Do not copy them as the same effect/CI 30 minutes later or throughout labor.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Baseline, assessment/exposure times, post-exposure values/effects/CIs, denominators and follow-up are needed. Preserve the original change difference without new calculations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline, assessment/exposure times, post-exposure values/effects/CIs, denominators and follow-up are needed. Preserve the original change difference without new calculations." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is Frey’s acute crossover replication of persistence?", "needed": "Brief contraction comparison versus post-exposure follow-up", "role": "Required", "role_reason": "This condition connects Brief contraction comparison versus post-exposure follow-up with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Brief contraction comparison versus post-exposure 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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Order/carryover, contraction/measurement windows, paired denominators, post-exposure follow-up and the same persistent estimand are needed. This records needed materials; no new research was executed.", "current_reports": [ "R02", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve Frey’s 27-person, about 10-minute crossover with pain/anxiety each -1.5 and original intervals. Brief contraction comparisons do not directly replicate persistence beyond 30 minutes.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Order/carryover, contraction/measurement windows, paired denominators, post-exposure follow-up and the same persistent estimand are needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Order/carryover, contraction/measurement windows, paired denominators, post-exposure follow-up and the same persistent estimand are needed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are Carus within-group and epidural results persistent effects?", "needed": "Epidural status, primary satisfaction, secondary pain and times", "role": "Required", "role_reason": "This condition connects Epidural status, primary satisfaction, secondary pain and times with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Epidural status, primary satisfaction, secondary pain and times must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Medication/epidural times, pain measurement/denominators, between-group effects/CIs, prespecified secondary hierarchy/multiplicity and concurrent care are needed. This records needed materials; no new research was executed.", "current_reports": [ "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve early within-group pain reduction and no post-epidural change in Carus’s 42 participants. Do not turn within-group values or another medication state into a between-group effect lasting 30 minutes before pharmacologic analgesia.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Medication/epidural times, pain measurement/denominators, between-group effects/CIs, prespecified secondary hierarchy/multiplicity and concurrent care are needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medication/epidural times, pain measurement/denominators, between-group effects/CIs, prespecified secondary hierarchy/multiplicity and concurrent care are needed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are parent and persistence-trial populations the same?", "needed": "Laboring women, labor stages, baseline pain and analgesia status", "role": "Required", "role_reason": "This condition connects Laboring women, labor stages, baseline pain and analgesia status with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Laboring women, labor stages, baseline pain and analgesia status must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report-specific labor stages, parity/term status, analgesia/cointerventions, baseline pain, exclusions/vulnerability and denominators are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Term nulliparous women before pharmacologic/neuraxial analgesia are parent Wong context. Correia’s detailed eligibility, labor stages and analgesia status are absent from the summary; do not fill all trials with identical population/medication conditions.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Report-specific labor stages, parity/term status, analgesia/cointerventions, baseline pain, exclusions/vulnerability and denominators are needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific labor stages, parity/term status, analgesia/cointerventions, baseline pain, exclusions/vulnerability and denominators are needed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Were time, labor progression and concurrent analgesia distinguished?", "needed": "Repeated measurement, arm-specific time changes and persistent effects", "role": "Required", "role_reason": "This condition connects Repeated measurement, arm-specific time changes and persistent effects with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Repeated measurement, arm-specific time changes and persistent effects must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Time-specific stages, medication, arm/time relationships, baseline adjustment, denominators, direct effects/CIs and missingness are needed. Create no new analgesia or medication-change instructions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original records separate during/immediately-after, 30-minutes-later and pre/post-epidural results. Details of arm-specific labor progression and analgesia administration are absent, so create no new causal attribution of persistence.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Time-specific stages, medication, arm/time relationships, baseline adjustment, denominators, direct effects/CIs and missingness are needed. Create no new analgesia or medication-change instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific stages, medication, arm/time relationships, baseline adjustment, denominators, direct effects/CIs and missingness are needed. Create no new analgesia or medication-change instructions." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are different content, scales and exposures combined as one persistent effect?", "needed": "Differences in devices, content, audio and medication status", "role": "Required", "role_reason": "This condition connects Differences in devices, content, audio and medication status with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Differences in devices, content, audio and medication status must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Links among devices, content/audio, exposure, comparators/contact, scales, medication status/times and original effects/CIs are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The parent records trial-specific differences in content, exposure duration, headsets and epidural status. Repeated brief support does not establish persistence for 30 minutes under identical conditions.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Links among devices, content/audio, exposure, comparators/contact, scales, medication status/times and original effects/CIs are needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Links among devices, content/audio, exposure, comparators/contact, scales, medication status/times and original effects/CIs are needed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are satisfaction, anxiety and MCID responses pain persistence?", "needed": "Different patient-reported endpoints, response criteria and times", "role": "Required", "role_reason": "This condition connects Different patient-reported endpoints, response criteria and times with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Different patient-reported endpoints, response criteria and times must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Tools, times, denominators, prespecified hierarchy/response criteria, external importance and direct persistence CIs are needed. Calculate no new responder counts or effects. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Carus satisfaction P=.04, Frey anxiety/sensory-pain intervals and Wong MCID 0% versus 23.8%, P=.049 concern different endpoints/times. Do not use them as the same persistent-pain effect.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Tools, times, denominators, prespecified hierarchy/response criteria, external importance and direct persistence CIs are needed. Calculate no new responder counts or effects.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Tools, times, denominators, prespecified hierarchy/response criteria, external importance and direct persistence CIs are needed. Calculate no new responder counts or effects." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Is persistent relief extended to less analgesia or operative birth?", "needed": "Pain follow-up versus medication/obstetric events and power", "role": "Required", "role_reason": "This condition connects Pain follow-up versus medication/obstetric events and power with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Pain follow-up versus medication/obstetric events 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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Event definitions, arm events/denominators, medication/follow-up times, direct effects/CIs and prespecified samples/power are needed. Create no new labor, analgesic or treatment instructions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The parent and separate event subclaim did not establish precise effects or adequate power for analgesia, cesarean or instrumental delivery. Unproven persistence does not become successful medication replacement/surgery prevention or precise no effect.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Event definitions, arm events/denominators, medication/follow-up times, direct effects/CIs and prespecified samples/power are needed. Create no new labor, analgesic or treatment instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event definitions, arm events/denominators, medication/follow-up times, direct effects/CIs and prespecified samples/power are needed. Create no new labor, analgesic or treatment instructions." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were persistence prespecification, selected times and bias verified?", "needed": "Original registration/plans, repeated times and subjective measurement", "role": "Required", "role_reason": "This condition connects Original registration/plans, repeated times and subjective measurement with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Original registration/plans, repeated times and subjective measurement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Registration/changes, protocols/SAPs, times/success rules, allocation/measurement, missingness and selective-reporting originals are needed. Perform no new formal bias assessment, grading or external lookup. This records needed materials; no new research was executed.", "current_reports": [ "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve Correia’s unverified exact CI/registration and the parent limitations of small subjective unblinded trials. During-use/30-minutes-later records do not establish prespecified hierarchy or completed overall review.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registration/changes, protocols/SAPs, times/success rules, allocation/measurement, missingness and selective-reporting originals are needed. Perform no new formal bias assessment, grading or external lookup.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/changes, protocols/SAPs, times/success rules, allocation/measurement, missingness and selective-reporting originals are needed. Perform no new formal bias assessment, grading or external lookup." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are brief pain and maternal/neonatal harms separated?", "needed": "Harms collection, events, denominators, timing and observation conditions", "role": "Supplementary", "role_reason": "This condition connects Harms collection, events, denominators, timing and observation conditions with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Harms collection, events, denominators, timing and observation conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original harm counts, denominators, active collection, severity/timing, stopping/cointerventions and vulnerable-population data are needed. Absence of numbers does not establish safety or justify new use/treatment instructions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The parent describes dizziness, motion sickness, discomfort/visual obstruction and monitoring/communication boundaries, noting that 40 participants are too few for rare maternal/neonatal harms.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original harm counts, denominators, active collection, severity/timing, stopping/cointerventions and vulnerable-population data are needed. Absence of numbers does not establish safety or justify new use/treatment instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harm counts, denominators, active collection, severity/timing, stopping/cointerventions and vulnerable-population data are needed. Absence of numbers does not establish safety or justify new use/treatment instructions." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is the scope of AppliedVR support and analysis noninvolvement?", "needed": "Same-cohort product support and analysis roles", "role": "Required", "role_reason": "This condition connects Same-cohort product support and analysis roles with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Same-cohort product support and analysis roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Money/in-kind support, author affiliations/COI, design/analysis/publication roles and same-cohort original-report identification are needed. Do not extend reported analysis noninvolvement to every role. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Wong's funding wording preserves AppliedVR device/software in-kind support and reported noninvolvement in analysis in a same-cohort report. Do not add a same-cohort qualitative study as a new trial.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Money/in-kind support, author affiliations/COI, design/analysis/publication roles and same-cohort original-report identification are needed. Do not extend reported analysis noninvolvement to every role.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Money/in-kind support, author affiliations/COI, design/analysis/publication roles and same-cohort original-report identification are needed. Do not extend reported analysis noninvolvement to every role." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What are funding and COI in other reports?", "needed": "Public funding, no-funding declarations, unverified support and company roles", "role": "Required", "role_reason": "This condition connects Public funding, no-funding declarations, unverified support and company roles with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Public funding, no-funding declarations, unverified support and company roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original money, device support, affiliations/COI, design/analysis/publication roles and company relationships are unverified. Do not promote these to complete support verification. This records needed materials; no new research was executed.", "current_reports": [ "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve Frey's NIH AR054115 and GM042725, Carus's reported no applicable funding/no conflicts and Correia's unverified support.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original money, device support, affiliations/COI, design/analysis/publication roles and company relationships are unverified. Do not promote these to complete support verification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original money, device support, affiliations/COI, design/analysis/publication roles and company relationships are unverified. Do not promote these to complete support verification." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Do identifiers verify prespecified hierarchy?", "needed": "Paper-registration linkage, original identifiers and registration/plan reading", "role": "Required", "role_reason": "This condition connects Paper-registration linkage, original identifiers and registration/plan reading with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Paper-registration linkage, original identifiers and registration/plan reading must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original registration/change history, protocols/SAPs, paper linkage and prespecified endpoints/denominators/success rules are needed. Infer no new URLs and perform no clinical link checks. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve unverified Wong paper–official-registration linkage, Frey NCT02926469, Carus NCT05032456 and unverified Correia registration. Identifiers/PMCID do not establish current reading or prospective prespecification.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original registration/change history, protocols/SAPs, paper linkage and prespecified endpoints/denominators/success rules are needed. Infer no new URLs and perform no clinical link checks.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration/change history, protocols/SAPs, paper linkage and prespecified endpoints/denominators/success rules are needed. Infer no new URLs and perform no clinical link checks." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can shared reports be counted as new independent trials?", "needed": "Parent/subclaims and same-cohort report relationships", "role": "Required", "role_reason": "This condition connects Parent/subclaims and same-cohort report relationships with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Parent/subclaims and same-cohort report relationships must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Registration, institutions, recruitment, participants, reports/support and qualitative/quantitative cohort relationships are needed. Do not sum reports, years or sheets as new unique-trial/participant totals. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The parent and three subclaims share four reports. Preserve the original rule against counting same-cohort qualitative material as replication.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registration, institutions, recruitment, participants, reports/support and qualitative/quantitative cohort relationships are needed. Do not sum reports, years or sheets as new unique-trial/participant totals.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, institutions, recruitment, participants, reports/support and qualitative/quantitative cohort relationships are needed. Do not sum reports, years or sheets as new unique-trial/participant totals." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are total samples every endpoint's denominators?", "needed": "Report-specific allocation, analysis and endpoint/time denominators", "role": "Required", "role_reason": "This condition connects Report-specific allocation, analysis and endpoint/time denominators with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Report-specific allocation, analysis and endpoint/time denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: All analyzed is key-trial context and is not copied to other reports. Original flow, missingness/stopping, cointerventions, analysis populations and sensitivity are needed; calculate no new totals, rates, responder counts or effects. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve original sizes separately: 40 participants (21/19), 27, 42 (21/21) and 61 (32/29). Identical crossover, satisfaction, pain, medication, event, time and harm denominators have not been verified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "All analyzed is key-trial context and is not copied to other reports. Original flow, missingness/stopping, cointerventions, analysis populations and sensitivity are needed; calculate no new totals, rates, responder counts or effects.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "All analyzed is key-trial context and is not copied to other reports. Original flow, missingness/stopping, cointerventions, analysis populations and sensitivity are needed; calculate no new totals, rates, responder counts or effects." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are research records turned into use or analgesia instructions?", "needed": "Original exposure/safety wording versus operational guidance", "role": "Supplementary", "role_reason": "This condition connects Original exposure/safety wording versus operational guidance with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Original exposure/safety wording versus operational guidance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual treatment/use decisions are separate. Create no methods or medication-change recommendations beyond the original text. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "This work preserves devices, content, comparisons and safety boundaries in an evidence table. Create no new VR use/setup steps, labor, analgesic or treatment instructions, or replacement guidance.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual treatment/use decisions are separate. Create no methods or medication-change recommendations beyond the original text.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual treatment/use decisions are separate. Create no methods or medication-change recommendations beyond the original text." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are subclaim grades distinguished from parent scores and axes?", "needed": "Subclaim grades, absent score/status/axes and parent context", "role": "Required", "role_reason": "This condition connects Subclaim grades, absent score/status/axes and parent context with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Subclaim grades, absent score/status/axes and parent context must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Do not fill absent subclaim fields from parent values or turn unrecorded/? into definite values. Create no new grades, scores or independence certification. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve immediate-pain C, persistence D and event ?. Subclaim scores/status/axes are absent; parent C with 50 points, Caution, original axes and unrecorded precision concern immediate-pain context.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Do not fill absent subclaim fields from parent values or turn unrecorded/? into definite values. Create no new grades, scores or independence certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Do not fill absent subclaim fields from parent values or turn unrecorded/? into definite values. Create no new grades, scores or independence certification." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are representative conditions copied to every report?", "needed": "Both languages, devices/content, population, timing and denominators", "role": "Required", "role_reason": "This condition connects Both languages, devices/content, population, timing and denominators with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Both languages, devices/content, population, timing 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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original report-specific populations, devices/content, comparators, denominators, endpoints/times and English correspondence are needed. No external English comparison or clinical correction review was performed now. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve parent bilingual text and representative conditions. Do not apply 40 participants, up to 30 minutes, standard care or pre-post differences as identical conditions for the 27-person crossover, 42-person satisfaction trial or 61-person persistence trial.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original report-specific populations, devices/content, comparators, denominators, endpoints/times and English correspondence are needed. No external English comparison or clinical correction review was performed now.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report-specific populations, devices/content, comparators, denominators, endpoints/times and English correspondence are needed. No external English comparison or clinical correction review was performed now." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are stored-summary and external-material reading distinguished?", "needed": "Material-specific existence, acquisition and actual reading", "role": "Required", "role_reason": "This condition connects Material-specific existence, acquisition and actual reading with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Material-specific existence, acquisition and actual reading must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: URLs, PMCID or identifiers do not establish acquisition, accessibility, reading or completed review. Actual material acquisition and review are separate events. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The complete stored parent summary was read for production. Historical verification, incorporation, cross-checks and same-cohort support wording are retained as history; external abstracts, full texts, registration and protocols/SAPs are unread.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "URLs, PMCID or identifiers do not establish acquisition, accessibility, reading or completed review. Actual material acquisition and review are separate events.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "URLs, PMCID or identifiers do not establish acquisition, accessibility, reading or completed review. Actual material acquisition and review are separate events." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How are evidence date, empty histories and production date distinguished?", "needed": "Original evidence date, correction/deliberation records and date roles", "role": "Required", "role_reason": "This condition connects Original evidence date, correction/deliberation records and date roles with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Original evidence date, correction/deliberation records and date roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Link complete originals, versions and events when new material/corrections are obtained. No new external lookup or original-verdict change was performed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve original evidence date 2026-09-07, empty corrections and empty deliberation. Retain the original 2026 report bibliography and periods; production date does not become a new evidence-verification date.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Link complete originals, versions and events when new material/corrections are obtained. No new external lookup or original-verdict change was performed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Link complete originals, versions and events when new material/corrections are obtained. No new external lookup or original-verdict change was performed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are material slots quality or independent-trial counts?", "needed": "Production structure versus unique clinical units and actual acquisition", "role": "Required", "role_reason": "This condition connects Production structure versus unique clinical units and actual acquisition with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Production structure versus unique clinical units and actual acquisition must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Do not double-count sharing across parent/subclaims. Distinguish original trials/cohorts and actual acquisition/reading; unique-trial/participant totals remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The 20 material slots comprise 4 stored summaries and 16 unread external slots. They are not acquired papers, unique trials, participants, independent replications or quality scores.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Do not double-count sharing across parent/subclaims. Distinguish original trials/cohorts and actual acquisition/reading; unique-trial/participant totals remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Do not double-count sharing across parent/subclaims. Distinguish original trials/cohorts and actual acquisition/reading; unique-trial/participant totals remain unverified." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How are new materials or changed questions updated?", "needed": "Separating criteria revisions, evidence updates and verdict-change events", "role": "Required", "role_reason": "This condition connects Separating criteria revisions, evidence updates and verdict-change events with during-use signals and follow-up pain persistence, exposure duration, time origin, denominators, concurrent analgesia and between-group effects/CIs, distinguishing immediate pain, satisfaction, anxiety and medication/obstetric events.", "application_exception": "Preserve selected D and the note that a during-use signal was not sustained. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn maximum exposure into post-exposure persistence or treat immediate, within-group, post-epidural or other endpoints as the same persistent effect. Nonpersistence does not establish exact effect 0, equivalence or null effects at all periods. Create no new effects, CIs, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Separating criteria revisions, evidence updates and verdict-change events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Record complete originals, criterion versions, events and reasons for change. Do not invent effects, CIs, independence or VR, labor, analgesic or treatment instructions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02", "R03", "R04" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Preserve original material and production conditions/observations. Link additions or question changes to relevant comparisons, denominators, endpoints/times, reports and subclaim boundaries; no new lookup, calculation or regrading occurred now.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Record complete originals, criterion versions, events and reasons for change. Do not invent effects, CIs, independence or VR, labor, analgesic or treatment instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Record complete originals, criterion versions, events and reasons for change. Do not invent effects, CIs, independence or VR, labor, analgesic or treatment instructions." } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/32485759/", "report_type": "Open randomized controlled trial", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Report shared across parent/subclaims; unique counts and independence unverified", "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.", "observed_result": "Control +0.58, VR -0.52; difference in change -1.10, P=.03", "result_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 direct replication of the selected persistent effect.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32485759/" } ] }, { "report_id": "R02", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/31094789/", "report_type": "Order-randomized acute crossover trial", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Report shared across parent/subclaims; unique counts and independence unverified", "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.", "observed_result": "Sensory pain -1.5 (95% CI -2.2 to -0.8); anxiety -1.5 (-2.3 to -0.8)", "result_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 direct replication of the selected persistent effect.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31094789/" } ] }, { "report_id": "R03", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/35461248/", "report_type": "Randomized controlled trial", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Report shared across parent/subclaims; unique counts and independence unverified", "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.", "observed_result": "Satisfaction P=.04; within-group early-pain reduction and no post-epidural change", "result_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 direct replication of the selected persistent effect.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. The citation registration annotation is unrecorded, separately from the case annotation. Identifiers/PMCID do not establish current reading or prospective status." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. The citation registration annotation is unrecorded, separately from the case annotation. Identifiers/PMCID do not establish current reading or prospective status." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. The citation registration annotation is unrecorded, separately from the case annotation. Identifiers/PMCID do not establish current reading or prospective status." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. The citation registration annotation is unrecorded, separately from the case annotation. Identifiers/PMCID do not establish current reading or prospective status." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Preserve original PMID 35461248, PMCID PMC9034564, DOI 10.1186/s12884-022-04598-y and NCT05032456. The citation registration annotation is unrecorded, separately from the case annotation. Identifiers/PMCID do not establish current reading or prospective status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/35461248/" } ] }, { "report_id": "R04", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/41896140/", "report_type": "Randomized controlled trial", "existence": "The stored summary contains a bibliography; acquisition and reading of external originals are unverified.", "acquired_read": "Stored summary read; external materials unread", "study_family": "Report shared across parent/subclaims; unique counts and independence unverified", "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.", "observed_result": "The during-use signal was not sustained 30 minutes later", "result_level": "During-use/30-minutes-later results from 61 participants, 32 versus 29, linked to the selected persistence note. Exact time origin, between-group effects/CIs, time-specific denominators, registration and support are unverified. Nonpersistence does not establish exact effect 0, equivalence or null effects at every period.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41896140/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Some information is present in the stored source, with detailed original materials still unverified; this does not mean review passed or clinical efficacy certified", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Awaiting user review", "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-19", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-19" }