{ "schema_version": "chamgap-public-criteria-1.0", "title": "Labor VR × immediate pain before analgesia: change signal and missing CI", "language": "en", "translation_date": "2026-10-19", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which immediate-pain claim is selected?", "needed": "Subclaim of immediate labor pain before pharmacologic analgesia", "role": "Required", "role_reason": "This condition connects Subclaim of immediate labor pain before pharmacologic analgesia with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Subclaim of immediate labor pain before pharmacologic analgesia 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: Materials are needed for populations, medication status, comparator, scale, timing, denominators and original effects/CIs. Create no new question or independence certification. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What is Wong's between-group pain-change difference?", "needed": "Direct between-group pre-post effects and original analysis", "role": "Required", "role_reason": "This condition connects Direct between-group pre-post effects and original analysis with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Direct between-group pre-post effects and original analysis 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 pain scale/direction, baseline/measurement windows, model, arm denominators, direct 95% CI and adjustment are unverified. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Were precision and importance of the original difference verified?", "needed": "Original effect, direct interval and patient-important difference", "role": "Required", "role_reason": "This condition connects Original effect, direct interval and patient-important difference with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Original effect, direct interval and patient-important difference 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 between-group intervals, variation/model, denominators, scales and patient-importance criteria are needed. Do not back-calculate CI, SE or standardized effects. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What do allocation and all analyzed mean?", "needed": "Allocation, analysis and endpoint/time-specific data/exposure denominators", "role": "Required", "role_reason": "This condition connects Allocation, analysis and endpoint/time-specific data/exposure denominators with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Allocation, analysis and endpoint/time-specific data/exposure 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 flow, missingness/stopping, endpoint/time-specific denominators, ITT/analysis definitions and harm exposure are needed. Calculate no new arm data or events. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Who was studied before pharmacologic or neuraxial analgesia?", "needed": "Term/nulliparous eligibility, labor status and pre-analgesia scope", "role": "Required", "role_reason": "This condition connects Term/nulliparous eligibility, labor status and pre-analgesia scope with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Term/nulliparous eligibility, labor status and pre-analgesia scope 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 pregnancy/labor stages, baseline pain, parity/term status, analgesia/cointerventions, high-risk/exclusion criteria and denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Were nature scenes, audio and distraction separated?", "needed": "Attribution of combined content and immersive devices", "role": "Required", "role_reason": "This condition connects Attribution of combined content and immersive devices with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Attribution of combined content and immersive devices 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: Materials distinguishing devices, content, audio/contact, exposure and comparator components, including active controls, are needed. Create no new VR setup, labor or analgesia instructions. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are original and active attention controls the same?", "needed": "Original comparator versus attention, contact and expectancy", "role": "Required", "role_reason": "This condition connects Original comparator versus attention, contact and expectancy with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Original comparator versus attention, contact and expectancy 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: Shared care, contact/guidance, active attention controls, expectancy/blinding, exact original contrasts and denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are pain and anxiety in the Frey crossover?", "needed": "Separate acute crossover endpoints, intervals and analysis", "role": "Required", "role_reason": "This condition connects Separate acute crossover endpoints, intervals and analysis with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Separate acute crossover endpoints, intervals and analysis 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 scales, contraction/assessment windows, order/periods/carryover, paired denominators, crossover estimation and hierarchy are unverified. Do not convert scales or newly assign an interval level to anxiety. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is crossover support replication under identical conditions?", "needed": "Content, scales, within-person correlation and independence wording", "role": "Required", "role_reason": "This condition connects Content, scales, within-person correlation and independence wording with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Content, scales, within-person correlation and independence wording 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 institutions, recruitment, registration/support, content/scales, order/carryover, paired denominators and original effects/CIs are needed. Create no new independence certification or totals. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are MCID responses separate confirmation?", "needed": "Response criteria, denominators, external validation and intervals", "role": "Required", "role_reason": "This condition connects Response criteria, denominators, external validation and intervals with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Response criteria, denominators, external validation and intervals 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: Criterion source/prespecification, arm order, responders/denominators, direct effects/CIs and multiplicity are needed. Calculate no new responder counts from allocation sizes. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are Carus satisfaction and pain distinguished?", "needed": "Primary satisfaction, secondary pain and pre/post-epidural results", "role": "Required", "role_reason": "This condition connects Primary satisfaction, secondary pain and pre/post-epidural results with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Primary satisfaction, secondary pain and pre/post-epidural results 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 turn satisfaction P or within-group pain into direct between-group primary pain effects. Original scales, time-specific denominators, medication status, between-group effects/CIs and hierarchy are needed. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are immediate signals transferred to persistent effects?", "needed": "Exposure duration versus during, immediate and post-exposure assessment", "role": "Required", "role_reason": "This condition connects Exposure duration versus during, immediate and post-exposure assessment with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Exposure duration versus during, immediate and post-exposure assessment 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 origins for exposure end, baseline/during/immediate/follow-up, original between-group effects/CIs, denominators and concurrent analgesia are unverified. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does a pain signal mean less analgesia or operative birth?", "needed": "Subjective pain versus epidural, cesarean and instrumental-delivery events", "role": "Required", "role_reason": "This condition connects Subjective pain versus epidural, cesarean and instrumental-delivery events with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Subjective pain versus epidural, cesarean and instrumental-delivery 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: Original event definitions, medication/timing, denominators, direct effects/CIs, prespecified sample/power and clinical plans are needed. Create no new labor or analgesia instructions. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are brief self-report and unblinded limitations retained?", "needed": "Pain measurement, expectancy, prespecified endpoints and selective reporting", "role": "Required", "role_reason": "This condition connects Pain measurement, expectancy, prespecified endpoints and selective reporting with populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, totals, independence/safety certification or VR, labor, analgesic or treatment instructions.", "criterion": "Material for Pain measurement, expectancy, prespecified endpoints and selective reporting 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: Allocation/concealment, assessors/participants, measurement/baseline adjustment, prespecified endpoints/registration/plans, missingness and selected times are unverified. Create no new formal bias assessment or grade. This records needed materials; no new research was executed." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." }, { "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 populations, combined content, actual comparators, scales, between-group pre-post change, denominators, timing, precision and harms for immediate pain before analgesia, distinguishing persistence, satisfaction and medication/obstetric events.", "application_exception": "Preserve selected C and the original brief signal. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not recalculate change differences, intervals, P or MCID responses, or combine within/between-group, primary/secondary, pre/post-epidural, immediate/persistent, pain/anxiety/event outcomes. Create no new effects, CIs, responder counts, 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." } ] }