{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Labor VR × persistent pain relief: during-use signal not sustained at 30 minutes",
  "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 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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}