{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Labor VR × analgesic use, cesarean birth and instrumental delivery: precise effects and power unverified",
  "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": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Awaiting user review, or actual review remains incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which outcome-reduction claim is selected?",
      "needed": "Existing subclaim versus parent pain and persistence questions",
      "role": "Required",
      "role_reason": "This condition connects Existing subclaim versus parent pain and persistence questions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Existing subclaim versus parent pain and persistence questions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 definitions, reports, registration and protocols for these outcomes are needed. Create no new claim or independence certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How do subclaim grade and parent score differ?",
      "needed": "Subclaim ?, original note, absent score/status and parent record",
      "role": "Required",
      "role_reason": "This condition connects Subclaim ?, original note, absent score/status and parent record with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Subclaim ?, original note, absent score/status and parent record must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: A changed original verdict requires complete before/after records. Do not fill absent subclaim score/status with parent values. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Who is eligible for each outcome question?",
      "needed": "Labor stage, parity, term status, analgesia and outcome eligibility",
      "role": "Required",
      "role_reason": "This condition connects Labor stage, parity, term status, analgesia and outcome eligibility with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Labor stage, parity, term status, analgesia and outcome eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Recruitment, exclusions, labor stage, obstetric risk and outcome-specific analysis tables are needed. Do not copy representative populations/samples to every report. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which VR components are recorded?",
      "needed": "Device, content, audio, actual exposure and discontinuation",
      "role": "Required",
      "role_reason": "This condition connects Device, content, audio, actual exposure and discontinuation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Device, content, audio, actual exposure and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Intervention specifications, versions, actual use/adherence and discontinuation records are needed. Create no new device-use instructions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What care is the reduction compared with?",
      "needed": "Standard care, no added intervention, non-VR contractions and decisions",
      "role": "Required",
      "role_reason": "This condition connects Standard care, no added intervention, non-VR contractions and decisions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Standard care, no added intervention, non-VR contractions and decisions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Comparator care, concurrent/rescue medication, epidural use, contact/audio and obstetric decision criteria are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are outcome observation periods verified?",
      "needed": "Exposure/pain assessments versus outcome collection/follow-up",
      "role": "Required",
      "role_reason": "This condition connects Exposure/pain assessments versus outcome collection/follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Exposure/pain assessments versus outcome collection/follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Outcome-specific start/end, labor completion and discharge/later follow-up records are needed. Do not turn exposure duration into outcome follow-up. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What defines reduced analgesic use?",
      "needed": "Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset",
      "role": "Required",
      "role_reason": "This condition connects Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Drug categories, neuraxial/epidural and rescue use, dose/frequency/onset must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Drug categories, outcome definitions, original administration records, registration/SAP, doses, frequency and onset times are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Is there a direct between-group analgesic effect?",
      "needed": "Arm-specific use/dose, direct effects, adjustment and CIs",
      "role": "Required",
      "role_reason": "This condition connects Arm-specific use/dose, direct effects, adjustment and CIs with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Arm-specific use/dose, direct effects, adjustment and CIs must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 arm-specific counts/doses, tables, models, adjustment, CIs and analysis units are needed. Symptom values do not substitute for outcome effects. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What are analgesic denominators and missingness?",
      "needed": "At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing",
      "role": "Required",
      "role_reason": "This condition connects At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for At-risk populations, allocation/follow-up/analysis, missing records and repeat dosing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Outcome flow diagrams, missingness, ITT/PP and crossover exposure/dosing rules are needed. Calculate no new event or attrition counts from original samples. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are direct comparative cesarean results available?",
      "needed": "Arm-specific events/denominators, effects/CIs and observation windows",
      "role": "Required",
      "role_reason": "This condition connects Arm-specific events/denominators, effects/CIs and observation windows with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Arm-specific events/denominators, effects/CIs and observation windows must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 surgery tables, birth types, denominators, effects/CIs, registration and analysis plans are needed. Unverified findings do not establish exact no effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are planned/emergency surgery and decision criteria distinguished?",
      "needed": "Indications, decision-makers, baseline risk and exposure/decision timing",
      "role": "Required",
      "role_reason": "This condition connects Indications, decision-makers, baseline risk and exposure/decision timing with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Indications, decision-makers, baseline risk and exposure/decision timing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Surgical indications, decision records, baseline obstetric risk and allocation/exposure/decision timelines are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are direct instrumental-delivery results available?",
      "needed": "Types, arm-specific events/denominators and effects/CIs",
      "role": "Required",
      "role_reason": "This condition connects Types, arm-specific events/denominators and effects/CIs with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Types, arm-specific events/denominators and effects/CIs must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 instrumental-delivery tables, types, prespecified definitions, denominators and effects/CIs are needed. Do not transfer other-endpoint values. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What population and unit define instrumental delivery?",
      "needed": "All allocated/vaginal-birth risk sets, attempts/completion, types and missingness",
      "role": "Required",
      "role_reason": "This condition connects All allocated/vaginal-birth risk sets, attempts/completion, types and missingness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for All allocated/vaginal-birth risk sets, attempts/completion, types and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Birth-pathway flow diagrams, risk sets, instrument types, attempts/completion, denominators, missingness and analysis plans are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "How were the selected outcomes prespecified?",
      "needed": "Registration/protocol/SAP hierarchy, times, denominators and power",
      "role": "Required",
      "role_reason": "This condition connects Registration/protocol/SAP hierarchy, times, denominators and power with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Registration/protocol/SAP hierarchy, times, denominators and power must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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, protocols, SAPs and outcome-specific original reports are needed. An identifier alone does not verify prespecified plans. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are Wong pain values outcome effects?",
      "needed": "Original pain change/CIs versus medication and birth outcomes",
      "role": "Required",
      "role_reason": "This condition connects Original pain change/CIs versus medication and birth outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original pain change/CIs versus medication and birth outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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/outcome tables, direct CIs, denominators and models are needed. Do not back-calculate new CIs/SEs from changes/P. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Does complete analysis establish each outcome denominator?",
      "needed": "Allocated samples versus outcome-specific observation/analysis denominators",
      "role": "Required",
      "role_reason": "This condition connects Allocated samples versus outcome-specific observation/analysis denominators with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Allocated samples versus outcome-specific observation/analysis denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Key-trial flow diagrams, outcome-specific denominators and original tables are needed. Do not extend all analyzed to complete data for every outcome/harm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Is MCID pain response an outcome reduction?",
      "needed": "Original proportions, threshold and intervals versus event rates",
      "role": "Required",
      "role_reason": "This condition connects Original proportions, threshold and intervals versus event rates with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original proportions, threshold and intervals versus event rates must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Threshold definitions, external validation, original response tables, exact denominators and intervals are needed. Calculate no new responder or event counts. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Is Wong linked to official registration?",
      "needed": "Original bibliography, official registration identity, dates and outcome plans",
      "role": "Required",
      "role_reason": "This condition connects Original bibliography, official registration identity, dates and outcome plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original bibliography, official registration identity, dates and outcome plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Official registration linked to the paper, protocols, prespecified endpoints, dates and change histories are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What is the scope of Frey pain/anxiety findings?",
      "needed": "Original sensory-pain/anxiety effects/intervals versus outcomes",
      "role": "Required",
      "role_reason": "This condition connects Original sensory-pain/anxiety effects/intervals versus outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original sensory-pain/anxiety effects/intervals versus outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 crossover pain/anxiety tables and outcome-specific direct effects, denominators and CIs are needed. Do not inherit intervals from another endpoint. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "How do crossover samples differ from repeated contractions?",
      "needed": "Order, periods, carryover information and within-person analysis",
      "role": "Required",
      "role_reason": "This condition connects Order, periods, carryover information and within-person analysis with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Order, periods, carryover information and within-person analysis must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Crossover protocols, order/periods, carryover, paired denominators, within-person models and outcome tables are needed. Do not count contractions as new independent participants. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What is the satisfaction/pain hierarchy?",
      "needed": "Carus primary satisfaction, secondary pain and outcome plans",
      "role": "Required",
      "role_reason": "This condition connects Carus primary satisfaction, secondary pain and outcome plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Carus primary satisfaction, secondary pain and outcome plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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, SAP, endpoint hierarchy and original satisfaction/pain/outcome tables are needed. Satisfaction P or within-group reduction is not a between-group outcome effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Does post-epidural pain answer reduced medication use?",
      "needed": "Epidural selection/timing, use/dose and denominators",
      "role": "Required",
      "role_reason": "This condition connects Epidural selection/timing, use/dose and denominators with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Epidural selection/timing, use/dose and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Pre/post-epidural population flow, original medication-use records, outcome tables and outcome-specific denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are Correia persistence findings outcome effects?",
      "needed": "During/follow-up pain, total allocation and outcomes",
      "role": "Required",
      "role_reason": "This condition connects During/follow-up pain, total allocation and outcomes with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for During/follow-up pain, total allocation and outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 during/post-use pain and birth-outcome tables, direct effects/CIs, denominators and registration are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Can different reports be combined as outcome replication?",
      "needed": "Content, populations, scales, epidural status, times and outcome definitions",
      "role": "Required",
      "role_reason": "This condition connects Content, populations, scales, epidural status, times and outcome definitions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Content, populations, scales, epidural status, times and outcome definitions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 conditions, outcome tables, common definitions, inclusion relationships, family identity and participant overlap are needed. Create no unique-trial/participant totals. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What is verified about randomization and concealment?",
      "needed": "Sequence generation/concealment, recruitment order and analysis units",
      "role": "Required",
      "role_reason": "This condition connects Sequence generation/concealment, recruitment order and analysis units with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Sequence generation/concealment, recruitment order and analysis units must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 procedures, flow diagrams, recruitment order and baseline obstetric-risk/arm-balance tables are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Who recorded and decided outcomes?",
      "needed": "Medication/birth records, extractors, adjudicators and allocation awareness",
      "role": "Required",
      "role_reason": "This condition connects Medication/birth records, extractors, adjudicators and allocation awareness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Medication/birth records, extractors, adjudicators and allocation awareness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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/birth-record collection, extraction, adjudication, masking and decision criteria are needed. Do not turn pain-bias explanations into a confirmed magnitude of outcome bias. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are attention effects separated from concurrent care?",
      "needed": "Active controls, contact/audio, rescue analgesia and concurrent procedures",
      "role": "Required",
      "role_reason": "This condition connects Active controls, contact/audio, rescue analgesia and concurrent procedures with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Active controls, contact/audio, rescue analgesia and concurrent procedures must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Active-control, contact/audio, common-care, rescue-analgesia and concurrent-procedure records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Do original samples differ from missing outcome data?",
      "needed": "Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions",
      "role": "Required",
      "role_reason": "This condition connects Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Allocation to observation to analysis, discontinuation and outcome-specific omissions/exclusions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Outcome flow diagrams, denominators, missingness, analysis exclusions, discontinuation reasons and missing-data rules are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Which effect do outcome analyses estimate?",
      "needed": "ITT/PP, actual use, baseline-risk adjustment and models",
      "role": "Required",
      "role_reason": "This condition connects ITT/PP, actual use, baseline-risk adjustment and models with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for ITT/PP, actual use, baseline-risk adjustment and models must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Outcome-specific SAPs, estimands, ITT/PP, denominators, actual use, covariates, models and estimates are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are outcome-specific CIs and power available?",
      "needed": "Effects/CIs, event counts, sample-size planning, importance and follow-up",
      "role": "Required",
      "role_reason": "This condition connects Effects/CIs, event counts, sample-size planning, importance and follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Effects/CIs, event counts, sample-size planning, importance and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Outcome-specific effects/CIs, planned effects, event counts, sample-size/power plans and importance thresholds are needed. Calculate no new power. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "How are same-cohort related reports counted?",
      "needed": "Primary, qualitative/support reports, registration and cohort identity",
      "role": "Required",
      "role_reason": "This condition connects Primary, qualitative/support reports, registration and cohort identity with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Primary, qualitative/support reports, registration and cohort identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Detailed primary/qualitative/support-report identities, registration, recruitment dates and outcome links are needed. Do not add new independent trials. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are registration identifiers separated from content verification?",
      "needed": "Original identifiers, official content, dates, changes and outcome links",
      "role": "Required",
      "role_reason": "This condition connects Original identifiers, official content, dates, changes and outcome links with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original identifiers, official content, dates, changes and outcome links must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Official registration, protocols, change histories and links to prespecified outcome endpoints/dates for each report are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What funding and interests are recorded?",
      "needed": "Funding, devices, roles, COI and related reports",
      "role": "Required",
      "role_reason": "This condition connects Funding, devices, roles, COI and related reports with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Funding, devices, roles, COI and related reports must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 funding, device, COI, design/analysis/publication-role and investigator-role documents and related reports are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read?",
      "needed": "Stored summary versus external abstracts/full texts/registration/plans",
      "role": "Required",
      "role_reason": "This condition connects Stored summary versus external abstracts/full texts/registration/plans with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Stored summary versus external abstracts/full texts/registration/plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Needed original abstracts/full texts, registration, protocols and SAPs are required. Do not turn unattempted access into access failure or full-text reading. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "How do historical verification and production dates differ?",
      "needed": "Original evidence date, empty change history and current scope",
      "role": "Required",
      "role_reason": "This condition connects Original evidence date, empty change history and current scope with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original evidence date, empty change history and current scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: New corrections/evidence updates require complete originals, events, before/after values and reasons. Do not fill an unrecorded review date with the production date. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "Are Korean/English question boundaries preserved?",
      "needed": "Original subclaim wording/notes versus parent pain/safety wording",
      "role": "Required",
      "role_reason": "This condition connects Original subclaim wording/notes versus parent pain/safety wording with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original subclaim wording/notes versus parent pain/safety wording must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Detailed comparison with external originals/corrections remains unverified. Preserve complete relevant originals and comparison records when needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Are parent axes inherited as a subclaim verdict?",
      "needed": "Original axes, unrecorded precision/override and absent subclaim fields",
      "role": "Required",
      "role_reason": "This condition connects Original axes, unrecorded precision/override and absent subclaim fields with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original axes, unrecorded precision/override and absent subclaim fields must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Changed axes/subclaim records require complete change events. Do not fill parent values or empty fields as new outcome verdicts/certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "How were harms collected?",
      "needed": "Symptoms, maternal/neonatal definitions and active/passive collection",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Symptoms, maternal/neonatal definitions and active/passive collection with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Symptoms, maternal/neonatal definitions and active/passive collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Harm definitions, active/passive collection, assessors, discontinuation/symptom records and original maternal/neonatal tables are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "When did harms, discontinuation and follow-up occur?",
      "needed": "Exposure start/end, symptoms and post-birth/discharge follow-up",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Exposure start/end, symptoms and post-birth/discharge follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Exposure start/end, symptoms and post-birth/discharge follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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, symptom, discontinuation, clinical-event, birth/discharge/later follow-up timelines are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "Were harms compared under equivalent observation conditions?",
      "needed": "Comparator care, common collection/observation and occurrence/discontinuation tables",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Comparator care, common collection/observation and occurrence/discontinuation tables with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Comparator care, common collection/observation and occurrence/discontinuation tables must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Comparator harm-collection, observation-period, discontinuation and original-table records and common procedures are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "Are event counts and denominators available for harm frequency?",
      "needed": "Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Exposure/observation/analysis, maternal/neonatal units, discontinuation and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 tables, exposure/follow-up flow, maternal/neonatal units and discontinuation reasons are needed. Do not newly calculate/certify event counts, rates or absence of harm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "Are concurrent care and alternative causes distinguished?",
      "needed": "Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Analgesia/neuraxial use, labor progression, obstetric risk and clinical observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 timing, concurrent drugs/procedures, baseline risk, actual interference records and independent adjudication material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "Were discomfort, discontinuation or follow-up losses omitted?",
      "needed": "Device refusal/discontinuation, reporting omissions and post-birth follow-up",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Device refusal/discontinuation, reporting omissions and post-birth follow-up with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Device refusal/discontinuation, reporting omissions and post-birth follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Refusal/discontinuation reasons, harm logs, outcome-publication scope and post-birth/discharge follow-up losses are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N44",
      "question_type": "Evidence condition",
      "question": "Have rare maternal/neonatal harms been excluded?",
      "needed": "Independent related harms, vulnerable groups and follow-up beyond brief observation",
      "role": "Supplementary; required for extending safety conclusions",
      "role_reason": "This condition connects Independent related harms, vulnerable groups and follow-up beyond brief observation with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Independent related harms, vulnerable groups and follow-up beyond brief observation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: Related harm reports, unique-event/family links, exposure/follow-up and vulnerable-group results are needed. Do not extend brief observation to overall safety. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N45",
      "question_type": "Evidence condition",
      "question": "How are conditions and new materials updated?",
      "needed": "Originals, criterion versions, creation/application order and update events",
      "role": "Required",
      "role_reason": "This condition connects Originals, criterion versions, creation/application order and update events with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Originals, criterion versions, creation/application order and update events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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: New reports, registration, outcome tables or corrections require complete originals linked to events, versions, before/after values and reasons. Distinguish criterion revisions from verdict changes. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N46",
      "question_type": "Evidence condition",
      "question": "Is pain extrapolated to medication/surgery replacement?",
      "needed": "Original advertising boundary, outcome gaps and use/treatment guidance",
      "role": "Required",
      "role_reason": "This condition connects Original advertising boundary, outcome gaps and use/treatment guidance with definitions, timing, actual comparisons, denominators, effects/CIs, power or harms for analgesic use, cesarean birth and instrumental delivery separately, distinguishing original acute-pain and other-endpoint results.",
      "application_exception": "Preserve original subclaim ? and unverified precise outcome effects/adequate power. Distinguish absent subclaim score/status/axes from parent C with 50 points, Caution and unrecorded precision. Do not turn pain, anxiety, satisfaction, MCID, persistence or representative samples into outcome effects/denominators. Unverified findings do not establish no effect, equivalence or safety certification. Create no new effects, CIs, event counts, totals, independence certification or VR, labor, analgesic or treatment instructions.",
      "criterion": "Material for Original advertising boundary, outcome gaps and use/treatment guidance must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "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 added original direct-outcome results in separate records. Do not establish unverified outcome reduction, whole-labor effects or replacement comparisons. This records needed materials; no new research was executed."
    }
  ]
}