{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Birth and peanut balls × acute labor pain",
  "language": "en",
  "translation_date": "2026-10-16",
  "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": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "User review pending.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which acute labor-pain claim is being checked?",
      "needed": "Selected claim, original grade/note and parent context",
      "role": "Required",
      "role_reason": "This condition connects Selected claim, original grade/note and parent context with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Selected claim, original grade/note and parent context must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Subclaim score, status and axes are absent. Do not fill them from parent values. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which populations, epidural conditions and high-BMI groups were studied?",
      "needed": "Report-specific eligibility, parity, anesthesia and baseline conditions",
      "role": "Required",
      "role_reason": "This condition connects Report-specific eligibility, parity, anesthesia and baseline conditions with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Report-specific eligibility, parity, anesthesia and baseline conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact S02/S03 eligibility/anesthesia, parity, BMI threshold, baseline pain and recruitment/exclusions are unlinked. Do not automatically transfer conditions between trials. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are peanut balls, round birth balls and movement packages the same?",
      "needed": "Ball shape/device, positioning/movement and actual delivery of the intervention",
      "role": "Required",
      "role_reason": "This condition connects Ball shape/device, positioning/movement and actual delivery of the intervention with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Ball shape/device, positioning/movement and actual delivery of the intervention 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: Ball specifications, positioning/movement components, providers, supervision and actual exposure are unlinked. Do not attribute varied package effects to a ball alone. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Were controls, labor management and contact comparable?",
      "needed": "Standard care, anesthesia/analgesics, positioning/attention and cointerventions",
      "role": "Supplementary",
      "role_reason": "This condition connects Standard care, anesthesia/analgesics, positioning/attention and cointerventions with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Standard care, anesthesia/analgesics, positioning/attention and cointerventions 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 controls/contact, anesthesia/analgesics, other labor management and intervention details are unlinked. Do not assign the representative control to every trial. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What are S02 pain and fatigue after 15 minutes?",
      "needed": "Separate patient-reported scales, original times and assessors",
      "role": "Required",
      "role_reason": "This condition connects Separate patient-reported scales, original times and assessors with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Separate patient-reported scales, original times and assessors 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: Scales, assessment windows, baseline/end values, units and between-group effects/CIs/P values are unlinked. Fatigue is not a substitute for pain. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What does the S02 sample of 90 establish?",
      "needed": "Allocation/completion, arm-/endpoint-specific denominators and missing data",
      "role": "Required",
      "role_reason": "This condition connects Allocation/completion, arm-/endpoint-specific denominators and missing data with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Allocation/completion, arm-/endpoint-specific denominators and missing data 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: Arm-specific allocation/completion, the 15-minute pain denominator, missing data/exclusions and analysis population are unlinked. Do not treat 90 as everyone analyzed or as one arm's denominator. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "How are S02 pain and total-duration P=.177 separated?",
      "needed": "Separate attribution of acute pain and total duration",
      "role": "Required",
      "role_reason": "This condition connects Separate attribution of acute pain and total duration with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Separate attribution of acute pain and total duration must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Do not use duration P as pain P or replace duration/operative benefit with pain findings. Duration models and precision are also unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What is the scope of S03 pain P=.001?",
      "needed": "High-BMI pain measurement, timing, original estimate and CI",
      "role": "Required",
      "role_reason": "This condition connects High-BMI pain measurement, timing, original estimate and CI with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for High-BMI pain measurement, timing, original estimate and CI 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: Scales, times, arm-specific baseline/end values, between-group effects/CIs and clinical-importance thresholds are unlinked. One P value does not establish effect size or generalizability across labor conditions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What do 70 randomized, 59 analyzed and completer wording mean?",
      "needed": "Arm-specific flow, attrition/exclusions and pain denominators",
      "role": "Required",
      "role_reason": "This condition connects Arm-specific flow, attrition/exclusions and pain denominators with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Arm-specific flow, attrition/exclusions and pain 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: Arm-specific losses/reasons, pain/duration denominators, missing data and all-randomized outcomes are unlinked. No new attrition counts, rates or denominators are calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What does co-primary pain and active-labor duration require?",
      "needed": "Prespecified joint contract, multiplicity and success rules",
      "role": "Required",
      "role_reason": "This condition connects Prespecified joint contract, multiplicity and success rules with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Prespecified joint contract, multiplicity and success rules must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact prespecified outcome hierarchy, joint success rules, multiplicity and amendments are unread. Positive pain does not establish success on both endpoints. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What do active-labor times 202.9/213.6 and P=.522 describe?",
      "needed": "Duration/dispersion, groups, timing and separation from pain",
      "role": "Required",
      "role_reason": "This condition connects Duration/dispersion, groups, timing and separation from pain with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Duration/dispersion, groups, timing and separation from pain 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: The meaning of ±, group correspondence, denominators and duration models/CIs are unlinked. Do not transfer this into pain effects, total labor duration or surgical prevention, or calculate a new difference. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What is Payton's epidural-duration/subgroup context?",
      "needed": "First-stage/parity/interaction and pushing scope",
      "role": "Required",
      "role_reason": "This condition connects First-stage/parity/interaction and pushing scope with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for First-stage/parity/interaction and pushing 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: Subgroup-duration P values are not selected pain values/effects. Exact pain, denominators, interaction models and prospective status are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Is the parent's representative duration endpoint direct pain evidence?",
      "needed": "Original representative context versus direct pain reports",
      "role": "Required",
      "role_reason": "This condition connects Original representative context versus direct pain reports with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Original representative context versus direct pain 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: Do not use this as S02/S03's representative primary pain endpoint or denominator. Link direct pain measurement separately by report. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What are allocation, concealment and blinding for patient-reported pain?",
      "needed": "Allocation, assessment/analysis roles, expectations and selection bias",
      "role": "Required",
      "role_reason": "This condition connects Allocation, assessment/analysis roles, expectations and selection bias with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Allocation, assessment/analysis roles, expectations and selection bias 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 concealment, pain-assessor/analyst blinding and anesthesia/contact/expectation matching are unlinked. Do not assign one bias value to every role. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are ITT/PP, baseline, repeats and missing data known?",
      "needed": "Pain target effect, models, repeats/baseline and sensitivity analyses",
      "role": "Required",
      "role_reason": "This condition connects Pain target effect, models, repeats/baseline and sensitivity analyses with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Pain target effect, models, repeats/baseline and sensitivity analyses 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: Pain ITT/PP, baseline adjustment, repeated measurements, post-analgesic measurements and missing-data/sensitivity analyses are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What is known about prespecification and NCT05276947?",
      "needed": "Original registration, dates, pain hierarchy, amendments and SAP",
      "role": "Required",
      "role_reason": "This condition connects Original registration, dates, pain hierarchy, amendments and SAP with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Original registration, dates, pain hierarchy, amendments and SAP 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 registry/protocol/SAP, hierarchy, amendments and multiplicity are unread. Identifiers or summaries do not establish verified prospective status. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are clinically important pain effects and precision available?",
      "needed": "Between-group estimates/CIs, meaningful change and sample-size plans",
      "role": "Required",
      "role_reason": "This condition connects Between-group estimates/CIs, meaningful change and sample-size plans with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Between-group estimates/CIs, meaningful change and sample-size 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: Pain effects/CIs, scale-specific clinical-importance thresholds and sample plans are unlinked, leaving exact ball-specific effect size unverified. No new effects, CIs or numerical examples are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are analgesics, positioning and movement separated?",
      "needed": "Anesthesia/analgesics, usual labor care, exposure and adherence",
      "role": "Supplementary",
      "role_reason": "This condition connects Anesthesia/analgesics, usual labor care, exposure and adherence with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Anesthesia/analgesics, usual labor care, exposure and adherence 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: Concurrent analgesics/care, intervention delivery/supervision and post-rescue-treatment outcome policy in direct pain reports are unlinked. Do not establish isolated ball or non-drug effects. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Does short-term pain establish operative or other obstetric outcomes?",
      "needed": "Cesarean/instrumental delivery, analgesics and maternal/neonatal boundaries",
      "role": "Required",
      "role_reason": "This condition connects Cesarean/instrumental delivery, analgesics and maternal/neonatal boundaries with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Cesarean/instrumental delivery, analgesics and maternal/neonatal boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Do not transfer positive pain into shorter labor, surgical prevention or long-term neonatal/maternal effects. Original event counts, denominators and CIs are unlinked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are persistence, other labor conditions and independent replication established?",
      "needed": "Protocols/controls, ball shape, anesthesia, duration and shared cohorts",
      "role": "Required",
      "role_reason": "This condition connects Protocols/controls, ball shape, anesthesia, duration and shared cohorts with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Protocols/controls, ball shape, anesthesia, duration and shared cohorts 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: Strict independent confirmation of the same pain/ball/control contract, persistence/other populations and unique-trial/participant totals are unconfirmed. No report/population totals are summed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What is known about funding, support and COI?",
      "needed": "Funding, device/material support, employee authors and separate roles",
      "role": "Required",
      "role_reason": "This condition connects Funding, device/material support, employee authors and separate roles with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Funding, device/material support, employee authors and separate roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Do not fill product/ball support, employee authorship, COI or analysis/assessment/publication roles with no involvement or established independence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are maternal/fetal harms, collection and denominators known?",
      "needed": "Harm definitions, arm-specific events/denominators, timing and discontinuation/missing data",
      "role": "Supplementary",
      "role_reason": "This condition connects Harm definitions, arm-specific events/denominators, timing and discontinuation/missing data with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Harm definitions, arm-specific events/denominators, timing and discontinuation/missing data 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 fall/positioning-related and maternal/fetal/neonatal event counts/denominators, collection, discontinuation and missing data are unlinked. Pain or completer findings do not certify safety. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What are vulnerable conditions, shared exposures and instruction limits?",
      "needed": "Labor/anesthesia-specific harms, alternative causes and persistence",
      "role": "Supplementary",
      "role_reason": "This condition connects Labor/anesthesia-specific harms, alternative causes and persistence with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Labor/anesthesia-specific harms, alternative causes and persistence 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: Population-/anesthesia-/time-specific harms, shared exposure and long-term maternal/neonatal material are unlinked. Unsupervised use or safety in other populations is not established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are original bibliography, languages, grades/axes and empty history preserved?",
      "needed": "Original report wording, parent/subclaim distinction, unrecorded precision and dates",
      "role": "Required",
      "role_reason": "This condition connects Original report wording, parent/subclaim distinction, unrecorded precision and dates with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Original report wording, parent/subclaim distinction, unrecorded precision and dates 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 external bibliography and historical cross-check wording do not establish review/certification in this work. No new grades, numbers or hypothetical examples. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What distinguishes summary reading from external links?",
      "needed": "Report-specific reading versus original papers, registration, plans and support access",
      "role": "Required",
      "role_reason": "This condition connects Report-specific reading versus original papers, registration, plans and support access with acute labor pain, ball shape and positioning/movement packages, anesthesia and controls, report-specific times and denominators, patient-reported pain, duration/operative outcomes, support and harms.",
      "application_exception": "Preserve original subclaim C, the short-term signal from several small unblinded trials, and absent score, status and axes. Distinguish ball shape, accompanying movement, anesthesia, control, timing and pain/fatigue/duration/operative outcomes. Do not sum randomized/analysis denominators or transfer pain P values into duration/cesarean benefit. Create no new effects, CIs, attrition counts/rates, totals, grades, independence/safety certification or labor-ball, delivery or treatment instructions.",
      "criterion": "Material for Report-specific reading versus original papers, registration, plans and support access 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: External papers, registration, protocols/SAPs and support originals are unread and access was not attempted. URLs or historical verification wording do not establish current reading or external link tests. This records needed materials; no new research was executed."
    }
  ]
}