# Birth and peanut balls × acute labor pain

Verdict 2998 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-07  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-16

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: The selected question is acute labor pain. S01 Payton provides epidural labor-duration background with no recorded numeric sample size. S02 Alan Dikmen records 90 participants; S03 Ozkececi records high-BMI participants with 70 randomized/59 analyzed. Exact eligibility, anesthesia, parity, BMI thresholds, baseline pain and arm-/endpoint-specific denominators are unverified.
- Ingredient, formulation and route: The parent distinguishes round birth balls from peanut balls and ball-only use from positioning/pelvic-movement packages. The direct bibliographies concern peanut-ball reports. Ball specifications, providers, supervision, actual components and exposure are unverified. Results of varied programs are not assigned to a ball alone or turned into new instructions.
- Dose: S02 pain/fatigue after 15 minutes is an original measurement time. Exact S03 pain timing/exposure is unverified and a program name is not a numeric dose. No new duration of use, repetition count or individualized delivery method is created or calculated from a measurement time.
- Comparator: The parent comparator label is standard care. Actual controls, anesthesia/analgesics, positioning, contact, other labor management and delivery of the intervention are unverified by report. Epidural conditions or a representative comparator are not automatically assigned to all S02/S03 participants or treated as isolated ball/non-drug effects.
- Measured outcome: The selected endpoint is patient-reported acute pain. Distinguish S02 positive 15-minute pain/fatigue from total labor duration P=.177, and S03 pain P=.001 from active-labor duration 202.9±59.5 versus 213.6±67.5 minutes/P=.522. S03 co-primary success rules are unverified. S01 first-stage subgroup/pushing durations are not direct pain estimates.
- Duration: Preserve S02 measurement after 15 minutes and the acute scope of the index labor. Exact S03 pain windows, persistence, other stages and long-term maternal/neonatal outcomes are unverified. Distinguish total, active-labor, first-stage and pushing durations; do not extend pain signals into shorter labor or surgical prevention.
- Questions outside this scope: Transferring acute pain/fatigue into total labor duration, operative delivery, reduced analgesics or long-term maternal/neonatal benefit; Substituting ball shapes, anesthesia, controls or positioning/pelvic-movement packages for the same ball-only intervention; Using duration P values as pain P values or upgrading positive pain within co-primary outcomes into joint success; Summing randomized/analyzed populations, subgroups, sheets or reports into new participant, unique-trial or independent-replication totals; Inheriting parent C50, axes or historical verification as missing subclaim values or a new verdict; Creating new effects, CIs, attrition counts/rates, grades, independence/safety certification or labor-ball, delivery or treatment instructions

## Checklist items

### N01 · Which acute labor-pain claim is being checked?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve the selected acute labor-pain claim, subclaim C and the note describing a short-term signal from small unblinded trials. Parent C50 remains parent context.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Subclaim score, status and axes are absent. Do not fill them from parent values.
- Required materials and conditions: Selected claim, original grade/note and parent context
- Materials to obtain first: Subclaim score, status and axes are absent. Do not fill them from parent values.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02, S03

### N02 · Which populations, epidural conditions and high-BMI groups were studied?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Payton concerns epidural laboring women; S02 records 90 participants and S03 high-BMI participants with 70 randomized/59 analyzed.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Exact S02/S03 eligibility/anesthesia, parity, BMI threshold, baseline pain and recruitment/exclusions are unlinked. Do not automatically transfer conditions between trials.
- Required materials and conditions: Report-specific eligibility, parity, anesthesia and baseline conditions
- Materials to obtain first: Exact S02/S03 eligibility/anesthesia, parity, BMI threshold, baseline pain and recruitment/exclusions are unlinked. Do not automatically transfer conditions between trials.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N03 · Are peanut balls, round birth balls and movement packages the same?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original manuscript distinguishes ball shapes and ball-only versus positioning/pelvic-movement packages. Direct citations concern peanut balls. This table does not provide labor-ball or delivery instructions.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Ball specifications, positioning/movement components, providers, supervision and actual exposure are unlinked. Do not attribute varied package effects to a ball alone.
- Required materials and conditions: Ball shape/device, positioning/movement and actual delivery of the intervention
- Materials to obtain first: Ball specifications, positioning/movement components, providers, supervision and actual exposure are unlinked. Do not attribute varied package effects to a ball alone.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N04 · Were controls, labor management and contact comparable?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The parent's representative summary says standard care; the original manuscript records different trial protocols and controls.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Report-specific controls/contact, anesthesia/analgesics, other labor management and intervention details are unlinked. Do not assign the representative control to every trial.
- Required materials and conditions: Standard care, anesthesia/analgesics, positioning/attention and cointerventions
- Materials to obtain first: Report-specific controls/contact, anesthesia/analgesics, other labor management and intervention details are unlinked. Do not assign the representative control to every trial.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N05 · What are S02 pain and fatigue after 15 minutes?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Alan Dikmen's endpoints are pain/fatigue after 15 minutes and total labor duration. Preserve the positive pain/fatigue wording.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Scales, assessment windows, baseline/end values, units and between-group effects/CIs/P values are unlinked. Fatigue is not a substitute for pain.
- Required materials and conditions: Separate patient-reported scales, original times and assessors
- Materials to obtain first: Scales, assessment windows, baseline/end values, units and between-group effects/CIs/P values are unlinked. Fatigue is not a substitute for pain.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02

### N06 · What does the S02 sample of 90 establish?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve the original S02 sample wording of 90 participants.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Allocation/completion, arm-/endpoint-specific denominators and missing data
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02

### N07 · How are S02 pain and total-duration P=.177 separated?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve positive S02 pain/fatigue alongside null total labor duration P=.177.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Do not use duration P as pain P or replace duration/operative benefit with pain findings. Duration models and precision are also unlinked.
- Required materials and conditions: Separate attribution of acute pain and total duration
- Materials to obtain first: Do not use duration P as pain P or replace duration/operative benefit with pain findings. Duration models and precision are also unlinked.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02

### N08 · What is the scope of S03 pain P=.001?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve original positive S03 pain P=.001 wording.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: High-BMI pain measurement, timing, original estimate and CI
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S03

### N09 · What do 70 randomized, 59 analyzed and completer wording mean?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve S03's 70 randomized/59 analyzed and the citation flag separating completer and joint-endpoint findings.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Arm-specific losses/reasons, pain/duration denominators, missing data and all-randomized outcomes are unlinked. No new attrition counts, rates or denominators are calculated.
- Required materials and conditions: Arm-specific flow, attrition/exclusions and pain denominators
- Materials to obtain first: Arm-specific losses/reasons, pain/duration denominators, missing data and all-randomized outcomes are unlinked. No new attrition counts, rates or denominators are calculated.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S03

### N10 · What does co-primary pain and active-labor duration require?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: S03 is a high-BMI co-primary trial with pain and active-labor-duration endpoints.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Exact prespecified outcome hierarchy, joint success rules, multiplicity and amendments are unread. Positive pain does not establish success on both endpoints.
- Required materials and conditions: Prespecified joint contract, multiplicity and success rules
- Materials to obtain first: Exact prespecified outcome hierarchy, joint success rules, multiplicity and amendments are unread. Positive pain does not establish success on both endpoints.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S03

### N11 · What do active-labor times 202.9/213.6 and P=.522 describe?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve original active-labor duration 202.9±59.5 versus 213.6±67.5 minutes, P=.522.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Duration/dispersion, groups, timing and separation from pain
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S03

### N12 · What is Payton's epidural-duration/subgroup context?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: S01 endpoints are first-stage and pushing duration. Preserve primiparous interaction P=.018, multiparous P=.057 and null pushing wording.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Subgroup-duration P values are not selected pain values/effects. Exact pain, denominators, interaction models and prospective status are unlinked.
- Required materials and conditions: First-stage/parity/interaction and pushing scope
- Materials to obtain first: Subgroup-duration P values are not selected pain values/effects. Exact pain, denominators, interaction models and prospective status are unlinked.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N13 · Is the parent's representative duration endpoint direct pain evidence?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The parent's representative population is a laboring-women trial without a numeric sample size; its recorded endpoint is first-stage/pushing duration.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Do not use this as S02/S03's representative primary pain endpoint or denominator. Link direct pain measurement separately by report.
- Required materials and conditions: Original representative context versus direct pain reports
- Materials to obtain first: Do not use this as S02/S03's representative primary pain endpoint or denominator. Link direct pain measurement separately by report.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N14 · What are allocation, concealment and blinding for patient-reported pain?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve original manuscript/subclaim wording concerning small randomized trials and absent/difficult blinding.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Report-specific concealment, pain-assessor/analyst blinding and anesthesia/contact/expectation matching are unlinked. Do not assign one bias value to every role.
- Required materials and conditions: Allocation, assessment/analysis roles, expectations and selection bias
- Materials to obtain first: Report-specific concealment, pain-assessor/analyst blinding and anesthesia/contact/expectation matching are unlinked. Do not assign one bias value to every role.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02, S03

### N15 · Are ITT/PP, baseline, repeats and missing data known?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve the original statement that completer material was not interpreted as surgical prevention.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Pain ITT/PP, baseline adjustment, repeated measurements, post-analgesic measurements and missing-data/sensitivity analyses are unlinked.
- Required materials and conditions: Pain target effect, models, repeats/baseline and sensitivity analyses
- Materials to obtain first: Pain ITT/PP, baseline adjustment, repeated measurements, post-analgesic measurements and missing-data/sensitivity analyses are unlinked.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02, S03

### N16 · What is known about prespecification and NCT05276947?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Original S01/S02 registration fields read unconfirmed; S03 evidence records NCT05276947.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Original registry/protocol/SAP, hierarchy, amendments and multiplicity are unread. Identifiers or summaries do not establish verified prospective status.
- Required materials and conditions: Original registration, dates, pain hierarchy, amendments and SAP
- Materials to obtain first: Original registry/protocol/SAP, hierarchy, amendments and multiplicity are unread. Identifiers or summaries do not establish verified prospective status.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N17 · Are clinically important pain effects and precision available?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve the original short-term positive pain signal from small unblinded trials.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Between-group estimates/CIs, meaningful change and sample-size plans
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S02, S03

### N18 · Are analgesics, positioning and movement separated?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original manuscript records comparing differences in epidural status, ball shape, timing and positioning/pelvic movement.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Anesthesia/analgesics, usual labor care, exposure and adherence
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N19 · Does short-term pain establish operative or other obstetric outcomes?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The parent records uncertain precise reductions in operative delivery/analgesics and does not interpret vaginal delivery among all completers as prevention.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Do not transfer positive pain into shorter labor, surgical prevention or long-term neonatal/maternal effects. Original event counts, denominators and CIs are unlinked.
- Required materials and conditions: Cesarean/instrumental delivery, analgesics and maternal/neonatal boundaries
- Materials to obtain first: Do not transfer positive pain into shorter labor, surgical prevention or long-term neonatal/maternal effects. Original event counts, denominators and CIs are unlinked.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N20 · Are persistence, other labor conditions and independent replication established?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve short-term signals from small, differing programs. S01 supplies duration context; S02/S03 concern direct pain.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Protocols/controls, ball shape, anesthesia, duration and shared cohorts
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N21 · What is known about funding, support and COI?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: All three original evidence entries record unverified detailed funding.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Do not fill product/ball support, employee authorship, COI or analysis/assessment/publication roles with no involvement or established independence.
- Required materials and conditions: Funding, device/material support, employee authors and separate roles
- Materials to obtain first: Do not fill product/ball support, employee authorship, COI or analysis/assessment/publication roles with no involvement or established independence.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N22 · Are maternal/fetal harms, collection and denominators known?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve original parent Caution safety wording and its labor-safety context.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Harm definitions, arm-specific events/denominators, timing and discontinuation/missing data
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N23 · What are vulnerable conditions, shared exposures and instruction limits?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve original parental safety wording as historical context; create no new labor-ball, delivery, treatment or action instructions.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Labor/anesthesia-specific harms, alternative causes and persistence
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N24 · Are original bibliography, languages, grades/axes and empty history preserved?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Preserve original PMID/DOI/journal wording. Retain parent C50/unrecorded precision, Korean/English, 2026-09-07, empty corrections/deliberation and selected C/note with absent score/status/axes.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Original external bibliography and historical cross-check wording do not establish review/certification in this work. No new grades, numbers or hypothetical examples.
- Required materials and conditions: Original report wording, parent/subclaim distinction, unrecorded precision and dates
- Materials to obtain first: Original external bibliography and historical cross-check wording do not establish review/certification in this work. No new grades, numbers or hypothetical examples.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

### N25 · What distinguishes summary reading from external links?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: This work prepares materials from the complete stored summary and bibliography, distinguishing summary reading, unread external materials and source URLs.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: 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.
- Required materials and conditions: Report-specific reading versus original papers, registration, plans and support access
- Materials to obtain first: 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.
- Further 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.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02, S03

## Evidence and sources

### S01

Payton CL, et al. Randomized Controlled Trial of Use of the Peanut Ball During Labor. Nurs Womens Health. 2016. PMID: 26859467. DOI: 10.1097/NMC.0000000000000232.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/26859467/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the summary: Primiparous interaction P=.018; multiparous P=.057; pushing null  
Record level: For the selected pain question, this is epidural labor-duration background. Preserve first-stage primiparous interaction P=.018, multiparous P=.057 and null pushing time. Numeric sample size, direct pain values, subgroup denominators/models, prospective status and effects/CIs are unverified.  
Independent replication: Parent 2998 and the pain/duration-operative subclaim sheets share the same three reports. S01 provides epidural duration/subgroup background; S02/S03 concern direct pain, with different ball shapes, anesthesia, movement packages, controls and endpoints. Randomized/analyzed populations, subgroups, outcomes, sheets and reports are not summed into new participant, unique-trial or independent-replication totals. Cohort relationships, confirmed totals and independence are unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | Preserve original PubMed URL, PMID 26859467, DOI 10.1097/NMC.0000000000000232, PMCID unrecorded and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 26859467, DOI 10.1097/NMC.0000000000000232, PMCID unrecorded and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 26859467, DOI 10.1097/NMC.0000000000000232, PMCID unrecorded and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 26859467, DOI 10.1097/NMC.0000000000000232, PMCID unrecorded and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 26859467, DOI 10.1097/NMC.0000000000000232, PMCID unrecorded and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 26859467, DOI 10.1097/NMC.0000000000000232, PMCID unrecorded and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |

### S02

Alan Dikmen H, et al. Effects of peanut ball use on perceived labor pain, fatigue, and mother's perception of childbirth: a randomized controlled trial. Arch Gynecol Obstet. 2025;311. PMID: 39103620. PMCID: PMC12055654. DOI: 10.1007/s00404-024-07656-2.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/39103620/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the summary: Pain and fatigue positive; total labor duration P=.177  
Record level: Direct acute-pain report. Distinguish 90 participants and positive pain/fatigue after 15 minutes from null total labor duration P=.177. Exact pain scales, effects/CIs/P values, arm-/endpoint-specific denominators, anesthesia and control are unverified. Duration P is not pain P.  
Independent replication: Parent 2998 and the pain/duration-operative subclaim sheets share the same three reports. S01 provides epidural duration/subgroup background; S02/S03 concern direct pain, with different ball shapes, anesthesia, movement packages, controls and endpoints. Randomized/analyzed populations, subgroups, outcomes, sheets and reports are not summed into new participant, unique-trial or independent-replication totals. Cohort relationships, confirmed totals and independence are unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | Preserve original PubMed URL, PMID 39103620, DOI 10.1007/s00404-024-07656-2, PMCID PMC12055654 and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 39103620, DOI 10.1007/s00404-024-07656-2, PMCID PMC12055654 and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 39103620, DOI 10.1007/s00404-024-07656-2, PMCID PMC12055654 and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 39103620, DOI 10.1007/s00404-024-07656-2, PMCID PMC12055654 and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 39103620, DOI 10.1007/s00404-024-07656-2, PMCID PMC12055654 and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 39103620, DOI 10.1007/s00404-024-07656-2, PMCID PMC12055654 and bibliographic wording unchanged. The original evidence registration field exists and reads unconfirmed. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |

### S03

Ozkececi F, et al. The Effect of Peanut Ball Use on the Labour Process and Maternal-Neonatal Outcomes in Parturient Women With High Maternal Body Mass Index: A Randomized Controlled Trial. Int J Nurs Pract. 2026;32:e70144. PMID: 42026814. PMCID: PMC13106928. DOI: 10.1111/ijn.70144.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/42026814/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the summary: Pain P=.001; duration 202.9±59.5 vs 213.6±67.5 min, P=.522  
Record level: High-BMI co-primary report. Distinguish 70 randomized/59 analyzed, pain P=.001 and active-labor duration 202.9±59.5 versus 213.6±67.5 minutes/P=.522. Pain scales, exact timing, effects/CIs, denominators, the meaning of ± and joint success rules are unverified. Completer results do not establish duration/surgical prevention.  
Independent replication: Parent 2998 and the pain/duration-operative subclaim sheets share the same three reports. S01 provides epidural duration/subgroup background; S02/S03 concern direct pain, with different ball shapes, anesthesia, movement packages, controls and endpoints. Randomized/analyzed populations, subgroups, outcomes, sheets and reports are not summed into new participant, unique-trial or independent-replication totals. Cohort relationships, confirmed totals and independence are unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | Preserve original PubMed URL, PMID 42026814, DOI 10.1111/ijn.70144, PMCID PMC13106928 and bibliographic wording unchanged. The original evidence registration field exists and reads NCT05276947. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 42026814, DOI 10.1111/ijn.70144, PMCID PMC13106928 and bibliographic wording unchanged. The original evidence registration field exists and reads NCT05276947. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 42026814, DOI 10.1111/ijn.70144, PMCID PMC13106928 and bibliographic wording unchanged. The original evidence registration field exists and reads NCT05276947. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 42026814, DOI 10.1111/ijn.70144, PMCID PMC13106928 and bibliographic wording unchanged. The original evidence registration field exists and reads NCT05276947. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 42026814, DOI 10.1111/ijn.70144, PMCID PMC13106928 and bibliographic wording unchanged. The original evidence registration field exists and reads NCT05276947. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |
| Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PubMed URL, PMID 42026814, DOI 10.1111/ijn.70144, PMCID PMC13106928 and bibliographic wording unchanged. The original evidence registration field exists and reads NCT05276947. Registration wording is unrecorded in the citation. Unconfirmed identifiers do not establish no registration; no new registry URL, prospective status or external bibliographic verification is inferred. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

## What the statuses mean

- 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.

## Change history

2026-10-16 · Public page/materials 1.0. The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed.
