{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Five alternative caesarean surgical techniques × Six-week maternal death or morbidity composite: evidence checklist",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "User review pending.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the selected question and original verdict?",
      "needed": "The distinction between the selected question and original D34 verdict/assessment axes",
      "role": "Required",
      "role_reason": "This item distinguishes The distinction between the selected question and original D34 verdict/assessment axes to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The distinction between the selected question and original D34 verdict/assessment axes must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposed later production record distinguishing the selected question from the existing verdict record. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which events are included in the six-week maternal death or morbidity composite?",
      "needed": "The composite definition, including clinical events such as death, readmission, reoperation and transfusion",
      "role": "Required",
      "role_reason": "This item distinguishes The composite definition, including clinical events such as death, readmission, reoperation and transfusion to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The composite definition, including clinical events such as death, readmission, reoperation and transfusion must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material reporting the composite and its components separately. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the population, sites, countries and recruitment scope?",
      "needed": "The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk",
      "role": "Required",
      "role_reason": "This item distinguishes The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The 15,935 women, 19 sites, seven countries and actual eligibility/baseline risk must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material distinguishing the original population from other settings/populations. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How were the five comparisons allocated in the fractional factorial design?",
      "needed": "The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site",
      "role": "Required",
      "role_reason": "This item distinguishes The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The distinction between the 2×2×2×2×2 nonregular fractional factorial design and three pairs per site must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M08 §8.1–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed fractional factorial reporting specifying comparison populations and sharing. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was the original six-week result for blunt versus sharp abdominal entry?",
      "needed": "Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry",
      "role": "Required",
      "role_reason": "This item distinguishes Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for blunt versus sharp abdominal entry must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was the original six-week result for exteriorized versus intra-abdominal uterine repair?",
      "needed": "Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair",
      "role": "Required",
      "role_reason": "This item distinguishes Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for exteriorized versus intra-abdominal uterine repair must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was the original six-week result for single- versus double-layer uterine closure?",
      "needed": "Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure",
      "role": "Required",
      "role_reason": "This item distinguishes Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for single- versus double-layer uterine closure must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was the original six-week result for peritoneal closure versus nonclosure?",
      "needed": "Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure",
      "role": "Required",
      "role_reason": "This item distinguishes Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for peritoneal closure versus nonclosure must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was the original six-week result for chromic catgut versus polyglactin-910 sutures?",
      "needed": "Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures",
      "role": "Required",
      "role_reason": "This item distinguishes Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Comparison direction, RR/95% CI and composite outcome for chromic catgut versus polyglactin-910 sutures must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material separating this comparison’s composite/component outcomes and intervals. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do nonsignificance and the original null verdict establish equivalence or exclude benefit?",
      "needed": "Original D34/E0/C0 and the absence of a benefit-exclusion boundary",
      "role": "Required",
      "role_reason": "This item distinguishes Original D34/E0/C0 and the absence of a benefit-exclusion boundary to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Original D34/E0/C0 and the absence of a benefit-exclusion boundary must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material specifying uncertainty about rare or small differences. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can absolute events and absolute differences be established from RRs?",
      "needed": "The distinction between absent absolute event counts in the original abstract and relative RRs",
      "role": "Required",
      "role_reason": "This item distinguishes The distinction between absent absolute event counts in the original abstract and relative RRs to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The distinction between absent absolute event counts in the original abstract and relative RRs must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material reporting absolute and relative outcomes from their respective original sources. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are the full 15,935 women and each factor’s denominator the same?",
      "needed": "Total randomized participants and factor-, component- and follow-up-specific denominators",
      "role": "Required",
      "role_reason": "This item distinguishes Total randomized participants and factor-, component- and follow-up-specific denominators to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Total randomized participants and factor-, component- and follow-up-specific denominators must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed reporting linking each outcome’s denominator to its factor/timepoint. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are shared participants, factors, groups, events and interactions distinguished?",
      "needed": "Fractional factorial overlap, repeated observations/interactions and independent comparisons",
      "role": "Required",
      "role_reason": "This item distinguishes Fractional factorial overlap, repeated observations/interactions and independent comparisons to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Fractional factorial overlap, repeated observations/interactions and independent comparisons must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed reporting separating shared structure from factor-specific results. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the scope of the original allocation concealment, open surgery and ITT statements?",
      "needed": "Central telephone randomization, unmasked surgery, ITT and actual implementation",
      "role": "Required",
      "role_reason": "This item distinguishes Central telephone randomization, unmasked surgery, ITT and actual implementation to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Central telephone randomization, unmasked surgery, ITT and actual implementation must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M08 §8.1–8.2.3; Chamgap application; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed reporting separating open surgery from event ascertainment/missingness. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What differs in common care, sites and surgical conditions?",
      "needed": "Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions",
      "role": "Required",
      "role_reason": "This item distinguishes Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Factor contrasts, other surgical/anaesthetic/drug treatments and site conditions must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material distinguishing technique comparisons from other treatment contributions. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the six-week observation window and follow-up/missingness specification?",
      "needed": "The six-week maternal composite, observation timing/duration and the period after it ends",
      "role": "Required",
      "role_reason": "This item distinguishes The six-week maternal composite, observation timing/duration and the period after it ends to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The six-week maternal composite, observation timing/duration and the period after it ends must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed reporting separating short-term endpoints from long-term follow-up. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the hierarchy and multiplicity rules for five primary comparisons and other outcomes?",
      "needed": "The original prespecified primary composite, five comparisons, plans and multiplicity",
      "role": "Required",
      "role_reason": "This item distinguishes The original prespecified primary composite, five comparisons, plans and multiplicity to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The original prespecified primary composite, five comparisons, plans and multiplicity must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material presenting planned and actually reported outcomes separately. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the 2016 follow-up a new independent trial?",
      "needed": "The 2013/2016 reports and the same CORONIS trial/population",
      "role": "Required",
      "role_reason": "This item distinguishes The 2013/2016 reports and the same CORONIS trial/population to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The 2013/2016 reports and the same CORONIS trial/population must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later linkage distinguishing report counts from study families/follow-up participants. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are the three-year report, mean 3.8 years and 13,153 women (84%) preserved?",
      "needed": "Report designation, actual mean follow-up and original follow-up counts/proportion",
      "role": "Required",
      "role_reason": "This item distinguishes Report designation, actual mean follow-up and original follow-up counts/proportion to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Report designation, actual mean follow-up and original follow-up counts/proportion must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed long-term reporting specifying how original numbers relate to populations/timepoints. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are representative long-term outcomes the same as the six-week composite?",
      "needed": "Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes",
      "role": "Required",
      "role_reason": "This item distinguishes Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Abdominal hernia, infertility, maternal death and subsequent-pregnancy uterine rupture versus six-week outcomes must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later material reporting uncertainty separately for each long-term outcome. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N21",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What does the original interval for rare uterine rupture not establish?",
      "needed": "Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29)",
      "role": "Supplementary",
      "role_reason": "This item distinguishes Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29) to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.",
      "criterion": "The relevant source material and analysis scope for Catgut/polyglactin subsequent-pregnancy uterine rupture RR 3.05 (0.32–29.29) must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material separately reporting rare harms and uncertainty in subsequent pregnancies. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the case 2641 azithromycin citation replication of the surgical technique evidence?",
      "needed": "A context link for a different infection-prevention drug versus direct technique comparisons",
      "role": "Required",
      "role_reason": "This item distinguishes A context link for a different infection-prevention drug versus direct technique comparisons to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for A context link for a different infection-prevention drug versus direct technique comparisons must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed relationship records separating technique and infection-prevention drug questions. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are public/nonprofit funding, COI and actual research roles the same?",
      "needed": "MRC/WHO funding, original I2 axis and product/author/control roles",
      "role": "Required",
      "role_reason": "This item distinguishes MRC/WHO funding, original I2 axis and product/author/control roles to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for MRC/WHO funding, original I2 axis and product/author/control roles must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed reporting distinguishing funding type from research control/contributions. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does ISRCTN31089967 and historical agreement mean the registration was read here?",
      "needed": "The stored registration text versus actual reading of registration/plans",
      "role": "Required",
      "role_reason": "This item distinguishes The stored registration text versus actual reading of registration/plans to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The stored registration text versus actual reading of registration/plans must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material linking registration versions with actually reported outcomes. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What are the 144 serious adverse events and 26 possibly related events?",
      "needed": "The distinction between original event counts/possible relatedness and participants, rates and causality",
      "role": "Supplementary",
      "role_reason": "This item distinguishes The distinction between original event counts/possible relatedness and participants, rates and causality to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.",
      "criterion": "The relevant source material and analysis scope for The distinction between original event counts/possible relatedness and participants, rates and causality must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed reporting distinguishing events from people and factor-specific safety outcomes. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N26",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Is absence of an established consistent harm advantage the same as overall safety?",
      "needed": "The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms",
      "role": "Supplementary",
      "role_reason": "This item distinguishes The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Supplements gaps in harm data for the selected six-week maternal death or morbidity composite question. Original serious adverse events/Good safety are not extended to safety of every technique/patient, harm causality/rates or exclusion of long-term differences. No guidance on choosing, performing or determining suitability of surgery/devices/sutures is created.",
      "criterion": "The relevant source material and analysis scope for The original safety summary and gaps in factor-specific, vulnerable-group and long-term harms must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.2.2–19.2.4 and M03 §3.2.3; Chamgap application; M19 §19.1.2–19.2.4 and M04 §4.6.3; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material distinguishing short-/long-term harms and vulnerable populations. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can the findings be extended to operating time, convenience or superiority in other populations?",
      "needed": "Technical convenience versus maternal clinical outcomes and exposure history",
      "role": "Required",
      "role_reason": "This item distinguishes Technical convenience versus maternal clinical outcomes and exposure history to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Technical convenience versus maternal clinical outcomes and exposure history must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.4; Chamgap interpretation boundary",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed material linking technical processes to patient clinical outcomes while distinguishing them. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N28",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How much of the original summary, external papers and Chamgap links was actually read?",
      "needed": "The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material",
      "role": "Required",
      "role_reason": "This item distinguishes The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for The full stored summary, initial/follow-up PMIDs, Chamgap links and unread external material must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed records separating full-text/summary acquisition from actual reading scope for each material. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N29",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are KO/EN, the original verdict, dates, correction history/empty values and historical cross-checks preserved?",
      "needed": "Original D34, Good, assessment axes, 2026-08-26 and existing empty values",
      "role": "Required",
      "role_reason": "This item distinguishes Original D34, Good, assessment axes, 2026-08-26 and existing empty values to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Original D34, Good, assessment axes, 2026-08-26 and existing empty values must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Question clarification principles in M03 §3.1 and §3.2.1–3.2.4; Detailed separation rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed records distinguishing original preservation from separate update/correction events. No new investigation, calculation or trial was performed here."
    },
    {
      "item_id": "N30",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are condition preservation, application, case production and review separate records?",
      "needed": "Production sequence and incomplete user review",
      "role": "Required",
      "role_reason": "This item distinguishes Production sequence and incomplete user review to connect the evidence needed for the selected question with the available material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "The relevant source material and analysis scope for Production sequence and incomplete user review must be available, with unverified points distinguished. This view links stored wording; user review remains pending.",
      "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M04 §4.5 and §4.6.3; Limits of this conversion follow the user-defined scope and Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "Proposed later records separately documenting production and user review/corrections. No new investigation, calculation or trial was performed here."
    }
  ]
}