{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Glyburide × noninferiority to insulin for the perinatal composite: evidence checklist",
  "language": "en",
  "translation_date": "2026-10-11",
  "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": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "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": "Existing content review remains incomplete.",
    "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": "Noninferiority comparison and production from preserved material",
      "question": "Which existing noninferiority question is being turned into a table?",
      "needed": "Separation of the selected question, subclaim grade, and parent context",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Separation of the selected question, subclaim grade, and parent context.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Separation of the selected question, subclaim grade, and parent context. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Update while maintaining the selected question and verdict record separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N02",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What were the actual INDAO population and recruitment conditions?",
      "needed": "Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish the actual population from other pregnancy/diabetes populations. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N03",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What were the actual intervention and comparator?",
      "needed": "Glyburide, subcutaneous insulin, study exposure, and comparison direction",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Glyburide, subcutaneous insulin, study exposure, and comparison direction.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Glyburide, subcutaneous insulin, study exposure, and comparison direction. Stored wording is linked here; the original content review remains incomplete.",
      "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link nominal assignment and actual exposure separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N04",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "How much is known about design, allocation, and blinding?",
      "needed": "Open-label randomized noninferiority design, concealment, and baseline balance",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Open-label randomized noninferiority design, concealment, and baseline balance.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Open-label randomized noninferiority design, concealment, and baseline balance. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate the design label from operational details actually verified. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N05",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "How was the perinatal composite defined?",
      "needed": "Composite-event definition, component criteria, and overlap counting",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Composite-event definition, component criteria, and overlap counting.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Composite-event definition, component criteria, and overlap counting. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Keep the composite and its individual components as different outcomes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N06",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "How much is known about perinatal timing and the observation period?",
      "needed": "Medication exposure, assessment around birth, and follow-up scope",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Medication exposure, assessment around birth, and follow-up scope.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Medication exposure, assessment around birth, and follow-up scope. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Record exposure timing and event-assessment timing separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N07",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Are the prespecified primary PP analysis and randomized denominator distinguished?",
      "needed": "Randomization, PP, arm-specific exclusions/switching, and analysis denominators",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Randomization, PP, arm-specific exclusions/switching, and analysis denominators.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Randomization, PP, arm-specific exclusions/switching, and analysis denominators. Stored wording is linked here; the original content review remains incomplete.",
      "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish assignment, actual exposure, maternal/neonatal observations, and analysis denominators. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N08",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Which population do the observed rates and absolute difference describe?",
      "needed": "Arm correspondence, events/people, denominators, and original estimator",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Arm correspondence, events/people, denominators, and original estimator.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Arm correspondence, events/people, denominators, and original estimator. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Attribute original rates, differences, and denominators individually. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N09",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What are the one-sided interval and noninferiority P value?",
      "needed": "One-sided confidence level, upper bound, testing hypothesis, and original P value",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: One-sided confidence level, upper bound, testing hypothesis, and original P value.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: One-sided confidence level, upper bound, testing hypothesis, and original P value. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish noninferiority and superiority test quantities. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N10",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What criterion does the prespecified +7-percentage-point margin represent?",
      "needed": "Rationale, direction, and timing of the noninferiority margin",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Rationale, direction, and timing of the noninferiority margin.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Rationale, direction, and timing of the noninferiority margin. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish the original margin from criteria in newly supplied material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N11",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "How is failure to demonstrate noninferiority preserved as a conclusion?",
      "needed": "Logical separation of demonstrating an acceptable margin from superiority in harm",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Logical separation of demonstrating an acceptable margin from superiority in harm.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Logical separation of demonstrating an acceptable margin from superiority in harm. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate design-specific questions and the scope of the original conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N12",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Which material addresses consistency in other analysis populations?",
      "needed": "ITT/other populations, denominators, quantitative results, and effect of interest",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: ITT/other populations, denominators, quantitative results, and effect of interest.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: ITT/other populations, denominators, quantitative results, and effect of interest. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link the primary PP analysis and actual supplementary analyses separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N13",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Are cointerventions, rescue insulin, and adherence/switching known?",
      "needed": "Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link assignment and treatment departures to the effect being estimated. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N14",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Were composite events measured under comparable conditions?",
      "needed": "Component measurement, testing, blinding, and differences in detection",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Component measurement, testing, blinding, and differences in detection.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Component measurement, testing, blinding, and differences in detection. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish objective event names from actual measurement conditions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N15",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What was verified about registration, protocol, and SAP?",
      "needed": "Registration identity, prespecified primary analysis, margin, and change history",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Registration identity, prespecified primary analysis, margin, and change history.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Registration identity, prespecified primary analysis, margin, and change history. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "If material is supplied, record prespecification, changes, and reporting separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N16",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What are INDAO’s public funding and sponsor?",
      "needed": "PHRC public grant, AP-HP sponsor, and roles",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: PHRC public grant, AP-HP sponsor, and roles.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: PHRC public grant, AP-HP sponsor, and roles. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link funding provision and research roles separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N17",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Are unreported commercial support and detailed COI distinguished?",
      "needed": "Commercial funding, study medication, author employment/patents, and analysis/writing support",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Commercial funding, study medication, author employment/patents, and analysis/writing support.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Commercial funding, study medication, author employment/patents, and analysis/writing support. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish the reporting scope from separately unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N18",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Did the earlier Langer trial have the same noninferiority framework?",
      "needed": "Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M03 §3.2.1; detailed population conditions are Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain different questions for the primary endpoint and secondary outcomes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N19",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "How are Langer’s individual complications and alternative conclusion preserved?",
      "needed": "LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design; M15 §15.3.1–15.3.3; own application; M04 §4.6.1–4.6.2, M15 §15.3.1; own application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Record the earlier opposing conclusion together with actual design differences. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N20",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Do Langer’s registration and funding entries establish actual identities?",
      "needed": "Original registration wording and actual support/COI information",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Original registration wording and actual support/COI information.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original registration wording and actual support/COI information. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate wording from actual identifiers and disclosure information. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N21",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Do Helal’s overall review and RCT subgroup have the same denominator?",
      "needed": "Study designs, overall/RCT subsets, and endpoint-specific denominators",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Study designs, overall/RCT subsets, and endpoint-specific denominators.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Study designs, overall/RCT subsets, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link overall synthesis and RCT subgroup analyses separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N22",
      "question_type": "Harm-information gaps and supplementation of the noninferiority table",
      "question": "Are RCT-subgroup and overall pooled results kept separate?",
      "needed": "Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels",
      "role": "Supplementary",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels.",
      "application_exception": "Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "If the original paper explains the wording difference, distinguish the source and correction event. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N23",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Are review support, registration, and protocol known?",
      "needed": "Funding/COI and plans for the review itself and its included trials",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Funding/COI and plans for the review itself and its included trials.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Funding/COI and plans for the review itself and its included trials. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Record roles/support for the review and included trials separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N24",
      "question_type": "Harm-information gaps and supplementation of the noninferiority table",
      "question": "Can component risks substitute for composite noninferiority?",
      "needed": "Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia",
      "role": "Supplementary",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia.",
      "application_exception": "Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate the composite, components, and events in other material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps and supplementation of the noninferiority table",
      "question": "What is the scope of maternal hypoglycemia and other harms?",
      "needed": "Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes",
      "role": "Supplementary",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes.",
      "application_exception": "Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain maternal and neonatal event units and comparisons separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N26",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "How are the same reports/cohorts distinguished from independent replication?",
      "needed": "Relationships among INDAO, Langer, Helal, included trials, and subsequent reports",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Relationships among INDAO, Langer, Helal, included trials, and subsequent reports.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Relationships among INDAO, Langer, Helal, included trials, and subsequent reports. Stored wording is linked here; the original content review remains incomplete.",
      "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish report counts from unique clinical-trial and participant counts. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N27",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Is the result extended to medications, periods, or clinical questions outside its scope?",
      "needed": "Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate the original noninferiority question from extension questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N28",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "What historical context do parent score, axes, bilingual manuscript, dates, and corrections provide?",
      "needed": "Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history.",
      "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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate original records from production and correction events. This is a proposal; no new investigation, calculation, or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Noninferiority comparison and production from preserved material",
      "question": "Are actual summary reading and unread external material separated?",
      "needed": "Existence, acquisition, actual reading, and original URLs for each material",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Existence, acquisition, actual reading, and original URLs for each 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": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Existence, acquisition, actual reading, and original URLs for each material. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Update material types and access/reading levels separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    }
  ]
}