{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Glyburide × superiority conclusion of significantly greater harm than insulin: 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": "Comparative harm and production from preserved material",
      "question": "What existing verdict accompanies the selected harm-superiority question?",
      "needed": "Exact claim, subclaim D/note, and separation from parent C54",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Exact claim, subclaim D/note, and separation from parent C54.",
      "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: Exact claim, subclaim D/note, and separation from parent C54. 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 Chamgap design; 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": "Maintain the two questions’ pointers and verdict contexts separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Which events and population are compared by “more harmful”?",
      "needed": "Fixed harm-event definitions, population, comparator, and period",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Fixed harm-event definitions, population, comparator, and period.",
      "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: Fixed harm-event definitions, population, comparator, and period. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; 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": "Attribute harm questions separately to the perinatal composite and individual events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are population, pregnancy timing, and baseline risk known?",
      "needed": "Actual recruitment conditions, medication requirement, and baseline risk",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Actual recruitment conditions, medication requirement, and baseline risk.",
      "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: Actual recruitment conditions, medication requirement, and baseline risk. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M19 §19.1.2–19.2.4; 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": "Separate the scope for other pregnancy/diabetes populations and vulnerable groups. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What are actual exposure, comparator, and concomitant treatment?",
      "needed": "Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care.",
      "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: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records 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 nominal assignment, actual exposure, and other causes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Was INDAO designed to test superiority in harm?",
      "needed": "Noninferiority/superiority hypotheses, prespecified tests, and analysis plan",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan.",
      "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: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; 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": "Distinguish results for different statistical questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What were actual randomization, open-label procedures, and measurement operations?",
      "needed": "Allocation, concealment, baseline balance, event measurement, and blinding",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Allocation, concealment, baseline balance, event measurement, and blinding.",
      "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: Allocation, concealment, baseline balance, event measurement, and blinding. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; 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": "Link design to limitations of actual event measurement. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What are perinatal-composite event definitions and counting units?",
      "needed": "Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling.",
      "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: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination 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",
      "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 composite person/event units and each harm separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are original event rates/difference interpreted directly as superiority in harm?",
      "needed": "Original rates, absolute difference, denominators, and testing framework",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Original rates, absolute difference, denominators, and testing framework.",
      "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 rates, absolute difference, denominators, and testing framework. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; 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": "Separate observed direction from testing conclusions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Is the one-sided noninferiority interval a harm-superiority interval?",
      "needed": "Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics.",
      "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: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation; 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 the hypothesis and interval definition of the original statistics. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative harm and production from preserved material",
      "question": "How does failure at the +7-percentage-point threshold differ from significant harm?",
      "needed": "Distinction between the noninferiority margin and superiority conclusion",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Distinction between the noninferiority margin and superiority 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: Distinction between the noninferiority margin and superiority conclusion. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; 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",
      "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 failed question from the distinct unconfirmed conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are assignment, PP, exposure, and neonatal denominators separated?",
      "needed": "Person/neonatal units and assignment/exposure/observation/analysis units",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Person/neonatal units and assignment/exposure/observation/analysis units.",
      "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: Person/neonatal units and assignment/exposure/observation/analysis units. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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": "Link exposed participants, people with events, and analysis units separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Do other analysis populations confirm the superiority conclusion?",
      "needed": "Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses.",
      "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: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; 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": "Maintain PP, supplementary analyses, and harm superiority as distinct records. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are harm-observation timing, missed tests, and discontinuation known?",
      "needed": "Exposure start/end, event timing, testing/follow-up, and discontinuation",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Exposure start/end, event timing, testing/follow-up, and discontinuation.",
      "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: Exposure start/end, event timing, testing/follow-up, and discontinuation. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; 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": "Distinguish unreported/unverified information from absence of events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Were concurrent treatment and alternative explanations reviewed?",
      "needed": "Baseline risk, concomitant treatment, switching, confounding, and adjustment",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Baseline risk, concomitant treatment, switching, confounding, and adjustment.",
      "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: Baseline risk, concomitant treatment, switching, confounding, and adjustment. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; 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": "Distinguish observed harm from causal attribution to a single medication. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What is the actual reading level for registration and the superiority plan?",
      "needed": "NCT identifier, hypotheses, change history, and protocol/SAP",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: NCT identifier, hypotheses, change history, and protocol/SAP.",
      "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: NCT identifier, hypotheses, change history, and protocol/SAP. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; 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 corresponding material is supplied, record differences among hypotheses, changes, and reporting. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What verification scope applies to public funding and unreported commercial support?",
      "needed": "PHRC/AP-HP, commercial support, medication, authors/COI, and roles",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: PHRC/AP-HP, commercial support, medication, authors/COI, 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/AP-HP, commercial support, medication, authors/COI, 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": "Distinguish disclosed information from unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Is INDAO maternal hypoglycemia evidence of composite superiority?",
      "needed": "Maternal-event definition, arm-specific values, denominators, and harm analysis",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Maternal-event definition, arm-specific values, denominators, and harm analysis.",
      "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: Maternal-event definition, arm-specific values, denominators, and harm analysis. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; 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": "Attribute maternal harms and the neonatal composite separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are INDAO’s individual neonatal-component results known?",
      "needed": "Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia.",
      "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: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; 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": "Separate comparison conclusions for the composite and each component. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative harm and production from preserved material",
      "question": "How are Helal’s overall synthesis and RCT subgroup analysis distinguished?",
      "needed": "24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: 24 studies/24,517 participants overall, 11 RCTs, 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: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations 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 synthesis reports from actual original-trial/population units. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What are the review’s RCT maternal hypoglycemia/LGA results?",
      "needed": "Subgroup endpoints, effects/intervals, arms/denominators, and definitions",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Subgroup endpoints, effects/intervals, arms/denominators, and definitions.",
      "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: Subgroup endpoints, effects/intervals, arms/denominators, and definitions. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; 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": "Attribute results individually by analysis level, event, and material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Which result does the overall pooled neonatal hypoglycemia OR describe?",
      "needed": "Overall pooling, neonatal events, OR/CI, and original analysis scope",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Overall pooling, neonatal events, OR/CI, and original analysis 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: Overall pooling, neonatal events, OR/CI, and original analysis scope. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; 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": "Link the original OR/interval only to its corresponding overall analysis. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What is the difference between stored-summary descriptions of the review’s analysis levels?",
      "needed": "Outcome attribution in evidence/safety explanations and external-verification scope",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Outcome attribution in evidence/safety explanations and external-verification 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: Outcome attribution in evidence/safety explanations and external-verification scope. 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; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and 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": "If the original paper is supplied, record explanations/correction events for the wording difference separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N23",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What information do Helal’s support and registration entries actually provide?",
      "needed": "Review/included-trial funding, COI, plans, and registration",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Review/included-trial funding, COI, plans, and registration.",
      "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: Review/included-trial funding, COI, plans, and registration. 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; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M04 §4.6.1–4.6.2; harm-material adaptations 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 material types, review roles, and original-trial support. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N24",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What were the earlier Langer trial’s opposing results?",
      "needed": "Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Primary/secondary endpoints, individual complications, nonsignificance, and 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: Primary/secondary endpoints, individual complications, nonsignificance, and 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; separation of statuses is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; 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": "Record opposing results together with limitations from different questions/designs. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N25",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What level do Langer’s funding/registration wordings represent?",
      "needed": "Actual supporter, product/COI, registration, and plans",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Actual supporter, product/COI, registration, and plans.",
      "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: Actual supporter, product/COI, registration, and plans. Stored wording is linked here; the original content review remains incomplete.",
      "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": "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 original wording from newly supplied actual identity material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N26",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are the same events, trials, and review counted as independent replications?",
      "needed": "Report-to-trial-to-event links, recitation, and review-inclusion relationships",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Report-to-trial-to-event links, recitation, and review-inclusion relationships.",
      "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: Report-to-trial-to-event links, recitation, and review-inclusion relationships. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations 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": "Maintain relationships among original trials, review recitations, and the same people/timepoints. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Does the current record establish comparison direction, a signal, or causality?",
      "needed": "Design, intervals, alternatives, and original-conclusion scope of each material",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Design, intervals, alternatives, and original-conclusion scope of 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: Design, intervals, alternatives, and original-conclusion scope of each material. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses 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": "Maintain each original report’s comparison/interpretation scope separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Is the result extended to other drugs, vulnerable groups, or long-term harms?",
      "needed": "Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk.",
      "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: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "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": "Separate the narrow comparative-harm question from questions outside its scope. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    },
    {
      "item_id": "N29",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What historical context do parent values, languages, empty values, dates, and corrections provide?",
      "needed": "Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections.",
      "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: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections. 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": "Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are actual summary reading and unread external material distinguished?",
      "needed": "Access status for preserved material, papers, registration, protocol, SAP, and disclosures",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Access status for preserved material, papers, registration, protocol, SAP, and disclosures.",
      "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: Access status for preserved material, papers, registration, protocol, SAP, and disclosures. 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 each material’s existence, acquisition, and reading level separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work."
    }
  ]
}