{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2949-s0",
  "verdict_number": "2949",
  "title": "Glyburide × noninferiority to insulin for the perinatal composite: evidence checklist",
  "view_version": "1.0",
  "view_created_date": "2026-10-11",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The original content review remains incomplete. External abstracts, full texts, registrations, protocols, and SAPs remain unread, and access was not attempted. Separate content, screen, and link reviews were not performed at the time.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "Gestational diabetes requiring medication even after 10 days of dietary treatment; 13 French university hospitals",
    "intervention": "Original study: oral glyburide; exact dose/duration/actual exposure unverified",
    "dose": null,
    "comparator": "Injected insulin; exact regimen/actual exposure unverified",
    "endpoint": "Noninferiority for a perinatal composite of at least one of macrosomia, neonatal hypoglycemia, or hyperbilirubinemia",
    "duration": "Perinatal; exact exposure/event-assessment windows unverified",
    "excluded_extensions": [
      "Changing failure to demonstrate noninferiority into significant superiority in harm, equivalence, an exactly zero effect, or confirmation of all safety outcomes",
      "Repurposing the one-sided 97.5% upper bound of +10.5 percentage points/noninferiority P=.19 as a full two-sided CI/harm-superiority P, or calculating new values",
      "Replacing 914 randomized (460/454), PP 809 (367/442), and maternal/neonatal/event denominators as the same unit, or calculating new exclusion/event/risk counts",
      "Treating the composite, macrosomia, LGA, neonatal hypoglycemia, hyperbilirubinemia, and maternal hypoglycemia as the same outcome",
      "Substituting Helal’s overall 24,517 participants, 11 RCTs, and endpoint-specific subset denominators, or repurposing the overall neonatal OR as an RCT-only/INDAO/composite value",
      "Automatically resolving or reassessing the review-attribution difference between the stored summary’s evidence list and safety explanation while the original paper remains unread",
      "Changing Langer’s 404 participants, primary glycemic control/secondary individual perinatal outcomes, or nonsignificance into passing composite NI at +7 percentage points, reversing INDAO, or zero harm",
      "Summing the review, original trial, subsequent reports, sibling tables, people/arms/events/timepoints as new independent trials, participants, or replications",
      "Changing funding reported in the original paper/systematic review, nct not applicable, or unreported commercial support into an actual provider, absence, registration identifier, or independence certification",
      "Inheriting parent C54, original axes, or historical cross-checking as selected C/D scores/axes, current content review, or external reading",
      "New calculations, invented values, new effects/CIs, reassessment, independence certification, or instructions to implement medication selection/substitution/administration/treatment/monitoring for pregnant women"
    ]
  },
  "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.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The selected question is “Noninferiority to insulin for the perinatal composite”; subclaim C and “the CI upper bound of +10.5 percentage points exceeded the +7-percentage-point margin” are preserved. The parent is C54.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subclaim score/status/axis keys are absent and are not filled from parent values. The sibling D question about harm superiority is separate. The original content review remains incomplete.",
      "missingness": "Subclaim score/status/axis keys are absent and are not filled from parent values. The sibling D question about harm superiority is separate.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Correction records for the selected claim and parent assessment"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original scope is women with gestational diabetes requiring medication even after 10 days of dietary treatment, at 13 French university hospitals.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Details of age, gestational week, diagnostic/glucose criteria, baseline risk, and inclusion/exclusion are unverified in this summary. The original content review remains incomplete.",
      "missingness": "Details of age, gestational week, diagnostic/glucose criteria, baseline risk, and inclusion/exclusion are unverified in this summary.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Recruitment criteria and baseline characteristics table"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript records a comparison of oral sulfonylurea glyburide with injected insulin. This wording describes historical study conditions; it is not medication-selection or administration guidance.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact doses, escalation, actual exposure duration, insulin type/regimen, and arm-specific changes are unverified. The original content review remains incomplete.",
      "missingness": "Exact doses, escalation, actual exposure duration, insulin type/regimen, and arm-specific changes are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Study intervention, comparator, and exposure records"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO is a multicenter open-label randomized noninferiority trial. It assigned 914 participants: 460 to glyburide and 454 to insulin.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation sequence, concealment, arm-specific baseline balance, and assessor/analyst blinding are unverified. The open-label design is not turned into a new failure judgment. The original content review remains incomplete.",
      "missingness": "Allocation sequence, concealment, arm-specific baseline balance, and assessor/analyst blinding are unverified. The open-label design is not turned into a new failure judgment.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation methods, baseline characteristics, and assessment-operation material"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The prespecified primary endpoint was a perinatal composite of at least one of macrosomia, neonatal hypoglycemia, or hyperbilirubinemia.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Component criteria, collection methods, neonatal denominators, handling of overlapping events, and exact period are unverified. The original content review remains incomplete.",
      "missingness": "Component criteria, collection methods, neonatal denominators, handling of overlapping events, and exact period are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Composite definition and component-event tables"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript describes a perinatal composite of actual birth-related events.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Treatment start/end, assessment windows around birth, and follow-up after discharge are unverified. The result is not extended to long-term offspring outcomes. The original content review remains incomplete.",
      "missingness": "Treatment start/end, assessment windows around birth, and follow-up after discharge are unverified. The result is not extended to long-term offspring outcomes.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Exposure schedule and perinatal/subsequent follow-up plan"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Original values are preserved: 914 randomized (460/454) and 809 in the prespecified primary PP analysis (367/442).",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. PP definition, arm-specific reasons for exclusion/switching, and neonatal analysis units are unverified. No new exclusion counts or rates are calculated. The original content review remains incomplete.",
      "missingness": "PP definition, arm-specific reasons for exclusion/switching, and neonatal analysis units are unverified. No new exclusion counts or rates are calculated.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Flow diagram, PP definition, and arm-specific analysis tables"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original INDAO perinatal-composite result is 27.6% with glyburide versus 23.4% with insulin, an absolute difference of +4.2 percentage points. It is linked to the prespecified primary PP analysis context.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Unrounded rates, event counts, and exact maternal/neonatal denominator correspondence are unverified. No event counts or new differences are calculated from rates. The original content review remains incomplete.",
      "missingness": "Unrounded rates, event counts, and exact maternal/neonatal denominator correspondence are unverified. No event counts or new differences are calculated from rates.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "PP composite-result table and analysis-unit definitions"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=0.19 are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The lower bound, full interval, calculation model, and superiority-test CI/P are unverified in this summary. No new two-sided CI or superiority P is calculated from the one-sided upper bound. The original content review remains incomplete.",
      "missingness": "The lower bound, full interval, calculation model, and superiority-test CI/P are unverified in this summary. No new two-sided CI or superiority P is calculated from the one-sided upper bound.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Noninferiority analysis table and SAP"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript declares a prespecified +7-percentage-point margin and records that the one-sided upper bound of +10.5 percentage points exceeded it.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Clinical/statistical rationale for the margin, the original prespecified plan, and sample-size assumptions remain unread. The original content review remains incomplete.",
      "missingness": "Clinical/statistical rationale for the margin, the original prespecified plan, and sample-size assumptions remain unread.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Protocol, margin rationale, and sample-size plan"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript states that being within the acceptable margin was not demonstrated, and explicitly distinguishes this from demonstrating significantly worse results.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusion of an exactly zero effect, equivalence, or significant harm is created. A separate superiority plan/analysis is unverified. The original content review remains incomplete.",
      "missingness": "No new conclusion of an exactly zero effect, equivalence, or significant harm is created. A separate superiority plan/analysis is unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Superiority plan/results and original noninferiority conclusion"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript says other analysis populations were used to assess consistency.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Their names, denominators, original effects/CIs, missing-data handling, and values relative to PP are unverified. They are not arbitrarily filled as quantitative ITT confirmation. The original content review remains incomplete.",
      "missingness": "Their names, denominators, original effects/CIs, missing-data handling, and values relative to PP are unverified. They are not arbitrarily filled as quantitative ITT confirmation.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Additional analysis populations, sensitivity results, and SAP"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The stored summary describes a population requiring medication after dietary treatment and a glyburide/insulin comparison.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. Arm-specific rescue treatment, switching, dose/adherence, concomitant care, and analytical handling are unverified. Actual switching is not invented. The original content review remains incomplete.",
      "missingness": "Arm-specific rescue treatment, switching, dose/adherence, concomitant care, and analytical handling are unverified. Actual switching is not invented.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Arm-specific adherence, concomitant treatment, and switching/rescue-treatment records"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original description of a perinatal composite in an open-label trial is preserved.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. Measurement criteria/schedules for macrosomia, hypoglycemia, and hyperbilirubinemia, missed tests, and decision-maker blinding are unverified. The original content review remains incomplete.",
      "missingness": "Measurement criteria/schedules for macrosomia, hypoglycemia, and hyperbilirubinemia, missed tests, and decision-maker blinding are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Component-event adjudication and measurement-operation material"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original registration identifier is NCT01731431. Preserved descriptions of prespecified PP, the primary composite, and +7 percentage points are linked.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Registration, protocol, SAP, and change history remain unread; access was not attempted. The number is not treated as review of agreement with the plan. The original content review remains incomplete.",
      "missingness": "Registration, protocol, SAP, and change history remain unread; access was not attempted. The number is not treated as review of agreement with the plan.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration history, protocol, and SAP"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The French Ministry of Health Programme Hospitalier de Recherche Clinique public grant and Assistance Publique–Hôpitaux de Paris public sponsor support are preserved as originally recorded.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, itemized amounts, and actual design/analysis/writing roles are unverified. Public funding is not extended to confirmation of all independence criteria. The original content review remains incomplete.",
      "missingness": "Contracts, itemized amounts, and actual design/analysis/writing roles are unverified. Public funding is not extended to confirmation of all independence criteria.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Funding/sponsor and role disclosures"
    },
    {
      "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.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript records that commercial pharmaceutical funding or free study medication was not reported.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual absence was not newly established. Employee authors, patents, outsourced analysis, individual COI, and writing/publication support details are unverified. The original content review remains incomplete.",
      "missingness": "Actual absence was not newly established. Employee authors, patents, outsourced analysis, individual COI, and writing/publication support details are unverified.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original funding/product and author/COI disclosures"
    },
    {
      "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.",
      "current_reports": [
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Langer 2000 was a 404-participant glyburide-versus-insulin RCT. The manuscript records primary glycemic control and secondary individual perinatal complications, without a prespecified noninferiority test.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed population, denominators, duration, glycemic-control values, and original plan remain unread. It is not counted as replication of the same perinatal-composite noninferiority question. The original content review remains incomplete.",
      "missingness": "Detailed population, denominators, duration, glycemic-control values, and original plan remain unread. It is not counted as replication of the same perinatal-composite noninferiority question.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Langer plan, population, and result tables"
    },
    {
      "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.",
      "current_reports": [
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "LGA 12% versus 13%, neonatal hypoglycemia 9% versus 6%, no significant difference in individual complications, and the “clinically effective alternative” conclusion are preserved as originally recorded.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Original CI/P, denominators, and definitions are unverified. Nonsignificance is not changed into being within an acceptable margin, equivalence, or reversal of INDAO. The original content review remains incomplete.",
      "missingness": "Original CI/P, denominators, and definitions are unverified. Nonsignificance is not changed into being within an acceptable margin, equivalence, or reversal of INDAO.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Individual-result tables and original conclusion"
    },
    {
      "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.",
      "current_reports": [
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The nct entry “not applicable” and funding entry “reported in the original paper” are preserved as originally recorded. The latter is not a verified provider name.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. Existence of registration/plans and actual funding, product support, and author COI are unverified. “Not applicable” is not used as current certification of absence. The original content review remains incomplete.",
      "missingness": "Existence of registration/plans and actual funding, product support, and author COI are unverified. “Not applicable” is not used as current certification of absence.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original Langer plan and funding/COI material"
    },
    {
      "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.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original review records 24 studies with a total of 24,517 participants and an 11-RCT subgroup analysis.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The RCT subgroup participant count, endpoint-specific denominators, and included-trial/overlap tables are unverified. The overall 24,517 is not repurposed as the 11-RCT denominator or newly summed with INDAO/Langer. The original content review remains incomplete.",
      "missingness": "The RCT subgroup participant count, endpoint-specific denominators, and included-trial/overlap tables are unverified. The overall 24,517 is not repurposed as the 11-RCT denominator or newly summed with INDAO/Langer.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Included-study table and design/endpoint-specific analysis tables"
    },
    {
      "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.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "S02’s evidence list distinguishes increased maternal hypoglycemia and LGA in the RCT subgroup from overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95).",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The Korean/English manuscript’s safety explanation describes increased neonatal hypoglycemia and LGA in the RCT subgroup, differing in specific attribution from the evidence list. Both wordings are preserved while the original paper remains unread; no automatic resolution or reassessment to a new analysis level is made. The original content review remains incomplete.",
      "missingness": "The Korean/English manuscript’s safety explanation describes increased neonatal hypoglycemia and LGA in the RCT subgroup, differing in specific attribution from the evidence list. Both wordings are preserved while the original paper remains unread; no automatic resolution or reassessment to a new analysis level is made.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Review tables of endpoint-specific overall/RCT results and original disclosures"
    },
    {
      "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.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The funding entry “systematic review; included-trial funding mixed” and nct entry “not applicable” are preserved as originally recorded.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. The review’s own funding/COI, registration/plans, and each included trial’s disclosures are unverified. Mixed support is not changed into identical independence or actual absence. The original content review remains incomplete.",
      "missingness": "The review’s own funding/COI, registration/plans, and each included trial’s disclosures are unverified. Mixed support is not changed into identical independence or actual absence.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Review plan, funding/COI, and included-trial disclosures"
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO’s primary endpoint is a composite of at least one of three events. Langer’s LGA/neonatal hypoglycemia and Helal’s individual safety results are separate endpoints.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. INDAO component-level quantitative results, multiplicity, and denominators are unverified. Macrosomia and LGA definitions are not filled as identical, and individual results are not transferred to the composite. The original content review remains incomplete.",
      "missingness": "INDAO component-level quantitative results, multiplicity, and denominators are unverified. Macrosomia and LGA definitions are not filled as identical, and individual results are not transferred to the composite.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "INDAO component-result tables and event definitions in each report"
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript records more frequent maternal hypoglycemia in the glyburide arm. This is not repurposed as significant superiority in harm for the entire perinatal composite.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific counts, denominators, CI/P, definitions, severity, other adverse events, and discontinuation information are unverified. No new incidence rates, causality conclusions, or safety grades are created. The original content review remains incomplete.",
      "missingness": "Arm-specific counts, denominators, CI/P, definitions, severity, other adverse events, and discontinuation information are unverified. No new incidence rates, causality conclusions, or safety grades are created.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Maternal adverse-event, discontinuation, and arm-specific result tables"
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO/NCT01731431, Langer 2000, and the Helal 2020 review are linked as separate report items. The two sibling sheets share the same stored summary and reports.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Review inclusion, subsequent reports, and trial-identity overlaps were not checked. Original R1/E~ are not used as new replication/independence certification; unique clinical totals remain unrecorded. The original content review remains incomplete.",
      "missingness": "Review inclusion, subsequent reports, and trial-identity overlaps were not checked. Original R1/E~ are not used as new replication/independence certification; unique clinical totals remain unrecorded.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Related/included-trial tables and registration/report links"
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript records that sulfonylurea placental transfer varies by drug and is not generalized to the entire class. Oral convenience is not noninferiority evidence.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct evidence for other drugs, conditions, pregnancy periods, and long-term offspring outcomes is unverified. No medication-selection, substitution, or administration instructions for pregnant women are created. The original content review remains incomplete.",
      "missingness": "Direct evidence for other drugs, conditions, pregnancy periods, and long-term offspring outcomes is unverified. No medication-selection, substitution, or administration instructions for pregnant women are created.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Separate medication/population and long-term-outcome material"
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "C54, safety Caution, unrecorded precision in the original axes, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, and historical cross-checking are preserved in the full stored summary.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This is not a current search, correction/retraction check, or completed content review. Parent scores or axes are not filled into subclaims C/D. The original content review remains incomplete.",
      "missingness": "This is not a current search, correction/retraction check, or completed content review. Parent scores or axes are not filled into subclaims C/D.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "New corrections, user comments, and supplied original material"
    },
    {
      "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.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The full stored summary’s three evidence entries, three citations, Korean/English manuscripts, and selected item were read for production. Summaries are marked “summary read”; external papers, registration/plans, and disclosures are marked “unread”, with original source links connected.",
      "condition_status": "Partly verified",
      "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration, protocols, SAPs, and disclosures were not accessed, clicked, or link-tested. Not attempted is not marked inaccessible. The original content review remains incomplete.",
      "missingness": "External abstracts/full texts, registration, protocols, SAPs, and disclosures were not accessed, clicked, or link-tested. Not attempted is not marked inaccessible.",
      "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original material and actual reading history for each report"
    }
  ],
  "reports": [
    {
      "report_id": "S01",
      "title": "Sénat MV et al. 2018 INDAO",
      "url": "https://pubmed.ncbi.nlm.nih.gov/29715355/",
      "report_type": "Multicenter open-label randomized noninferiority trial",
      "existence": "Stored bibliography exists; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "study_family": "RG2949-INDAO",
      "independent_replication": null,
      "observed_result": "27.6% versus 23.4%, difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points; noninferiority P=0.19. The original conclusion that being within the prespecified +7-percentage-point margin was not demonstrated is preserved. Rates, difference, one-sided upper bound, and PP context are distinct; no new event counts, RR/OR, two-sided CI, or superiority P are calculated.",
      "result_level": "Outcome wording in the stored summary",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Stored file",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete."
        },
        {
          "material_type": "External paper",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Registration material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Protocol",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Funding, product-support and COI material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/29715355/"
        }
      ]
    },
    {
      "report_id": "S02",
      "title": "Helal KF et al. 2020 systematic review and meta-analysis",
      "url": "https://pubmed.ncbi.nlm.nih.gov/31989292/",
      "report_type": "11-RCT subgroup analysis within 24 studies",
      "existence": "Stored bibliography exists; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "study_family": "SYN2949-HELAL-2020",
      "independent_replication": null,
      "observed_result": "More maternal hypoglycemia and LGA with glyburide in the RCT subgroup, and overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95). Wording at a different analysis level in the stored summary’s safety explanation is also preserved. The overall OR is not repurposed as RCT-only/INDAO/composite data; no new effects/CIs/totals/reassessment are created.",
      "result_level": "Outcome wording in the stored summary",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Stored file",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete."
        },
        {
          "material_type": "External paper",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Registration material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Protocol",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Funding, product-support and COI material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/31989292/"
        }
      ]
    },
    {
      "report_id": "S03",
      "title": "Langer O et al. 2000",
      "url": "https://pubmed.ncbi.nlm.nih.gov/11036118/",
      "report_type": "Randomized glyburide-versus-insulin trial",
      "existence": "Stored bibliography exists; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "study_family": "RG2949-LANGER-2000",
      "independent_replication": null,
      "observed_result": "LGA 12% versus 13%, neonatal hypoglycemia 9% versus 6%; no significant difference in individual complications; “clinically effective alternative” conclusion. Individual values and the original alternative conclusion are attributed to that earlier trial. Gaps in denominators/original CI/P/plans remain; no new judgment of passing NI, significant harm, or an exactly zero effect is made.",
      "result_level": "Outcome wording in the stored summary",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Stored file",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete."
        },
        {
          "material_type": "External paper",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Registration material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Protocol",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Statistical analysis plan",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        },
        {
          "material_type": "Funding, product-support and COI material",
          "public_status": "Public availability unverified; only bibliography links preserved",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/11036118/"
        }
      ]
    }
  ],
  "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"
    },
    {
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      "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"
    },
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      "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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications."
  },
  "history": [
    {
      "date": "2026-10-11",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-11"
}