{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2949-s1",
  "verdict_number": "2949",
  "title": "Glyburide × superiority conclusion of significantly greater harm than insulin: 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": "Original gestational-diabetes population requiring medication; shared with the sibling noninferiority sheet",
    "intervention": "Original study: glyburide; assignment/actual exposure/concomitant treatment/switching unverified",
    "dose": null,
    "comparator": "Insulin; observed direction separated from harm-superiority testing",
    "endpoint": "Superiority conclusion that glyburide is significantly more harmful; INDAO note: unconfirmed; composite/individual harms distinguished",
    "duration": "Perinatal context; exact event period/long-term outcomes 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": "Comparative harm and production from preserved material",
      "question": "What existing verdict accompanies the selected harm-superiority question?",
      "needed": "Exact claim, subclaim D/note, and separation from parent C54",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Exact claim, subclaim D/note, and separation from parent C54.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Exact claim, subclaim D/note, and separation from parent C54. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain the two questions’ pointers and verdict contexts separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "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 “Superiority conclusion that glyburide is significantly more harmful”; D and “INDAO did not confirm that conclusion” are preserved. Sibling noninferiority C and parent C54 are separate contexts.",
      "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/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm. The original content review remains incomplete.",
      "missingness": "Subclaim score/status/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm.",
      "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": "Comparative harm and production from preserved material",
      "question": "Which events and population are compared by “more harmful”?",
      "needed": "Fixed harm-event definitions, population, comparator, and period",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Fixed harm-event definitions, population, comparator, and period.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Fixed harm-event definitions, population, comparator, and period. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Attribute harm questions separately to the perinatal composite and individual events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original context is a glyburide-versus-insulin perinatal comparison in gestational diabetes requiring medication. The INDAO composite and individual maternal/neonatal events are separated.",
      "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 selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations. The original content review remains incomplete.",
      "missingness": "The selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations.",
      "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": "Prespecified superiority-question definition and event-specific results"
    },
    {
      "item_id": "N03",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are population, pregnancy timing, and baseline risk known?",
      "needed": "Actual recruitment conditions, medication requirement, and baseline risk",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Actual recruitment conditions, medication requirement, and baseline risk.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Actual recruitment conditions, medication requirement, and baseline risk. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate the scope for other pregnancy/diabetes populations and vulnerable groups. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original scope of 13 French university hospitals and gestational diabetes requiring medication even after 10 days of dietary treatment is 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. Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion are unverified. The original content review remains incomplete.",
      "missingness": "Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion 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": "Recruitment, baseline-characteristic, and risk tables"
    },
    {
      "item_id": "N04",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What are actual exposure, comparator, and concomitant treatment?",
      "needed": "Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate nominal assignment, actual exposure, and other causes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript records oral glyburide versus injected insulin. Only original study conditions are described; no administration/substitution instructions are created.",
      "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. Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences are unverified. The original content review remains incomplete.",
      "missingness": "Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences 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": "Arm-specific intervention, exposure, and concomitant-treatment/change records"
    },
    {
      "item_id": "N05",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Was INDAO designed to test superiority in harm?",
      "needed": "Noninferiority/superiority hypotheses, prespecified tests, and analysis plan",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish results for different statistical questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO is an open-label randomized noninferiority trial. The selected note records that the superiority-in-harm conclusion was not confirmed.",
      "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. A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design. The original content review remains incomplete.",
      "missingness": "A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design.",
      "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": "Hypothesis/testing plans in the protocol and SAP"
    },
    {
      "item_id": "N06",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What were actual randomization, open-label procedures, and measurement operations?",
      "needed": "Allocation, concealment, baseline balance, event measurement, and blinding",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Allocation, concealment, baseline balance, event measurement, and blinding.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Allocation, concealment, baseline balance, event measurement, and blinding. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link design to limitations of actual event measurement. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original description is open-label randomization of 914 participants (460/454) at 13 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. Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design. The original content review remains incomplete.",
      "missingness": "Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design.",
      "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, measurement, and blinding-operation material"
    },
    {
      "item_id": "N07",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What are perinatal-composite event definitions and counting units?",
      "needed": "Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Record composite person/event units and each harm separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO’s primary composite is at least one of three components. Maternal hypoglycemia is not moved into this explicitly stated 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. Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods are unverified. The original content review remains incomplete.",
      "missingness": "Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods 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/component definitions and event tables"
    },
    {
      "item_id": "N08",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are original event rates/difference interpreted directly as superiority in harm?",
      "needed": "Original rates, absolute difference, denominators, and testing framework",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Original rates, absolute difference, denominators, and testing framework.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original rates, absolute difference, denominators, and testing framework. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate observed direction from testing conclusions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original composite rates of 27.6% versus 23.4% and absolute difference of +4.2 percentage points are preserved. Observed direction and confirmation of significant superiority in harm do not mean the same thing.",
      "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 event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is calculated. The original content review remains incomplete.",
      "missingness": "Exact event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is 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": "Event/denominator result tables and superiority analysis"
    },
    {
      "item_id": "N09",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Is the one-sided noninferiority interval a harm-superiority interval?",
      "needed": "Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain the hypothesis and interval definition of the original statistics. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Supplied values are a one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=.19.",
      "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 superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P. The original content review remains incomplete.",
      "missingness": "The superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P.",
      "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": "Prespecified superiority plan and corresponding original analysis table"
    },
    {
      "item_id": "N10",
      "question_type": "Comparative harm and production from preserved material",
      "question": "How does failure at the +7-percentage-point threshold differ from significant harm?",
      "needed": "Distinction between the noninferiority margin and superiority conclusion",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Distinction between the noninferiority margin and superiority conclusion.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Distinction between the noninferiority margin and superiority conclusion. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate the failed question from the distinct unconfirmed conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript says the +10.5-percentage-point upper bound exceeded the prespecified +7-percentage-point margin, so being within the acceptable margin was not demonstrated. It explicitly states this was not proof of significantly worse outcomes.",
      "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 superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is created. The original content review remains incomplete.",
      "missingness": "No new superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is 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": "Original noninferiority/superiority plans and conclusions"
    },
    {
      "item_id": "N11",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are assignment, PP, exposure, and neonatal denominators separated?",
      "needed": "Person/neonatal units and assignment/exposure/observation/analysis units",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Person/neonatal units and assignment/exposure/observation/analysis units.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Person/neonatal units and assignment/exposure/observation/analysis units. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link exposed participants, people with events, and analysis units separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "914 randomized (460/454) and the prespecified PP 809 (367/442) are preserved separately.",
      "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 exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks are calculated. The original content review remains incomplete.",
      "missingness": "Arm-specific exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks 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 endpoint-specific denominator tables"
    },
    {
      "item_id": "N12",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Do other analysis populations confirm the superiority conclusion?",
      "needed": "Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain PP, supplementary analyses, and harm superiority as distinct records. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript records only that 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. Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or ITT confirmation. The original content review remains incomplete.",
      "missingness": "Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or 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": "Supplementary analyses/SAP and effect-of-interest material"
    },
    {
      "item_id": "N13",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are harm-observation timing, missed tests, and discontinuation known?",
      "needed": "Exposure start/end, event timing, testing/follow-up, and discontinuation",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Exposure start/end, event timing, testing/follow-up, and discontinuation.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Exposure start/end, event timing, testing/follow-up, and discontinuation. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish unreported/unverified information from absence of events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Only the historical study context of the perinatal composite and medication assignment is available.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information are unverified. The original content review remains incomplete.",
      "missingness": "Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information 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": "Event-collection, follow-up, and discontinuation records"
    },
    {
      "item_id": "N14",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Were concurrent treatment and alternative explanations reviewed?",
      "needed": "Baseline risk, concomitant treatment, switching, confounding, and adjustment",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Baseline risk, concomitant treatment, switching, confounding, and adjustment.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Baseline risk, concomitant treatment, switching, confounding, and adjustment. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish observed harm from causal attribution to a single medication. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original descriptions of an open-label randomized comparison and medication requirement after dietary treatment are preserved.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted. The original content review remains incomplete.",
      "missingness": "Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted.",
      "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": "Baseline/concomitant treatment, actual exposure, and adjusted-analysis tables"
    },
    {
      "item_id": "N15",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What is the actual reading level for registration and the superiority plan?",
      "needed": "NCT identifier, hypotheses, change history, and protocol/SAP",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: NCT identifier, hypotheses, change history, and protocol/SAP.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: NCT identifier, hypotheses, change history, and protocol/SAP. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "If corresponding material is supplied, record differences among hypotheses, changes, and reporting. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "NCT01731431 is preserved as originally recorded. The number does not mean the superiority plan was read.",
      "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 registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established. The original content review remains incomplete.",
      "missingness": "External registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established.",
      "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": "Comparative harm and production from preserved material",
      "question": "What verification scope applies to public funding and unreported commercial support?",
      "needed": "PHRC/AP-HP, commercial support, medication, authors/COI, and roles",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: PHRC/AP-HP, commercial support, medication, authors/COI, and roles.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: PHRC/AP-HP, commercial support, medication, authors/COI, and roles. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish disclosed information from unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The original description of French Ministry of Health PHRC and AP-HP public sponsor support, and unreported commercial pharmaceutical funding/free study medication, is 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. Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification is made. The original content review remains incomplete.",
      "missingness": "Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification 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": "Original funding, product, author/COI, and role material"
    },
    {
      "item_id": "N17",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Is INDAO maternal hypoglycemia evidence of composite superiority?",
      "needed": "Maternal-event definition, arm-specific values, denominators, and harm analysis",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Maternal-event definition, arm-specific values, denominators, and harm analysis.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Maternal-event definition, arm-specific values, denominators, and harm analysis. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Attribute maternal harms and the neonatal composite separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The manuscript describes more frequent maternal hypoglycemia in the glyburide arm. It is not transferred to 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 values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance. The original content review remains incomplete.",
      "missingness": "Arm-specific values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance.",
      "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 hypoglycemia result table and analysis plan"
    },
    {
      "item_id": "N18",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are INDAO’s individual neonatal-component results known?",
      "needed": "Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate comparison conclusions for the composite and each component. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The pivotal report supplies composite results for three components.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm rates. The original content review remains incomplete.",
      "missingness": "Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm 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": "Component results, definitions, and testing plan"
    },
    {
      "item_id": "N19",
      "question_type": "Comparative harm and production from preserved material",
      "question": "How are Helal’s overall synthesis and RCT subgroup analysis distinguished?",
      "needed": "24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate synthesis reports from actual original-trial/population units. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The review records 24 studies with 24,517 participants overall and an 11-RCT subgroup.",
      "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. RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets. The original content review remains incomplete.",
      "missingness": "RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets.",
      "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-trial and design/endpoint-specific analysis tables"
    },
    {
      "item_id": "N20",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What are the review’s RCT maternal hypoglycemia/LGA results?",
      "needed": "Subgroup endpoints, effects/intervals, arms/denominators, and definitions",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Subgroup endpoints, effects/intervals, arms/denominators, and definitions.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Subgroup endpoints, effects/intervals, arms/denominators, and definitions. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Attribute results individually by analysis level, event, and material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "S02’s evidence/citation entries record more maternal hypoglycemia and LGA in the RCT subgroup.",
      "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. Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO composite. The original content review remains incomplete.",
      "missingness": "Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO 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": "Original endpoint-specific RCT subgroup analysis tables"
    },
    {
      "item_id": "N21",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Which result does the overall pooled neonatal hypoglycemia OR describe?",
      "needed": "Overall pooling, neonatal events, OR/CI, and original analysis scope",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Overall pooling, neonatal events, OR/CI, and original analysis scope.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Overall pooling, neonatal events, OR/CI, and original analysis scope. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Link the original OR/interval only to its corresponding overall analysis. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "S02’s evidence entry supplies 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. Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms. The original content review remains incomplete.",
      "missingness": "Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms.",
      "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": "Endpoint/design-specific result tables for the overall pooling"
    },
    {
      "item_id": "N22",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What is the difference between stored-summary descriptions of the review’s analysis levels?",
      "needed": "Outcome attribution in evidence/safety explanations and external-verification scope",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Outcome attribution in evidence/safety explanations and external-verification scope.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Outcome attribution in evidence/safety explanations and external-verification scope. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "If the original paper is supplied, record explanations/correction events for the wording difference separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The Korean/English safety explanation records increased neonatal hypoglycemia and LGA in the RCT subgroup. The evidence list distinguishes RCT maternal hypoglycemia/LGA from the overall neonatal hypoglycemia OR.",
      "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. Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint is made. The original content review remains incomplete.",
      "missingness": "Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint 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": "Endpoint-specific overall/RCT tables in the original review"
    },
    {
      "item_id": "N23",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What information do Helal’s support and registration entries actually provide?",
      "needed": "Review/included-trial funding, COI, plans, and registration",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Review/included-trial funding, COI, plans, and registration.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Review/included-trial funding, COI, plans, and registration. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate material types, review roles, and original-trial support. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S02"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The funding entry is “systematic review; included-trial funding mixed”, and nct is “not applicable”. The actual registration identifier remains null.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification. The original content review remains incomplete.",
      "missingness": "The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification.",
      "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, disclosures, and included-trial support table"
    },
    {
      "item_id": "N24",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What were the earlier Langer trial’s opposing results?",
      "needed": "Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Record opposing results together with limitations from different questions/designs. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The 404-participant RCT had primary glycemic control and secondary individual perinatal outcomes. LGA 12/13%, neonatal hypoglycemia 9/6%, no significant difference, 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. Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success. The original content review remains incomplete.",
      "missingness": "Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success.",
      "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 and individual-event result tables"
    },
    {
      "item_id": "N25",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What level do Langer’s funding/registration wordings represent?",
      "needed": "Actual supporter, product/COI, registration, and plans",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Actual supporter, product/COI, registration, and plans.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Actual supporter, product/COI, registration, and plans. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish original wording from newly supplied actual identity material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Funding “reported in the original paper” and nct “not applicable” are preserved as originally recorded. These wordings are not an actual funding provider or registration number.",
      "condition_status": "Unverified",
      "status_reason": "Currently required information in the stored summary is unverified. External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established. The original content review remains incomplete.",
      "missingness": "External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established.",
      "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 plan, support, and COI material"
    },
    {
      "item_id": "N26",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are the same events, trials, and review counted as independent replications?",
      "needed": "Report-to-trial-to-event links, recitation, and review-inclusion relationships",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Report-to-trial-to-event links, recitation, and review-inclusion relationships.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Report-to-trial-to-event links, recitation, and review-inclusion relationships. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain relationships among original trials, review recitations, and the same people/timepoints. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO, the Helal review, and Langer are linked as separate report slots and shared with the sibling noninferiority sheet.",
      "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, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals. The original content review remains incomplete.",
      "missingness": "Review inclusion, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals.",
      "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 and event-linking tables"
    },
    {
      "item_id": "N27",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Does the current record establish comparison direction, a signal, or causality?",
      "needed": "Design, intervals, alternatives, and original-conclusion scope of each material",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Design, intervals, alternatives, and original-conclusion scope of each material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Design, intervals, alternatives, and original-conclusion scope of each material. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Maintain each original report’s comparison/interpretation scope separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "INDAO’s failure to demonstrate noninferiority/unconfirmed superiority are distinguished from individual maternal/neonatal harm contexts. Selected D is the original-data verdict, not a new harm grade.",
      "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 conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority are created. The original content review remains incomplete.",
      "missingness": "No new conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority 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": "Original hypothesis/interval and event-specific conclusions, plus alternative material"
    },
    {
      "item_id": "N28",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Is the result extended to other drugs, vulnerable groups, or long-term harms?",
      "needed": "Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Separate the narrow comparative-harm question from questions outside its scope. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "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 characteristics vary by drug and are not generalized to the whole class.",
      "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 material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring are created. The original content review remains incomplete.",
      "missingness": "Direct material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring 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-harm material"
    },
    {
      "item_id": "N29",
      "question_type": "Comparative harm and production from preserved material",
      "question": "What historical context do parent values, languages, empty values, dates, and corrections provide?",
      "needed": "Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "Parent C54, unrecorded precision, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, historical cross-checking, and selected D/note 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. Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review. The original content review remains incomplete.",
      "missingness": "Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review.",
      "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, user comments, and supplied original material"
    },
    {
      "item_id": "N30",
      "question_type": "Comparative harm and production from preserved material",
      "question": "Are actual summary reading and unread external material distinguished?",
      "needed": "Access status for preserved material, papers, registration, protocol, SAP, and disclosures",
      "role": "Required",
      "role_reason": "A production item connecting required and available material for the selected question by distinguishing: Access status for preserved material, papers, registration, protocol, SAP, and disclosures.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Access status for preserved material, papers, registration, protocol, SAP, and disclosures. Stored wording is linked here; the original content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Update each material’s existence, acquisition, and reading level separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.",
      "current_reports": [
        "S01",
        "S02",
        "S03"
      ],
      "existence": "Stored summary/bibliography links; external identity unverified",
      "acquired_read": "Summary read; external material unread",
      "observation": "The full JSON with three evidence entries and three citations was read for production, and original links are preserved. Summaries are labeled “summary read”; external material is labeled “unread”.",
      "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, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access. The original content review remains incomplete.",
      "missingness": "External abstracts/full texts, registration, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access.",
      "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": "Each material and actual reading record"
    }
  ],
  "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": "The original note that INDAO did not confirm the superiority conclusion of significantly greater harm is preserved. 27.6% versus 23.4%, difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, and noninferiority P=0.19 are noninferiority results; that CI upper bound/P is not repurposed as a superiority interval/test. Observed composite direction, maternal-hypoglycemia descriptions, and superiority confirmation are distinct.",
      "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"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "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": "The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-11"
}