{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2948-s1", "verdict_number": "2948", "title": "Metformin × birthweight above 4000 g: evidence checklist for pregnancy with overweight or obesity and no diabetes", "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 entire existing stored summary was read during production and original URLs and identifiers were linked. External abstracts, full texts, registrations, protocols and SAPs were not newly read or checked.", "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": "Pregnancy with overweight or obesity and no diabetes; trial-specific eligibility and baseline details remain unread", "intervention": "Metformin research intervention in the relevant trials; no instructions for selecting, using, taking or replacing medication", "dose": "Only historical EMPOWaR research conditions are preserved: up to 2500 mg/day from 12–16 weeks of pregnancy until delivery; not transferred to MOP or GRoW", "comparator": "Placebo in each trial; the GRoW comparison context of addition to dietary and lifestyle advice is preserved", "endpoint": "Selected reduction in births above 4000 g; direct GRoW results are distinct from z-score results in other trials", "duration": "Outcome at birth; GRoW exposure details remain unverified", "excluded_extensions": [ "Transfer to treatment of gestational or type 2 diabetes", "Copying different results between z-score, mean-gram and birthweight-above-4000-g endpoints", "Confirmation of effects on long-term obesity or other clinical events", "Medication selection, use, replacement, dosing or pregnancy-management instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Comparative efficacy", "question": "Is the original birthweight-above-4000-g claim and subclaim verdict separate from the parent z-score context?", "needed": "Distinction between selected wording, grade and note, and parent values", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Distinction between selected wording, grade and note, and parent values", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If additional material arrives, link the selected endpoint and parent context separately.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing question is “Fewer births above 4000 g”; its original grade is D and its note records GRoW aRR 0.97, P=0.899. The parent verdict is D, 30 points, safety Caution, and synthesizes z-score and other results.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.", "missingness": "Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absent subclaim score, status and axes are not filled from parent values. No new verdict is made." }, { "item_id": "N02", "question_type": "Comparative efficacy", "question": "Is the actual GRoW population distinguished from other pregnancy and diabetes contexts?", "needed": "Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original GRoW eligibility, baseline characteristics, recruitment conditions and denominators.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The GRoW bibliography specifies pregnant women with overweight or obesity; the parent record describes the context as pregnancy without diabetes.", "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. Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.", "missingness": "Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes." }, { "item_id": "N03", "question_type": "Comparative efficacy", "question": "Are GRoW intervention, placebo and research exposure directly preserved?", "needed": "Trial-specific original records of ingredient, formulation, dose, exposure and adherence", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Trial-specific original records of ingredient, formulation, dose, exposure and adherence", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link supplied original GRoW protocol and actual exposure material.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW is recorded as a multicenter double-blind placebo-controlled randomized trial of metformin.", "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. GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.", "missingness": "GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred." }, { "item_id": "N04", "question_type": "Comparative efficacy", "question": "Is the comparison of medication added to dietary and lifestyle advice preserved?", "needed": "Original material on common advice, placebo, added intervention and other care", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Original material on common advice, placebo, added intervention and other care", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original trial arm-specific common and differing care and actual exposure.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The GRoW bibliography records the comparison as metformin added to dietary and lifestyle advice.", "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. Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.", "missingness": "Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created." }, { "item_id": "N05", "question_type": "Comparative efficacy", "question": "Are the above-4000-g threshold, birth measurement and assessment unit distinguished?", "needed": "Strictly-above definition, measurement timing, measurement method and analysis unit", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Strictly-above definition, measurement timing, measurement method and analysis unit", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain the original endpoint definition, birthweight measurement, boundary-value handling and analysis unit.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The existing endpoint is “birthweight above 4000 g”; its English wording is birthweight above 4000 g.", "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. It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.", "missingness": "It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread." }, { "item_id": "N06", "question_type": "Comparative efficacy", "question": "What are trial-specific primary/secondary hierarchies and plans for the birth endpoint?", "needed": "Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link endpoint hierarchies and change histories separately from each trial’s registration, protocol and SAP.", "current_reports": [ "R01", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR records standardized z score as primary. GRoW birthweight above 4000 g is preserved as a separate result.", "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. EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.", "missingness": "EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread." }, { "item_id": "N07", "question_type": "Comparative efficacy", "question": "Are GRoW randomized and analyzed counts distinguished?", "needed": "Original arm-specific assignment, analysis, follow-up and missingness flow and denominators", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Original arm-specific assignment, analysis, follow-up and missingness flow and denominators", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original tables of arm-specific participant flow, exclusion, follow-up and outcome-specific analysis denominators.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW had 524 randomized and 514 analyzed.", "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 assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.", "missingness": "Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome." }, { "item_id": "N08", "question_type": "Comparative efficacy", "question": "Are denominators for pregnant women, infants, birth events and repeated measurements the same?", "needed": "Analysis units for people, pregnancies, infants and birth events, with handling of overlap", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Analysis units for people, pregnancies, infants and birth events, with handling of overlap", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original analysis units, pregnancy/birth mapping, exclusions and denominators.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original material records randomized and analyzed counts as people, and birthweight above 4000 g as 40 versus 37 people.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.", "missingness": "Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed." }, { "item_id": "N09", "question_type": "Comparative efficacy", "question": "Are the original 40 (16%) versus 37 (14%) values and arm order maintained?", "needed": "Original arm-specific events, proportions, denominators and outcome tables", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Original arm-specific events, proportions, denominators and outcome tables", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link original table arm labels, events, denominators and proportions exactly as recorded.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The GRoW evidence list records 40 (16%) versus 37 (14%); the original text also preserves 16% versus 14%.", "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. Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.", "missingness": "Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit." }, { "item_id": "N10", "question_type": "Comparative efficacy", "question": "Are adjusted RR, CI and P preserved separately from original proportions?", "needed": "Original material on adjusted effect, model, variables, interval and test", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Original material on adjusted effect, model, variables, interval and test", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain adjustment plans, variables, arm-specific denominators and original between-arm effect tables.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "aRR 0.97 (95% CI 0.65 to 1.47), P=0.899 is recorded as originally given.", "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 crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.", "missingness": "No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread." }, { "item_id": "N11", "question_type": "Comparative efficacy", "question": "Has a null result been kept separate from confirmed exclusion of meaningful reduction?", "needed": "A validated prespecified clinical threshold and effect interval", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "A validated prespecified clinical threshold and effect interval", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain importance criteria, a prespecified validated threshold and plans suited to the population and endpoint.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text records no demonstrated birthweight benefit but says meaningful benefit cannot be declared excluded because a validated prespecified clinical threshold is absent.", "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 aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.", "missingness": "The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction." }, { "item_id": "N12", "question_type": "Comparative efficacy", "question": "Were GRoW allocation and masking details kept separate from EMPOWaR?", "needed": "Trial-specific allocation concealment, masking and outcome-measurement procedures", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Trial-specific allocation concealment, masking and outcome-measurement procedures", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain allocation, concealment, measurement and analysis procedures from the original GRoW methods.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW’s design is a multicenter double-blind placebo-controlled randomized trial. EMPOWaR has separate allocation and masking quotations.", "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. EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.", "missingness": "EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details." }, { "item_id": "N13", "question_type": "Comparative efficacy", "question": "Are GRoW analysis population, missingness and follow-up methods directly supplied?", "needed": "Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain GRoW analysis-population definitions, arm exclusions, missing-data handling and sensitivity material.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Only the summary of 524 randomized and 514 analyzed is preserved for GRoW. Explicit modified ITT and 97% belong to the EMPOWaR context.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.", "missingness": "The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred." }, { "item_id": "N14", "question_type": "Comparative efficacy", "question": "Are actual exposure, gastrointestinal symptoms and adherence linked to the birth analysis?", "needed": "Trial-specific records of actual exposure, adherence, discontinuation and outcomes", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Trial-specific records of actual exposure, adherence, discontinuation and outcomes", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain actual GRoW exposure, discontinuation and adherence material and the prespecified effect of interest.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The parent record describes gastrointestinal adverse effects and lower adherence.", "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. GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.", "missingness": "GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated." }, { "item_id": "N15", "question_type": "Comparative efficacy", "question": "Are birthweight above 4000 g, mean grams and z score the same endpoint?", "needed": "Separate original definitions, denominators, timepoints and effects for each measure", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Separate original definitions, denominators, timepoints and effects for each measure", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If trial- and measure-specific results are supplied, link original endpoints and denominators separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR means of 3462 g versus 3463 g and its adjusted z-score difference of −0.029 are from a different trial and measures. MOP z scores are also 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. Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.", "missingness": "Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events." }, { "item_id": "N16", "question_type": "Comparative efficacy", "question": "Are the EMPOWaR primary z-score result and analysis denominators maintained as context?", "needed": "Endpoint, denominator and plan boundaries of another trial", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Endpoint, denominator and plan boundaries of another trial", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If EMPOWaR material for the selected event endpoint is supplied, link it with direct definitions and denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR randomized 449 (226/223) and had 434 in modified ITT; its adjusted z-score difference was −0.029 (95% CI −0.217 to 0.158), P=0.7597.", "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. These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.", "missingness": "These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary." }, { "item_id": "N17", "question_type": "Comparative efficacy", "question": "Is the MOP z-score report and registration link kept separate from direct evidence for the selected event?", "needed": "Distinction between trial-specific bibliographies, material types, endpoints and effects", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Distinction between trial-specific bibliographies, material types, endpoints and effects", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain registration and the paper separately to link the selected event endpoint, plans and denominators.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "MOP z scores of 0.05 versus 0.17, P=0.66 and “400 analyzed” are preserved. The citation URL is the NCT01273584 registration page.", "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. MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.", "missingness": "MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text." }, { "item_id": "N18", "question_type": "Comparative efficacy", "question": "Are original repeated-null and independence wording distinguished from certification in this work?", "needed": "Links between ingredient, pregnancy without diabetes, trial identity and study families", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Links between ingredient, pregnancy without diabetes, trial identity and study families", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link only direct trial-to-endpoint relationships and pass additional material to content review.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The parent text records null birthweight results in three trials; GRoW’s original evidence-role wording is independent repeated null evidence.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.", "missingness": "The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification." }, { "item_id": "N19", "question_type": "Comparative efficacy", "question": "Do the two related sheets share the same reports, trials and cohorts?", "needed": "Explicit links between stored summary, bibliographies, trials and participants", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Explicit links between stored summary, bibliographies, trials and participants", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link additional reports to existing identifiers and preserve same-population relationships.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The z-score and above-4000-g sheets share the entire stored parent-verdict 2948 summary and three reports.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.", "missingness": "Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded." }, { "item_id": "N20", "question_type": "Comparative efficacy", "question": "Has the birth event been kept separate from later obesity and other clinical pregnancy outcomes?", "needed": "Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Each clinical outcome requires separate direct measurement, follow-up, denominators and effects.", "current_reports": [ "R01", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text records birthweight as a surrogate for later obesity risk. The fatal composite is a separate harm outcome.", "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. Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.", "missingness": "Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes." }, { "item_id": "N21", "question_type": "Comparative efficacy", "question": "Has the verdict’s scope been kept separate from other diabetes treatment and pregnancy management?", "needed": "Direct evidence and boundaries for disease and indication contexts", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Direct evidence and boundaries for disease and indication contexts", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link evidence for a new indication to its separate population, comparator and endpoint.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text explicitly states that the verdict does not apply to treatment of gestational or type 2 diabetes and that mechanism explanations do not substitute for birthweight efficacy.", "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 medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.", "missingness": "No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced." }, { "item_id": "N22", "question_type": "Comparative efficacy", "question": "Are GRoW public funding and gaps in the four company roles distinguished?", "needed": "Separate records for cash support, product provision, affiliated authors and outside analysis providers", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Separate records for cash support, product provision, affiliated authors and outside analysis providers", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original GRoW funding, product supply, affiliations, analysis and writing roles separately.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW funding names the Australian National Health and Medical Research Council; the citation records publicly funded independent replication.", "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. Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.", "missingness": "Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary." }, { "item_id": "N23", "question_type": "Comparative efficacy", "question": "Were EMPOWaR Merck supply and role declarations kept separate from GRoW funding?", "needed": "Trial-specific relationships of public support, sponsorship, products and company roles", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Trial-specific relationships of public support, sponsorship, products and company roles", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link original conflict-of-interest material for the three trials separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR MRC·NIHR support, Edinburgh/NHS co-sponsorship, free Merck drug/placebo supply and the no-role declaration 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. They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.", "missingness": "They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording." }, { "item_id": "N24", "question_type": "Supplementary harm evidence", "question": "Are person, event and exposure denominators available for gastrointestinal harm, discontinuation and adherence?", "needed": "Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original GRoW safety tables and exposure, discontinuation and adherence material.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Gastrointestinal adverse effects and lower adherence are recorded in the original safety account.", "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. GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.", "missingness": "GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety." }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Has the EMPOWaR fatal composite’s composition and figures been kept separate from GRoW harm?", "needed": "Distinction between trials, arms, component events, follow-up and denominators", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Distinction between trials, arms, component events, follow-up and denominators", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link each trial’s component event definitions, original arm event tables and denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The EMPOWaR miscarriage, pregnancy termination, stillbirth and neonatal-death composite was 7 with metformin versus 2 with placebo, OR 3.60 (95% CI 0.74 to 17.50), P=0.11.", "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. These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.", "missingness": "These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread." }, { "item_id": "N26", "question_type": "Supplementary harm evidence", "question": "Are nonsignificance and wide CIs for rare harm distinguished from confirmed safety?", "needed": "Material directly addressing effects, precision, exposure and rare harm", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Material directly addressing effects, precision, exposure and rare harm", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Adequate arm-specific follow-up, component events, original effects and rare-harm material are needed.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text distinguishes confirmed harm from an uncertain signal because of the wide EMPOWaR CI and P=0.11.", "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 record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.", "missingness": "The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced." }, { "item_id": "N27", "question_type": "Supplementary harm evidence", "question": "Are gaps for maternal, infant and long-term harm and replication material maintained?", "needed": "Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link population-specific direct harm, long-term follow-up and report relationships to original trials.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The current preserved account covers pregnancy and birth-time outcomes and some harm summaries.", "condition_status": "Unverified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.", "missingness": "No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed." }, { "item_id": "N28", "question_type": "Comparative efficacy", "question": "Are original URLs, registration identifiers and actual reading status shown individually?", "needed": "Individual material entries for summary, abstract, full text, registration, protocol and SAP", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Individual material entries for summary, abstract, full text, registration, protocol and SAP", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link user-obtained original material with its individual material type and access status.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW preserves its PubMed bibliography URL and ACTRN12612001277831 identifier. MOP connects its actual original registration URL to a separate registration entry.", "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 URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.", "missingness": "No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread." }, { "item_id": "N29", "question_type": "Comparative efficacy", "question": "Are reference date, original languages, corrections, empty values and parent history preserved?", "needed": "Separate preservation of the entire stored summary, selected verdict record and parent values", "role": "Required", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Separate preservation of the entire stored summary, selected verdict record and parent values", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Reflect new material and decisions as separate change events while preserving the entire original.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The reference date 2026-08-26, empty correction array and empty deliberation string, Korean/English text, parent D30 with safety Caution, and original axes are preserved.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.", "missingness": "This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review." }, { "item_id": "N30", "question_type": "Comparative efficacy", "question": "Is the incomplete content-review marker distinguished from actual production and independence status?", "needed": "Separate records of original candidate history, production status and review status", "role": "Supplementary", "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries", "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.", "criterion": "Separate records of original candidate history, production status and review status", "basis": "Fewer births above 4000 g", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Reflect only user-provided decisions and materials as separate events.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "Existing review-pending, production-eligibility and boundary-review-needed values are preserved as history. The original content review is incomplete; the original model, content and boundary active-pending and completion markers are false.", "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. There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.", "missingness": "There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded." } ], "reports": [ { "report_id": "R01", "title": "Chiswick C, Reynolds RM, Denison F, et al. Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR). Lancet Diabetes Endocrinol. 2015;3:778-786. PMID: 26165398.", "url": "https://pubmed.ncbi.nlm.nih.gov/26165398/", "report_type": "Trial report", "existence": "Materials preserved in original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F01", "independent_replication": false, "observed_result": "0.2464 versus 0.2680; adjusted difference −0.029 (95% CI −0.217 to 0.158), P=0.7597; raw means 3462 g versus 3463 g", "result_level": "Stored evidence summary; not a result of directly reading external papers or registration", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "local_summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Stored parent-verdict summary" }, { "material_type": "abstract", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; an existing link does not mean acquisition, reading or completed content review" }, { "material_type": "fulltext", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; an existing link does not mean acquisition, reading or completed content review" }, { "material_type": "registration", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; an existing link does not mean acquisition, reading or completed content review" }, { "material_type": "protocol_sap", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; an existing link does not mean acquisition, reading or completed content review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26165398/" } ] }, { "report_id": "R02", "title": "Syngelaki A, Nicolaides KH, Balani J, et al. Metformin versus Placebo in Obese Pregnant Women without Diabetes Mellitus. N Engl J Med. 2016. 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