{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2948-s0", "verdict_number": "2948", "title": "Metformin × birthweight z score: 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 birthweight z score; EMPOWaR primary and MOP z-score outcomes are distinct from the GRoW binary endpoint", "duration": "Outcome at birth; EMPOWaR research exposure from 12–16 weeks of pregnancy until delivery", "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 selected z-score claim and subclaim verdict separate from the parent context?", "needed": "Separate records of subclaim wording, grade and note, and the parent verdict", "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 of subclaim wording, grade and note, and the parent verdict", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If additional material is supplied, link material for the subclaim question and the parent context separately.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing question is “Lower birthweight z score”; its original grade is D and its note says EMPOWaR and MOP were null. The parent verdict is D, 30 points, with safety marked Caution.", "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 and axes are absent and are not filled from the parent values. This production is not a new grade assessment.", "missingness": "Subclaim score, status and axes are absent and are not filled from the parent values. This production is not a new grade assessment.", "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": "Subclaim score, status and axes are absent and are not filled from the parent values. This production is not a new grade assessment." }, { "item_id": "N02", "question_type": "Comparative efficacy", "question": "What defines the population of pregnant women with overweight or obesity and no diabetes?", "needed": "Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific 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": "Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link original trial-specific eligibility, baseline characteristics and population denominators.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original population is pregnant women with overweight or obesity and no diabetes; EMPOWaR took place at 15 UK NHS hospitals. The parent verdict does not apply to treatment of gestational or type 2 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. Detailed original tables of trial-specific BMI, age, diabetes exclusion criteria and baseline characteristics remain unread.", "missingness": "Detailed original tables of trial-specific BMI, age, diabetes exclusion criteria and baseline characteristics 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": "Detailed original tables of trial-specific BMI, age, diabetes exclusion criteria and baseline characteristics remain unread." }, { "item_id": "N03", "question_type": "Comparative efficacy", "question": "Is EMPOWaR research exposure distinguished from exposure in the other trials?", "needed": "Trial-specific original records of ingredient, formulation, research dose, start time and duration", "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, research dose, start time and duration", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link research exposure recorded in each trial’s original protocol and actual exposure material.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR’s historical research conditions were metformin from 12–16 weeks of pregnancy until delivery, up to 2500 mg/day.", "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 conditions are not transferred as MOP or GRoW doses or used as instructions for taking, choosing or replacing medication during pregnancy. Formulation and actual exposure remain unverified.", "missingness": "These conditions are not transferred as MOP or GRoW doses or used as instructions for taking, choosing or replacing medication during pregnancy. Formulation and actual exposure remain unverified.", "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 conditions are not transferred as MOP or GRoW doses or used as instructions for taking, choosing or replacing medication during pregnancy. Formulation and actual exposure remain unverified." }, { "item_id": "N04", "question_type": "Comparative efficacy", "question": "Were placebo and accompanying care, including dietary and lifestyle advice, the same conditions?", "needed": "Records of each arm’s placebo, common accompanying care, contact and additional treatment", "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": "Records of each arm’s placebo, common accompanying care, contact and additional treatment", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Preserve original trial-specific comparators and common and differing accompanying care.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR, MOP and GRoW are all summarized as placebo-controlled. The GRoW bibliography specifies comparison of 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. GRoW lifestyle advice is not filled in as identical exposure in the other two trials. Details and deviations in each arm’s care remain unread.", "missingness": "GRoW lifestyle advice is not filled in as identical exposure in the other two trials. Details and deviations in each arm’s care 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": "GRoW lifestyle advice is not filled in as identical exposure in the other two trials. Details and deviations in each arm’s care remain unread." }, { "item_id": "N05", "question_type": "Comparative efficacy", "question": "What are the standardized definition and measurement timing of birthweight z score?", "needed": "Birth measurement, gestational age, parity and sex standardization methods and units", "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": "Birth measurement, gestational age, parity and sex standardization methods and units", "basis": "Lower birthweight z score", "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, standardization rules and birthweight measurement methods.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The stored original text describes the EMPOWaR primary endpoint as the z score corresponding to the gestational-age-, parity- and sex-standardized birthweight percentile.", "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 specific reference population, formula, measurement procedure and application to individual deliveries remain unread; no new z-score calculation is made.", "missingness": "The specific reference population, formula, measurement procedure and application to individual deliveries remain unread; no new z-score calculation 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": "The specific reference population, formula, measurement procedure and application to individual deliveries remain unread; no new z-score calculation is made." }, { "item_id": "N06", "question_type": "Comparative efficacy", "question": "Are EMPOWaR z-score means and the adjusted mean difference, CI and P preserved as recorded?", "needed": "Original arm means, adjusted effect, interval, test and analysis model", "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 means, adjusted effect, interval, test and analysis model", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link the original report’s adjustment model, variables, denominators and between-arm effect.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR z scores were 0.2464 versus 0.2680, with an adjusted difference of −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. The difference between original means is not recalculated and the adjusted model is not inferred. Adjustment variables and outcome-specific arm denominators are absent from the summary.", "missingness": "The difference between original means is not recalculated and the adjusted model is not inferred. Adjustment variables and outcome-specific arm denominators are absent from the 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": "The difference between original means is not recalculated and the adjusted model is not inferred. Adjustment variables and outcome-specific arm denominators are absent from the summary." }, { "item_id": "N07", "question_type": "Comparative efficacy", "question": "Are raw birthweight in grams and standardized z score the same outcome?", "needed": "Original units, arm order, distributions 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": "Original units, arm order, distributions and effects for each measure", "basis": "Lower birthweight z score", "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, raw gram values, standardized results and uncertainty separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The text records placebo 3463 g and metformin 3462 g, with the original wording of a 1 g difference. The evidence list shows metformin 3462 g versus placebo 3463 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. Arm order is preserved; gram values are not converted into z-score effects. No new calculation, variance or CI is produced.", "missingness": "Arm order is preserved; gram values are not converted into z-score effects. No new calculation, variance or CI 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": "Arm order is preserved; gram values are not converted into z-score effects. No new calculation, variance or CI is produced." }, { "item_id": "N08", "question_type": "Comparative efficacy", "question": "What are the EMPOWaR randomized and modified intention-to-treat denominators?", "needed": "Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria", "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": "Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain the modified intention-to-treat definition, arm-specific exclusions and missingness reasons, and outcome-specific analysis denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "There were 449 randomized participants (226/223) and 434 in the modified intention-to-treat analysis; the original text records 97%.", "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 434 participants are not newly allocated to arms, and no difference, attrition rate or event count is calculated. Exclusion criteria and arm-specific analysis counts remain unread.", "missingness": "The 434 participants are not newly allocated to arms, and no difference, attrition rate or event count is calculated. Exclusion criteria and arm-specific analysis counts 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": "The 434 participants are not newly allocated to arms, and no difference, attrition rate or event count is calculated. Exclusion criteria and arm-specific analysis counts remain unread." }, { "item_id": "N09", "question_type": "Comparative efficacy", "question": "To which trial do the original allocation concealment and masking records apply?", "needed": "Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material", "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 and participant, caregiver and study-personnel masking material", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain each trial’s original methods and allocation, measurement and analysis procedures separately.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text quotes a web-based computer-generated block randomization procedure and masking of participants, caregivers and study personnel for EMPOWaR.", "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 detailed procedures are not transferred as verified MOP or GRoW procedures. Parent axis B0 is a historical value of the existing verdict.", "missingness": "These detailed procedures are not transferred as verified MOP or GRoW procedures. Parent axis B0 is a historical value of the existing verdict.", "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 detailed procedures are not transferred as verified MOP or GRoW procedures. Parent axis B0 is a historical value of the existing verdict." }, { "item_id": "N10", "question_type": "Comparative efficacy", "question": "Are prespecified primary outcomes distinguished from access to registration, protocol and SAP?", "needed": "Original z-score prespecification, registration, changes and analysis-plan material", "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 z-score prespecification, registration, changes and analysis-plan material", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If original registration, protocol and SAP are supplied, link endpoint hierarchy and change history.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text states that the EMPOWaR primary z-score endpoint matches ISRCTN51279843. The evidence list records ISRCTN51279843 · EudraCT 2009-017134-47.", "condition_status": "Partly verified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Registration, protocol and SAP were not opened in this work; only identifiers are preserved. No new original-registration URL is created.", "missingness": "Registration, protocol and SAP were not opened in this work; only identifiers are preserved. No new original-registration URL is 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": "Registration, protocol and SAP were not opened in this work; only identifiers are preserved. No new original-registration URL is created." }, { "item_id": "N11", "question_type": "Comparative efficacy", "question": "Are MOP z-score results and analysis denominators preserved separately?", "needed": "Original MOP population, denominators, endpoint definition, effect and interval material", "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 MOP population, denominators, endpoint definition, effect and interval material", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original MOP denominators, arm labels, measurement definition, effect, CI and missing-data handling.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "MOP z scores were 0.05 versus 0.17, P=0.66. The evidence-list sample size is preserved as “400 analyzed” and the Korean text as “about 400”.", "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. Randomized counts, arm-specific analysis counts, CI and standardization details are not supplied. Approximate values and original wording are not newly harmonized.", "missingness": "Randomized counts, arm-specific analysis counts, CI and standardization details are not supplied. Approximate values and original wording are not newly harmonized.", "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": "Randomized counts, arm-specific analysis counts, CI and standardization details are not supplied. Approximate values and original wording are not newly harmonized." }, { "item_id": "N12", "question_type": "Comparative efficacy", "question": "Are the MOP paper bibliography and registration URL different material types?", "needed": "Separate links for the paper, registration identifier and actual access", "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 links for the paper, registration identifier and actual access", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If the paper and original registration are supplied separately, link their individual access, endpoints and plans.", "current_reports": [ "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The MOP citation is a 2016 NEJM paper bibliography; its URL is clinicaltrials.gov/study/NCT01273584.", "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 registration URL is not marked as reading the paper’s abstract or full text. No PMID, DOI or alternative paper URL is invented.", "missingness": "A registration URL is not marked as reading the paper’s abstract or full text. No PMID, DOI or alternative paper URL is invented.", "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": "A registration URL is not marked as reading the paper’s abstract or full text. No PMID, DOI or alternative paper URL is invented." }, { "item_id": "N13", "question_type": "Comparative efficacy", "question": "Were the effects of the two z-score trials kept separate rather than converted into new figures?", "needed": "The alignment scope of trial-specific standardization, analysis, denominators 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": "The alignment scope of trial-specific standardization, analysis, denominators and effects", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link trial-specific original definitions, denominators, adjustment and CI side by side while preserving their relationships.", "current_reports": [ "R01", "R02" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "EMPOWaR and MOP share the original note that birthweight z-score results were null, but their original effect information and level of standardization detail differ.", "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 meta-analysis, trial-count sum, total participant count or between-arm difference calculation is made.", "missingness": "No new meta-analysis, trial-count sum, total participant count or between-arm difference calculation 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": "No new meta-analysis, trial-count sum, total participant count or between-arm difference calculation is made." }, { "item_id": "N14", "question_type": "Comparative efficacy", "question": "Is the GRoW result for birthweight above 4000 g a direct z-score result?", "needed": "Direct distinction between a continuous standardized measure and a binary birth outcome", "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 a continuous standardized measure and a binary birth outcome", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If z-score material from the same trial is supplied, link its definition, hierarchy and denominator separately.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW records birthweight above 4000 g: 40 (16%) versus 37 (14%), aRR 0.97 (95% CI 0.65 to 1.47), P=0.899.", "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 different measure is not converted into a GRoW z-score effect. This summary contains no GRoW z-score figure.", "missingness": "A different measure is not converted into a GRoW z-score effect. This summary contains no GRoW z-score figure.", "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": "A different measure is not converted into a GRoW z-score effect. This summary contains no GRoW z-score figure." }, { "item_id": "N15", "question_type": "Comparative efficacy", "question": "Are GRoW randomized and analyzed counts distinguished from pregnancy and birth analysis units?", "needed": "Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria", "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": "Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain outcome-specific analysis flow, arm denominators, follow-up and exclusion criteria.", "current_reports": [ "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "GRoW is preserved as 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. These values are not transferred as z-score analysis counts or denominators for every pregnancy and neonatal outcome. Details of pregnant-woman, infant and event units remain unread.", "missingness": "These values are not transferred as z-score analysis counts or denominators for every pregnancy and neonatal outcome. Details of pregnant-woman, infant and event units 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 values are not transferred as z-score analysis counts or denominators for every pregnancy and neonatal outcome. Details of pregnant-woman, infant and event units remain unread." }, { "item_id": "N16", "question_type": "Comparative efficacy", "question": "Are null results distinguished from exclusion of clinically meaningful benefit?", "needed": "A validated prespecified clinical-importance 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-importance threshold and effect interval", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If a prespecified validated threshold and original plan suitable for the population and endpoint are supplied, link them.", "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 records null results in three trials but judges that meaningful benefit cannot be 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. No new threshold, equivalence claim or certification that every effect is zero is created. Parent grade D, 30 points and precision C0 are original values.", "missingness": "No new threshold, equivalence claim or certification that every effect is zero is created. Parent grade D, 30 points and precision C0 are original values.", "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 threshold, equivalence claim or certification that every effect is zero is created. Parent grade D, 30 points and precision C0 are original values." }, { "item_id": "N17", "question_type": "Comparative efficacy", "question": "Has birthweight z score been kept separate from later obesity itself?", "needed": "Direct evidence distinguishing a birth surrogate measure from long-term clinical 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 evidence distinguishing a birth surrogate measure from long-term clinical outcomes", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "A long-term clinical question requires its own outcome definition, follow-up, denominator and direct effect.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text explicitly states that birthweight z score was a surrogate for later obesity risk, not later obesity itself.", "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. Birth outcomes are not expanded into efficacy or null conclusions for long-term obesity, metabolic or developmental outcomes.", "missingness": "Birth outcomes are not expanded into efficacy or null conclusions for long-term obesity, metabolic or developmental 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": "Birth outcomes are not expanded into efficacy or null conclusions for long-term obesity, metabolic or developmental outcomes." }, { "item_id": "N18", "question_type": "Comparative efficacy", "question": "Are population and mechanism explanations distinguished from gestational-diabetes treatment effects?", "needed": "Direct boundaries between the selected indication context and other diseases or mechanisms", "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 boundaries between the selected indication context and other diseases or mechanisms", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If evidence for a new population is supplied, link it as a separate question even when the ingredient is the same.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The record states that an insulin-resistance explanation does not substitute for lower birthweight and that the verdict does not apply to treatment of gestational or type 2 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. No medication selection, use, stopping or replacement instructions for other diseases or pregnancy-management guidance are created.", "missingness": "No medication selection, use, stopping or replacement instructions for other diseases or pregnancy-management guidance 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": "No medication selection, use, stopping or replacement instructions for other diseases or pregnancy-management guidance are created." }, { "item_id": "N19", "question_type": "Comparative efficacy", "question": "Are shared relationships between reports, trials and related sheets maintained?", "needed": "Links between the same stored summary, bibliography, trial, population and 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": "Links between the same stored summary, bibliography, trial, population and endpoint", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link additional reports to the original trial identifiers without newly certifying independence.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The three EMPOWaR, MOP and GRoW bibliographies are shared by two subclaim sheets. The original text’s replication RX, independence I1 and repeated-null wording are preserved as parent-verdict history.", "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. Trials, participants and independent replication are not newly summed because they appear in two sheets. Final unique-trial and participant totals are not recorded.", "missingness": "Trials, participants and independent replication are not newly summed because they appear in two sheets. Final unique-trial and participant totals are not recorded.", "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": "Trials, participants and independent replication are not newly summed because they appear in two sheets. Final unique-trial and participant totals are not recorded." }, { "item_id": "N20", "question_type": "Comparative efficacy", "question": "Are EMPOWaR public funding, co-sponsorship and Merck in-kind supply distinguished?", "needed": "Separate original disclosure records for funding, sponsorship, products, authors and analysis 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": "Separate original disclosure records for funding, sponsorship, products, authors and analysis roles", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link original material separately for cash funding, free provision, affiliated authors and outside analysis roles.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "MRC·NIHR EME 08/246/09 funding, Edinburgh·NHS Lothian co-sponsorship, and free active drug and matched placebo supplied by Merck KGaA 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. Public funding is not converted into absence of product supply. Detailed identities of company-affiliated authors and outside analysis providers remain unverified.", "missingness": "Public funding is not converted into absence of product supply. Detailed identities of company-affiliated authors and outside analysis providers remain unverified.", "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": "Public funding is not converted into absence of product supply. Detailed identities of company-affiliated authors and outside analysis providers remain unverified." }, { "item_id": "N21", "question_type": "Comparative efficacy", "question": "Is the original declaration of no manufacturer role separate from certification of independence?", "needed": "The actual original declaration on involvement in design, collection, analysis, interpretation and writing", "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": "The actual original declaration on involvement in design, collection, analysis, interpretation and writing", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original disclosed roles, affiliations and data-access records and link them for content review.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The record preserves that the original EMPOWaR paper stated Merck had no role in design, collection, analysis, interpretation or writing.", "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 work does not compare the external full text or certify the independence of that declaration. Product supply and the role declaration are retained together.", "missingness": "This work does not compare the external full text or certify the independence of that declaration. Product supply and the role declaration are retained together.", "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 work does not compare the external full text or certify the independence of that declaration. Product supply and the role declaration are retained together." }, { "item_id": "N22", "question_type": "Comparative efficacy", "question": "Is the original scope of MOP and GRoW funding and independent-replication wording preserved?", "needed": "Material-specific records of each trial’s funding, affiliations and research 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": "Material-specific records of each trial’s funding, affiliations and research roles", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original material for each trial’s four company roles and public support separately.", "current_reports": [ "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "MOP funding is recorded as “funding as reported in the source publication”; GRoW names the Australian National Health and Medical Research Council. GRoW independent-replication wording appears in the existing evidence and citation lists.", "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 ambiguous MOP wording is not filled as no funding, and original independence wording is not used as new review certification.", "missingness": "The ambiguous MOP wording is not filled as no funding, and original independence wording is not used as new review 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 ambiguous MOP wording is not filled as no funding, and original independence wording is not used as new review certification." }, { "item_id": "N23", "question_type": "Supplementary harm evidence", "question": "What actual information and denominators are available for gastrointestinal adverse effects and lower adherence?", "needed": "Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation 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 arm tables of harm definitions, exposure, incidence, discontinuation and adherence", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain trial-specific harm collection, arm events, exposure, discontinuation and adherence material.", "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 records reports of gastrointestinal adverse effects and lower adherence to 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. Incidence rates, discontinuation counts, trial-specific denominators and adherence figures are not supplied. They are not filled as long-term harm or safety.", "missingness": "Incidence rates, discontinuation counts, trial-specific denominators and adherence figures are not supplied. They are not filled as long-term harm 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": "Incidence rates, discontinuation counts, trial-specific denominators and adherence figures are not supplied. They are not filled as long-term harm or safety." }, { "item_id": "N24", "question_type": "Supplementary harm evidence", "question": "Does the fatal pregnancy-outcome composite distinguish component events, people and denominators?", "needed": "Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event 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": "Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Obtain original event definitions, component event tables, follow-up and denominators.", "current_reports": [ "R01" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The EMPOWaR 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. Composite counts are not copied as counts for each component. Analysis units for pregnant women, fetuses, infants and recurrent events, and component-specific denominators remain unread.", "missingness": "Composite counts are not copied as counts for each component. Analysis units for pregnant women, fetuses, infants and recurrent events, and component-specific 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": "Composite counts are not copied as counts for each component. Analysis units for pregnant women, fetuses, infants and recurrent events, and component-specific denominators remain unread." }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Are a rare harm signal’s wide CI and confirmed harm distinguished?", "needed": "Direct material on rare-harm effects, intervals, tests and follow-up duration", "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 material on rare-harm effects, intervals, tests and follow-up duration", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Adequate follow-up, original event-specific 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 records that the composite P=0.11 does not establish harm and that the CI is very wide.", "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 point estimate is not converted into confirmed harm, and nonsignificance is not certification of no risk. No new harm rate or NNH is calculated.", "missingness": "The point estimate is not converted into confirmed harm, and nonsignificance is not certification of no risk. No new harm rate or NNH is 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": "The point estimate is not converted into confirmed harm, and nonsignificance is not certification of no risk. No new harm rate or NNH is calculated." }, { "item_id": "N26", "question_type": "Supplementary harm evidence", "question": "Do gaps remain for other trials, long-term harm and post-birth follow-up?", "needed": "Trial-specific maternal, fetal and neonatal harm, follow-up and replication material", "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 maternal, fetal and neonatal harm, follow-up and replication material", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link direct maternal, infant and long-term follow-up harm material to the original trials.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The current summary mainly covers the EMPOWaR fatal composite and gastrointestinal and adherence information.", "condition_status": "Unverified", "status_reason": "Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Matching MOP or GRoW harm rates and long-term post-birth harm are not newly filled. There is no new harm-replication certification.", "missingness": "Matching MOP or GRoW harm rates and long-term post-birth harm are not newly filled. There is no new harm-replication 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": "Matching MOP or GRoW harm rates and long-term post-birth harm are not newly filled. There is no new harm-replication certification." }, { "item_id": "N27", "question_type": "Comparative efficacy", "question": "Is reading the stored summary distinguished from unread external papers, registration, protocol and SAP?", "needed": "Individual original links, material types and actual access records", "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 original links, material types and actual access records", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Link only original material obtained by the user with its material-specific actual access status.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The entire stored parent-verdict summary was read during production and original bibliography links are connected. R02 is a registration link; the other two URLs are PubMed.", "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 link does not mean that an abstract, full text, registration, protocol or SAP has been read or that content review is complete. The source records no separate link check.", "missingness": "A link does not mean that an abstract, full text, registration, protocol or SAP has been read or that content review is complete. The source records no separate link check.", "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": "A link does not mean that an abstract, full text, registration, protocol or SAP has been read or that content review is complete. The source records no separate link check." }, { "item_id": "N28", "question_type": "Comparative efficacy", "question": "Are reference date, Korean/English text, corrections, original parent axes and empty values preserved?", "needed": "A complete copy of original languages, grades, axes, dates, corrections and empty 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": "A complete copy of original languages, grades, axes, dates, corrections and empty values", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "If new material or a user decision is supplied, preserve the original and reflect it as a separate change event.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information recorded in the preserved summary", "acquired_read": "Summary read; external materials not read", "observation": "The original reference date 2026-08-26, an empty correction array and empty deliberation string, Korean/English text, and parent D, 30 points, safety Caution and axes are preserved in the entire 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. The production date is not converted into a new clinical-verification date. Stored cross-check wording is historical and does not mean this work’s content review is complete.", "missingness": "The production date is not converted into a new clinical-verification date. Stored cross-check wording is historical and does not mean this work’s content review is complete.", "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 production date is not converted into a new clinical-verification date. Stored cross-check wording is historical and does not mean this work’s content review is complete." }, { "item_id": "N29", "question_type": "Comparative efficacy", "question": "Are production status, content review and independent certification shown separately?", "needed": "Separate records of original candidate history and production status with incomplete content review", "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 and production status with incomplete content review", "basis": "Lower birthweight z score", "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled", "proposed_research": "Proposal: Reflect only user-provided materials or decisions 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": "Original review-pending and production-eligibility markers and boundary-review requirements 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 structural units remain 0 and the final independent count remains unrecorded.", "missingness": "There is no new verdict, split or independence certification. Additional structural units remain 0 and the final independent count remains 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 structural units remain 0 and the final independent count remains 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. NCT01273584.", "url": "https://clinicaltrials.gov/study/NCT01273584", "report_type": "Paper bibliography and registration link", "existence": "Materials preserved in original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F02", "independent_replication": false, "observed_result": "0.05 versus 0.17, P=0.66", "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": "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": "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": "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": "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": "Official source", "url": "https://clinicaltrials.gov/study/NCT01273584" } ] }, { "report_id": "R03", "title": "Dodd JM, Louise J, Deussen AR, et al. Effect of metformin in addition to dietary and lifestyle advice for pregnant women who are overweight or obese: the GRoW trial. Lancet Diabetes Endocrinol. 2019;7:15-24. 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