Metformin × birthweight z score: evidence checklist for pregnancy with overweight or obesity and no diabetes

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacyIs the selected z-score claim and subclaim verdict separate from the parent context?Required	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. R01 R02	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.	Separate records of subclaim wording, grade and note, and the parent verdict	If additional material is supplied, link material for the subclaim question and the parent context separately.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacyWhat defines the population of pregnant women with overweight or obesity and no diabetes?Required	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. R01 R02 R03	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.	Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators	Link original trial-specific eligibility, baseline characteristics and population denominators.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacyIs EMPOWaR research exposure distinguished from exposure in the other trials?Required	EMPOWaR’s historical research conditions were metformin from 12–16 weeks of pregnancy until delivery, up to 2500 mg/day. R01	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.	Trial-specific original records of ingredient, formulation, research dose, start time and duration	Link research exposure recorded in each trial’s original protocol and actual exposure material.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacyWere placebo and accompanying care, including dietary and lifestyle advice, the same conditions?Required	EMPOWaR, MOP and GRoW are all summarized as placebo-controlled. The GRoW bibliography specifies comparison of metformin added to dietary and lifestyle advice. R01 R02 R03	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.	Records of each arm’s placebo, common accompanying care, contact and additional treatment	Preserve original trial-specific comparators and common and differing accompanying care.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacyWhat are the standardized definition and measurement timing of birthweight z score?Required	The stored original text describes the EMPOWaR primary endpoint as the z score corresponding to the gestational-age-, parity- and sex-standardized birthweight percentile. R01	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.	Birth measurement, gestational age, parity and sex standardization methods and units	Obtain the original endpoint definition, standardization rules and birthweight measurement methods.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacyAre EMPOWaR z-score means and the adjusted mean difference, CI and P preserved as recorded?Required	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. R01	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.	Original arm means, adjusted effect, interval, test and analysis model	Link the original report’s adjustment model, variables, denominators and between-arm effect.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacyAre raw birthweight in grams and standardized z score the same outcome?Required	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. R01	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.	Original units, arm order, distributions and effects for each measure	Link original table arm labels, raw gram values, standardized results and uncertainty separately.
8	Partly verified	Full text not readStored summary read	N08 · Comparative efficacyWhat are the EMPOWaR randomized and modified intention-to-treat denominators?Required	There were 449 randomized participants (226/223) and 434 in the modified intention-to-treat analysis; the original text records 97%. R01	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.	Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria	Obtain the modified intention-to-treat definition, arm-specific exclusions and missingness reasons, and outcome-specific analysis denominators.
9	Partly verified	Full text not readStored summary read	N09 · Comparative efficacyTo which trial do the original allocation concealment and masking records apply?Required	The original text quotes a web-based computer-generated block randomization procedure and masking of participants, caregivers and study personnel for EMPOWaR. R01	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.	Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material	Obtain each trial’s original methods and allocation, measurement and analysis procedures separately.
10	Partly verified	Full text not readStored summary read	N10 · Comparative efficacyAre prespecified primary outcomes distinguished from access to registration, protocol and SAP?Required	The original text states that the EMPOWaR primary z-score endpoint matches ISRCTN51279843. The evidence list records ISRCTN51279843 · EudraCT 2009-017134-47. R01	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.	Original z-score prespecification, registration, changes and analysis-plan material	If original registration, protocol and SAP are supplied, link endpoint hierarchy and change history.
11	Partly verified	Full text not readStored summary read	N11 · Comparative efficacyAre MOP z-score results and analysis denominators preserved separately?Required	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”. R02	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.	Original MOP population, denominators, endpoint definition, effect and interval material	Obtain original MOP denominators, arm labels, measurement definition, effect, CI and missing-data handling.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacyAre the MOP paper bibliography and registration URL different material types?Required	The MOP citation is a 2016 NEJM paper bibliography; its URL is clinicaltrials.gov/study/NCT01273584. R02	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.	Separate links for the paper, registration identifier and actual access	If the paper and original registration are supplied separately, link their individual access, endpoints and plans.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacyWere the effects of the two z-score trials kept separate rather than converted into new figures?Required	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. R01 R02	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.	The alignment scope of trial-specific standardization, analysis, denominators and effects	Link trial-specific original definitions, denominators, adjustment and CI side by side while preserving their relationships.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacyIs the GRoW result for birthweight above 4000 g a direct z-score result?Required	GRoW records birthweight above 4000 g: 40 (16%) versus 37 (14%), aRR 0.97 (95% CI 0.65 to 1.47), P=0.899. R03	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.	Direct distinction between a continuous standardized measure and a binary birth outcome	If z-score material from the same trial is supplied, link its definition, hierarchy and denominator separately.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacyAre GRoW randomized and analyzed counts distinguished from pregnancy and birth analysis units?Required	GRoW is preserved as 524 randomized and 514 analyzed. R03	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.	Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria	Obtain outcome-specific analysis flow, arm denominators, follow-up and exclusion criteria.
16	Partly verified	Full text not readStored summary read	N16 · Comparative efficacyAre null results distinguished from exclusion of clinically meaningful benefit?Required	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. R01 R02 R03	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.	A validated prespecified clinical-importance threshold and effect interval	If a prespecified validated threshold and original plan suitable for the population and endpoint are supplied, link them.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacyHas birthweight z score been kept separate from later obesity itself?Required	The original text explicitly states that birthweight z score was a surrogate for later obesity risk, not later obesity itself. R01	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.	Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes	A long-term clinical question requires its own outcome definition, follow-up, denominator and direct effect.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacyAre population and mechanism explanations distinguished from gestational-diabetes treatment effects?Required	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. R01 R02 R03	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.	Direct boundaries between the selected indication context and other diseases or mechanisms	If evidence for a new population is supplied, link it as a separate question even when the ingredient is the same.
19	Partly verified	Full text not readStored summary read	N19 · Comparative efficacyAre shared relationships between reports, trials and related sheets maintained?Required	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. R01 R02 R03	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.	Links between the same stored summary, bibliography, trial, population and endpoint	Link additional reports to the original trial identifiers without newly certifying independence.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacyAre EMPOWaR public funding, co-sponsorship and Merck in-kind supply distinguished?Required	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. R01	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.	Separate original disclosure records for funding, sponsorship, products, authors and analysis roles	Link original material separately for cash funding, free provision, affiliated authors and outside analysis roles.
21	Partly verified	Full text not readStored summary read	N21 · Comparative efficacyIs the original declaration of no manufacturer role separate from certification of independence?Required	The record preserves that the original EMPOWaR paper stated Merck had no role in design, collection, analysis, interpretation or writing. R01	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.	The actual original declaration on involvement in design, collection, analysis, interpretation and writing	Obtain original disclosed roles, affiliations and data-access records and link them for content review.
22	Partly verified	Full text not readStored summary read	N22 · Comparative efficacyIs the original scope of MOP and GRoW funding and independent-replication wording preserved?Required	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. R02 R03	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.	Material-specific records of each trial’s funding, affiliations and research roles	Obtain original material for each trial’s four company roles and public support separately.
23	Partly verified	Full text not readStored summary read	N23 · Supplementary harm evidenceWhat actual information and denominators are available for gastrointestinal adverse effects and lower adherence?Required	The original text records reports of gastrointestinal adverse effects and lower adherence to metformin. R01 R02 R03	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.	Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence	Obtain trial-specific harm collection, arm events, exposure, discontinuation and adherence material.
24	Partly verified	Full text not readStored summary read	N24 · Supplementary harm evidenceDoes the fatal pregnancy-outcome composite distinguish component events, people and denominators?Required	The EMPOWaR composite was 7 with metformin versus 2 with placebo, OR 3.60 (95% CI 0.74 to 17.50), P=0.11. R01	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.	Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators	Obtain original event definitions, component event tables, follow-up and denominators.
25	Partly verified	Full text not readStored summary read	N25 · Supplementary harm evidenceAre a rare harm signal’s wide CI and confirmed harm distinguished?Required	The original text records that the composite P=0.11 does not establish harm and that the CI is very wide. R01	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.	Direct material on rare-harm effects, intervals, tests and follow-up duration	Adequate follow-up, original event-specific effects and rare-harm material are needed.
26	Unverified	Full text not readStored summary read	N26 · Supplementary harm evidenceDo gaps remain for other trials, long-term harm and post-birth follow-up?Required	The current summary mainly covers the EMPOWaR fatal composite and gastrointestinal and adherence information. R01 R02 R03	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.	Trial-specific maternal, fetal and neonatal harm, follow-up and replication material	Link direct maternal, infant and long-term follow-up harm material to the original trials.
27	Partly verified	Full text not readStored summary read	N27 · Comparative efficacyIs reading the stored summary distinguished from unread external papers, registration, protocol and SAP?Required	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. R01 R02 R03	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.	Individual original links, material types and actual access records	Link only original material obtained by the user with its material-specific actual access status.
28	Partly verified	Full text not readStored summary read	N28 · Comparative efficacyAre reference date, Korean/English text, corrections, original parent axes and empty values preserved?Required	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. R01 R02 R03	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.	A complete copy of original languages, grades, axes, dates, corrections and empty values	If new material or a user decision is supplied, preserve the original and reflect it as a separate change event.
29	Partly verified	Full text not readStored summary read	N29 · Comparative efficacyAre production status, content review and independent certification shown separately?Supplementary	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. R01 R02 R03	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.	Separate records of original candidate history and production status with incomplete content review	Proposal: Reflect only user-provided materials or decisions as separate events.

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29 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Pregnancy with overweight or obesity and no diabetes; trial-specific eligibility and baseline details remain unread
Ingredient, formulation and route: 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
Measured outcome: 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
Questions outside this scope: 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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · 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.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 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
Record level: Stored evidence summary; not a result of directly reading external papers or registration
Study overlap and independent replication: EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Stored parent-verdict summary
abstract	Original source link preserved	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
registration	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review

R02 · Syngelaki A, Nicolaides KH, Balani J, et al. Metformin versus Placebo in Obese Pregnant Women without Diabetes Mellitus. N Engl J Med. 2016. NCT01273584.

Official source

Material type: Paper bibliography and registration link
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 0.05 versus 0.17, P=0.66
Record level: Stored evidence summary; not a result of directly reading external papers or registration
Study overlap and independent replication: EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Stored parent-verdict summary
abstract	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
registration	Original source link preserved	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review

R03 · 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. PMID: 30528218.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 40 (16%) versus 37 (14%), aRR 0.97 (95% CI 0.65 to 1.47), P=0.899
Record level: Stored evidence summary; not a result of directly reading external papers or registration
Study overlap and independent replication: EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Stored parent-verdict summary
abstract	Original source link preserved	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
registration	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; an existing link does not mean acquisition, reading or completed content review

Report counts versus independent study counts

EMPOWaR: report shared by two subclaim sheets; MOP: paper bibliography and registration link shared by two subclaim sheets; GRoW: report shared by two subclaim sheets. Report connections do not certify a unique-trial count; existing trials, reports, related sheets and participants are not newly summed.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Is the selected z-score claim and subclaim verdict separate from the parent context?

Required materials and conditions: Separate records of subclaim wording, grade and note, and the parent verdict
Conditions for verification: Separate records of subclaim wording, grade and note, and the parent verdict
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N02 · What defines the population of pregnant women with overweight or obesity and no diabetes?

Required materials and conditions: Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators
Conditions for verification: Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N03 · Is EMPOWaR research exposure distinguished from exposure in the other trials?

Required materials and conditions: Trial-specific original records of ingredient, formulation, research dose, start time and duration
Conditions for verification: Trial-specific original records of ingredient, formulation, research dose, start time and duration
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N04 · Were placebo and accompanying care, including dietary and lifestyle advice, the same conditions?

Required materials and conditions: Records of each arm’s placebo, common accompanying care, contact and additional treatment
Conditions for verification: Records of each arm’s placebo, common accompanying care, contact and additional treatment
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N05 · What are the standardized definition and measurement timing of birthweight z score?

Required materials and conditions: Birth measurement, gestational age, parity and sex standardization methods and units
Conditions for verification: Birth measurement, gestational age, parity and sex standardization methods and units
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N06 · Are EMPOWaR z-score means and the adjusted mean difference, CI and P preserved as recorded?

Required materials and conditions: Original arm means, adjusted effect, interval, test and analysis model
Conditions for verification: Original arm means, adjusted effect, interval, test and analysis model
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N07 · Are raw birthweight in grams and standardized z score the same outcome?

Required materials and conditions: Original units, arm order, distributions and effects for each measure
Conditions for verification: Original units, arm order, distributions and effects for each measure
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N08 · What are the EMPOWaR randomized and modified intention-to-treat denominators?

Required materials and conditions: Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria
Conditions for verification: Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N09 · To which trial do the original allocation concealment and masking records apply?

Required materials and conditions: Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material
Conditions for verification: Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N10 · Are prespecified primary outcomes distinguished from access to registration, protocol and SAP?

Required materials and conditions: Original z-score prespecification, registration, changes and analysis-plan material
Conditions for verification: Original z-score prespecification, registration, changes and analysis-plan material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N11 · Are MOP z-score results and analysis denominators preserved separately?

Required materials and conditions: Original MOP population, denominators, endpoint definition, effect and interval material
Conditions for verification: Original MOP population, denominators, endpoint definition, effect and interval material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N12 · Are the MOP paper bibliography and registration URL different material types?

Required materials and conditions: Separate links for the paper, registration identifier and actual access
Conditions for verification: Separate links for the paper, registration identifier and actual access
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N13 · Were the effects of the two z-score trials kept separate rather than converted into new figures?

Required materials and conditions: The alignment scope of trial-specific standardization, analysis, denominators and effects
Conditions for verification: The alignment scope of trial-specific standardization, analysis, denominators and effects
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N14 · Is the GRoW result for birthweight above 4000 g a direct z-score result?

Required materials and conditions: Direct distinction between a continuous standardized measure and a binary birth outcome
Conditions for verification: Direct distinction between a continuous standardized measure and a binary birth outcome
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N15 · Are GRoW randomized and analyzed counts distinguished from pregnancy and birth analysis units?

Required materials and conditions: Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria
Conditions for verification: Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N16 · Are null results distinguished from exclusion of clinically meaningful benefit?

Required materials and conditions: A validated prespecified clinical-importance threshold and effect interval
Conditions for verification: A validated prespecified clinical-importance threshold and effect interval
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N17 · Has birthweight z score been kept separate from later obesity itself?

Required materials and conditions: Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes
Conditions for verification: Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N18 · Are population and mechanism explanations distinguished from gestational-diabetes treatment effects?

Required materials and conditions: Direct boundaries between the selected indication context and other diseases or mechanisms
Conditions for verification: Direct boundaries between the selected indication context and other diseases or mechanisms
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N19 · Are shared relationships between reports, trials and related sheets maintained?

Required materials and conditions: Links between the same stored summary, bibliography, trial, population and endpoint
Conditions for verification: Links between the same stored summary, bibliography, trial, population and endpoint
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N20 · Are EMPOWaR public funding, co-sponsorship and Merck in-kind supply distinguished?

Required materials and conditions: Separate original disclosure records for funding, sponsorship, products, authors and analysis roles
Conditions for verification: Separate original disclosure records for funding, sponsorship, products, authors and analysis roles
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N21 · Is the original declaration of no manufacturer role separate from certification of independence?

Required materials and conditions: The actual original declaration on involvement in design, collection, analysis, interpretation and writing
Conditions for verification: The actual original declaration on involvement in design, collection, analysis, interpretation and writing
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N22 · Is the original scope of MOP and GRoW funding and independent-replication wording preserved?

Required materials and conditions: Material-specific records of each trial’s funding, affiliations and research roles
Conditions for verification: Material-specific records of each trial’s funding, affiliations and research roles
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N23 · What actual information and denominators are available for gastrointestinal adverse effects and lower adherence?

Required materials and conditions: Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence
Conditions for verification: Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N24 · Does the fatal pregnancy-outcome composite distinguish component events, people and denominators?

Required materials and conditions: Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators
Conditions for verification: Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N25 · Are a rare harm signal’s wide CI and confirmed harm distinguished?

Required materials and conditions: Direct material on rare-harm effects, intervals, tests and follow-up duration
Conditions for verification: Direct material on rare-harm effects, intervals, tests and follow-up duration
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N26 · Do gaps remain for other trials, long-term harm and post-birth follow-up?

Required materials and conditions: Trial-specific maternal, fetal and neonatal harm, follow-up and replication material
Conditions for verification: Trial-specific maternal, fetal and neonatal harm, follow-up and replication material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N27 · Is reading the stored summary distinguished from unread external papers, registration, protocol and SAP?

Required materials and conditions: Individual original links, material types and actual access records
Conditions for verification: Individual original links, material types and actual access records
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N28 · Are reference date, Korean/English text, corrections, original parent axes and empty values preserved?

Required materials and conditions: A complete copy of original languages, grades, axes, dates, corrections and empty values
Conditions for verification: A complete copy of original languages, grades, axes, dates, corrections and empty values
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

N29 · Are production status, content review and independent certification shown separately?

Required materials and conditions: Separate records of original candidate history and production status with incomplete content review
Conditions for verification: Separate records of original candidate history and production status with incomplete content review
Requirement and applicability: Supplementary
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Referenced methods: Lower birthweight z score

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-11 · Public page/material version 1.0

Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Is the selected z-score claim and subclaim verdict separate from the parent context?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Subclaim score, status and axes are absent and are not filled from the parent values. This production is not a new grade assessment.
Required materials and conditions: Separate records of subclaim wording, grade and note, and the parent verdict
Materials to obtain first: Subclaim score, status and axes are absent and are not filled from the parent values. This production is not a new grade assessment.
Further research: If additional material is supplied, link material for the subclaim question and the parent context separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of subclaim wording, grade and note, and the parent verdict
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02

N02 · What defines the population of pregnant women with overweight or obesity and no diabetes?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Detailed original tables of trial-specific BMI, age, diabetes exclusion criteria and baseline characteristics remain unread.
Required materials and conditions: Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators
Materials to obtain first: Detailed original tables of trial-specific BMI, age, diabetes exclusion criteria and baseline characteristics remain unread.
Further research: Link original trial-specific eligibility, baseline characteristics and population denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N03 · Is EMPOWaR research exposure distinguished from exposure in the other trials?

Current findings: EMPOWaR’s historical research conditions were metformin from 12–16 weeks of pregnancy until delivery, up to 2500 mg/day.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Trial-specific original records of ingredient, formulation, research dose, start time and duration
Materials to obtain first: 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.
Further research: Link research exposure recorded in each trial’s original protocol and actual exposure material.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific original records of ingredient, formulation, research dose, start time and duration
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N04 · Were placebo and accompanying care, including dietary and lifestyle advice, the same conditions?

Current findings: EMPOWaR, MOP and GRoW are all summarized as placebo-controlled. The GRoW bibliography specifies comparison of metformin added to dietary and lifestyle advice.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Records of each arm’s placebo, common accompanying care, contact and additional treatment
Materials to obtain first: 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.
Further research: Preserve original trial-specific comparators and common and differing accompanying care.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Records of each arm’s placebo, common accompanying care, contact and additional treatment
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N05 · What are the standardized definition and measurement timing of birthweight z score?

Current findings: The stored original text describes the EMPOWaR primary endpoint as the z score corresponding to the gestational-age-, parity- and sex-standardized birthweight percentile.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: The specific reference population, formula, measurement procedure and application to individual deliveries remain unread; no new z-score calculation is made.
Required materials and conditions: Birth measurement, gestational age, parity and sex standardization methods and units
Materials to obtain first: The specific reference population, formula, measurement procedure and application to individual deliveries remain unread; no new z-score calculation is made.
Further research: Obtain the original endpoint definition, standardization rules and birthweight measurement methods.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Birth measurement, gestational age, parity and sex standardization methods and units
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N06 · Are EMPOWaR z-score means and the adjusted mean difference, CI and P preserved as recorded?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Original arm means, adjusted effect, interval, test and analysis model
Materials to obtain first: 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.
Further research: Link the original report’s adjustment model, variables, denominators and between-arm effect.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original arm means, adjusted effect, interval, test and analysis model
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N07 · Are raw birthweight in grams and standardized z score the same outcome?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Arm order is preserved; gram values are not converted into z-score effects. No new calculation, variance or CI is produced.
Required materials and conditions: Original units, arm order, distributions and effects for each measure
Materials to obtain first: Arm order is preserved; gram values are not converted into z-score effects. No new calculation, variance or CI is produced.
Further research: Link original table arm labels, raw gram values, standardized results and uncertainty separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original units, arm order, distributions and effects for each measure
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N08 · What are the EMPOWaR randomized and modified intention-to-treat denominators?

Current findings: There were 449 randomized participants (226/223) and 434 in the modified intention-to-treat analysis; the original text records 97%.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria
Materials to obtain first: 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.
Further research: Obtain the modified intention-to-treat definition, arm-specific exclusions and missingness reasons, and outcome-specific analysis denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N09 · To which trial do the original allocation concealment and masking records apply?

Current findings: The original text quotes a web-based computer-generated block randomization procedure and masking of participants, caregivers and study personnel for EMPOWaR.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: These detailed procedures are not transferred as verified MOP or GRoW procedures. Parent axis B0 is a historical value of the existing verdict.
Required materials and conditions: Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material
Materials to obtain first: These detailed procedures are not transferred as verified MOP or GRoW procedures. Parent axis B0 is a historical value of the existing verdict.
Further research: Obtain each trial’s original methods and allocation, measurement and analysis procedures separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N10 · Are prespecified primary outcomes distinguished from access to registration, protocol and SAP?

Current findings: The original text states that the EMPOWaR primary z-score endpoint matches ISRCTN51279843. The evidence list records ISRCTN51279843 · EudraCT 2009-017134-47.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Registration, protocol and SAP were not opened in this work; only identifiers are preserved. No new original-registration URL is created.
Required materials and conditions: Original z-score prespecification, registration, changes and analysis-plan material
Materials to obtain first: Registration, protocol and SAP were not opened in this work; only identifiers are preserved. No new original-registration URL is created.
Further research: If original registration, protocol and SAP are supplied, link endpoint hierarchy and change history.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original z-score prespecification, registration, changes and analysis-plan material
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N11 · Are MOP z-score results and analysis denominators preserved separately?

Current findings: 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”.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Randomized counts, arm-specific analysis counts, CI and standardization details are not supplied. Approximate values and original wording are not newly harmonized.
Required materials and conditions: Original MOP population, denominators, endpoint definition, effect and interval material
Materials to obtain first: Randomized counts, arm-specific analysis counts, CI and standardization details are not supplied. Approximate values and original wording are not newly harmonized.
Further research: Obtain original MOP denominators, arm labels, measurement definition, effect, CI and missing-data handling.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original MOP population, denominators, endpoint definition, effect and interval material
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R02

N12 · Are the MOP paper bibliography and registration URL different material types?

Current findings: The MOP citation is a 2016 NEJM paper bibliography; its URL is clinicaltrials.gov/study/NCT01273584.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: A registration URL is not marked as reading the paper’s abstract or full text. No PMID, DOI or alternative paper URL is invented.
Required materials and conditions: Separate links for the paper, registration identifier and actual access
Materials to obtain first: A registration URL is not marked as reading the paper’s abstract or full text. No PMID, DOI or alternative paper URL is invented.
Further research: If the paper and original registration are supplied separately, link their individual access, endpoints and plans.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate links for the paper, registration identifier and actual access
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R02

N13 · Were the effects of the two z-score trials kept separate rather than converted into new figures?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: No new meta-analysis, trial-count sum, total participant count or between-arm difference calculation is made.
Required materials and conditions: The alignment scope of trial-specific standardization, analysis, denominators and effects
Materials to obtain first: No new meta-analysis, trial-count sum, total participant count or between-arm difference calculation is made.
Further research: Link trial-specific original definitions, denominators, adjustment and CI side by side while preserving their relationships.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: The alignment scope of trial-specific standardization, analysis, denominators and effects
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02

N14 · Is the GRoW result for birthweight above 4000 g a direct z-score result?

Current findings: GRoW records birthweight above 4000 g: 40 (16%) versus 37 (14%), aRR 0.97 (95% CI 0.65 to 1.47), P=0.899.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: A different measure is not converted into a GRoW z-score effect. This summary contains no GRoW z-score figure.
Required materials and conditions: Direct distinction between a continuous standardized measure and a binary birth outcome
Materials to obtain first: A different measure is not converted into a GRoW z-score effect. This summary contains no GRoW z-score figure.
Further research: If z-score material from the same trial is supplied, link its definition, hierarchy and denominator separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct distinction between a continuous standardized measure and a binary birth outcome
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R03

N15 · Are GRoW randomized and analyzed counts distinguished from pregnancy and birth analysis units?

Current findings: GRoW is preserved as 524 randomized and 514 analyzed.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria
Materials to obtain first: 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.
Further research: Obtain outcome-specific analysis flow, arm denominators, follow-up and exclusion criteria.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R03

N16 · Are null results distinguished from exclusion of clinically meaningful benefit?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: A validated prespecified clinical-importance threshold and effect interval
Materials to obtain first: 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.
Further research: If a prespecified validated threshold and original plan suitable for the population and endpoint are supplied, link them.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: A validated prespecified clinical-importance threshold and effect interval
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N17 · Has birthweight z score been kept separate from later obesity itself?

Current findings: The original text explicitly states that birthweight z score was a surrogate for later obesity risk, not later obesity itself.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Birth outcomes are not expanded into efficacy or null conclusions for long-term obesity, metabolic or developmental outcomes.
Required materials and conditions: Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes
Materials to obtain first: Birth outcomes are not expanded into efficacy or null conclusions for long-term obesity, metabolic or developmental outcomes.
Further research: A long-term clinical question requires its own outcome definition, follow-up, denominator and direct effect.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N18 · Are population and mechanism explanations distinguished from gestational-diabetes treatment effects?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: No medication selection, use, stopping or replacement instructions for other diseases or pregnancy-management guidance are created.
Required materials and conditions: Direct boundaries between the selected indication context and other diseases or mechanisms
Materials to obtain first: No medication selection, use, stopping or replacement instructions for other diseases or pregnancy-management guidance are created.
Further research: If evidence for a new population is supplied, link it as a separate question even when the ingredient is the same.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct boundaries between the selected indication context and other diseases or mechanisms
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N19 · Are shared relationships between reports, trials and related sheets maintained?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Trials, participants and independent replication are not newly summed because they appear in two sheets. Final unique-trial and participant totals are not recorded.
Required materials and conditions: Links between the same stored summary, bibliography, trial, population and endpoint
Materials to obtain first: Trials, participants and independent replication are not newly summed because they appear in two sheets. Final unique-trial and participant totals are not recorded.
Further research: Link additional reports to the original trial identifiers without newly certifying independence.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Links between the same stored summary, bibliography, trial, population and endpoint
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N20 · Are EMPOWaR public funding, co-sponsorship and Merck in-kind supply distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Public funding is not converted into absence of product supply. Detailed identities of company-affiliated authors and outside analysis providers remain unverified.
Required materials and conditions: Separate original disclosure records for funding, sponsorship, products, authors and analysis roles
Materials to obtain first: Public funding is not converted into absence of product supply. Detailed identities of company-affiliated authors and outside analysis providers remain unverified.
Further research: Link original material separately for cash funding, free provision, affiliated authors and outside analysis roles.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate original disclosure records for funding, sponsorship, products, authors and analysis roles
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N21 · Is the original declaration of no manufacturer role separate from certification of independence?

Current findings: The record preserves that the original EMPOWaR paper stated Merck had no role in design, collection, analysis, interpretation or writing.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: The actual original declaration on involvement in design, collection, analysis, interpretation and writing
Materials to obtain first: 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.
Further research: Obtain original disclosed roles, affiliations and data-access records and link them for content review.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: The actual original declaration on involvement in design, collection, analysis, interpretation and writing
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N22 · Is the original scope of MOP and GRoW funding and independent-replication wording preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: The ambiguous MOP wording is not filled as no funding, and original independence wording is not used as new review certification.
Required materials and conditions: Material-specific records of each trial’s funding, affiliations and research roles
Materials to obtain first: The ambiguous MOP wording is not filled as no funding, and original independence wording is not used as new review certification.
Further research: Obtain original material for each trial’s four company roles and public support separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Material-specific records of each trial’s funding, affiliations and research roles
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R02 R03

N23 · What actual information and denominators are available for gastrointestinal adverse effects and lower adherence?

Current findings: The original text records reports of gastrointestinal adverse effects and lower adherence to metformin.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Incidence rates, discontinuation counts, trial-specific denominators and adherence figures are not supplied. They are not filled as long-term harm or safety.
Required materials and conditions: Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence
Materials to obtain first: Incidence rates, discontinuation counts, trial-specific denominators and adherence figures are not supplied. They are not filled as long-term harm or safety.
Further research: Obtain trial-specific harm collection, arm events, exposure, discontinuation and adherence material.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N24 · Does the fatal pregnancy-outcome composite distinguish component events, people and denominators?

Current findings: The EMPOWaR composite was 7 with metformin versus 2 with placebo, OR 3.60 (95% CI 0.74 to 17.50), P=0.11.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators
Materials to obtain first: 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.
Further research: Obtain original event definitions, component event tables, follow-up and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N25 · Are a rare harm signal’s wide CI and confirmed harm distinguished?

Current findings: The original text records that the composite P=0.11 does not establish harm and that the CI is very wide.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Direct material on rare-harm effects, intervals, tests and follow-up duration
Materials to obtain first: 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.
Further research: Adequate follow-up, original event-specific effects and rare-harm material are needed.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct material on rare-harm effects, intervals, tests and follow-up duration
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01

N26 · Do gaps remain for other trials, long-term harm and post-birth follow-up?

Current findings: The current summary mainly covers the EMPOWaR fatal composite and gastrointestinal and adherence information.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: Matching MOP or GRoW harm rates and long-term post-birth harm are not newly filled. There is no new harm-replication certification.
Required materials and conditions: Trial-specific maternal, fetal and neonatal harm, follow-up and replication material
Materials to obtain first: Matching MOP or GRoW harm rates and long-term post-birth harm are not newly filled. There is no new harm-replication certification.
Further research: Link direct maternal, infant and long-term follow-up harm material to the original trials.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Trial-specific maternal, fetal and neonatal harm, follow-up and replication material
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N27 · Is reading the stored summary distinguished from unread external papers, registration, protocol and SAP?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Individual original links, material types and actual access records
Materials to obtain first: 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.
Further research: Link only original material obtained by the user with its material-specific actual access status.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Individual original links, material types and actual access records
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N28 · Are reference date, Korean/English text, corrections, original parent axes and empty values preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: A complete copy of original languages, grades, axes, dates, corrections and empty values
Materials to obtain first: 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.
Further research: If new material or a user decision is supplied, preserve the original and reflect it as a separate change event.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: A complete copy of original languages, grades, axes, dates, corrections and empty values
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03

N29 · Are production status, content review and independent certification shown separately?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: 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.
Reason for missing information: There is no new verdict, split or independence certification. Additional structural units remain 0 and the final independent count remains unrecorded.
Required materials and conditions: Separate records of original candidate history and production status with incomplete content review
Materials to obtain first: There is no new verdict, split or independence certification. Additional structural units remain 0 and the final independent count remains unrecorded.
Further research: Proposal: Reflect only user-provided materials or decisions as separate events.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of original candidate history and production status with incomplete content review
Why this condition is needed: An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries
Application exceptions: Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.
Referenced methods: Lower birthweight z score

Related sources R01 R02 R03