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

Verdict 2948 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-11

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: EMPOWaR’s historical research conditions were metformin from 12–16 weeks of pregnancy until delivery, up to 2500 mg/day.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: There were 449 randomized participants (226/223) and 434 in the modified intention-to-treat analysis; the original text records 97%.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original text quotes a web-based computer-generated block randomization procedure and masking of participants, caregivers and study personnel for EMPOWaR.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original text states that the EMPOWaR primary z-score endpoint matches ISRCTN51279843. The evidence list records ISRCTN51279843 · EudraCT 2009-017134-47.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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”.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R02

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The MOP citation is a 2016 NEJM paper bibliography; its URL is clinicaltrials.gov/study/NCT01273584.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: GRoW is preserved as 524 randomized and 514 analyzed.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original text explicitly states that birthweight z score was a surrogate for later obesity risk, not later obesity itself.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The record preserves that the original EMPOWaR paper stated Merck had no role in design, collection, analysis, interpretation or writing.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original text records reports of gastrointestinal adverse effects and lower adherence to metformin.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original text records that the composite P=0.11 does not establish harm and that the CI is very wide.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The current summary mainly covers the EMPOWaR fatal composite and gastrointestinal and adherence information.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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.
- 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.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Lower birthweight z score
- Related sources: R01, R02, R03

## Evidence and sources

### 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](https://pubmed.ncbi.nlm.nih.gov/26165398/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the 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  
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.

| 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](https://clinicaltrials.gov/study/NCT01273584)

Materials actually read: Summary read; external materials not read  
Findings recorded in the summary: 0.05 versus 0.17, P=0.66  
Record level: Stored evidence summary; not a result of directly reading external papers or registration  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/30528218/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the 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  
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.

| 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 |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.
