# Metformin × birthweight above 4000 g: 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 births above 4000 g; direct GRoW results are distinct from z-score results in other trials
- Duration: Outcome at birth; GRoW exposure details remain unverified
- 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 original birthweight-above-4000-g claim and subclaim verdict separate from the parent z-score context?

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

- Current findings: The selected existing question is “Fewer births above 4000 g”; its original grade is D and its note records GRoW aRR 0.97, P=0.899. The parent verdict is D, 30 points, safety Caution, and synthesizes z-score and other results.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.
- Reason for missing information: Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.
- Required materials and conditions: Distinction between selected wording, grade and note, and parent values
- Materials to obtain first: Absent subclaim score, status and axes are not filled from parent values. No new verdict is made.
- Further research: If additional material arrives, link the selected endpoint and parent context separately.
- Conditions for verification: Distinction between selected wording, grade and note, and parent 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: Fewer births above 4000 g
- Related sources: R03

### N02 · Is the actual GRoW population distinguished from other pregnancy and diabetes contexts?

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

- Current findings: The GRoW bibliography specifies pregnant women with overweight or obesity; the parent record describes the context as pregnancy without diabetes.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.
- Reason for missing information: Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.
- Required materials and conditions: Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status
- Materials to obtain first: Trial-specific age, BMI, diabetes exclusions and pregnancy timing details remain unread. The verdict is not applied to treatment of gestational or type 2 diabetes.
- Further research: Obtain original GRoW eligibility, baseline characteristics, recruitment conditions and denominators.
- Conditions for verification: Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status
- 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: Fewer births above 4000 g
- Related sources: R03

### N03 · Are GRoW intervention, placebo and research exposure directly preserved?

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

- Current findings: GRoW is recorded as a multicenter double-blind placebo-controlled randomized trial of metformin.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.
- Reason for missing information: GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.
- Required materials and conditions: Trial-specific original records of ingredient, formulation, dose, exposure and adherence
- Materials to obtain first: GRoW research dose, formulation, starting gestational week and actual exposure are absent from the summary. The EMPOWaR maximum of 2500 mg/day is not transferred.
- Further research: Link supplied original GRoW protocol and actual exposure material.
- Conditions for verification: Trial-specific original records of ingredient, formulation, dose, exposure 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: Fewer births above 4000 g
- Related sources: R03

### N04 · Is the comparison of medication added to dietary and lifestyle advice preserved?

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

- Current findings: The GRoW bibliography records the comparison as 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. Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.
- Reason for missing information: Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.
- Required materials and conditions: Original material on common advice, placebo, added intervention and other care
- Materials to obtain first: Whether advice content, contact, adherence and additional treatment were actually identical remains unread. No new dietary or pregnancy-management instructions are created.
- Further research: Obtain original trial arm-specific common and differing care and actual exposure.
- Conditions for verification: Original material on common advice, placebo, added intervention and other care
- 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: Fewer births above 4000 g
- Related sources: R03

### N05 · Are the above-4000-g threshold, birth measurement and assessment unit distinguished?

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

- Current findings: The existing endpoint is “birthweight above 4000 g”; its English wording is birthweight above 4000 g.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.
- Reason for missing information: It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.
- Required materials and conditions: Strictly-above definition, measurement timing, measurement method and analysis unit
- Materials to obtain first: It is not changed to at least 4000 g, birthweight z score, lower mean grams or another macrosomia definition. Measurement details remain unread.
- Further research: Obtain the original endpoint definition, birthweight measurement, boundary-value handling and analysis unit.
- Conditions for verification: Strictly-above definition, measurement timing, measurement method and analysis unit
- 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: Fewer births above 4000 g
- Related sources: R03

### N06 · What are trial-specific primary/secondary hierarchies and plans for the birth endpoint?

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

- Current findings: EMPOWaR records standardized z score as primary. GRoW birthweight above 4000 g is preserved as a separate result.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.
- Reason for missing information: EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.
- Required materials and conditions: Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint
- Materials to obtain first: EMPOWaR’s primary hierarchy is not transferred to GRoW, and GRoW’s own hierarchy is not newly confirmed. Detailed prespecified plans remain unread.
- Further research: Link endpoint hierarchies and change histories separately from each trial’s registration, protocol and SAP.
- Conditions for verification: Registration, protocol, SAP and multiplicity hierarchy for the selected 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: Fewer births above 4000 g
- Related sources: R01, R03

### N07 · Are GRoW randomized and analyzed counts distinguished?

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

- Current findings: GRoW had 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. Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.
- Reason for missing information: Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.
- Required materials and conditions: Original arm-specific assignment, analysis, follow-up and missingness flow and denominators
- Materials to obtain first: Arm-specific assignment or analysis counts and attrition rates absent from the original are not newly calculated. The 514 is not confirmed as a common denominator for every outcome.
- Further research: Obtain original tables of arm-specific participant flow, exclusion, follow-up and outcome-specific analysis denominators.
- Conditions for verification: Original arm-specific assignment, analysis, follow-up and missingness flow and 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: Fewer births above 4000 g
- Related sources: R03

### N08 · Are denominators for pregnant women, infants, birth events and repeated measurements the same?

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

- Current findings: The original material records randomized and analyzed counts as people, and birthweight above 4000 g as 40 versus 37 people.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.
- Reason for missing information: Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.
- Required materials and conditions: Analysis units for people, pregnancies, infants and birth events, with handling of overlap
- Materials to obtain first: Detailed infant/pregnant-woman mapping, multiple-birth handling and recurrent events are absent from the summary and are not newly determined. Related sheets and participants are not summed.
- Further research: Obtain original analysis units, pregnancy/birth mapping, exclusions and denominators.
- Conditions for verification: Analysis units for people, pregnancies, infants and birth events, with handling of overlap
- 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: Fewer births above 4000 g
- Related sources: R03

### N09 · Are the original 40 (16%) versus 37 (14%) values and arm order maintained?

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

- Current findings: The GRoW evidence list records 40 (16%) versus 37 (14%); the original text also preserves 16% versus 14%.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.
- Reason for missing information: Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.
- Required materials and conditions: Original arm-specific events, proportions, denominators and outcome tables
- Materials to obtain first: Denominators are not reverse-calculated from percentages, and events are not increased. Original-summary arm-specific analysis denominators are not explicit.
- Further research: Link original table arm labels, events, denominators and proportions exactly as recorded.
- Conditions for verification: Original arm-specific events, proportions, denominators and outcome tables
- 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: Fewer births above 4000 g
- Related sources: R03

### N10 · Are adjusted RR, CI and P preserved separately from original proportions?

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

- Current findings: aRR 0.97 (95% CI 0.65 to 1.47), P=0.899 is recorded as originally given.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.
- Reason for missing information: No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.
- Required materials and conditions: Original material on adjusted effect, model, variables, interval and test
- Materials to obtain first: No crude RR, risk difference or NNT is calculated from original proportions, and reproduction of the adjusted value is not claimed. Adjustment variables and model remain unread.
- Further research: Obtain adjustment plans, variables, arm-specific denominators and original between-arm effect tables.
- Conditions for verification: Original material on adjusted effect, model, variables, interval and test
- 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: Fewer births above 4000 g
- Related sources: R03

### N11 · Has a null result been kept separate from confirmed exclusion of meaningful reduction?

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

- Current findings: The original text records no demonstrated birthweight benefit but says meaningful benefit cannot be declared 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. The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.
- Reason for missing information: The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.
- Required materials and conditions: A validated prespecified clinical threshold and effect interval
- Materials to obtain first: The aRR CI and P are not converted into certification of zero effect, equivalence or exclusion of meaningful reduction.
- Further research: Obtain importance criteria, a prespecified validated threshold and plans suited to the population and endpoint.
- Conditions for verification: A validated prespecified clinical 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: Fewer births above 4000 g
- Related sources: R03

### N12 · Were GRoW allocation and masking details kept separate from EMPOWaR?

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

- Current findings: GRoW’s design is a multicenter double-blind placebo-controlled randomized trial. EMPOWaR has separate allocation and masking quotations.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.
- Reason for missing information: EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.
- Required materials and conditions: Trial-specific allocation concealment, masking and outcome-measurement procedures
- Materials to obtain first: EMPOWaR web-based block randomization and study-personnel masking wording are not transferred as actual GRoW details.
- Further research: Obtain allocation, concealment, measurement and analysis procedures from the original GRoW methods.
- Conditions for verification: Trial-specific allocation concealment, masking and outcome-measurement procedures
- 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: Fewer births above 4000 g
- Related sources: R03

### N13 · Are GRoW analysis population, missingness and follow-up methods directly supplied?

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

- Current findings: Only the summary of 524 randomized and 514 analyzed is preserved for GRoW. Explicit modified ITT and 97% belong to the EMPOWaR context.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.
- Reason for missing information: The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.
- Required materials and conditions: Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses
- Materials to obtain first: The EMPOWaR modified-ITT definition is not transferred to GRoW. No new missing-data handling or attrition rate is inferred.
- Further research: Obtain GRoW analysis-population definitions, arm exclusions, missing-data handling and sensitivity material.
- Conditions for verification: Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses
- 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: Fewer births above 4000 g
- Related sources: R03

### N14 · Are actual exposure, gastrointestinal symptoms and adherence linked to the birth analysis?

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

- Current findings: The parent record describes gastrointestinal adverse effects and lower adherence.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.
- Reason for missing information: GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.
- Required materials and conditions: Trial-specific records of actual exposure, adherence, discontinuation and outcomes
- Materials to obtain first: GRoW adherence counts or figures and symptom-specific exposure/outcome mapping cannot be verified from the summary. No post hoc adherence effect is newly calculated.
- Further research: Obtain actual GRoW exposure, discontinuation and adherence material and the prespecified effect of interest.
- Conditions for verification: Trial-specific records of actual exposure, adherence, discontinuation and 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: Fewer births above 4000 g
- Related sources: R03

### N15 · Are birthweight above 4000 g, mean grams and z score the same endpoint?

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

- Current findings: EMPOWaR means of 3462 g versus 3463 g and its adjusted z-score difference of −0.029 are from a different trial and measures. MOP z scores are also preserved separately.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.
- Reason for missing information: Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.
- Required materials and conditions: Separate original definitions, denominators, timepoints and effects for each measure
- Materials to obtain first: Other trial measures are not filled as direct GRoW birthweight-above-4000-g values. A lower mean is not converted into fewer events.
- Further research: If trial- and measure-specific results are supplied, link original endpoints and denominators separately.
- Conditions for verification: Separate original definitions, denominators, timepoints 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N16 · Are the EMPOWaR primary z-score result and analysis denominators maintained as context?

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

- Current findings: EMPOWaR randomized 449 (226/223) and had 434 in modified ITT; its adjusted z-score difference was −0.029 (95% CI −0.217 to 0.158), P=0.7597.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.
- Reason for missing information: These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.
- Required materials and conditions: Endpoint, denominator and plan boundaries of another trial
- Materials to obtain first: These denominators and CI are not copied as birthweight-above-4000-g results. The relevant EMPOWaR event count and effect are absent from this stored summary.
- Further research: If EMPOWaR material for the selected event endpoint is supplied, link it with direct definitions and denominators.
- Conditions for verification: Endpoint, denominator and plan boundaries of another trial
- 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: Fewer births above 4000 g
- Related sources: R01

### N17 · Is the MOP z-score report and registration link kept separate from direct evidence for the selected event?

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

- Current findings: MOP z scores of 0.05 versus 0.17, P=0.66 and “400 analyzed” are preserved. The citation URL is the NCT01273584 registration page.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.
- Reason for missing information: MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.
- Required materials and conditions: Distinction between trial-specific bibliographies, material types, endpoints and effects
- Materials to obtain first: MOP birthweight-above-4000-g events, effects and arm denominators are not supplied. The registration URL is not labeled as the paper’s full text.
- Further research: Obtain registration and the paper separately to link the selected event endpoint, plans and denominators.
- Conditions for verification: Distinction between trial-specific bibliographies, material types, endpoints 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: Fewer births above 4000 g
- Related sources: R02

### N18 · Are original repeated-null and independence wording distinguished from certification in this work?

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

- Current findings: The parent text records null birthweight results in three trials; GRoW’s original evidence-role wording is independent repeated null evidence.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.
- Reason for missing information: The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.
- Required materials and conditions: Links between ingredient, pregnancy without diabetes, trial identity and study families
- Materials to obtain first: The three trials with different endpoints are not all counted as direct birthweight-above-4000-g trials. Original axes RX and I1 are not used as new independence certification.
- Further research: Link only direct trial-to-endpoint relationships and pass additional material to content review.
- Conditions for verification: Links between ingredient, pregnancy without diabetes, trial identity and study families
- 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N19 · Do the two related sheets share the same reports, trials and cohorts?

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

- Current findings: The z-score and above-4000-g sheets share the entire stored parent-verdict 2948 summary and three reports.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.
- Reason for missing information: Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.
- Required materials and conditions: Explicit links between stored summary, bibliographies, trials and participants
- Materials to obtain first: Reports, participants, trials and repeated measurements are not summed as new independent material because there are two sheets. Unique trials and total participants remain unrecorded.
- Further research: Link additional reports to existing identifiers and preserve same-population relationships.
- Conditions for verification: Explicit links between stored summary, bibliographies, trials and participants
- 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N20 · Has the birth event been kept separate from later obesity and other clinical pregnancy outcomes?

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

- Current findings: The original text records birthweight as a surrogate for later obesity risk. The fatal composite is a separate harm outcome.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.
- Reason for missing information: Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.
- Required materials and conditions: Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes
- Materials to obtain first: Birthweight-above-4000-g results are not converted into efficacy or null conclusions for later obesity, cesarean delivery, delivery complications or all pregnancy outcomes.
- Further research: Each clinical outcome requires separate direct measurement, follow-up, denominators and effects.
- Conditions for verification: Direct distinction between birth measures, long-term clinical outcomes and other pregnancy 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: Fewer births above 4000 g
- Related sources: R01, R03

### N21 · Has the verdict’s scope been kept separate from other diabetes treatment and pregnancy management?

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

- Current findings: The original text explicitly states that the verdict does not apply to treatment of gestational or type 2 diabetes and that mechanism explanations do not substitute for birthweight efficacy.
- 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, dosing, stopping or replacement instructions or pregnancy-management methods are produced.
- Reason for missing information: No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.
- Required materials and conditions: Direct evidence and boundaries for disease and indication contexts
- Materials to obtain first: No medication selection, use, dosing, stopping or replacement instructions or pregnancy-management methods are produced.
- Further research: Link evidence for a new indication to its separate population, comparator and endpoint.
- Conditions for verification: Direct evidence and boundaries for disease and indication contexts
- 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N22 · Are GRoW public funding and gaps in the four company roles distinguished?

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

- Current findings: GRoW funding names the Australian National Health and Medical Research Council; the citation records publicly funded independent replication.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.
- Reason for missing information: Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.
- Required materials and conditions: Separate records for cash support, product provision, affiliated authors and outside analysis providers
- Materials to obtain first: Manufacturer cash support, drug/placebo supply, employee authors and outside analysis-role details are not all filled as absent from this summary.
- Further research: Obtain original GRoW funding, product supply, affiliations, analysis and writing roles separately.
- Conditions for verification: Separate records for cash support, product provision, affiliated authors and outside analysis providers
- 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: Fewer births above 4000 g
- Related sources: R03

### N23 · Were EMPOWaR Merck supply and role declarations kept separate from GRoW funding?

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

- Current findings: EMPOWaR MRC·NIHR support, Edinburgh/NHS co-sponsorship, free Merck drug/placebo supply and the no-role declaration are preserved as originally recorded.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.
- Reason for missing information: They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.
- Required materials and conditions: Trial-specific relationships of public support, sponsorship, products and company roles
- Materials to obtain first: They are not transferred as GRoW or MOP support, supply or analysis declarations. MOP funding retains the ambiguous original wording.
- Further research: Link original conflict-of-interest material for the three trials separately.
- Conditions for verification: Trial-specific relationships of public support, sponsorship, products and company 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N24 · Are person, event and exposure denominators available for gastrointestinal harm, discontinuation and adherence?

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

- Current findings: Gastrointestinal adverse effects and lower adherence are recorded in the original safety account.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.
- Reason for missing information: GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.
- Required materials and conditions: Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables
- Materials to obtain first: GRoW occurrence counts, rates, event relatedness, discontinuation counts and denominators separately remain unread. They are not filled as no adverse effects or safety.
- Further research: Obtain original GRoW safety tables and exposure, discontinuation and adherence material.
- Conditions for verification: Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables
- 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: Fewer births above 4000 g
- Related sources: R03

### N25 · Has the EMPOWaR fatal composite’s composition and figures been kept separate from GRoW harm?

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

- Current findings: The EMPOWaR miscarriage, pregnancy termination, stillbirth and neonatal-death composite was 7 with metformin versus 2 with placebo, OR 3.60 (95% CI 0.74 to 17.50), P=0.11.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.
- Reason for missing information: These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.
- Required materials and conditions: Distinction between trials, arms, component events, follow-up and denominators
- Materials to obtain first: These figures are not copied as matching GRoW event counts or effects. Component-specific and pregnant-woman/infant denominators remain unread.
- Further research: Link each trial’s component event definitions, original arm event tables and denominators.
- Conditions for verification: Distinction between trials, arms, component events, follow-up and 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: Fewer births above 4000 g
- Related sources: R01

### N26 · Are nonsignificance and wide CIs for rare harm distinguished from confirmed safety?

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

- Current findings: The original text distinguishes confirmed harm from an uncertain signal because of the wide EMPOWaR CI and P=0.11.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.
- Reason for missing information: The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.
- Required materials and conditions: Material directly addressing effects, precision, exposure and rare harm
- Materials to obtain first: The record is not converted into no risk, absence of all harm or confirmed harm. No new harm figure, CI or rate is produced.
- Further research: Adequate arm-specific follow-up, component events, original effects and rare-harm material are needed.
- Conditions for verification: Material directly addressing effects, precision, exposure and rare harm
- 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: Fewer births above 4000 g
- Related sources: R01

### N27 · Are gaps for maternal, infant and long-term harm and replication material maintained?

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

- Current findings: The current preserved account covers pregnancy and birth-time outcomes and some harm summaries.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.
- Reason for missing information: No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.
- Required materials and conditions: Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up
- Materials to obtain first: No new search was made for long-term GRoW maternal or infant follow-up or independent harm-replication material. Long-term safety is not confirmed.
- Further research: Link population-specific direct harm, long-term follow-up and report relationships to original trials.
- Conditions for verification: Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up
- 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: Fewer births above 4000 g
- Related sources: R03

### N28 · Are original URLs, registration identifiers and actual reading status shown individually?

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

- Current findings: GRoW preserves its PubMed bibliography URL and ACTRN12612001277831 identifier. MOP connects its actual original registration URL to a separate registration entry.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.
- Reason for missing information: No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.
- Required materials and conditions: Individual material entries for summary, abstract, full text, registration, protocol and SAP
- Materials to obtain first: No new URL is constructed from an identifier, and link existence alone does not upgrade a record to completed reading. All external material remains unread.
- Further research: Link user-obtained original material with its individual material type and access status.
- Conditions for verification: Individual material entries for summary, abstract, full text, registration, protocol and SAP
- 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N29 · Are reference date, original languages, corrections, empty values and parent history preserved?

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

- Current findings: The reference date 2026-08-26, empty correction array and empty deliberation string, Korean/English text, parent D30 with safety Caution, and original axes are preserved.
- Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.
- Reason for missing information: This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.
- Required materials and conditions: Separate preservation of the entire stored summary, selected verdict record and parent values
- Materials to obtain first: This production date is not changed into a clinical-verification date, and past cross-checks are not marked as passing this work’s content review.
- Further research: Reflect new material and decisions as separate change events while preserving the entire original.
- Conditions for verification: Separate preservation of the entire stored summary, selected verdict record and parent 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: Fewer births above 4000 g
- Related sources: R01, R02, R03

### N30 · Is the incomplete content-review marker distinguished from actual production and independence status?

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

- Current findings: Existing review-pending, production-eligibility and boundary-review-needed values are preserved as history. The original content review is incomplete; the original model, content and boundary active-pending and completion markers are false.
- 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 new units remain 0 and the final independent count unrecorded.
- Reason for missing information: There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.
- Required materials and conditions: Separate records of original candidate history, production status and review status
- Materials to obtain first: There is no new verdict, split or independence certification; additional new units remain 0 and the final independent count unrecorded.
- Further research: Reflect only user-provided decisions and materials as separate events.
- Conditions for verification: Separate records of original candidate history, production status and review status
- 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: Fewer births above 4000 g
- 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. The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.