# Peer-led monthly lifestyle program · Original null result for prespecified nine-year diabetes incidence

Verdict 2963 · 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: 2026-10-12

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: High-risk residents without diabetes, aged 30-60 with IDRS at least 60, in 60 polling areas in Kerala, India. Detailed selection, baseline diagnosis and testing are unverified.
- Ingredient, formulation and route: A 12-month monthly group lifestyle program led by trained community peers
- Dose: Original exposure to a 12-month monthly group lifestyle program. Actual sessions/attendance and post-intervention maintenance are unverified; this is not implementation guidance.
- Comparator: Education booklet. Actual content, distribution/reading, long-term concurrent care and cluster-contamination details are unverified.
- Measured outcome: Prespecified nine-year cumulative incidence: FPG at least 126 mg/dL or HbA1c at least 6.5%, including physician diagnosis or glucose-lowering medication initiation during follow-up. 125/419 (30%) versus 142/422 (34%), RR 0.88 (95% CI 0.73-1.08), P=.24. Cluster/missingness analysis details are unverified.
- Duration: Initial intervention for 12 months; selected outcome is nine-year cumulative incidence. The same trial’s earlier 24-month report is a separate time point. Actual follow-up duration and visit windows are unverified.
- Questions outside this scope: Transfer the positive FPG-only RR/CI/P to the prespecified primary composite definition; Add 24-month/nine-year/definition-specific events, clusters, people or bibliographies as new independent trials/participants; Copy 1,007 allocated participants into the nine-year 841 available-case denominator; Calculate a difference between 144 lost to follow-up and 841 analyzed to create new exclusion counts/causes; Newly confirm cluster adjustment, ICC, missingness handling or testing/diagnostic procedures; Extend the monthly peer-led result to ineffectiveness of all expert-led intensive programs; Extend missing nine-year abstract safety counts/no related events at 24 months to zero of all long-term harms; Provide lifestyle, diet, exercise, glucose-lowering medication or diabetes-prevention/treatment instructions

## Checklist items

### N01 · What are the selected original question and assessment record?

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

- Current findings: The selected original question is reduced diabetes incidence by the prespecified nine-year definition. Its subclaim record is distinguished from the parent and sibling FPG-only definition context.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. No independent-claim certification, new subclaim split or invented main verdict was made.
- Reason for missing information: No independent-claim certification, new subclaim split or invented main verdict was made.
- Required materials and conditions: Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition
- Materials to obtain first: Original subclaim and complete preserved parent JSON
- Further research: If the question boundary changes, retain the original wording, previous complete version and change event separately.
- Conditions for verification: Connect Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition.
- Application exceptions: Do not turn the parent, sibling or other time points into new independent trials/participants.
- Remaining uncertainty: Within the preparation scope of the preserved summary. No independent-claim certification, new subclaim split or invented main verdict was made.
- Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design
- Related sources: R01

### N02 · How do subclaim D and parent D34, axes and history differ?

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

- Current findings: The subclaim is D, with “RR 0.88, P=.24, a null result”; it has no score, status or axes keys. Parent D34, Good safety, B/H/R1/I2/E0/B1/C0 and the true large hard-outcome RCT flag are retained as parent context.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Selected-row score, status and axes are unrecorded; parent values are not inserted.
- Reason for missing information: Selected-row score, status and axes are unrecorded; parent values are not inserted.
- Required materials and conditions: Subclaim grade/note, absent score/status/axes and actual parent values
- Materials to obtain first: Original subclaim record and parent grade/score/axes and assessment history
- Further research: Separate preservation of original values from a new decision event when evidence is actually updated.
- Conditions for verification: Connect Subclaim grade/note, absent score/status/axes and actual parent values to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Subclaim grade/note, absent score/status/axes and actual parent values.
- Application exceptions: Do not inherit parent scores, axes or cross-check history as new review approval, subclaim scores or independence certification.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Selected-row score, status and axes are unrecorded; parent values are not inserted.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: R01

### N03 · Which high-risk community residents were selected?

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

- Current findings: In 60 polling areas in Kerala, India, 1,007 residents aged 30-60, without diabetes and with IDRS at least 60, were allocated.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Baseline diabetes-exclusion testing, IDRS components, prediabetes proportion, sex, baseline glucose/weight, selection and representativeness details are unverified.
- Reason for missing information: Baseline diabetes-exclusion testing, IDRS components, prediabetes proportion, sex, baseline glucose/weight, selection and representativeness details are unverified.
- Required materials and conditions: Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes
- Materials to obtain first: Original eligibility/exclusion criteria, baseline characteristics, high-risk score and recruitment flow
- Further research: Distinguish other high-risk groups using their actual risk definitions and selection materials.
- Conditions for verification: Connect Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes.
- Application exceptions: Do not turn a high-risk score or the prediabetes tag into a prediabetes diagnosis for all participants.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Baseline diabetes-exclusion testing, IDRS components, prediabetes proportion, sex, baseline glucose/weight, selection and representativeness details are unverified.
- Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design
- Related sources: R01

### N04 · What was the actual peer-led intervention?

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

- Current findings: The original intervention was a 12-month monthly group lifestyle program led by trained community peers, distinct from expert-led intensive interventions.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Session content, education/support, peer training, delivery quality, attendance and actual implementation are unverified.
- Reason for missing information: Session content, education/support, peer training, delivery quality, attendance and actual implementation are unverified.
- Required materials and conditions: Trained community peers and monthly group lifestyle sessions
- Materials to obtain first: Original program description, facilitator training and session/attendance records
- Further research: Record actual program identity, intensity, delivery and peer roles together in subsequent materials.
- Conditions for verification: Connect Trained community peers and monthly group lifestyle sessions to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Trained community peers and monthly group lifestyle sessions.
- Application exceptions: Do not create new diet, exercise or lifestyle treatment/prevention instructions.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Session content, education/support, peer training, delivery quality, attendance and actual implementation are unverified.
- Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design
- Related sources: R01

### N05 · Are the 12-month program and nine-year outcome period distinguished?

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

- Current findings: The program consisted of monthly sessions for 12 months; the selected outcome is cumulative diabetes incidence at nine years.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Maintenance, additional sessions, other care, individual follow-up duration and visit windows after the program are unverified.
- Reason for missing information: Maintenance, additional sessions, other care, individual follow-up duration and visit windows after the program are unverified.
- Required materials and conditions: Initial intervention duration, long-term follow-up and maintenance/additional exposure
- Materials to obtain first: Initial exposure, post-program care and long-term follow-up schedule
- Further research: Report original intervention duration separately from maintenance/additional exposure during follow-up.
- Conditions for verification: Connect Initial intervention duration, long-term follow-up and maintenance/additional exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Initial intervention duration, long-term follow-up and maintenance/additional exposure.
- Application exceptions: Do not state that monthly intervention continued throughout nine years or retained the same intensity.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Maintenance, additional sessions, other care, individual follow-up duration and visit windows after the program are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
- Related sources: R01

### N06 · What were the control and direction of comparison?

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

- Current findings: The 500 intervention participants received the monthly peer-led program; 507 control participants received an education booklet. The control is not relabeled as no education or no treatment.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Booklet content, distribution/reading, actual control care and differences in education common to both groups are unverified.
- Reason for missing information: Booklet content, distribution/reading, actual control care and differences in education common to both groups are unverified.
- Required materials and conditions: Education-booklet control and original intervention/control correspondence
- Materials to obtain first: Education booklet, shared support and actual control-exposure materials
- Further research: Do not automatically combine materials using a different control as the same comparison.
- Conditions for verification: Connect Education-booklet control and original intervention/control correspondence to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Education-booklet control and original intervention/control correspondence.
- Application exceptions: Prepare only the actual stored-summary scope; do not create absent numbers, definitions, denominators or method confirmations.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Booklet content, distribution/reading, actual control care and differences in education common to both groups are unverified.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
- Related sources: R01

### N07 · What were the cluster-allocation unit and number?

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

- Current findings: This trial cluster randomized 60 polling areas. The 500/507 allocation among 1,007 individuals represents people.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Clusters per group, cluster sizes, recruitment order, post-allocation selection, retention of all clusters and concealment are unverified.
- Reason for missing information: Clusters per group, cluster sizes, recruitment order, post-allocation selection, retention of all clusters and concealment are unverified.
- Required materials and conditions: 60 polling-area clusters, distinguished from individual recruitment/analysis
- Materials to obtain first: Cluster flow, people per cluster and allocation/recruitment process
- Further research: Record cluster and individual recruitment, allocation, follow-up and analysis together.
- Conditions for verification: Connect 60 polling-area clusters, distinguished from individual recruitment/analysis to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of 60 polling-area clusters, distinguished from individual recruitment/analysis.
- Application exceptions: Do not divide 60 to create new group cluster counts or turn people into independent randomized units.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Clusters per group, cluster sizes, recruitment order, post-allocation selection, retention of all clusters and concealment are unverified.
- Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design
- Related sources: R01

### N08 · What were the allocation, masking and diagnostic-collection processes?

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

- Current findings: The original design is recorded as long-term follow-up of a cluster-randomized controlled trial.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Allocation generation/concealment, facilitator/resident masking, tester/adjudicator/analyst masking and outcome-collection details are unverified.
- Reason for missing information: Allocation generation/concealment, facilitator/resident masking, tester/adjudicator/analyst masking and outcome-collection details are unverified.
- Required materials and conditions: Cluster allocation concealment, participant/assessor masking and outcome collection
- Materials to obtain first: Original allocation method and assessment/testing/adjudication/analysis procedures
- Further research: When methods are provided, link actual role-specific masking and diagnostic collection to the corresponding outcome.
- Conditions for verification: Connect Cluster allocation concealment, participant/assessor masking and outcome collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Cluster allocation concealment, participant/assessor masking and outcome collection.
- Application exceptions: Do not newly judge masking or count method defects from the program name.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Allocation generation/concealment, facilitator/resident masking, tester/adjudicator/analyst masking and outcome-collection details are unverified.
- Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application
- Related sources: R01

### N09 · What were long-term co-interventions and cluster contamination?

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

- Current findings: The original summary retains nine-year outcomes for the program versus education booklet.
- Why unverified: Required direct values, definitions or materials are unverified within the current stored-summary/unread-external-material scope. Other lifestyle support, weight/activity changes, preventive medication, medical access, contact/contamination between clusters and group differences during follow-up are unverified.
- Reason for missing information: Other lifestyle support, weight/activity changes, preventive medication, medical access, contact/contamination between clusters and group differences during follow-up are unverified.
- Required materials and conditions: Diet, activity, medicines, other programs and contact between clusters
- Materials to obtain first: Long-term co-exposure, care changes, cluster contact and lifestyle records
- Further research: Record actual measurement/management of post-intervention exposure and cluster contamination in subsequent research.
- Conditions for verification: Connect Diet, activity, medicines, other programs and contact between clusters to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Diet, activity, medicines, other programs and contact between clusters.
- Application exceptions: Do not newly establish separate diet/activity effects or actual amounts of lifestyle change.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Other lifestyle support, weight/activity changes, preventive medication, medical access, contact/contamination between clusters and group differences during follow-up are unverified.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation
- Related sources: R01

### N10 · What were the components of the prespecified diabetes-incidence definition?

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

- Current findings: The prespecified primary definition is cumulative incidence based on FPG at least 126 mg/dL or HbA1c at least 6.5%, including physician diagnosis or initiation of glucose-lowering medication during follow-up.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Detailed confirmation of each criterion, repeat testing, record sources, component-specific events and overlap are unverified.
- Reason for missing information: Detailed confirmation of each criterion, repeat testing, record sources, component-specific events and overlap are unverified.
- Required materials and conditions: FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up
- Materials to obtain first: Prespecified definition, component-specific diagnostic/testing criteria and incidence tables
- Further research: Link each criterion, combination rule and overlap separately in new definition materials.
- Conditions for verification: Connect FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up.
- Application exceptions: Do not turn the original FPG-plus-HbA1c shorthand into a rule requiring both tests to be positive.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Detailed confirmation of each criterion, repeat testing, record sources, component-specific events and overlap are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application
- Related sources: R01

### N11 · How were glucose and HbA1c measured and confirmed?

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

- Current findings: The original incidence criteria include FPG and HbA1c thresholds.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Fasting confirmation, blood sampling/assays, repeat confirmation, testing by visit, failed/indeterminate tests and adjudicator details are unverified.
- Reason for missing information: Fasting confirmation, blood sampling/assays, repeat confirmation, testing by visit, failed/indeterminate tests and adjudicator details are unverified.
- Required materials and conditions: Fasting tests, assay methods, repeat confirmation, timing and missingness
- Materials to obtain first: Testing methods, visit-specific confirmation and repeat/missingness rules
- Further research: Distinguish collection of test-based incidence from physician-diagnosis/medication-based incidence.
- Conditions for verification: Connect Fasting tests, assay methods, repeat confirmation, timing and missingness to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Fasting tests, assay methods, repeat confirmation, timing and missingness.
- Application exceptions: Do not create OGTTs, repeat-test counts, additional glucose values or diagnostic procedures.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Fasting confirmation, blood sampling/assays, repeat confirmation, testing by visit, failed/indeterminate tests and adjudicator details are unverified.
- Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application
- Related sources: R01

### N12 · How were physician diagnosis and glucose-lowering medication initiation included?

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

- Current findings: The original prespecified definition includes physician diagnosis and initiation of glucose-lowering medication during follow-up.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Medical-record/self-report sources, initiation indications, diabetes confirmation, component overlap and event dates are unverified.
- Reason for missing information: Medical-record/self-report sources, initiation indications, diabetes confirmation, component overlap and event dates are unverified.
- Required materials and conditions: Sources, confirmation and incidence attribution for diagnosis/medication initiation
- Materials to obtain first: Original confirmation rules and event links for physician diagnosis/medication initiation
- Further research: Link actual criterion-specific attribution and overlap when registration/plans and result tables are provided.
- Conditions for verification: Connect Sources, confirmation and incidence attribution for diagnosis/medication initiation to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Sources, confirmation and incidence attribution for diagnosis/medication initiation.
- Application exceptions: Do not turn medication initiation into an invented diagnosis, a specific drug/dose or treatment-need guidance.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Medical-record/self-report sources, initiation indications, diabetes confirmation, component overlap and event dates are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application
- Related sources: R01

### N13 · What time and analysis measure does nine-year cumulative incidence represent?

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

- Current findings: The selected primary outcome is nine-year cumulative diabetes incidence, recorded as an available-case analysis.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Individual follow-up duration, testing/diagnostic visit intervals, event dates, censoring, death/competing-event handling and person-time are unverified.
- Reason for missing information: Individual follow-up duration, testing/diagnostic visit intervals, event dates, censoring, death/competing-event handling and person-time are unverified.
- Required materials and conditions: Nominal nine years, cumulative incidence, analysis population and follow-up duration
- Materials to obtain first: Cumulative counts, follow-up schedule and event/censoring/competing-event methods
- Further research: Distinguish cumulative incidence risk, incidence rate and time models in new time-related materials.
- Conditions for verification: Connect Nominal nine years, cumulative incidence, analysis population and follow-up duration to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Nominal nine years, cumulative incidence, analysis population and follow-up duration.
- Application exceptions: Do not calculate/convert nine-year cumulative proportions into annual incidence, person-years or hazard ratios.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Individual follow-up duration, testing/diagnostic visit intervals, event dates, censoring, death/competing-event handling and person-time are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design
- Related sources: R01

### N14 · What were the original nine-year event numerators, denominators and proportions?

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

- Current findings: The stored summary records prespecified nine-year outcomes as intervention 125/419 (30%) versus control 142/422 (34%).
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Component-specific events, repeated counts, overlap by person and original-table details are unverified.
- Reason for missing information: Component-specific events, repeated counts, overlap by person and original-table details are unverified.
- Required materials and conditions: Attribution of intervention 125/419 (30%) and control 142/422 (34%)
- Materials to obtain first: Original prespecified-definition result table, counting units and component numerators
- Further research: Link original numerators, denominators and proportions to the corresponding definition/time point as materials are supplemented.
- Conditions for verification: Connect Attribution of intervention 125/419 (30%) and control 142/422 (34%) to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Attribution of intervention 125/419 (30%) and control 142/422 (34%).
- Application exceptions: Do not back-calculate events or create new absolute risk differences, numbers prevented or component totals.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Component-specific events, repeated counts, overlap by person and original-table details are unverified.
- Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed
- Related sources: R01

### N15 · What is the scope of the RR, interval, P value and null-result wording?

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

- Current findings: The prespecified nine-year result is RR 0.88 (95% CI 0.73-1.08), P=.24; the original subclaim D/note records a null result.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Model, cluster adjustment, adjustment variables, estimand and interval-calculation details are unverified.
- Reason for missing information: Model, cluster adjustment, adjustment variables, estimand and interval-calculation details are unverified.
- Required materials and conditions: RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment
- Materials to obtain first: Nine-year estimation model, adjustment, interval calculation and actual analysis table
- Further research: Link the estimate to its adjustment and units when original methods are provided.
- Conditions for verification: Connect RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment.
- Application exceptions: Do not turn nonsignificance into an exact zero effect, equivalence, prevention worthlessness or ineffectiveness of all programs.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Model, cluster adjustment, adjustment variables, estimand and interval-calculation details are unverified.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application
- Related sources: R01

### N16 · What were the randomized and actual nine-year analysis denominators?

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

- Current findings: Allocation was 1,007 participants (500 intervention/507 control); actual nine-year data analysis used 841 (419/422). The original summary says available cases rather than all randomized participants.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Group-specific exclusion reasons, valid-data criteria, cluster retention in analysis and alternative analyses based on full allocation are unverified.
- Reason for missing information: Group-specific exclusion reasons, valid-data criteria, cluster retention in analysis and alternative analyses based on full allocation are unverified.
- Required materials and conditions: 1,007 randomized (500/507) and 841 available cases (419/422)
- Materials to obtain first: Nine-year cluster/individual flow, analysis selection and exclusion reasons
- Further research: Link allocation, acquired data, valid outcomes and actual analysis denominators separately when follow-up data are added.
- Conditions for verification: Connect 1,007 randomized (500/507) and 841 available cases (419/422) to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of 1,007 randomized (500/507) and 841 available cases (419/422).
- Application exceptions: Do not copy 1,007 or 500/507 into actual nine-year outcome denominators or make 841 a new cohort.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Group-specific exclusion reasons, valid-data criteria, cluster retention in analysis and alternative analyses based on full allocation are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design
- Related sources: R01

### N17 · Are the 144 lost to follow-up and 841 analyzed distinguished?

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

- Current findings: The source separately records loss to follow-up of 144/1,007 (14.3%) and the historical assessment of below 15%; it records 841 in the nine-year analysis.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Relationships among exclusions beyond loss to follow-up, indeterminate data, death and group-specific reasons are unverified.
- Reason for missing information: Relationships among exclusions beyond loss to follow-up, indeterminate data, death and group-specific reasons are unverified.
- Required materials and conditions: Original loss to follow-up, 144/1,007 (14.3%), and analysis flow
- Materials to obtain first: Original flow diagram distinguishing loss, death, incomplete data and analysis exclusion
- Further research: Link definitions and reasons for each state when original flow materials are supplemented.
- Conditions for verification: Connect Original loss to follow-up, 144/1,007 (14.3%), and analysis flow to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Original loss to follow-up, 144/1,007 (14.3%), and analysis flow.
- Application exceptions: Do not calculate allocation-analysis or loss-to-follow-up differences to fill new dropout counts, rates or exclusion causes.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Relationships among exclusions beyond loss to follow-up, indeterminate data, death and group-specific reasons are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design
- Related sources: R01

### N18 · What were the available-case and missingness/selection assumptions?

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

- Current findings: The original rationale records nine-year available-case analysis as a limitation.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Cluster/individual missingness reasons, mechanisms, additional analyses, imputation, inverse-probability/sensitivity analysis use and results are unverified.
- Reason for missing information: Cluster/individual missingness reasons, mechanisms, additional analyses, imputation, inverse-probability/sensitivity analysis use and results are unverified.
- Required materials and conditions: Analysis of people with data, missingness reasons and imputation/sensitivity analyses
- Materials to obtain first: Missingness/exclusion, analysis populations, sensitivity results and plans
- Further research: Distinguish analysis of people with data from assumptions for the full allocated population.
- Conditions for verification: Connect Analysis of people with data, missingness reasons and imputation/sensitivity analyses to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Analysis of people with data, missingness reasons and imputation/sensitivity analyses.
- Application exceptions: Do not turn available-case analysis into completed full ITT analysis or absence of missingness effects.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Cluster/individual missingness reasons, mechanisms, additional analyses, imputation, inverse-probability/sensitivity analysis use and results are unverified.
- Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.
- Related sources: R01

### N19 · What were the cluster correlation, sizes and estimation model?

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

- Current findings: The original design is a 60-cluster randomized controlled trial, and the stored summary supplies RR/CI results.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. ICC, cluster sizes, events per cluster, within-person repetition, variance/weighting and whether estimates were cluster adjusted are absent from the summary.
- Reason for missing information: ICC, cluster sizes, events per cluster, within-person repetition, variance/weighting and whether estimates were cluster adjusted are absent from the summary.
- Required materials and conditions: Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures
- Materials to obtain first: Cluster-analysis methods, ICC, participants/events per cluster and adjusted model
- Further research: Link actual cluster correlation/weighting to the original estimand when cluster data are added.
- Conditions for verification: Connect Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures.
- Application exceptions: Do not certify cluster adjustment from the design name or calculate new CIs assuming independent individuals.
- Remaining uncertainty: Within the preparation scope of the preserved summary. ICC, cluster sizes, events per cluster, within-person repetition, variance/weighting and whether estimates were cluster adjusted are absent from the summary.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M08 §8.1–8.2.3; CHAMGAP adaptation
- Related sources: R01

### N20 · What were the prespecified primary definition and outcome hierarchy?

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

- Current findings: The stored summary identifies the FPG/HbA1c, physician-diagnosis and medication-initiation definition as prespecified primary; it says FPG alone was not the prespecified primary definition.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Designation dates, changes, definition/analysis hierarchy and multiplicity details are unverified because external plans are unread.
- Reason for missing information: Designation dates, changes, definition/analysis hierarchy and multiplicity details are unverified because external plans are unread.
- Required materials and conditions: Prespecified nine-year definition, analysis plan and multiple definitions/tests
- Materials to obtain first: Nine-year definition/time point/hierarchy in protocols, SAPs and registration history
- Further research: Link the contemporary prespecified/post hoc status, change history and outcome definition when plans are provided.
- Conditions for verification: Connect Prespecified nine-year definition, analysis plan and multiple definitions/tests to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Prespecified nine-year definition, analysis plan and multiple definitions/tests.
- Application exceptions: Do not upgrade the parent H endpoint/large hard-outcome RCT flag or historical prespecified wording into current registration/plan review certification.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Designation dates, changes, definition/analysis hierarchy and multiplicity details are unverified because external plans are unread.
- Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application
- Related sources: R01

### N21 · What separate definition produced the positive FPG-only result?

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

- Current findings: The FPG-only definition gives RR 0.72 (95% CI 0.53-0.98), P=.036. Sibling s1 is C and says it was not the prespecified primary endpoint. Both this and selected s0’s null result are preserved.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Actual FPG-only numerators/denominators, valid-testing population, other definition results, adjustment and multiple testing are unverified.
- Reason for missing information: Actual FPG-only numerators/denominators, valid-testing population, other definition results, adjustment and multiple testing are unverified.
- Required materials and conditions: RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition
- Materials to obtain first: Original definition-specific results, valid-test denominators and hierarchy/adjustment
- Further research: Link results for each definition to separate measures/denominators even at the same time point.
- Conditions for verification: Connect RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition.
- Application exceptions: Do not transfer FPG-only RR, CI or P to the prespecified composite definition or count the definitions as independent trials.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Actual FPG-only numerators/denominators, valid-testing population, other definition results, adjustment and multiple testing are unverified.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation
- Related sources: R01

### N22 · How do the original paired registration identifiers and actual content-reading state differ?

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

- Current findings: The original evidence record gives “ACTRN12611000262909 · CTRI/2021/10/037191”. The paired original values are preserved.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Registration content, dates, changes, nine-year-plan correspondence and public results were not read/confirmed in this work. Citations have no separate registration-number key.
- Reason for missing information: Registration content, dates, changes, nine-year-plan correspondence and public results were not read/confirmed in this work. Citations have no separate registration-number key.
- Required materials and conditions: ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope
- Materials to obtain first: Both original registrations, histories and prespecified-definition plan
- Further research: Distinguish original identity, dates, changes and actual reading scope when registration materials are provided.
- Conditions for verification: Connect ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope.
- Application exceptions: Do not force identifiers stored under the historical nct key into NCT numbers or count two registrations as independent trials.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Registration content, dates, changes, nine-year-plan correspondence and public results were not read/confirmed in this work. Citations have no separate registration-number key.
- Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application
- Related sources: R01

### N23 · What are the bibliographies and stored-source locations of the two reports?

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

- Current findings: R01 is Jeemon et al., 2026 Lancet Global Health, nine-year K-DPP, PMID 41997166. R02 is Thankappan et al., 2018 Diabetes Care, the earlier 24-month report, PMID 29874236. The source has one evidence entry and two citations.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. DOIs, PMCIDs, current external bibliographies and original table/method locations are not provided.
- Reason for missing information: DOIs, PMCIDs, current external bibliographies and original table/method locations are not provided.
- Required materials and conditions: Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs
- Materials to obtain first: Original bibliographies, full texts and trial links for both reports
- Further research: Retain previous original values and each report’s identity when bibliographies are supplemented/corrected.
- Conditions for verification: Connect Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs.
- Application exceptions: Do not create a nonexistent second evidence entry for R02 or infer a DOI from an article number.
- Remaining uncertainty: Within the preparation scope of the preserved summary. DOIs, PMCIDs, current external bibliographies and original table/method locations are not provided.
- Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations
- Related sources: R01, R02

### N24 · Are the earlier report and long-term follow-up from the same trial?

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

- Current findings: The original research account and second citation identify 24 months as an earlier report from the same trial. Nine years is long-term follow-up of the 60-cluster trial.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Actual participant links, cluster retention and time-specific outcomes are externally unread; unique trial/participant counts are not newly certified.
- Reason for missing information: Actual participant links, cluster retention and time-specific outcomes are externally unread; unique trial/participant counts are not newly certified.
- Required materials and conditions: 2018/2026 K-DPP clusters/participants and report family
- Materials to obtain first: Report-trial-cluster-person-time linkage table
- Further research: Distinguish genuinely different recruitment/registration when an independent new trial is provided.
- Conditions for verification: Connect 2018/2026 K-DPP clusters/participants and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of 2018/2026 K-DPP clusters/participants and report family.
- Application exceptions: Do not add the two reports, 24-month/nine-year results, two definitions or parent/sibling sheets as new trials/participants.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Actual participant links, cluster retention and time-specific outcomes are externally unread; unique trial/participant counts are not newly certified.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: R01, R02

### N25 · What separate time point does the original 24-month result represent?

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

- Current findings: At 24 months, the same trial reported 68/456 (14.9%) versus 79/463 (17.1%), RR 0.88 (95% CI 0.66-1.16), P=.36. The RR matches nine years numerically, but time, denominators, interval and P differ.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Original 24-month diagnostic definition, testing, missingness/model and person-specific links to nine years are unverified.
- Reason for missing information: Original 24-month diagnostic definition, testing, missingness/model and person-specific links to nine years are unverified.
- Required materials and conditions: 68/456(14.9%)·79/463(17.1%)·RR0.88·CI/P
- Materials to obtain first: Original 24-month methods, definition, results, denominators and follow-up links
- Further research: Record each time point’s definition, denominators and effect separately when materials are provided.
- Conditions for verification: Connect 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P.
- Application exceptions: Do not add 24-month events to nine-year events or automatically copy the nine-year FPG/HbA1c definition to 24 months.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Original 24-month diagnostic definition, testing, missingness/model and person-specific links to nine years are unverified.
- Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed
- Related sources: R02

### N26 · What heterogeneity was assessed by high-risk subgroup and period?

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

- Current findings: The source retains the selected overall population’s nine-year available-case result.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Prespecified subgroups and interaction results for prediabetes/baseline glucose, sex, cluster, attendance and period are unverified.
- Reason for missing information: Prespecified subgroups and interaction results for prediabetes/baseline glucose, sex, cluster, attendance and period are unverified.
- Required materials and conditions: Baseline glucose/risk, sex, cluster, time and actual effects
- Materials to obtain first: Prespecified subgroup plan, subgroup denominators/results and interactions
- Further research: Report actual prespecified criteria and intervals for group/time differences in subsequent materials.
- Conditions for verification: Connect Baseline glucose/risk, sex, cluster, time and actual effects to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Baseline glucose/risk, sex, cluster, time and actual effects.
- Application exceptions: Do not turn overall nonsignificance into zero effects for every individual/subgroup.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Prespecified subgroups and interaction results for prediabetes/baseline glucose, sex, cluster, attendance and period are unverified.
- Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design
- Related sources: R01

### N27 · Are the monthly peer-led program and expert-led intensive interventions distinguished?

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

- Current findings: The original account says this does not mean all expert-led intensive diet, exercise and behavioral programs are ineffective. DPP, DPS and verdict 1531 A94 are historical context for a different question.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Original texts of other programs, direct intensity/facilitator superiority comparisons and general applicability were not queried here.
- Reason for missing information: Original texts of other programs, direct intensity/facilitator superiority comparisons and general applicability were not queried here.
- Required materials and conditions: Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators
- Materials to obtain first: Direct materials and comparison conditions for other actual programs
- Further research: Specify program identity, population, intensity and control in new applicability materials.
- Conditions for verification: Connect Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators.
- Application exceptions: Do not create verdict 1531, DPP or DPS as new report/trial slots or current independence certification; their pages/files are not opened.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Original texts of other programs, direct intensity/facilitator superiority comparisons and general applicability were not queried here.
- Referenced methods: M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed
- Related sources: R01

### N28 · How does actual diabetes incidence differ from other outcomes?

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

- Current findings: The selected outcome is prespecified diabetes incidence, not short-term glucose, weight or risk-score change itself.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Direct nine-year complication, death, quality-of-life and other metabolic-outcome values/denominators are absent from this source.
- Reason for missing information: Direct nine-year complication, death, quality-of-life and other metabolic-outcome values/denominators are absent from this source.
- Required materials and conditions: Incidence events versus risk-score/glucose changes, complications and death
- Materials to obtain first: Outcome-specific direct events/measurements, time points and denominators
- Further research: Link incidence, surrogate markers and complications to their own definitions and time points.
- Conditions for verification: Connect Incidence events versus risk-score/glucose changes, complications and death to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Incidence events versus risk-score/glucose changes, complications and death.
- Application exceptions: Do not extend nonsignificant incidence to all health outcomes, long-term care or safety conclusions.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Direct nine-year complication, death, quality-of-life and other metabolic-outcome values/denominators are absent from this source.
- Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed
- Related sources: R01

### N29 · What is the scope of NHMRC support and no commercial product?

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

- Current findings: The source records support by the Australian National Health and Medical Research Council and no commercial product used.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Each report’s author interests, funder design/analysis/publication roles, sponsor and current relationship declarations are unread.
- Reason for missing information: Each report’s author interests, funder design/analysis/publication roles, sponsor and current relationship declarations are unread.
- Required materials and conditions: Trial funding, products, facilitator/analysis/publication roles and disclosed relationships
- Materials to obtain first: Original report-specific support, author disclosures and funder-role declarations
- Further research: Distinguish public funding, commercial products and other relationships/roles when support materials are provided.
- Conditions for verification: Connect Trial funding, products, facilitator/analysis/publication roles and disclosed relationships to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Trial funding, products, facilitator/analysis/publication roles and disclosed relationships.
- Application exceptions: Do not turn historical public funding/no commercial product into no conflicts, new independence certification or reading of individual 2018 declarations.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Each report’s author interests, funder design/analysis/publication roles, sponsor and current relationship declarations are unread.
- Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: R01, R02

### N30 · What were the original date, Korean/English text, corrections, empty fields and verdict history?

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

- Current findings: The reference date is 2026-08-26, corrections are an empty array and deliberation an empty string. Korean/English text, synthesis, grade-decision records, axes and false/true flags are preserved in the complete source.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections are not a current external correction/retraction check.
- Reason for missing information: Separate classification information and the primary-failed/secondary-positive indicator are absent from this stored review summary. Empty corrections are not a current external correction/retraction check.
- Required materials and conditions: 2026-08-26, empty correction/deliberation records and original axes/grades
- Materials to obtain first: Complete previous summary and actual change/correction events
- Further research: Retain the complete original text, event, version and separate application when changes occur.
- Conditions for verification: Connect 2026-08-26, empty correction/deliberation records and original axes/grades to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of 2026-08-26, empty correction/deliberation records and original axes/grades.
- Application exceptions: Do not fill absent/empty fields or historical cross-checks with new values or current completed review.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections are not a current external correction/retraction check.
- Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design
- Related sources: R01

### N31 · What level of material was actually read for this work?

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

- Current findings: Preparation read the complete preserved 2963 JSON and its selected original question. Report-specific summary reading is separated from unread external-material slots.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. External abstracts, full texts, registrations, plans, original results/harms and funding declarations were not accessed/acquired. Historical abstract/report wording is not current reading.
- Reason for missing information: External abstracts, full texts, registrations, plans, original results/harms and funding declarations were not accessed/acquired. Historical abstract/report wording is not current reading.
- Required materials and conditions: Complete preserved JSON, own selected question and unread external materials
- Materials to obtain first: Original materials provided by the user and actual acquisition/reading records
- Further research: Distinguish public availability, access, acquisition, actual reading, scope and dates for new materials.
- Conditions for verification: Connect Complete preserved JSON, own selected question and unread external materials to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Complete preserved JSON, own selected question and unread external materials.
- Application exceptions: Do not upgrade URL, citation or copy existence into external-link confirmation, full-text reading or successful access.
- Remaining uncertainty: Within the preparation scope of the preserved summary. External abstracts, full texts, registrations, plans, original results/harms and funding declarations were not accessed/acquired. Historical abstract/report wording is not current reading.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: R01, R02

### N32 · How do report/material slots differ from trials/populations?

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

- Current findings: The two reports are the same trial’s nine-year follow-up and earlier 24-month report. Material slots are preparation counts linking reading/required materials.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. No new calculation/certification of unique trials, total participants or independent replication was made.
- Reason for missing information: No new calculation/certification of unique trials, total participants or independent replication was made.
- Required materials and conditions: Two bibliographies, material-specific states and shared clusters/people/time points
- Materials to obtain first: Report-material-trial-cluster-person-outcome links
- Further research: Distinguish material types and same/different-population relationships when additional reports appear.
- Conditions for verification: Connect Two bibliographies, material-specific states and shared clusters/people/time points to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Two bibliographies, material-specific states and shared clusters/people/time points.
- Application exceptions: Do not sum 1,007, 841, 419/422, 456/463, 60 clusters or two bibliographies into new total samples/trials.
- Remaining uncertainty: Within the preparation scope of the preserved summary. No new calculation/certification of unique trials, total participants or independent replication was made.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations
- Related sources: R01, R02

### N33 · What is updated when new material appears?

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

- Current findings: The original question and original numbers/verdict are prepared in the same seven-column format. Conditions were saved/frozen first; observations were written at a separate application time.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. No new search, calculation, evidence/effect, regrading, independent certification or model/self-review was performed.
- Reason for missing information: No new search, calculation, evidence/effect, regrading, independent certification or model/self-review was performed.
- Required materials and conditions: Separation of conditions, originals, observations, reading and change events
- Materials to obtain first: User-provided prespecified definitions, cluster/follow-up flow, models, corrections and harms
- Further research: For actual additions/changes, separately retain the previous complete text, event, condition version/freeze, application and current handoff.
- Conditions for verification: Connect Separation of conditions, originals, observations, reading and change events to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Separation of conditions, originals, observations, reading and change events.
- Application exceptions: Candidate pending/eligibility values are history and are not revived as active model/content/boundary review waits.
- Remaining uncertainty: Within the preparation scope of the preserved summary. No new search, calculation, evidence/effect, regrading, independent certification or model/self-review was performed.
- Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design
- Related sources: R01, R02

### H01 · How were adverse events and intervention relatedness defined?

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

- Current findings: The original 24-month report is recorded as having no intervention-related adverse events; the nine-year abstract is recorded as providing no separate safety-outcome counts.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. All adverse events, relatedness assessment, collection/severity criteria and outcome-specific definitions are unverified.
- Reason for missing information: All adverse events, relatedness assessment, collection/severity criteria and outcome-specific definitions are unverified.
- Required materials and conditions: Adverse events, relatedness, severity and collection
- Materials to obtain first: Harms definitions, collection/relatedness assessment and original results for each report
- Further research: Record all collected harms separately from judgments of intervention relatedness.
- Conditions for verification: Connect Adverse events, relatedness, severity and collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Adverse events, relatedness, severity and collection.
- Application exceptions: Do not turn historical no-intervention-related-event wording into zero of all adverse events.
- Remaining uncertainty: Within the preparation scope of the preserved summary. All adverse events, relatedness assessment, collection/severity criteria and outcome-specific definitions are unverified.
- Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation
- Related sources: R01, R02

### H02 · How do safety observations at 12-month exposure, 24 months and nine years differ?

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

- Current findings: The program lasted 12 months; the 24-month related-event account and absence of nine-year abstract safety counts are retained separately.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Actual start/end of safety collection, post-intervention events, long-term care exposure and collection frequency are unverified.
- Reason for missing information: Actual start/end of safety collection, post-intervention events, long-term care exposure and collection frequency are unverified.
- Required materials and conditions: Intervention duration, safety-collection timing and long-term exposure
- Materials to obtain first: Time-specific harms-collection schedule, exposure and subsequent follow-up
- Further research: Record intervention exposure separately from actual observation duration in long-term harms materials.
- Conditions for verification: Connect Intervention duration, safety-collection timing and long-term exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Intervention duration, safety-collection timing and long-term exposure.
- Application exceptions: Do not inherit the 24-month related-event account as completed nine-year safety follow-up.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Actual start/end of safety collection, post-intervention events, long-term care exposure and collection frequency are unverified.
- Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed
- Related sources: R01, R02

### H03 · Is there a nine-year between-group safety comparison?

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

- Current findings: The original source says the nine-year abstract had no separate safety counts. Those external abstracts/full texts were not read in this work.
- Why unverified: Required direct values, definitions or materials are unverified within the current stored-summary/unread-external-material scope. Group-specific harms, serious events, related events, CIs and diagnosis/observation are unverified within the current unread-external-material scope.
- Reason for missing information: Group-specific harms, serious events, related events, CIs and diagnosis/observation are unverified within the current unread-external-material scope.
- Required materials and conditions: Nine-year intervention/control harms, relatedness and intervals
- Materials to obtain first: Original nine-year harms results, group counts and observation/relatedness materials
- Further research: Link new harms results to actual group-specific definitions, denominators and periods.
- Conditions for verification: Connect Nine-year intervention/control harms, relatedness and intervals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Nine-year intervention/control harms, relatedness and intervals.
- Application exceptions: Do not conclude from historical missing abstract counts that the full text also omitted them, events were zero or safety was equivalent.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Group-specific harms, serious events, related events, CIs and diagnosis/observation are unverified within the current unread-external-material scope.
- Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation
- Related sources: R01

### H04 · Are safety denominators the same as incidence-analysis denominators?

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

- Current findings: The source gives 1007 allocated for incidence, 841 analyzed at nine years and 456/463 for 24-month outcomes, but no separate safety-analysis denominator.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Harms-collection, intervention-exposure, period-specific safety populations/clusters and missingness denominators are unverified.
- Reason for missing information: Harms-collection, intervention-exposure, period-specific safety populations/clusters and missingness denominators are unverified.
- Required materials and conditions: Harms collection/exposure/analysis n, clusters and individuals
- Materials to obtain first: Safety flow, denominators, exposure and valid collection for each report
- Further research: Distinguish actual harms collection/analysis populations from incidence denominators.
- Conditions for verification: Connect Harms collection/exposure/analysis n, clusters and individuals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Harms collection/exposure/analysis n, clusters and individuals.
- Application exceptions: Do not copy incidence-analysis participants into safety denominators or calculate incidence from unread originals.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Harms-collection, intervention-exposure, period-specific safety populations/clusters and missingness denominators are unverified.
- Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed
- Related sources: R01, R02

### H05 · What alternative explanations link lifestyle/care changes and harms?

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

- Current findings: The source only supplies the account of no intervention-related adverse events at 24 months.
- Why unverified: Required direct values, definitions or materials are unverified within the current stored-summary/unread-external-material scope. Baseline risks, co-interventions, other programs, background events, relatedness adjudication and case details are unverified.
- Reason for missing information: Baseline risks, co-interventions, other programs, background events, relatedness adjudication and case details are unverified.
- Required materials and conditions: Baseline disease, other activities/medicines, relatedness and timing
- Materials to obtain first: Actual harms cases, timing, co-exposure and relatedness assessment
- Further research: Distinguish program-related events from baseline/concurrent factors in harms materials.
- Conditions for verification: Connect Baseline disease, other activities/medicines, relatedness and timing to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Baseline disease, other activities/medicines, relatedness and timing.
- Application exceptions: Do not invent background events, activity injuries or medication harms as actual events.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Baseline risks, co-interventions, other programs, background events, relatedness adjudication and case details are unverified.
- Referenced methods: M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed
- Related sources: R01, R02

### H06 · Are unread materials, absence from an abstract, nonreporting and zero events distinguished?

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

- Current findings: The original safety account distinguishes missing nine-year abstract safety counts from no related events at 24 months. Currently, the preserved JSON summary was actually read.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Noncollection/nonreporting/indeterminate/actual-zero distinctions in external originals and all harms outcomes are unverified.
- Reason for missing information: Noncollection/nonreporting/indeterminate/actual-zero distinctions in external originals and all harms outcomes are unverified.
- Required materials and conditions: Original historical reading narrative and current unread state
- Materials to obtain first: Original safety plan, complete tables, omission reasons and actual reading records
- Further research: Distinguish actual collection, nonreporting, missingness and zero at the corresponding location/time when materials are provided.
- Conditions for verification: Connect Original historical reading narrative and current unread state to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Original historical reading narrative and current unread state.
- Application exceptions: Do not turn current unread external materials into failed access, study absence or a safe zero.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Noncollection/nonreporting/indeterminate/actual-zero distinctions in external originals and all harms outcomes are unverified.
- Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation
- Related sources: R01, R02

### H07 · Are harms from the same cohort kept from being counted as independent replication?

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

- Current findings: The two reports are earlier results and long-term follow-up of the same cluster trial; harms status at each time point is retained separately.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Repeated/new events, individual/cluster relationships and long-term harms counts are unverified.
- Reason for missing information: Repeated/new events, individual/cluster relationships and long-term harms counts are unverified.
- Required materials and conditions: 24 months/nine years, people, events and report family
- Materials to obtain first: Person-event-period-report links within the same trial
- Further research: Distinguish repeated/new events, time points and actual counts in added harms materials.
- Conditions for verification: Connect 24 months/nine years, people, events and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of 24 months/nine years, people, events and report family.
- Application exceptions: Do not add the same reports, periods, people or clusters as independent harms trials/participants.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Repeated/new events, individual/cluster relationships and long-term harms counts are unverified.
- Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations
- Related sources: R01, R02

### H08 · What gaps concern other risk groups, intensity and long-term safety?

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

- Current findings: The parent safety status is Good; this question covers a specific peer-led program among high-risk Kerala residents.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. Direct materials for other ages, diseases, risk groups, intensities/expert-led programs and long-term harms are unverified in this source.
- Reason for missing information: Direct materials for other ages, diseases, risk groups, intensities/expert-led programs and long-term harms are unverified in this source.
- Required materials and conditions: Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms
- Materials to obtain first: Direct population/intensity-specific harms and long-term collection materials
- Further research: Specify harms by actual population, intensity and exposure duration in subsequent research.
- Conditions for verification: Connect Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms.
- Application exceptions: Do not extend parent Good status or the 24-month related-event account into long-term safety guarantees for all lifestyle programs/exercise.
- Remaining uncertainty: Within the preparation scope of the preserved summary. Direct materials for other ages, diseases, risk groups, intensities/expert-led programs and long-term harms are unverified in this source.
- Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation
- Related sources: R01

### H09 · Are the null incidence result and safety gaps both retained?

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

- Current findings: The prespecified nine-year incidence result is originally D/null. Historical no-related-event wording at 24 months and missing nine-year safety counts are retained separately as harms context.
- Why unverified: The corresponding stored-summary information is linked for preparation; this is not clinical confirmation, fulfillment of conditions or completed content review. No new benefit-harm synthesis, clinical treatment/prevention choice or implementation guidance was created.
- Reason for missing information: No new benefit-harm synthesis, clinical treatment/prevention choice or implementation guidance was created.
- Required materials and conditions: Separate interpretation of incidence results, related-event wording and long-term harms gaps
- Materials to obtain first: Additional original incidence, harms and follow-up materials
- Further research: Link effects, harms and change events to each original location when new materials are provided.
- Conditions for verification: Connect Separate interpretation of incidence results, related-event wording and long-term harms gaps to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
- Why this condition is needed: Preparation condition for retaining the original scope of Separate interpretation of incidence results, related-event wording and long-term harms gaps.
- Application exceptions: Do not turn null incidence into no harm or ineffectiveness of all programs, or write prevention/treatment guidance.
- Remaining uncertainty: Within the preparation scope of the preserved summary. No new benefit-harm synthesis, clinical treatment/prevention choice or implementation guidance was created.
- Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run
- Related sources: R01, R02

## Evidence and sources

### R01

Jeemon P, et al. Effects of a peer-support lifestyle intervention on diabetes incidence in India (K-DPP): 9-year follow-up of a cluster-randomised, controlled trial. Lancet Glob Health. 2026;14:103927. PMID: 41997166.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/41997166/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the summary: 125/419 (30%) versus 142/422 (34%), RR 0.88 (95% CI 0.73-1.08), P=.24; 841 available cases (419/422), distinguished from 1,007 allocated (500/507). The positive FPG-only result uses a separate definition.  
Record level: First original evidence entry · Parent nine-year result  
Independent replication: Jeemon’s 2026 nine-year report and Thankappan’s 2018 24-month report are long-term/earlier reports of the same 60-cluster K-DPP trial. Shared people, clusters, events, definitions, time points and parent/sibling sheets are not added as independent trials/participants.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Locally preserved summary | Local copy acquired | Summary read | Preparation reading of the corresponding bibliography, time point/results and harms context in the complete 2963 summary; not external-paper reading. |
| External abstract | Current publication and access unverified | Access not attempted; not acquired | Not read | Only the citation URL in the review summary is connected; no current abstract/access verification was made. |
| External full text | Current publication and access unverified | Access not attempted; not acquired | Not read | Only the preserved bibliographic identity URL is linked; the full-text location and current availability/access are unverified. |
| Registration | Current publication and access unverified | Access not attempted; not acquired | Not read | Same-trial context of the original paired ACTRN12611000262909 · CTRI/2021/10/037191; actual registration content is unread. |
| Protocol | Current publication and access unverified | Access not attempted; not acquired | Not read | Required-material slot; actual file existence/availability, definitions, hierarchy and dates are unverified. |
| Statistical analysis plan | Current publication and access unverified | Access not attempted; not acquired | Not read | Required-material slot for cluster adjustment, denominators, missingness, multiple definitions and estimands. |
| Results, denominator and harm details | Current publication and access unverified | Access not attempted; not acquired | Not read | Required-material slot for original definition-specific denominators, follow-up/analysis selection, cluster structure and harms. |
| Support and interests | Current publication and access unverified | Access not attempted; not acquired | Not read | Public-funding trial context is distinguished from report-specific declarations; current external disclosures are unread. |

### R02

Thankappan KR, et al. A peer-support lifestyle intervention to prevent type 2 diabetes in India: a cluster-randomized controlled trial. Diabetes Care. 2018. PMID: 29874236.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/29874236/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the summary: Same trial at 24 months: 68/456 (14.9%) versus 79/463 (17.1%), RR 0.88 (95% CI 0.66-1.16), P=.36. Actual definition, model and missingness details are unverified; this is a separate time point from nine years.  
Record level: Second citation · Earlier result in the parent research account  
Independent replication: Jeemon’s 2026 nine-year report and Thankappan’s 2018 24-month report are long-term/earlier reports of the same 60-cluster K-DPP trial. Shared people, clusters, events, definitions, time points and parent/sibling sheets are not added as independent trials/participants.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Locally preserved summary | Local copy acquired | Summary read | Preparation reading of the corresponding bibliography, time point/results and harms context in the complete 2963 summary; not external-paper reading. |
| External abstract | Current publication and access unverified | Access not attempted; not acquired | Not read | Only the citation URL in the review summary is connected; no current abstract/access verification was made. |
| External full text | Current publication and access unverified | Access not attempted; not acquired | Not read | Only the preserved bibliographic identity URL is linked; the full-text location and current availability/access are unverified. |
| Registration | Current publication and access unverified | Access not attempted; not acquired | Not read | Same-trial context of the original paired ACTRN12611000262909 · CTRI/2021/10/037191; actual registration content is unread. |
| Protocol | Current publication and access unverified | Access not attempted; not acquired | Not read | Required-material slot; actual file existence/availability, definitions, hierarchy and dates are unverified. |
| Statistical analysis plan | Current publication and access unverified | Access not attempted; not acquired | Not read | Required-material slot for cluster adjustment, denominators, missingness, multiple definitions and estimands. |
| Results, denominator and harm details | Current publication and access unverified | Access not attempted; not acquired | Not read | Required-material slot for original definition-specific denominators, follow-up/analysis selection, cluster structure and harms. |
| Support and interests | Current publication and access unverified | Access not attempted; not acquired | Not read | Public-funding trial context is distinguished from report-specific declarations; current external disclosures are unread. |

## 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. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- 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. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- 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. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- 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. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- 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. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

## What the statuses mean

- Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
- Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
- Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
- Review incomplete: Review of existing content or actual review incomplete.
- Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
- Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
- Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
- Not applicable: Used when the reason it does not apply to the original question is stated.
- Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

## Change history

2026-10-12 · Public page/materials 1.0. Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.