{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2963-s0", "verdict_number": "2963", "title": "Peer-led monthly lifestyle program · Original null result for prespecified nine-year diabetes incidence", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy · Boundaries · Materials", "question": "What are the selected original question and assessment record?", "needed": "Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition", "role": "Required", "role_reason": "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_exception": "Do not turn the parent, sibling or other time points into new independent trials/participants.", "criterion": "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.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "If the question boundary changes, retain the original wording, previous complete version and change event separately.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No independent-claim certification, new subclaim split or invented main verdict was made.", "uncertainty": "Within the preparation scope of the preserved summary. No independent-claim certification, new subclaim split or invented main verdict was made.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim and complete preserved parent JSON" }, { "item_id": "N02", "question_type": "Efficacy · Boundaries · Materials", "question": "How do subclaim D and parent D34, axes and history differ?", "needed": "Subclaim grade/note, absent score/status/axes and actual parent values", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Subclaim grade/note, absent score/status/axes and actual parent values.", "application_exception": "Do not inherit parent scores, axes or cross-check history as new review approval, subclaim scores or independence certification.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Separate preservation of original values from a new decision event when evidence is actually updated.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Selected-row score, status and axes are unrecorded; parent values are not inserted.", "uncertainty": "Within the preparation scope of the preserved summary. Selected-row score, status and axes are unrecorded; parent values are not inserted.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim record and parent grade/score/axes and assessment history" }, { "item_id": "N03", "question_type": "Efficacy · Boundaries · Materials", "question": "Which high-risk community residents were selected?", "needed": "Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes.", "application_exception": "Do not turn a high-risk score or the prediabetes tag into a prediabetes diagnosis for all participants.", "criterion": "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.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish other high-risk groups using their actual risk definitions and selection materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "In 60 polling areas in Kerala, India, 1,007 residents aged 30-60, without diabetes and with IDRS at least 60, were allocated.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Baseline diabetes-exclusion testing, IDRS components, prediabetes proportion, sex, baseline glucose/weight, selection and representativeness details are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility/exclusion criteria, baseline characteristics, high-risk score and recruitment flow" }, { "item_id": "N04", "question_type": "Efficacy · Boundaries · Materials", "question": "What was the actual peer-led intervention?", "needed": "Trained community peers and monthly group lifestyle sessions", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Trained community peers and monthly group lifestyle sessions.", "application_exception": "Do not create new diet, exercise or lifestyle treatment/prevention instructions.", "criterion": "Connect Trained community peers and monthly group lifestyle sessions to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Record actual program identity, intensity, delivery and peer roles together in subsequent materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original intervention was a 12-month monthly group lifestyle program led by trained community peers, distinct from expert-led intensive interventions.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Session content, education/support, peer training, delivery quality, attendance and actual implementation are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Session content, education/support, peer training, delivery quality, attendance and actual implementation are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original program description, facilitator training and session/attendance records" }, { "item_id": "N05", "question_type": "Efficacy · Boundaries · Materials", "question": "Are the 12-month program and nine-year outcome period distinguished?", "needed": "Initial intervention duration, long-term follow-up and maintenance/additional exposure", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Initial intervention duration, long-term follow-up and maintenance/additional exposure.", "application_exception": "Do not state that monthly intervention continued throughout nine years or retained the same intensity.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Report original intervention duration separately from maintenance/additional exposure during follow-up.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The program consisted of monthly sessions for 12 months; the selected outcome is cumulative diabetes incidence at nine years.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Maintenance, additional sessions, other care, individual follow-up duration and visit windows after the program are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial exposure, post-program care and long-term follow-up schedule" }, { "item_id": "N06", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the control and direction of comparison?", "needed": "Education-booklet control and original intervention/control correspondence", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Education-booklet control and original intervention/control correspondence.", "application_exception": "Prepare only the actual stored-summary scope; do not create absent numbers, definitions, denominators or method confirmations.", "criterion": "Connect Education-booklet control and original intervention/control correspondence to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Do not automatically combine materials using a different control as the same comparison.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Booklet content, distribution/reading, actual control care and differences in education common to both groups are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Education booklet, shared support and actual control-exposure materials" }, { "item_id": "N07", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the cluster-allocation unit and number?", "needed": "60 polling-area clusters, distinguished from individual recruitment/analysis", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of 60 polling-area clusters, distinguished from individual recruitment/analysis.", "application_exception": "Do not divide 60 to create new group cluster counts or turn people into independent randomized units.", "criterion": "Connect 60 polling-area clusters, distinguished from individual recruitment/analysis to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Record cluster and individual recruitment, allocation, follow-up and analysis together.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "This trial cluster randomized 60 polling areas. The 500/507 allocation among 1,007 individuals represents people.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Clusters per group, cluster sizes, recruitment order, post-allocation selection, retention of all clusters and concealment are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cluster flow, people per cluster and allocation/recruitment process" }, { "item_id": "N08", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the allocation, masking and diagnostic-collection processes?", "needed": "Cluster allocation concealment, participant/assessor masking and outcome collection", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Cluster allocation concealment, participant/assessor masking and outcome collection.", "application_exception": "Do not newly judge masking or count method defects from the program name.", "criterion": "Connect Cluster allocation concealment, participant/assessor masking and outcome collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "When methods are provided, link actual role-specific masking and diagnostic collection to the corresponding outcome.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original design is recorded as long-term follow-up of a cluster-randomized controlled trial.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Allocation generation/concealment, facilitator/resident masking, tester/adjudicator/analyst masking and outcome-collection details are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation method and assessment/testing/adjudication/analysis procedures" }, { "item_id": "N09", "question_type": "Efficacy · Boundaries · Materials", "question": "What were long-term co-interventions and cluster contamination?", "needed": "Diet, activity, medicines, other programs and contact between clusters", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Diet, activity, medicines, other programs and contact between clusters.", "application_exception": "Do not newly establish separate diet/activity effects or actual amounts of lifestyle change.", "criterion": "Connect Diet, activity, medicines, other programs and contact between clusters to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Record actual measurement/management of post-intervention exposure and cluster contamination in subsequent research.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary retains nine-year outcomes for the program versus education booklet.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Other lifestyle support, weight/activity changes, preventive medication, medical access, contact/contamination between clusters and group differences during follow-up are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term co-exposure, care changes, cluster contact and lifestyle records" }, { "item_id": "N10", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the components of the prespecified diabetes-incidence definition?", "needed": "FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up", "role": "Required", "role_reason": "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_exception": "Do not turn the original FPG-plus-HbA1c shorthand into a rule requiring both tests to be positive.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link each criterion, combination rule and overlap separately in new definition materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed confirmation of each criterion, repeat testing, record sources, component-specific events and overlap are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified definition, component-specific diagnostic/testing criteria and incidence tables" }, { "item_id": "N11", "question_type": "Efficacy · Boundaries · Materials", "question": "How were glucose and HbA1c measured and confirmed?", "needed": "Fasting tests, assay methods, repeat confirmation, timing and missingness", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Fasting tests, assay methods, repeat confirmation, timing and missingness.", "application_exception": "Do not create OGTTs, repeat-test counts, additional glucose values or diagnostic procedures.", "criterion": "Connect Fasting tests, assay methods, repeat confirmation, timing and missingness to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish collection of test-based incidence from physician-diagnosis/medication-based incidence.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original incidence criteria include FPG and HbA1c thresholds.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Fasting confirmation, blood sampling/assays, repeat confirmation, testing by visit, failed/indeterminate tests and adjudicator details are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Testing methods, visit-specific confirmation and repeat/missingness rules" }, { "item_id": "N12", "question_type": "Efficacy · Boundaries · Materials", "question": "How were physician diagnosis and glucose-lowering medication initiation included?", "needed": "Sources, confirmation and incidence attribution for diagnosis/medication initiation", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Sources, confirmation and incidence attribution for diagnosis/medication initiation.", "application_exception": "Do not turn medication initiation into an invented diagnosis, a specific drug/dose or treatment-need guidance.", "criterion": "Connect Sources, confirmation and incidence attribution for diagnosis/medication initiation to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link actual criterion-specific attribution and overlap when registration/plans and result tables are provided.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original prespecified definition includes physician diagnosis and initiation of glucose-lowering medication during follow-up.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Medical-record/self-report sources, initiation indications, diabetes confirmation, component overlap and event dates are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original confirmation rules and event links for physician diagnosis/medication initiation" }, { "item_id": "N13", "question_type": "Efficacy · Boundaries · Materials", "question": "What time and analysis measure does nine-year cumulative incidence represent?", "needed": "Nominal nine years, cumulative incidence, analysis population and follow-up duration", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Nominal nine years, cumulative incidence, analysis population and follow-up duration.", "application_exception": "Do not calculate/convert nine-year cumulative proportions into annual incidence, person-years or hazard ratios.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish cumulative incidence risk, incidence rate and time models in new time-related materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected primary outcome is nine-year cumulative diabetes incidence, recorded as an available-case analysis.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual follow-up duration, testing/diagnostic visit intervals, event dates, censoring, death/competing-event handling and person-time are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cumulative counts, follow-up schedule and event/censoring/competing-event methods" }, { "item_id": "N14", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the original nine-year event numerators, denominators and proportions?", "needed": "Attribution of intervention 125/419 (30%) and control 142/422 (34%)", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Attribution of intervention 125/419 (30%) and control 142/422 (34%).", "application_exception": "Do not back-calculate events or create new absolute risk differences, numbers prevented or component totals.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link original numerators, denominators and proportions to the corresponding definition/time point as materials are supplemented.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The stored summary records prespecified nine-year outcomes as intervention 125/419 (30%) versus control 142/422 (34%).", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Component-specific events, repeated counts, overlap by person and original-table details are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Component-specific events, repeated counts, overlap by person and original-table details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original prespecified-definition result table, counting units and component numerators" }, { "item_id": "N15", "question_type": "Efficacy · Boundaries · Materials", "question": "What is the scope of the RR, interval, P value and null-result wording?", "needed": "RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment.", "application_exception": "Do not turn nonsignificance into an exact zero effect, equivalence, prevention worthlessness or ineffectiveness of all programs.", "criterion": "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.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link the estimate to its adjustment and units when original methods are provided.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Model, cluster adjustment, adjustment variables, estimand and interval-calculation details are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Model, cluster adjustment, adjustment variables, estimand and interval-calculation details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Nine-year estimation model, adjustment, interval calculation and actual analysis table" }, { "item_id": "N16", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the randomized and actual nine-year analysis denominators?", "needed": "1,007 randomized (500/507) and 841 available cases (419/422)", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of 1,007 randomized (500/507) and 841 available cases (419/422).", "application_exception": "Do not copy 1,007 or 500/507 into actual nine-year outcome denominators or make 841 a new cohort.", "criterion": "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.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link allocation, acquired data, valid outcomes and actual analysis denominators separately when follow-up data are added.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Group-specific exclusion reasons, valid-data criteria, cluster retention in analysis and alternative analyses based on full allocation are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Nine-year cluster/individual flow, analysis selection and exclusion reasons" }, { "item_id": "N17", "question_type": "Efficacy · Boundaries · Materials", "question": "Are the 144 lost to follow-up and 841 analyzed distinguished?", "needed": "Original loss to follow-up, 144/1,007 (14.3%), and analysis flow", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Original loss to follow-up, 144/1,007 (14.3%), and analysis flow.", "application_exception": "Do not calculate allocation-analysis or loss-to-follow-up differences to fill new dropout counts, rates or exclusion causes.", "criterion": "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.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link definitions and reasons for each state when original flow materials are supplemented.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Relationships among exclusions beyond loss to follow-up, indeterminate data, death and group-specific reasons are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original flow diagram distinguishing loss, death, incomplete data and analysis exclusion" }, { "item_id": "N18", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the available-case and missingness/selection assumptions?", "needed": "Analysis of people with data, missingness reasons and imputation/sensitivity analyses", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Analysis of people with data, missingness reasons and imputation/sensitivity analyses.", "application_exception": "Do not turn available-case analysis into completed full ITT analysis or absence of missingness effects.", "criterion": "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.", "basis": "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.", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish analysis of people with data from assumptions for the full allocated population.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original rationale records nine-year available-case analysis as a limitation.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Cluster/individual missingness reasons, mechanisms, additional analyses, imputation, inverse-probability/sensitivity analysis use and results are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Missingness/exclusion, analysis populations, sensitivity results and plans" }, { "item_id": "N19", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the cluster correlation, sizes and estimation model?", "needed": "Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures.", "application_exception": "Do not certify cluster adjustment from the design name or calculate new CIs assuming independent individuals.", "criterion": "Connect Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M08 §8.1–8.2.3; CHAMGAP adaptation", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link actual cluster correlation/weighting to the original estimand when cluster data are added.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original design is a 60-cluster randomized controlled trial, and the stored summary supplies RR/CI results.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "ICC, cluster sizes, events per cluster, within-person repetition, variance/weighting and whether estimates were cluster adjusted are absent from the summary.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cluster-analysis methods, ICC, participants/events per cluster and adjusted model" }, { "item_id": "N20", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the prespecified primary definition and outcome hierarchy?", "needed": "Prespecified nine-year definition, analysis plan and multiple definitions/tests", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Prespecified nine-year definition, analysis plan and multiple definitions/tests.", "application_exception": "Do not upgrade the parent H endpoint/large hard-outcome RCT flag or historical prespecified wording into current registration/plan review certification.", "criterion": "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.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link the contemporary prespecified/post hoc status, change history and outcome definition when plans are provided.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Designation dates, changes, definition/analysis hierarchy and multiplicity details are unverified because external plans are unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Nine-year definition/time point/hierarchy in protocols, SAPs and registration history" }, { "item_id": "N21", "question_type": "Efficacy · Boundaries · Materials", "question": "What separate definition produced the positive FPG-only result?", "needed": "RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition", "role": "Required", "role_reason": "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_exception": "Do not transfer FPG-only RR, CI or P to the prespecified composite definition or count the definitions as independent trials.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link results for each definition to separate measures/denominators even at the same time point.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual FPG-only numerators/denominators, valid-testing population, other definition results, adjustment and multiple testing are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definition-specific results, valid-test denominators and hierarchy/adjustment" }, { "item_id": "N22", "question_type": "Efficacy · Boundaries · Materials", "question": "How do the original paired registration identifiers and actual content-reading state differ?", "needed": "ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope.", "application_exception": "Do not force identifiers stored under the historical nct key into NCT numbers or count two registrations as independent trials.", "criterion": "Connect ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish original identity, dates, changes and actual reading scope when registration materials are provided.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original evidence record gives “ACTRN12611000262909 · CTRI/2021/10/037191”. The paired original values are preserved.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both original registrations, histories and prespecified-definition plan" }, { "item_id": "N23", "question_type": "Efficacy · Boundaries · Materials", "question": "What are the bibliographies and stored-source locations of the two reports?", "needed": "Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs.", "application_exception": "Do not create a nonexistent second evidence entry for R02 or infer a DOI from an article number.", "criterion": "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.", "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Retain previous original values and each report’s identity when bibliographies are supplemented/corrected.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "DOIs, PMCIDs, current external bibliographies and original table/method locations are not provided.", "uncertainty": "Within the preparation scope of the preserved summary. DOIs, PMCIDs, current external bibliographies and original table/method locations are not provided.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliographies, full texts and trial links for both reports" }, { "item_id": "N24", "question_type": "Efficacy · Boundaries · Materials", "question": "Are the earlier report and long-term follow-up from the same trial?", "needed": "2018/2026 K-DPP clusters/participants and report family", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of 2018/2026 K-DPP clusters/participants and report family.", "application_exception": "Do not add the two reports, 24-month/nine-year results, two definitions or parent/sibling sheets as new trials/participants.", "criterion": "Connect 2018/2026 K-DPP clusters/participants and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish genuinely different recruitment/registration when an independent new trial is provided.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual participant links, cluster retention and time-specific outcomes are externally unread; unique trial/participant counts are not newly certified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-trial-cluster-person-time linkage table" }, { "item_id": "N25", "question_type": "Efficacy · Boundaries · Materials", "question": "What separate time point does the original 24-month result represent?", "needed": "68/456(14.9%)·79/463(17.1%)·RR0.88·CI/P", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P.", "application_exception": "Do not add 24-month events to nine-year events or automatically copy the nine-year FPG/HbA1c definition to 24 months.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Record each time point’s definition, denominators and effect separately when materials are provided.", "current_reports": [ "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original 24-month diagnostic definition, testing, missingness/model and person-specific links to nine years are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 24-month methods, definition, results, denominators and follow-up links" }, { "item_id": "N26", "question_type": "Efficacy · Boundaries · Materials", "question": "What heterogeneity was assessed by high-risk subgroup and period?", "needed": "Baseline glucose/risk, sex, cluster, time and actual effects", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Baseline glucose/risk, sex, cluster, time and actual effects.", "application_exception": "Do not turn overall nonsignificance into zero effects for every individual/subgroup.", "criterion": "Connect Baseline glucose/risk, sex, cluster, time and actual effects to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Report actual prespecified criteria and intervals for group/time differences in subsequent materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The source retains the selected overall population’s nine-year available-case result.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prespecified subgroups and interaction results for prediabetes/baseline glucose, sex, cluster, attendance and period are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified subgroup plan, subgroup denominators/results and interactions" }, { "item_id": "N27", "question_type": "Efficacy · Boundaries · Materials", "question": "Are the monthly peer-led program and expert-led intensive interventions distinguished?", "needed": "Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators.", "application_exception": "Do not create verdict 1531, DPP or DPS as new report/trial slots or current independence certification; their pages/files are not opened.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Specify program identity, population, intensity and control in new applicability materials.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original texts of other programs, direct intensity/facilitator superiority comparisons and general applicability were not queried here.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials and comparison conditions for other actual programs" }, { "item_id": "N28", "question_type": "Efficacy · Boundaries · Materials", "question": "How does actual diabetes incidence differ from other outcomes?", "needed": "Incidence events versus risk-score/glucose changes, complications and death", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Incidence events versus risk-score/glucose changes, complications and death.", "application_exception": "Do not extend nonsignificant incidence to all health outcomes, long-term care or safety conclusions.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link incidence, surrogate markers and complications to their own definitions and time points.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected outcome is prespecified diabetes incidence, not short-term glucose, weight or risk-score change itself.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct nine-year complication, death, quality-of-life and other metabolic-outcome values/denominators are absent from this source.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome-specific direct events/measurements, time points and denominators" }, { "item_id": "N29", "question_type": "Efficacy · Boundaries · Materials", "question": "What is the scope of NHMRC support and no commercial product?", "needed": "Trial funding, products, facilitator/analysis/publication roles and disclosed relationships", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Trial funding, products, facilitator/analysis/publication roles and disclosed relationships.", "application_exception": "Do not turn historical public funding/no commercial product into no conflicts, new independence certification or reading of individual 2018 declarations.", "criterion": "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.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish public funding, commercial products and other relationships/roles when support materials are provided.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The source records support by the Australian National Health and Medical Research Council and no commercial product used.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Each report’s author interests, funder design/analysis/publication roles, sponsor and current relationship declarations are unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report-specific support, author disclosures and funder-role declarations" }, { "item_id": "N30", "question_type": "Efficacy · Boundaries · Materials", "question": "What were the original date, Korean/English text, corrections, empty fields and verdict history?", "needed": "2026-08-26, empty correction/deliberation records and original axes/grades", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of 2026-08-26, empty correction/deliberation records and original axes/grades.", "application_exception": "Do not fill absent/empty fields or historical cross-checks with new values or current completed review.", "criterion": "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.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Retain the complete original text, event, version and separate application when changes occur.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete previous summary and actual change/correction events" }, { "item_id": "N31", "question_type": "Efficacy · Boundaries · Materials", "question": "What level of material was actually read for this work?", "needed": "Complete preserved JSON, own selected question and unread external materials", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Complete preserved JSON, own selected question and unread external materials.", "application_exception": "Do not upgrade URL, citation or copy existence into external-link confirmation, full-text reading or successful access.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish public availability, access, acquisition, actual reading, scope and dates for new materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preparation read the complete preserved 2963 JSON and its selected original question. Report-specific summary reading is separated from unread external-material slots.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registrations, plans, original results/harms and funding declarations were not accessed/acquired. Historical abstract/report wording is not current reading.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials provided by the user and actual acquisition/reading records" }, { "item_id": "N32", "question_type": "Efficacy · Boundaries · Materials", "question": "How do report/material slots differ from trials/populations?", "needed": "Two bibliographies, material-specific states and shared clusters/people/time points", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Two bibliographies, material-specific states and shared clusters/people/time points.", "application_exception": "Do not sum 1,007, 841, 419/422, 456/463, 60 clusters or two bibliographies into new total samples/trials.", "criterion": "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.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish material types and same/different-population relationships when additional reports appear.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new calculation/certification of unique trials, total participants or independent replication was made.", "uncertainty": "Within the preparation scope of the preserved summary. No new calculation/certification of unique trials, total participants or independent replication was made.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-material-trial-cluster-person-outcome links" }, { "item_id": "N33", "question_type": "Efficacy · Boundaries · Materials", "question": "What is updated when new material appears?", "needed": "Separation of conditions, originals, observations, reading and change events", "role": "Required", "role_reason": "Preparation condition for retaining the original scope of Separation of conditions, originals, observations, reading and change events.", "application_exception": "Candidate pending/eligibility values are history and are not revived as active model/content/boundary review waits.", "criterion": "Connect Separation of conditions, originals, observations, reading and change events to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "For actual additions/changes, separately retain the previous complete text, event, condition version/freeze, application and current handoff.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new search, calculation, evidence/effect, regrading, independent certification or model/self-review was performed.", "uncertainty": "Within the preparation scope of the preserved summary. No new search, calculation, evidence/effect, regrading, independent certification or model/self-review was performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided prespecified definitions, cluster/follow-up flow, models, corrections and harms" }, { "item_id": "H01", "question_type": "Harms", "question": "How were adverse events and intervention relatedness defined?", "needed": "Adverse events, relatedness, severity and collection", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Adverse events, relatedness, severity and collection.", "application_exception": "Do not turn historical no-intervention-related-event wording into zero of all adverse events.", "criterion": "Connect Adverse events, relatedness, severity and collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Record all collected harms separately from judgments of intervention relatedness.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "All adverse events, relatedness assessment, collection/severity criteria and outcome-specific definitions are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. All adverse events, relatedness assessment, collection/severity criteria and outcome-specific definitions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harms definitions, collection/relatedness assessment and original results for each report" }, { "item_id": "H02", "question_type": "Harms", "question": "How do safety observations at 12-month exposure, 24 months and nine years differ?", "needed": "Intervention duration, safety-collection timing and long-term exposure", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Intervention duration, safety-collection timing and long-term exposure.", "application_exception": "Do not inherit the 24-month related-event account as completed nine-year safety follow-up.", "criterion": "Connect Intervention duration, safety-collection timing and long-term exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Record intervention exposure separately from actual observation duration in long-term harms materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The program lasted 12 months; the 24-month related-event account and absence of nine-year abstract safety counts are retained separately.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual start/end of safety collection, post-intervention events, long-term care exposure and collection frequency are unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific harms-collection schedule, exposure and subsequent follow-up" }, { "item_id": "H03", "question_type": "Harms", "question": "Is there a nine-year between-group safety comparison?", "needed": "Nine-year intervention/control harms, relatedness and intervals", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Nine-year intervention/control harms, relatedness and intervals.", "application_exception": "Do not conclude from historical missing abstract counts that the full text also omitted them, events were zero or safety was equivalent.", "criterion": "Connect Nine-year intervention/control harms, relatedness and intervals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link new harms results to actual group-specific definitions, denominators and periods.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original source says the nine-year abstract had no separate safety counts. Those external abstracts/full texts were not read in this work.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group-specific harms, serious events, related events, CIs and diagnosis/observation are unverified within the current unread-external-material scope.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original nine-year harms results, group counts and observation/relatedness materials" }, { "item_id": "H04", "question_type": "Harms", "question": "Are safety denominators the same as incidence-analysis denominators?", "needed": "Harms collection/exposure/analysis n, clusters and individuals", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Harms collection/exposure/analysis n, clusters and individuals.", "application_exception": "Do not copy incidence-analysis participants into safety denominators or calculate incidence from unread originals.", "criterion": "Connect Harms collection/exposure/analysis n, clusters and individuals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish actual harms collection/analysis populations from incidence denominators.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Harms-collection, intervention-exposure, period-specific safety populations/clusters and missingness denominators are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Harms-collection, intervention-exposure, period-specific safety populations/clusters and missingness denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety flow, denominators, exposure and valid collection for each report" }, { "item_id": "H05", "question_type": "Harms", "question": "What alternative explanations link lifestyle/care changes and harms?", "needed": "Baseline disease, other activities/medicines, relatedness and timing", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Baseline disease, other activities/medicines, relatedness and timing.", "application_exception": "Do not invent background events, activity injuries or medication harms as actual events.", "criterion": "Connect Baseline disease, other activities/medicines, relatedness and timing to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish program-related events from baseline/concurrent factors in harms materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The source only supplies the account of no intervention-related adverse events at 24 months.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Baseline risks, co-interventions, other programs, background events, relatedness adjudication and case details are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Baseline risks, co-interventions, other programs, background events, relatedness adjudication and case details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual harms cases, timing, co-exposure and relatedness assessment" }, { "item_id": "H06", "question_type": "Harms", "question": "Are unread materials, absence from an abstract, nonreporting and zero events distinguished?", "needed": "Original historical reading narrative and current unread state", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Original historical reading narrative and current unread state.", "application_exception": "Do not turn current unread external materials into failed access, study absence or a safe zero.", "criterion": "Connect Original historical reading narrative and current unread state to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish actual collection, nonreporting, missingness and zero at the corresponding location/time when materials are provided.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Noncollection/nonreporting/indeterminate/actual-zero distinctions in external originals and all harms outcomes are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Noncollection/nonreporting/indeterminate/actual-zero distinctions in external originals and all harms outcomes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety plan, complete tables, omission reasons and actual reading records" }, { "item_id": "H07", "question_type": "Harms", "question": "Are harms from the same cohort kept from being counted as independent replication?", "needed": "24 months/nine years, people, events and report family", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of 24 months/nine years, people, events and report family.", "application_exception": "Do not add the same reports, periods, people or clusters as independent harms trials/participants.", "criterion": "Connect 24 months/nine years, people, events and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.", "basis": "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", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Distinguish repeated/new events, time points and actual counts in added harms materials.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Repeated/new events, individual/cluster relationships and long-term harms counts are unverified.", "uncertainty": "Within the preparation scope of the preserved summary. Repeated/new events, individual/cluster relationships and long-term harms counts are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Person-event-period-report links within the same trial" }, { "item_id": "H08", "question_type": "Harms", "question": "What gaps concern other risk groups, intensity and long-term safety?", "needed": "Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms.", "application_exception": "Do not extend parent Good status or the 24-month related-event account into long-term safety guarantees for all lifestyle programs/exercise.", "criterion": "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.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Specify harms by actual population, intensity and exposure duration in subsequent research.", "current_reports": [ "R01" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent safety status is Good; this question covers a specific peer-led program among high-risk Kerala residents.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct materials for other ages, diseases, risk groups, intensities/expert-led programs and long-term harms are unverified in this source.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population/intensity-specific harms and long-term collection materials" }, { "item_id": "H09", "question_type": "Harms", "question": "Are the null incidence result and safety gaps both retained?", "needed": "Separate interpretation of incidence results, related-event wording and long-term harms gaps", "role": "Supporting harm information", "role_reason": "Preparation condition for retaining the original scope of Separate interpretation of incidence results, related-event wording and long-term harms gaps.", "application_exception": "Do not turn null incidence into no harm or ineffectiveness of all programs, or write prevention/treatment guidance.", "criterion": "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.", "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run", "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user", "proposed_research": "Link effects, harms and change events to each original location when new materials are provided.", "current_reports": [ "R01", "R02" ], "existence": "Links to the preserved summary; existence and current publication of needed external details are unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new benefit-harm synthesis, clinical treatment/prevention choice or implementation guidance was created.", "uncertainty": "Within the preparation scope of the preserved summary. No new benefit-harm synthesis, clinical treatment/prevention choice or implementation guidance was created.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional original incidence, harms and follow-up materials" } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/41997166/", "report_type": "Nine-year long-term follow-up report of the 60-cluster K-DPP trial", "existence": "Preserved bibliography and URL from the stored-summary citations", "acquired_read": "Summary read; external materials not read", "study_family": "K-DPP · The same cluster-randomized population", "independent_replication": false, "observed_result": "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.", "result_level": "First original evidence entry · Parent nine-year result", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:23:51.074055+09:00", "qualification": "Preparation reading of the corresponding bibliography, time point/results and harms context in the complete 2963 summary; not external-paper reading." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the citation URL in the review summary is connected; no current abstract/access verification was made." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the preserved bibliographic identity URL is linked; the full-text location and current availability/access are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Same-trial context of the original paired ACTRN12611000262909 · CTRI/2021/10/037191; actual registration content is unread." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot; actual file existence/availability, definitions, hierarchy and dates are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot for cluster adjustment, denominators, missingness, multiple definitions and estimands." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot for original definition-specific denominators, follow-up/analysis selection, cluster structure and harms." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Public-funding trial context is distinguished from report-specific declarations; current external disclosures are unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41997166/" } ] }, { "report_id": "R02", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/29874236/", "report_type": "Earlier 24-month report of the same K-DPP trial", "existence": "Preserved bibliography and URL from the stored-summary citations", "acquired_read": "Summary read; external materials not read", "study_family": "K-DPP · The same cluster-randomized population", "independent_replication": false, "observed_result": "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.", "result_level": "Second citation · Earlier result in the parent research account", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Locally preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:23:51.074055+09:00", "qualification": "Preparation reading of the corresponding bibliography, time point/results and harms context in the complete 2963 summary; not external-paper reading." }, { "material_type": "External abstract", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the citation URL in the review summary is connected; no current abstract/access verification was made." }, { "material_type": "External full text", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the preserved bibliographic identity URL is linked; the full-text location and current availability/access are unverified." }, { "material_type": "Registration", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Same-trial context of the original paired ACTRN12611000262909 · CTRI/2021/10/037191; actual registration content is unread." }, { "material_type": "Protocol", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot; actual file existence/availability, definitions, hierarchy and dates are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot for cluster adjustment, denominators, missingness, multiple definitions and estimands." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot for original definition-specific denominators, follow-up/analysis selection, cluster structure and harms." }, { "material_type": "Support and interests", "public_status": "Current publication and access unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Public-funding trial context is distinguished from report-specific declarations; current external disclosures are unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29874236/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }