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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Efficacy · Boundaries · MaterialsWhat are the selected original question and assessment record?Required	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. R01	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.	Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition	If the question boundary changes, retain the original wording, previous complete version and change event separately.
2	Partly verified	Full text not readStored summary read	N02 · Efficacy · Boundaries · MaterialsHow do subclaim D and parent D34, axes and history differ?Required	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. R01	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.	Subclaim grade/note, absent score/status/axes and actual parent values	Separate preservation of original values from a new decision event when evidence is actually updated.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy · Boundaries · MaterialsWhich high-risk community residents were selected?Required	In 60 polling areas in Kerala, India, 1,007 residents aged 30-60, without diabetes and with IDRS at least 60, were allocated. R01	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.	Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes	Distinguish other high-risk groups using their actual risk definitions and selection materials.
4	Partly verified	Full text not readStored summary read	N04 · Efficacy · Boundaries · MaterialsWhat was the actual peer-led intervention?Required	The original intervention was a 12-month monthly group lifestyle program led by trained community peers, distinct from expert-led intensive interventions. R01	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.	Trained community peers and monthly group lifestyle sessions	Record actual program identity, intensity, delivery and peer roles together in subsequent materials.
5	Partly verified	Full text not readStored summary read	N05 · Efficacy · Boundaries · MaterialsAre the 12-month program and nine-year outcome period distinguished?Required	The program consisted of monthly sessions for 12 months; the selected outcome is cumulative diabetes incidence at nine years. R01	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.	Initial intervention duration, long-term follow-up and maintenance/additional exposure	Report original intervention duration separately from maintenance/additional exposure during follow-up.
6	Partly verified	Full text not readStored summary read	N06 · Efficacy · Boundaries · MaterialsWhat were the control and direction of comparison?Required	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. R01	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.	Education-booklet control and original intervention/control correspondence	Do not automatically combine materials using a different control as the same comparison.
7	Partly verified	Full text not readStored summary read	N07 · Efficacy · Boundaries · MaterialsWhat were the cluster-allocation unit and number?Required	This trial cluster randomized 60 polling areas. The 500/507 allocation among 1,007 individuals represents people. R01	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.	60 polling-area clusters, distinguished from individual recruitment/analysis	Record cluster and individual recruitment, allocation, follow-up and analysis together.
8	Partly verified	Full text not readStored summary read	N08 · Efficacy · Boundaries · MaterialsWhat were the allocation, masking and diagnostic-collection processes?Required	The original design is recorded as long-term follow-up of a cluster-randomized controlled trial. R01	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.	Cluster allocation concealment, participant/assessor masking and outcome collection	When methods are provided, link actual role-specific masking and diagnostic collection to the corresponding outcome.
9	Unverified	Full text not readStored summary read	N09 · Efficacy · Boundaries · MaterialsWhat were long-term co-interventions and cluster contamination?Required	The original summary retains nine-year outcomes for the program versus education booklet. R01	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.	Diet, activity, medicines, other programs and contact between clusters	Record actual measurement/management of post-intervention exposure and cluster contamination in subsequent research.
10	Partly verified	Full text not readStored summary read	N10 · Efficacy · Boundaries · MaterialsWhat were the components of the prespecified diabetes-incidence definition?Required	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. R01	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.	FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up	Link each criterion, combination rule and overlap separately in new definition materials.
11	Partly verified	Full text not readStored summary read	N11 · Efficacy · Boundaries · MaterialsHow were glucose and HbA1c measured and confirmed?Required	The original incidence criteria include FPG and HbA1c thresholds. R01	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.	Fasting tests, assay methods, repeat confirmation, timing and missingness	Distinguish collection of test-based incidence from physician-diagnosis/medication-based incidence.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy · Boundaries · MaterialsHow were physician diagnosis and glucose-lowering medication initiation included?Required	The original prespecified definition includes physician diagnosis and initiation of glucose-lowering medication during follow-up. R01	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.	Sources, confirmation and incidence attribution for diagnosis/medication initiation	Link actual criterion-specific attribution and overlap when registration/plans and result tables are provided.
13	Partly verified	Full text not readStored summary read	N13 · Efficacy · Boundaries · MaterialsWhat time and analysis measure does nine-year cumulative incidence represent?Required	The selected primary outcome is nine-year cumulative diabetes incidence, recorded as an available-case analysis. R01	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.	Nominal nine years, cumulative incidence, analysis population and follow-up duration	Distinguish cumulative incidence risk, incidence rate and time models in new time-related materials.
14	Partly verified	Full text not readStored summary read	N14 · Efficacy · Boundaries · MaterialsWhat were the original nine-year event numerators, denominators and proportions?Required	The stored summary records prespecified nine-year outcomes as intervention 125/419 (30%) versus control 142/422 (34%). R01	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.	Attribution of intervention 125/419 (30%) and control 142/422 (34%)	Link original numerators, denominators and proportions to the corresponding definition/time point as materials are supplemented.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy · Boundaries · MaterialsWhat is the scope of the RR, interval, P value and null-result wording?Required	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. R01	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.	RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment	Link the estimate to its adjustment and units when original methods are provided.
16	Partly verified	Full text not readStored summary read	N16 · Efficacy · Boundaries · MaterialsWhat were the randomized and actual nine-year analysis denominators?Required	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. R01	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.	1,007 randomized (500/507) and 841 available cases (419/422)	Link allocation, acquired data, valid outcomes and actual analysis denominators separately when follow-up data are added.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy · Boundaries · MaterialsAre the 144 lost to follow-up and 841 analyzed distinguished?Required	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. R01	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.	Original loss to follow-up, 144/1,007 (14.3%), and analysis flow	Link definitions and reasons for each state when original flow materials are supplemented.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy · Boundaries · MaterialsWhat were the available-case and missingness/selection assumptions?Required	The original rationale records nine-year available-case analysis as a limitation. R01	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.	Analysis of people with data, missingness reasons and imputation/sensitivity analyses	Distinguish analysis of people with data from assumptions for the full allocated population.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy · Boundaries · MaterialsWhat were the cluster correlation, sizes and estimation model?Required	The original design is a 60-cluster randomized controlled trial, and the stored summary supplies RR/CI results. R01	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.	Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures	Link actual cluster correlation/weighting to the original estimand when cluster data are added.
20	Partly verified	Full text not readStored summary read	N20 · Efficacy · Boundaries · MaterialsWhat were the prespecified primary definition and outcome hierarchy?Required	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. R01	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.	Prespecified nine-year definition, analysis plan and multiple definitions/tests	Link the contemporary prespecified/post hoc status, change history and outcome definition when plans are provided.
21	Partly verified	Full text not readStored summary read	N21 · Efficacy · Boundaries · MaterialsWhat separate definition produced the positive FPG-only result?Required	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. R01	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.	RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition	Link results for each definition to separate measures/denominators even at the same time point.
22	Partly verified	Full text not readStored summary read	N22 · Efficacy · Boundaries · MaterialsHow do the original paired registration identifiers and actual content-reading state differ?Required	The original evidence record gives “ACTRN12611000262909 · CTRI/2021/10/037191”. The paired original values are preserved. R01	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.	ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope	Distinguish original identity, dates, changes and actual reading scope when registration materials are provided.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy · Boundaries · MaterialsWhat are the bibliographies and stored-source locations of the two reports?Required	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. R01 R02	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.	Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs	Retain previous original values and each report’s identity when bibliographies are supplemented/corrected.
24	Partly verified	Full text not readStored summary read	N24 · Efficacy · Boundaries · MaterialsAre the earlier report and long-term follow-up from the same trial?Required	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. R01 R02	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.	2018/2026 K-DPP clusters/participants and report family	Distinguish genuinely different recruitment/registration when an independent new trial is provided.
25	Partly verified	Full text not readStored summary read	N25 · Efficacy · Boundaries · MaterialsWhat separate time point does the original 24-month result represent?Required	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. R02	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.	68/456(14.9%)·79/463(17.1%)·RR0.88·CI/P	Record each time point’s definition, denominators and effect separately when materials are provided.
26	Partly verified	Full text not readStored summary read	N26 · Efficacy · Boundaries · MaterialsWhat heterogeneity was assessed by high-risk subgroup and period?Required	The source retains the selected overall population’s nine-year available-case result. R01	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.	Baseline glucose/risk, sex, cluster, time and actual effects	Report actual prespecified criteria and intervals for group/time differences in subsequent materials.
27	Partly verified	Full text not readStored summary read	N27 · Efficacy · Boundaries · MaterialsAre the monthly peer-led program and expert-led intensive interventions distinguished?Required	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. R01	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.	Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators	Specify program identity, population, intensity and control in new applicability materials.
28	Partly verified	Full text not readStored summary read	N28 · Efficacy · Boundaries · MaterialsHow does actual diabetes incidence differ from other outcomes?Required	The selected outcome is prespecified diabetes incidence, not short-term glucose, weight or risk-score change itself. R01	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.	Incidence events versus risk-score/glucose changes, complications and death	Link incidence, surrogate markers and complications to their own definitions and time points.
29	Partly verified	Full text not readStored summary read	N29 · Efficacy · Boundaries · MaterialsWhat is the scope of NHMRC support and no commercial product?Required	The source records support by the Australian National Health and Medical Research Council and no commercial product used. R01 R02	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.	Trial funding, products, facilitator/analysis/publication roles and disclosed relationships	Distinguish public funding, commercial products and other relationships/roles when support materials are provided.
30	Partly verified	Full text not readStored summary read	N30 · Efficacy · Boundaries · MaterialsWhat were the original date, Korean/English text, corrections, empty fields and verdict history?Required	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. R01	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.	2026-08-26, empty correction/deliberation records and original axes/grades	Retain the complete original text, event, version and separate application when changes occur.
31	Partly verified	Full text not readStored summary read	N31 · Efficacy · Boundaries · MaterialsWhat level of material was actually read for this work?Required	Preparation read the complete preserved 2963 JSON and its selected original question. Report-specific summary reading is separated from unread external-material slots. R01 R02	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.	Complete preserved JSON, own selected question and unread external materials	Distinguish public availability, access, acquisition, actual reading, scope and dates for new materials.
32	Partly verified	Full text not readStored summary read	N32 · Efficacy · Boundaries · MaterialsHow do report/material slots differ from trials/populations?Required	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. R01 R02	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.	Two bibliographies, material-specific states and shared clusters/people/time points	Distinguish material types and same/different-population relationships when additional reports appear.
33	Partly verified	Full text not readStored summary read	N33 · Efficacy · Boundaries · MaterialsWhat is updated when new material appears?Required	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. R01 R02	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.	Separation of conditions, originals, observations, reading and change events	For actual additions/changes, separately retain the previous complete text, event, condition version/freeze, application and current handoff.
34	Partly verified	Full text not readStored summary read	H01 · HarmsHow were adverse events and intervention relatedness defined?Supporting harm information	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. R01 R02	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.	Adverse events, relatedness, severity and collection	Record all collected harms separately from judgments of intervention relatedness.
35	Partly verified	Full text not readStored summary read	H02 · HarmsHow do safety observations at 12-month exposure, 24 months and nine years differ?Supporting harm information	The program lasted 12 months; the 24-month related-event account and absence of nine-year abstract safety counts are retained separately. R01 R02	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.	Intervention duration, safety-collection timing and long-term exposure	Record intervention exposure separately from actual observation duration in long-term harms materials.
36	Unverified	Full text not readStored summary read	H03 · HarmsIs there a nine-year between-group safety comparison?Supporting harm information	The original source says the nine-year abstract had no separate safety counts. Those external abstracts/full texts were not read in this work. R01	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.	Nine-year intervention/control harms, relatedness and intervals	Link new harms results to actual group-specific definitions, denominators and periods.
37	Partly verified	Full text not readStored summary read	H04 · HarmsAre safety denominators the same as incidence-analysis denominators?Supporting harm information	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. R01 R02	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.	Harms collection/exposure/analysis n, clusters and individuals	Distinguish actual harms collection/analysis populations from incidence denominators.
38	Unverified	Full text not readStored summary read	H05 · HarmsWhat alternative explanations link lifestyle/care changes and harms?Supporting harm information	The source only supplies the account of no intervention-related adverse events at 24 months. R01 R02	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.	Baseline disease, other activities/medicines, relatedness and timing	Distinguish program-related events from baseline/concurrent factors in harms materials.
39	Partly verified	Full text not readStored summary read	H06 · HarmsAre unread materials, absence from an abstract, nonreporting and zero events distinguished?Supporting harm information	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. R01 R02	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.	Original historical reading narrative and current unread state	Distinguish actual collection, nonreporting, missingness and zero at the corresponding location/time when materials are provided.
40	Partly verified	Full text not readStored summary read	H07 · HarmsAre harms from the same cohort kept from being counted as independent replication?Supporting harm information	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. R01 R02	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.	24 months/nine years, people, events and report family	Distinguish repeated/new events, time points and actual counts in added harms materials.
41	Partly verified	Full text not readStored summary read	H08 · HarmsWhat gaps concern other risk groups, intensity and long-term safety?Supporting harm information	The parent safety status is Good; this question covers a specific peer-led program among high-risk Kerala residents. R01	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.	Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms	Specify harms by actual population, intensity and exposure duration in subsequent research.
42	Partly verified	Full text not readStored summary read	H09 · HarmsAre the null incidence result and safety gaps both retained?Supporting harm information	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. R01 R02	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.	Separate interpretation of incidence results, related-event wording and long-term harms gaps	Link effects, harms and change events to each original location when new materials are provided.

No items match your search or filter.

42 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: High-risk residents without diabetes, aged 30-60 with IDRS at least 60, in 60 polling areas in Kerala, India. Detailed selection, baseline diagnosis and testing are unverified.
Ingredient, formulation and route: A 12-month monthly group lifestyle program led by trained community peers
Dose: Original exposure to a 12-month monthly group lifestyle program. Actual sessions/attendance and post-intervention maintenance are unverified; this is not implementation guidance.
Comparator: Education booklet. Actual content, distribution/reading, long-term concurrent care and cluster-contamination details are unverified.
Measured outcome: Prespecified nine-year cumulative incidence: FPG at least 126 mg/dL or HbA1c at least 6.5%, including physician diagnosis or glucose-lowering medication initiation during follow-up. 125/419 (30%) versus 142/422 (34%), RR 0.88 (95% CI 0.73-1.08), P=.24. Cluster/missingness analysis details are unverified.
Duration: Initial intervention for 12 months; selected outcome is nine-year cumulative incidence. The same trial’s earlier 24-month report is a separate time point. Actual follow-up duration and visit windows are unverified.
Questions outside this scope: Transfer the positive FPG-only RR/CI/P to the prespecified primary composite definition; Add 24-month/nine-year/definition-specific events, clusters, people or bibliographies as new independent trials/participants; Copy 1,007 allocated participants into the nine-year 841 available-case denominator; Calculate a difference between 144 lost to follow-up and 841 analyzed to create new exclusion counts/causes; Newly confirm cluster adjustment, ICC, missingness handling or testing/diagnostic procedures; Extend the monthly peer-led result to ineffectiveness of all expert-led intensive programs; Extend missing nine-year abstract safety counts/no related events at 24 months to zero of all long-term harms; Provide lifestyle, diet, exercise, glucose-lowering medication or diabetes-prevention/treatment instructions

Evidence and sources

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

R01 · Jeemon P, et al. Effects of a peer-support lifestyle intervention on diabetes incidence in India (K-DPP): 9-year follow-up of a cluster-randomised, controlled trial. Lancet Glob Health. 2026;14:103927. PMID: 41997166.

PubMed

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

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

R02 · Thankappan KR, et al. A peer-support lifestyle intervention to prevent type 2 diabetes in India: a cluster-randomized controlled trial. Diabetes Care. 2018. PMID: 29874236.

PubMed

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

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

Report counts versus independent study counts

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.

Review criteria

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

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

Required materials and conditions: Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition
Conditions for verification: Connect Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn the parent, sibling or other time points into new independent trials/participants.
Why this condition is needed: Preparation condition for retaining the original scope of Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design

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

Required materials and conditions: Subclaim grade/note, absent score/status/axes and actual parent values
Conditions for verification: Connect Subclaim grade/note, absent score/status/axes and actual parent values to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not inherit parent scores, axes or cross-check history as new review approval, subclaim scores or independence certification.
Why this condition is needed: Preparation condition for retaining the original scope of Subclaim grade/note, absent score/status/axes and actual parent values.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · Which high-risk community residents were selected?

Required materials and conditions: Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes
Conditions for verification: Connect Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn a high-risk score or the prediabetes tag into a prediabetes diagnosis for all participants.
Why this condition is needed: Preparation condition for retaining the original scope of Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N04 · What was the actual peer-led intervention?

Required materials and conditions: Trained community peers and monthly group lifestyle sessions
Conditions for verification: Connect Trained community peers and monthly group lifestyle sessions to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not create new diet, exercise or lifestyle treatment/prevention instructions.
Why this condition is needed: Preparation condition for retaining the original scope of Trained community peers and monthly group lifestyle sessions.
Referenced methods: M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design

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

Required materials and conditions: Initial intervention duration, long-term follow-up and maintenance/additional exposure
Conditions for verification: Connect Initial intervention duration, long-term follow-up and maintenance/additional exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not state that monthly intervention continued throughout nine years or retained the same intensity.
Why this condition is needed: Preparation condition for retaining the original scope of Initial intervention duration, long-term follow-up and maintenance/additional exposure.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N06 · What were the control and direction of comparison?

Required materials and conditions: Education-booklet control and original intervention/control correspondence
Conditions for verification: Connect Education-booklet control and original intervention/control correspondence to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Prepare only the actual stored-summary scope; do not create absent numbers, definitions, denominators or method confirmations.
Why this condition is needed: Preparation condition for retaining the original scope of Education-booklet control and original intervention/control correspondence.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

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

Required materials and conditions: 60 polling-area clusters, distinguished from individual recruitment/analysis
Conditions for verification: Connect 60 polling-area clusters, distinguished from individual recruitment/analysis to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not divide 60 to create new group cluster counts or turn people into independent randomized units.
Why this condition is needed: Preparation condition for retaining the original scope of 60 polling-area clusters, distinguished from individual recruitment/analysis.
Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design

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

Required materials and conditions: Cluster allocation concealment, participant/assessor masking and outcome collection
Conditions for verification: Connect Cluster allocation concealment, participant/assessor masking and outcome collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not newly judge masking or count method defects from the program name.
Why this condition is needed: Preparation condition for retaining the original scope of Cluster allocation concealment, participant/assessor masking and outcome collection.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

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

Required materials and conditions: Diet, activity, medicines, other programs and contact between clusters
Conditions for verification: Connect Diet, activity, medicines, other programs and contact between clusters to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not newly establish separate diet/activity effects or actual amounts of lifestyle change.
Why this condition is needed: Preparation condition for retaining the original scope of Diet, activity, medicines, other programs and contact between clusters.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

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

Required materials and conditions: FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up
Conditions for verification: Connect FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn the original FPG-plus-HbA1c shorthand into a rule requiring both tests to be positive.
Why this condition is needed: Preparation condition for retaining the original scope of FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

N11 · How were glucose and HbA1c measured and confirmed?

Required materials and conditions: Fasting tests, assay methods, repeat confirmation, timing and missingness
Conditions for verification: Connect Fasting tests, assay methods, repeat confirmation, timing and missingness to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not create OGTTs, repeat-test counts, additional glucose values or diagnostic procedures.
Why this condition is needed: Preparation condition for retaining the original scope of Fasting tests, assay methods, repeat confirmation, timing and missingness.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

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

Required materials and conditions: Sources, confirmation and incidence attribution for diagnosis/medication initiation
Conditions for verification: Connect Sources, confirmation and incidence attribution for diagnosis/medication initiation to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn medication initiation into an invented diagnosis, a specific drug/dose or treatment-need guidance.
Why this condition is needed: Preparation condition for retaining the original scope of Sources, confirmation and incidence attribution for diagnosis/medication initiation.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application

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

Required materials and conditions: Nominal nine years, cumulative incidence, analysis population and follow-up duration
Conditions for verification: Connect Nominal nine years, cumulative incidence, analysis population and follow-up duration to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not calculate/convert nine-year cumulative proportions into annual incidence, person-years or hazard ratios.
Why this condition is needed: Preparation condition for retaining the original scope of Nominal nine years, cumulative incidence, analysis population and follow-up duration.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design

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

Required materials and conditions: Attribution of intervention 125/419 (30%) and control 142/422 (34%)
Conditions for verification: Connect Attribution of intervention 125/419 (30%) and control 142/422 (34%) to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not back-calculate events or create new absolute risk differences, numbers prevented or component totals.
Why this condition is needed: Preparation condition for retaining the original scope of Attribution of intervention 125/419 (30%) and control 142/422 (34%).
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

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

Required materials and conditions: RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment
Conditions for verification: Connect RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn nonsignificance into an exact zero effect, equivalence, prevention worthlessness or ineffectiveness of all programs.
Why this condition is needed: Preparation condition for retaining the original scope of RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

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

Required materials and conditions: 1,007 randomized (500/507) and 841 available cases (419/422)
Conditions for verification: Connect 1,007 randomized (500/507) and 841 available cases (419/422) to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not copy 1,007 or 500/507 into actual nine-year outcome denominators or make 841 a new cohort.
Why this condition is needed: Preparation condition for retaining the original scope of 1,007 randomized (500/507) and 841 available cases (419/422).
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

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

Required materials and conditions: Original loss to follow-up, 144/1,007 (14.3%), and analysis flow
Conditions for verification: Connect Original loss to follow-up, 144/1,007 (14.3%), and analysis flow to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not calculate allocation-analysis or loss-to-follow-up differences to fill new dropout counts, rates or exclusion causes.
Why this condition is needed: Preparation condition for retaining the original scope of Original loss to follow-up, 144/1,007 (14.3%), and analysis flow.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

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

Required materials and conditions: Analysis of people with data, missingness reasons and imputation/sensitivity analyses
Conditions for verification: Connect Analysis of people with data, missingness reasons and imputation/sensitivity analyses to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn available-case analysis into completed full ITT analysis or absence of missingness effects.
Why this condition is needed: Preparation condition for retaining the original scope of Analysis of people with data, missingness reasons and imputation/sensitivity analyses.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

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

Required materials and conditions: Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures
Conditions for verification: Connect Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not certify cluster adjustment from the design name or calculate new CIs assuming independent individuals.
Why this condition is needed: Preparation condition for retaining the original scope of Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures.
Referenced methods: M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M08 §8.1–8.2.3; CHAMGAP adaptation

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

Required materials and conditions: Prespecified nine-year definition, analysis plan and multiple definitions/tests
Conditions for verification: Connect Prespecified nine-year definition, analysis plan and multiple definitions/tests to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not upgrade the parent H endpoint/large hard-outcome RCT flag or historical prespecified wording into current registration/plan review certification.
Why this condition is needed: Preparation condition for retaining the original scope of Prespecified nine-year definition, analysis plan and multiple definitions/tests.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application

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

Required materials and conditions: RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition
Conditions for verification: Connect RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not transfer FPG-only RR, CI or P to the prespecified composite definition or count the definitions as independent trials.
Why this condition is needed: Preparation condition for retaining the original scope of RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation

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

Required materials and conditions: ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope
Conditions for verification: Connect ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not force identifiers stored under the historical nct key into NCT numbers or count two registrations as independent trials.
Why this condition is needed: Preparation condition for retaining the original scope of ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application

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

Required materials and conditions: Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs
Conditions for verification: Connect Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not create a nonexistent second evidence entry for R02 or infer a DOI from an article number.
Why this condition is needed: Preparation condition for retaining the original scope of Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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

Required materials and conditions: 2018/2026 K-DPP clusters/participants and report family
Conditions for verification: Connect 2018/2026 K-DPP clusters/participants and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not add the two reports, 24-month/nine-year results, two definitions or parent/sibling sheets as new trials/participants.
Why this condition is needed: Preparation condition for retaining the original scope of 2018/2026 K-DPP clusters/participants and report family.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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

Required materials and conditions: 68/456(14.9%)·79/463(17.1%)·RR0.88·CI/P
Conditions for verification: Connect 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not add 24-month events to nine-year events or automatically copy the nine-year FPG/HbA1c definition to 24 months.
Why this condition is needed: Preparation condition for retaining the original scope of 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed

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

Required materials and conditions: Baseline glucose/risk, sex, cluster, time and actual effects
Conditions for verification: Connect Baseline glucose/risk, sex, cluster, time and actual effects to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn overall nonsignificance into zero effects for every individual/subgroup.
Why this condition is needed: Preparation condition for retaining the original scope of Baseline glucose/risk, sex, cluster, time and actual effects.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design

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

Required materials and conditions: Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators
Conditions for verification: Connect Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not create verdict 1531, DPP or DPS as new report/trial slots or current independence certification; their pages/files are not opened.
Why this condition is needed: Preparation condition for retaining the original scope of Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators.
Referenced methods: M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed

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

Required materials and conditions: Incidence events versus risk-score/glucose changes, complications and death
Conditions for verification: Connect Incidence events versus risk-score/glucose changes, complications and death to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not extend nonsignificant incidence to all health outcomes, long-term care or safety conclusions.
Why this condition is needed: Preparation condition for retaining the original scope of Incidence events versus risk-score/glucose changes, complications and death.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

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

Required materials and conditions: Trial funding, products, facilitator/analysis/publication roles and disclosed relationships
Conditions for verification: Connect Trial funding, products, facilitator/analysis/publication roles and disclosed relationships to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not turn historical public funding/no commercial product into no conflicts, new independence certification or reading of individual 2018 declarations.
Why this condition is needed: Preparation condition for retaining the original scope of Trial funding, products, facilitator/analysis/publication roles and disclosed relationships.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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

Required materials and conditions: 2026-08-26, empty correction/deliberation records and original axes/grades
Conditions for verification: Connect 2026-08-26, empty correction/deliberation records and original axes/grades to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not fill absent/empty fields or historical cross-checks with new values or current completed review.
Why this condition is needed: Preparation condition for retaining the original scope of 2026-08-26, empty correction/deliberation records and original axes/grades.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

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

Required materials and conditions: Complete preserved JSON, own selected question and unread external materials
Conditions for verification: Connect Complete preserved JSON, own selected question and unread external materials to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not upgrade URL, citation or copy existence into external-link confirmation, full-text reading or successful access.
Why this condition is needed: Preparation condition for retaining the original scope of Complete preserved JSON, own selected question and unread external materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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

Required materials and conditions: Two bibliographies, material-specific states and shared clusters/people/time points
Conditions for verification: Connect Two bibliographies, material-specific states and shared clusters/people/time points to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Do not sum 1,007, 841, 419/422, 456/463, 60 clusters or two bibliographies into new total samples/trials.
Why this condition is needed: Preparation condition for retaining the original scope of Two bibliographies, material-specific states and shared clusters/people/time points.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations

N33 · What is updated when new material appears?

Required materials and conditions: Separation of conditions, originals, observations, reading and change events
Conditions for verification: Connect Separation of conditions, originals, observations, reading and change events to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Required
Application exceptions: Candidate pending/eligibility values are history and are not revived as active model/content/boundary review waits.
Why this condition is needed: Preparation condition for retaining the original scope of Separation of conditions, originals, observations, reading and change events.
Referenced methods: M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

H01 · How were adverse events and intervention relatedness defined?

Required materials and conditions: Adverse events, relatedness, severity and collection
Conditions for verification: Connect Adverse events, relatedness, severity and collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn historical no-intervention-related-event wording into zero of all adverse events.
Why this condition is needed: Preparation condition for retaining the original scope of Adverse events, relatedness, severity and collection.
Referenced methods: M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation

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

Required materials and conditions: Intervention duration, safety-collection timing and long-term exposure
Conditions for verification: Connect Intervention duration, safety-collection timing and long-term exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not inherit the 24-month related-event account as completed nine-year safety follow-up.
Why this condition is needed: Preparation condition for retaining the original scope of Intervention duration, safety-collection timing and long-term exposure.
Referenced methods: M19 §19.2 design-specific harm questions; timing details are Chamgap-designed

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

Required materials and conditions: Nine-year intervention/control harms, relatedness and intervals
Conditions for verification: Connect Nine-year intervention/control harms, relatedness and intervals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not conclude from historical missing abstract counts that the full text also omitted them, events were zero or safety was equivalent.
Why this condition is needed: Preparation condition for retaining the original scope of Nine-year intervention/control harms, relatedness and intervals.
Referenced methods: M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation

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

Required materials and conditions: Harms collection/exposure/analysis n, clusters and individuals
Conditions for verification: Connect Harms collection/exposure/analysis n, clusters and individuals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not copy incidence-analysis participants into safety denominators or calculate incidence from unread originals.
Why this condition is needed: Preparation condition for retaining the original scope of Harms collection/exposure/analysis n, clusters and individuals.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

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

Required materials and conditions: Baseline disease, other activities/medicines, relatedness and timing
Conditions for verification: Connect Baseline disease, other activities/medicines, relatedness and timing to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not invent background events, activity injuries or medication harms as actual events.
Why this condition is needed: Preparation condition for retaining the original scope of Baseline disease, other activities/medicines, relatedness and timing.
Referenced methods: M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed

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

Required materials and conditions: Original historical reading narrative and current unread state
Conditions for verification: Connect Original historical reading narrative and current unread state to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn current unread external materials into failed access, study absence or a safe zero.
Why this condition is needed: Preparation condition for retaining the original scope of Original historical reading narrative and current unread state.
Referenced methods: M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation

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

Required materials and conditions: 24 months/nine years, people, events and report family
Conditions for verification: Connect 24 months/nine years, people, events and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not add the same reports, periods, people or clusters as independent harms trials/participants.
Why this condition is needed: Preparation condition for retaining the original scope of 24 months/nine years, people, events and report family.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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

Required materials and conditions: Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms
Conditions for verification: Connect Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not extend parent Good status or the 24-month related-event account into long-term safety guarantees for all lifestyle programs/exercise.
Why this condition is needed: Preparation condition for retaining the original scope of Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms.
Referenced methods: M19 §§19.1.2–19.2.4; Chamgap adaptation

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

Required materials and conditions: Separate interpretation of incidence results, related-event wording and long-term harms gaps
Conditions for verification: Connect Separate interpretation of incidence results, related-event wording and long-term harms gaps to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.
Requirement and applicability: Supporting harm information
Application exceptions: Do not turn null incidence into no harm or ineffectiveness of all programs, or write prevention/treatment guidance.
Why this condition is needed: Preparation condition for retaining the original scope of Separate interpretation of incidence results, related-event wording and long-term harms gaps.
Referenced methods: Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

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

Change history

2026-10-12 · Public page/material version 1.0

Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.

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

Researcher downloads

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

View all item details

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

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

Related sources R01

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

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

Related sources R01

N03 · Which high-risk community residents were selected?

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

Related sources R01

N04 · What was the actual peer-led intervention?

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

Related sources R01

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

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

Related sources R01

N06 · What were the control and direction of comparison?

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

N11 · How were glucose and HbA1c measured and confirmed?

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01 R02

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

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

Related sources R01 R02

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

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

Related sources R02

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01

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

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

Related sources R01 R02

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

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

Related sources R01

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

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

Related sources R01 R02

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

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

Related sources R01 R02

N33 · What is updated when new material appears?

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

Related sources R01 R02

H01 · How were adverse events and intervention relatedness defined?

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

Related sources R01 R02

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

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

Related sources R01 R02

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

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

Related sources R01

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

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

Related sources R01 R02

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

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

Related sources R01 R02

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

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

Related sources R01 R02

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

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

Related sources R01 R02

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

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

Related sources R01

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

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

Related sources R01 R02