{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Peer-led monthly lifestyle program · Original null result for prespecified nine-year diabetes incidence",
  "language": "en",
  "translation_date": "2026-10-12",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What are the selected original question and assessment record?",
      "needed": "Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition.",
      "application_exception": "Do not turn the parent, sibling or other time points into new independent trials/participants.",
      "criterion": "Connect Korean/English wording and record link for reduced diabetes incidence by the prespecified nine-year definition to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "If the question boundary changes, retain the original wording, previous complete version and change event separately."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "How do subclaim D and parent D34, axes and history differ?",
      "needed": "Subclaim grade/note, absent score/status/axes and actual parent values",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Subclaim grade/note, absent score/status/axes and actual parent values.",
      "application_exception": "Do not inherit parent scores, axes or cross-check history as new review approval, subclaim scores or independence certification.",
      "criterion": "Connect Subclaim grade/note, absent score/status/axes and actual parent values to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Separate preservation of original values from a new decision event when evidence is actually updated."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "Which high-risk community residents were selected?",
      "needed": "Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes.",
      "application_exception": "Do not turn a high-risk score or the prediabetes tag into a prediabetes diagnosis for all participants.",
      "criterion": "Connect Kerala, India; ages 30-60; IDRS at least 60; no baseline diabetes to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish other high-risk groups using their actual risk definitions and selection materials."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What was the actual peer-led intervention?",
      "needed": "Trained community peers and monthly group lifestyle sessions",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Trained community peers and monthly group lifestyle sessions.",
      "application_exception": "Do not create new diet, exercise or lifestyle treatment/prevention instructions.",
      "criterion": "Connect Trained community peers and monthly group lifestyle sessions to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Record actual program identity, intensity, delivery and peer roles together in subsequent materials."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "Are the 12-month program and nine-year outcome period distinguished?",
      "needed": "Initial intervention duration, long-term follow-up and maintenance/additional exposure",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Initial intervention duration, long-term follow-up and maintenance/additional exposure.",
      "application_exception": "Do not state that monthly intervention continued throughout nine years or retained the same intensity.",
      "criterion": "Connect Initial intervention duration, long-term follow-up and maintenance/additional exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Report original intervention duration separately from maintenance/additional exposure during follow-up."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the control and direction of comparison?",
      "needed": "Education-booklet control and original intervention/control correspondence",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Education-booklet control and original intervention/control correspondence.",
      "application_exception": "Prepare only the actual stored-summary scope; do not create absent numbers, definitions, denominators or method confirmations.",
      "criterion": "Connect Education-booklet control and original intervention/control correspondence to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Do not automatically combine materials using a different control as the same comparison."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the cluster-allocation unit and number?",
      "needed": "60 polling-area clusters, distinguished from individual recruitment/analysis",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of 60 polling-area clusters, distinguished from individual recruitment/analysis.",
      "application_exception": "Do not divide 60 to create new group cluster counts or turn people into independent randomized units.",
      "criterion": "Connect 60 polling-area clusters, distinguished from individual recruitment/analysis to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Record cluster and individual recruitment, allocation, follow-up and analysis together."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the allocation, masking and diagnostic-collection processes?",
      "needed": "Cluster allocation concealment, participant/assessor masking and outcome collection",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Cluster allocation concealment, participant/assessor masking and outcome collection.",
      "application_exception": "Do not newly judge masking or count method defects from the program name.",
      "criterion": "Connect Cluster allocation concealment, participant/assessor masking and outcome collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "When methods are provided, link actual role-specific masking and diagnostic collection to the corresponding outcome."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were long-term co-interventions and cluster contamination?",
      "needed": "Diet, activity, medicines, other programs and contact between clusters",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Diet, activity, medicines, other programs and contact between clusters.",
      "application_exception": "Do not newly establish separate diet/activity effects or actual amounts of lifestyle change.",
      "criterion": "Connect Diet, activity, medicines, other programs and contact between clusters to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Record actual measurement/management of post-intervention exposure and cluster contamination in subsequent research."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the components of the prespecified diabetes-incidence definition?",
      "needed": "FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up.",
      "application_exception": "Do not turn the original FPG-plus-HbA1c shorthand into a rule requiring both tests to be positive.",
      "criterion": "Connect FPG at least 126 mg/dL or HbA1c at least 6.5%, plus physician diagnosis/medication initiation during follow-up to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link each criterion, combination rule and overlap separately in new definition materials."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "How were glucose and HbA1c measured and confirmed?",
      "needed": "Fasting tests, assay methods, repeat confirmation, timing and missingness",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Fasting tests, assay methods, repeat confirmation, timing and missingness.",
      "application_exception": "Do not create OGTTs, repeat-test counts, additional glucose values or diagnostic procedures.",
      "criterion": "Connect Fasting tests, assay methods, repeat confirmation, timing and missingness to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish collection of test-based incidence from physician-diagnosis/medication-based incidence."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "How were physician diagnosis and glucose-lowering medication initiation included?",
      "needed": "Sources, confirmation and incidence attribution for diagnosis/medication initiation",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Sources, confirmation and incidence attribution for diagnosis/medication initiation.",
      "application_exception": "Do not turn medication initiation into an invented diagnosis, a specific drug/dose or treatment-need guidance.",
      "criterion": "Connect Sources, confirmation and incidence attribution for diagnosis/medication initiation to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link actual criterion-specific attribution and overlap when registration/plans and result tables are provided."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What time and analysis measure does nine-year cumulative incidence represent?",
      "needed": "Nominal nine years, cumulative incidence, analysis population and follow-up duration",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Nominal nine years, cumulative incidence, analysis population and follow-up duration.",
      "application_exception": "Do not calculate/convert nine-year cumulative proportions into annual incidence, person-years or hazard ratios.",
      "criterion": "Connect Nominal nine years, cumulative incidence, analysis population and follow-up duration to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish cumulative incidence risk, incidence rate and time models in new time-related materials."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the original nine-year event numerators, denominators and proportions?",
      "needed": "Attribution of intervention 125/419 (30%) and control 142/422 (34%)",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Attribution of intervention 125/419 (30%) and control 142/422 (34%).",
      "application_exception": "Do not back-calculate events or create new absolute risk differences, numbers prevented or component totals.",
      "criterion": "Connect Attribution of intervention 125/419 (30%) and control 142/422 (34%) to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link original numerators, denominators and proportions to the corresponding definition/time point as materials are supplemented."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What is the scope of the RR, interval, P value and null-result wording?",
      "needed": "RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment.",
      "application_exception": "Do not turn nonsignificance into an exact zero effect, equivalence, prevention worthlessness or ineffectiveness of all programs.",
      "criterion": "Connect RR 0.88, 95% CI 0.73-1.08, P=.24 and analysis/adjustment to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link the estimate to its adjustment and units when original methods are provided."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the randomized and actual nine-year analysis denominators?",
      "needed": "1,007 randomized (500/507) and 841 available cases (419/422)",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of 1,007 randomized (500/507) and 841 available cases (419/422).",
      "application_exception": "Do not copy 1,007 or 500/507 into actual nine-year outcome denominators or make 841 a new cohort.",
      "criterion": "Connect 1,007 randomized (500/507) and 841 available cases (419/422) to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link allocation, acquired data, valid outcomes and actual analysis denominators separately when follow-up data are added."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "Are the 144 lost to follow-up and 841 analyzed distinguished?",
      "needed": "Original loss to follow-up, 144/1,007 (14.3%), and analysis flow",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Original loss to follow-up, 144/1,007 (14.3%), and analysis flow.",
      "application_exception": "Do not calculate allocation-analysis or loss-to-follow-up differences to fill new dropout counts, rates or exclusion causes.",
      "criterion": "Connect Original loss to follow-up, 144/1,007 (14.3%), and analysis flow to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link definitions and reasons for each state when original flow materials are supplemented."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the available-case and missingness/selection assumptions?",
      "needed": "Analysis of people with data, missingness reasons and imputation/sensitivity analyses",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Analysis of people with data, missingness reasons and imputation/sensitivity analyses.",
      "application_exception": "Do not turn available-case analysis into completed full ITT analysis or absence of missingness effects.",
      "criterion": "Connect Analysis of people with data, missingness reasons and imputation/sensitivity analyses to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish analysis of people with data from assumptions for the full allocated population."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the cluster correlation, sizes and estimation model?",
      "needed": "Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures.",
      "application_exception": "Do not certify cluster adjustment from the design name or calculate new CIs assuming independent individuals.",
      "criterion": "Connect Cluster structure, ICC, cluster-adjusted estimation, weighting/repeated measures to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M08 §8.1–8.2.3; CHAMGAP adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link actual cluster correlation/weighting to the original estimand when cluster data are added."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the prespecified primary definition and outcome hierarchy?",
      "needed": "Prespecified nine-year definition, analysis plan and multiple definitions/tests",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Prespecified nine-year definition, analysis plan and multiple definitions/tests.",
      "application_exception": "Do not upgrade the parent H endpoint/large hard-outcome RCT flag or historical prespecified wording into current registration/plan review certification.",
      "criterion": "Connect Prespecified nine-year definition, analysis plan and multiple definitions/tests to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link the contemporary prespecified/post hoc status, change history and outcome definition when plans are provided."
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What separate definition produced the positive FPG-only result?",
      "needed": "RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition.",
      "application_exception": "Do not transfer FPG-only RR, CI or P to the prespecified composite definition or count the definitions as independent trials.",
      "criterion": "Connect RR 0.72, 95% CI 0.53-0.98, P=.036 and difference from the selected definition to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link results for each definition to separate measures/denominators even at the same time point."
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "How do the original paired registration identifiers and actual content-reading state differ?",
      "needed": "ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope.",
      "application_exception": "Do not force identifiers stored under the historical nct key into NCT numbers or count two registrations as independent trials.",
      "criterion": "Connect ACTRN12611000262909 · CTRI/2021/10/037191 and current reading scope to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M08 Table 8.2.a and M04 §4.6.3; Chamgap application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish original identity, dates, changes and actual reading scope when registration materials are provided."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What are the bibliographies and stored-source locations of the two reports?",
      "needed": "Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs.",
      "application_exception": "Do not create a nonexistent second evidence entry for R02 or infer a DOI from an article number.",
      "criterion": "Connect Jeemon 2026 nine-year report, Thankappan 2018 24-month report and PMIDs to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Retain previous original values and each report’s identity when bibliographies are supplemented/corrected."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "Are the earlier report and long-term follow-up from the same trial?",
      "needed": "2018/2026 K-DPP clusters/participants and report family",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of 2018/2026 K-DPP clusters/participants and report family.",
      "application_exception": "Do not add the two reports, 24-month/nine-year results, two definitions or parent/sibling sheets as new trials/participants.",
      "criterion": "Connect 2018/2026 K-DPP clusters/participants and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish genuinely different recruitment/registration when an independent new trial is provided."
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What separate time point does the original 24-month result represent?",
      "needed": "68/456(14.9%)·79/463(17.1%)·RR0.88·CI/P",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P.",
      "application_exception": "Do not add 24-month events to nine-year events or automatically copy the nine-year FPG/HbA1c definition to 24 months.",
      "criterion": "Connect 68/456 (14.9%), 79/463 (17.1%), RR 0.88 and CI/P to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Record each time point’s definition, denominators and effect separately when materials are provided."
    },
    {
      "item_id": "N26",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What heterogeneity was assessed by high-risk subgroup and period?",
      "needed": "Baseline glucose/risk, sex, cluster, time and actual effects",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Baseline glucose/risk, sex, cluster, time and actual effects.",
      "application_exception": "Do not turn overall nonsignificance into zero effects for every individual/subgroup.",
      "criterion": "Connect Baseline glucose/risk, sex, cluster, time and actual effects to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.1; detailed population conditions are Chamgap’s own design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Report actual prespecified criteria and intervals for group/time differences in subsequent materials."
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "Are the monthly peer-led program and expert-led intensive interventions distinguished?",
      "needed": "Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators.",
      "application_exception": "Do not create verdict 1531, DPP or DPS as new report/trial slots or current independence certification; their pages/files are not opened.",
      "criterion": "Connect Identity of the low-cost peer-led program and direct evidence for different intensity/facilitators to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Specify program identity, population, intensity and control in new applicability materials."
    },
    {
      "item_id": "N28",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "How does actual diabetes incidence differ from other outcomes?",
      "needed": "Incidence events versus risk-score/glucose changes, complications and death",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Incidence events versus risk-score/glucose changes, complications and death.",
      "application_exception": "Do not extend nonsignificant incidence to all health outcomes, long-term care or safety conclusions.",
      "criterion": "Connect Incidence events versus risk-score/glucose changes, complications and death to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link incidence, surrogate markers and complications to their own definitions and time points."
    },
    {
      "item_id": "N29",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What is the scope of NHMRC support and no commercial product?",
      "needed": "Trial funding, products, facilitator/analysis/publication roles and disclosed relationships",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Trial funding, products, facilitator/analysis/publication roles and disclosed relationships.",
      "application_exception": "Do not turn historical public funding/no commercial product into no conflicts, new independence certification or reading of individual 2018 declarations.",
      "criterion": "Connect Trial funding, products, facilitator/analysis/publication roles and disclosed relationships to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish public funding, commercial products and other relationships/roles when support materials are provided."
    },
    {
      "item_id": "N30",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What were the original date, Korean/English text, corrections, empty fields and verdict history?",
      "needed": "2026-08-26, empty correction/deliberation records and original axes/grades",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of 2026-08-26, empty correction/deliberation records and original axes/grades.",
      "application_exception": "Do not fill absent/empty fields or historical cross-checks with new values or current completed review.",
      "criterion": "Connect 2026-08-26, empty correction/deliberation records and original axes/grades to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Retain the complete original text, event, version and separate application when changes occur."
    },
    {
      "item_id": "N31",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What level of material was actually read for this work?",
      "needed": "Complete preserved JSON, own selected question and unread external materials",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Complete preserved JSON, own selected question and unread external materials.",
      "application_exception": "Do not upgrade URL, citation or copy existence into external-link confirmation, full-text reading or successful access.",
      "criterion": "Connect Complete preserved JSON, own selected question and unread external materials to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish public availability, access, acquisition, actual reading, scope and dates for new materials."
    },
    {
      "item_id": "N32",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "How do report/material slots differ from trials/populations?",
      "needed": "Two bibliographies, material-specific states and shared clusters/people/time points",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Two bibliographies, material-specific states and shared clusters/people/time points.",
      "application_exception": "Do not sum 1,007, 841, 419/422, 456/463, 60 clusters or two bibliographies into new total samples/trials.",
      "criterion": "Connect Two bibliographies, material-specific states and shared clusters/people/time points to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish material types and same/different-population relationships when additional reports appear."
    },
    {
      "item_id": "N33",
      "question_type": "Efficacy · Boundaries · Materials",
      "question": "What is updated when new material appears?",
      "needed": "Separation of conditions, originals, observations, reading and change events",
      "role": "Required",
      "role_reason": "Preparation condition for retaining the original scope of Separation of conditions, originals, observations, reading and change events.",
      "application_exception": "Candidate pending/eligibility values are history and are not revived as active model/content/boundary review waits.",
      "criterion": "Connect Separation of conditions, originals, observations, reading and change events to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "For actual additions/changes, separately retain the previous complete text, event, condition version/freeze, application and current handoff."
    },
    {
      "item_id": "H01",
      "question_type": "Harms",
      "question": "How were adverse events and intervention relatedness defined?",
      "needed": "Adverse events, relatedness, severity and collection",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Adverse events, relatedness, severity and collection.",
      "application_exception": "Do not turn historical no-intervention-related-event wording into zero of all adverse events.",
      "criterion": "Connect Adverse events, relatedness, severity and collection to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Record all collected harms separately from judgments of intervention relatedness."
    },
    {
      "item_id": "H02",
      "question_type": "Harms",
      "question": "How do safety observations at 12-month exposure, 24 months and nine years differ?",
      "needed": "Intervention duration, safety-collection timing and long-term exposure",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Intervention duration, safety-collection timing and long-term exposure.",
      "application_exception": "Do not inherit the 24-month related-event account as completed nine-year safety follow-up.",
      "criterion": "Connect Intervention duration, safety-collection timing and long-term exposure to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Record intervention exposure separately from actual observation duration in long-term harms materials."
    },
    {
      "item_id": "H03",
      "question_type": "Harms",
      "question": "Is there a nine-year between-group safety comparison?",
      "needed": "Nine-year intervention/control harms, relatedness and intervals",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Nine-year intervention/control harms, relatedness and intervals.",
      "application_exception": "Do not conclude from historical missing abstract counts that the full text also omitted them, events were zero or safety was equivalent.",
      "criterion": "Connect Nine-year intervention/control harms, relatedness and intervals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link new harms results to actual group-specific definitions, denominators and periods."
    },
    {
      "item_id": "H04",
      "question_type": "Harms",
      "question": "Are safety denominators the same as incidence-analysis denominators?",
      "needed": "Harms collection/exposure/analysis n, clusters and individuals",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Harms collection/exposure/analysis n, clusters and individuals.",
      "application_exception": "Do not copy incidence-analysis participants into safety denominators or calculate incidence from unread originals.",
      "criterion": "Connect Harms collection/exposure/analysis n, clusters and individuals to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish actual harms collection/analysis populations from incidence denominators."
    },
    {
      "item_id": "H05",
      "question_type": "Harms",
      "question": "What alternative explanations link lifestyle/care changes and harms?",
      "needed": "Baseline disease, other activities/medicines, relatedness and timing",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Baseline disease, other activities/medicines, relatedness and timing.",
      "application_exception": "Do not invent background events, activity injuries or medication harms as actual events.",
      "criterion": "Connect Baseline disease, other activities/medicines, relatedness and timing to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §§19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap-designed",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish program-related events from baseline/concurrent factors in harms materials."
    },
    {
      "item_id": "H06",
      "question_type": "Harms",
      "question": "Are unread materials, absence from an abstract, nonreporting and zero events distinguished?",
      "needed": "Original historical reading narrative and current unread state",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Original historical reading narrative and current unread state.",
      "application_exception": "Do not turn current unread external materials into failed access, study absence or a safe zero.",
      "criterion": "Connect Original historical reading narrative and current unread state to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish actual collection, nonreporting, missingness and zero at the corresponding location/time when materials are provided."
    },
    {
      "item_id": "H07",
      "question_type": "Harms",
      "question": "Are harms from the same cohort kept from being counted as independent replication?",
      "needed": "24 months/nine years, people, events and report family",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of 24 months/nine years, people, events and report family.",
      "application_exception": "Do not add the same reports, periods, people or clusters as independent harms trials/participants.",
      "criterion": "Connect 24 months/nine years, people, events and report family to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Distinguish repeated/new events, time points and actual counts in added harms materials."
    },
    {
      "item_id": "H08",
      "question_type": "Harms",
      "question": "What gaps concern other risk groups, intensity and long-term safety?",
      "needed": "Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms.",
      "application_exception": "Do not extend parent Good status or the 24-month related-event account into long-term safety guarantees for all lifestyle programs/exercise.",
      "criterion": "Connect Selected high-risk ages 30-60, monthly peer-led intensity and long-term harms to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Specify harms by actual population, intensity and exposure duration in subsequent research."
    },
    {
      "item_id": "H09",
      "question_type": "Harms",
      "question": "Are the null incidence result and safety gaps both retained?",
      "needed": "Separate interpretation of incidence results, related-event wording and long-term harms gaps",
      "role": "Supporting harm information",
      "role_reason": "Preparation condition for retaining the original scope of Separate interpretation of incidence results, related-event wording and long-term harms gaps.",
      "application_exception": "Do not turn null incidence into no harm or ineffectiveness of all programs, or write prevention/treatment guidance.",
      "criterion": "Connect Separate interpretation of incidence results, related-event wording and long-term harms gaps to actual definitions, time points, clusters/individuals, denominators and analysis, distinguishing what is unverified.",
      "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run",
      "condition_origin": "CHAMGAP’s own design prepared from original materials; existing content review remains with the user",
      "proposed_research": "Link effects, harms and change events to each original location when new materials are provided."
    }
  ]
}