{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2963-s1", "verdict_number": "2963", "title": "Peer-led monthly lifestyle program × Reduced incidence by FPG alone", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Community residents aged 30-60 in 60 polling areas in Kerala, India, with IDRS at least 60 and no diabetes. The 1,007 randomized (500/507), 841 nine-year available cases (419/422) and original loss-to-follow-up account of 144/1,007 (14.3%) are retained separately. Exact FPG-only events/denominators, baseline/observation/missingness and stage-specific population flow are unverified; no subtraction or new totals are calculated.", "intervention": "A 12-month monthly group lifestyle program led by trained community peers. Actual components, intensity, attendance/adherence and subsequent exposure are unverified. It is not recast as the effect of a single activity or intensive expert-led intervention, or as new lifestyle/prevention/treatment instructions.", "dose": "The monthly 12-month intervention is distinguished from nine-year/24-month outcome follow-up. Continued identical intervention/exposure throughout nine years is not assumed. Actual individual timing/attendance/changes and other intensities/durations remain unverified.", "comparator": "Cluster-randomized comparison of education booklet for 507 participants versus monthly program for 500. Actual control use, other support/exposure, allocation/masking, cluster adjustment/contamination and concurrent treatment/activity are unverified. Education booklet is not relabeled as no action.", "endpoint": "Selected FPG-only RR 0.72 (95% CI 0.53-0.98), P=.036 and the original note that it was not the prespecified primary endpoint are retained. Exact cutoff, testing/confirmation, group events/denominators, model and multiplicity are unverified. Prespecified nine-year composite FPG at least 126 mg/dL or HbA1c at least 6.5%, including physician diagnosis/starting glucose-lowering medication, and 125/419 (30%) versus 142/422 (34%), RR 0.88 (0.73-1.08), P=.24 are different results. The two definitions are not assigned identical events/denominators.", "duration": "The selected positive FPG result belongs to the nine-year discussion context and is distinguished from 12-month intervention exposure. Same-trial 24-month primary 68/456 (14.9%) versus 79/463 (17.1%), RR 0.88 (0.66-1.16), P=.36 is a preserved report at another time/definition. Actual selected FPG assessment window, cumulative/repeated events and subsequent follow-up are unverified.", "excluded_extensions": [ "Upgrade FPG-only RR 0.72/P=.036 to the prespecified composite primary conclusion or efficacy across all definitions/intensive expert-led programs", "Reuse composite nine-year/24-month primary events, denominators, cutoffs or components as verified selected FPG values", "Subtract/reconcile original 1,007, 841 and 144 recruitment/analysis/follow-up accounts to calculate new omission counts or event proportions", "Add 60 clusters, shared people/groups, times/definitions, two reports/registrations or sibling sheets as new independent trials/participants", "Convert public funding/nonuse of commercial products into absence of individual support/COI or new independence certification", "Convert missing nine-year safety counts/no related adverse events at 24 months into zero harms or confirmed long-term safety", "Inheriting parent scores/axes, historical cross-checks or registration descriptions as subclaim scores, current verification or external reading", "New calculations, invented values, effects/confidence intervals, grades, independence certification or instructions for lifestyle, product intake, testing or treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected FPG question and original values", "needed": "Selected subclaim grade/note, parent context and presence of score/status/axes", "role": "Required", "role_reason": "Preparation item distinguishing Selected subclaim grade/note, parent context and presence of score/status/axes to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Selected subclaim grade/note, parent context and presence of score/status/axes must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to link the original question scope to additional materials for updating; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original FPG-only incidence-reduction subclaim is C. Parent D34 is context for the original prespecified composite-incidence verdict, not the subclaim score/axes.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score, status and axes are absent; parent values are not inserted. Existing content review remains incomplete.", "missingness": "Subclaim score, status and axes are absent; parent values are not inserted.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials distinguishing the selected record from the parent original verdict" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "High-risk adults without diabetes in Kerala", "needed": "Population, recruitment criteria, baseline state and applicability", "role": "Required", "role_reason": "Preparation item distinguishing Population, recruitment criteria, baseline state and applicability to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Population, recruitment criteria, baseline state and applicability must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine applicability under the same population specification; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original population comprises 1,007 community residents aged 30-60 in Kerala, India, with IDRS at least 60 and no diabetes.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Baseline FPG/HbA1c, detailed eligibility/risk, group characteristics and the selected FPG denominator are unverified. Existing content review remains incomplete.", "missingness": "Baseline FPG/HbA1c, detailed eligibility/risk, group characteristics and the selected FPG denominator are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment, eligibility, baseline characteristics and outcome-specific population materials" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Trained peers and monthly group program", "needed": "Intervention components, facilitators, intensity and actual delivery", "role": "Required", "role_reason": "Preparation item distinguishing Intervention components, facilitators, intensity and actual delivery to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Intervention components, facilitators, intensity and actual delivery must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine program components and actual delivery; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original intervention is a 12-month monthly group lifestyle program led by trained community peers. It is not replaced with a single activity or intensive expert-led intervention.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Education/session components, attendance, facilitator training, fidelity and actual individual exposure are unverified. Existing content review remains incomplete.", "missingness": "Education/session components, attendance, facilitator training, fidelity and actual individual exposure are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original program components, attendance/fidelity and exposure materials" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Education-booklet control", "needed": "Actual control and differences in accompanying exposure", "role": "Required", "role_reason": "Preparation item distinguishing Actual control and differences in accompanying exposure to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Actual control and differences in accompanying exposure must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; M03 §3.2.3, M08 §8.2.2–8.2.3; CHAMGAP adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish the actual intervention/control differences; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original allocation of 500 intervention participants and 507 education-booklet participants is retained. The control is not described as no action, no information or identical conditions.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Booklet content/use, other support/exposure and actual control participation are unverified. Existing content review remains incomplete.", "missingness": "Booklet content/use, other support/exposure and actual control participation are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control components, use and accompanying exposure materials" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "12-month intervention and nine-year follow-up", "needed": "Distinction between exposure duration and outcome follow-up", "role": "Required", "role_reason": "Preparation item distinguishing Distinction between exposure duration and outcome follow-up to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Distinction between exposure duration and outcome follow-up must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine exposure and long-term outcomes; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The monthly program lasted 12 months; nine-year outcomes are long-term follow-up of the same trial. Continued identical intervention throughout nine years is not assumed.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Individual attendance/exposure, subsequent activity/treatment, assessment windows and discontinuation/crossover are unverified. Existing content review remains incomplete.", "missingness": "Individual attendance/exposure, subsequent activity/treatment, assessment windows and discontinuation/crossover are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention/follow-up timing, actual exposure and change records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Cluster allocation of 60 polling areas", "needed": "Cluster/individual units and allocation/concealment procedures", "role": "Required", "role_reason": "Preparation item distinguishing Cluster/individual units and allocation/concealment procedures to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Cluster/individual units and allocation/concealment procedures must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine cluster structure and population distribution; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original design cluster randomized 60 polling areas. Clusters, intervention/control groups and individuals are not counted as independent trials.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Allocation generation/concealment, stratification, cluster sizes, access rights and actual procedures are unread. Existing content review remains incomplete.", "missingness": "Allocation generation/concealment, stratification, cluster sizes, access rights and actual procedures are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cluster allocation, cluster-specific populations and procedure materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Masking and measurement roles", "needed": "Role-specific procedures for incidence adjudication, testing and analysis", "role": "Required", "role_reason": "Preparation item distinguishing Role-specific procedures for incidence adjudication, testing and analysis to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Role-specific procedures for incidence adjudication, testing and analysis must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine measurement/adjudication bias; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The stored cluster-intervention design is linked to test-based outcomes.", "condition_status": "Unverified", "status_reason": "Currently required information is unverified in the preserved summary. Actual masking, test access and roles of participants/facilitators, laboratory staff/adjudicators and analysts are unverified. The design name alone does not certify absence of bias. Existing content review remains incomplete.", "missingness": "Actual masking, test access and roles of participants/facilitators, laboratory staff/adjudicators and analysts are unverified. The design name alone does not certify absence of bias.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Testing/adjudication/analysis procedures and role-specific masking materials" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "FPG-only definition and testing", "needed": "Selected incidence cutoff, testing/confirmation and event unit", "role": "Required", "role_reason": "Preparation item distinguishing Selected incidence cutoff, testing/confirmation and event unit to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Selected incidence cutoff, testing/confirmation and event unit must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine results under the definition/measurement specification; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account of a positive result using FPG alone is retained. All components/procedures of the prespecified composite definition are not automatically applied to this definition.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. The selected FPG cutoff, fasting/testing, repeat confirmation, inclusion of physician diagnosis/medication and detailed event unit are unverified. Existing content review remains incomplete.", "missingness": "The selected FPG cutoff, fasting/testing, repeat confirmation, inclusion of physician diagnosis/medication and detailed event unit are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original FPG-only definition, testing/confirmation and adjudication materials" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "FPG RR0.72·CI·P", "needed": "Selected between-group estimate, confidence interval and model", "role": "Required", "role_reason": "Preparation item distinguishing Selected between-group estimate, confidence interval and model to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Selected between-group estimate, confidence interval and model must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; CHAMGAP adaptation; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine precision for the same definition/estimate; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original FPG-only RR 0.72 (95% CI 0.53-0.98), P=.036 is retained. No new risk difference, NNT or effect/CI is calculated.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Group-specific events/denominators, cluster adjustment, adjustment variables, estimation model and original output are unverified. Existing content review remains incomplete.", "missingness": "Group-specific events/denominators, cluster adjustment, adjustment variables, estimation model and original output are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific results, model and exact output for the selected definition" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "FPG events, denominators and timing", "needed": "Selected-definition analysis/observed denominator, events and time", "role": "Required", "role_reason": "Preparation item distinguishing Selected-definition analysis/observed denominator, events and time to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Selected-definition analysis/observed denominator, events and time must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine the same people and definition-specific outcomes; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The FPG-only result is linked to the nine-year discussion context. Composite-incidence 125/419 and 142/422 are not transferred to FPG events/denominators.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. FPG group-specific event counts, denominators, assessment windows, cumulative/repeated events and omission/missingness handling are unverified. Existing content review remains incomplete.", "missingness": "FPG group-specific event counts, denominators, assessment windows, cumulative/repeated events and omission/missingness handling are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definition-specific observed/analysis populations, events and timing materials" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Prespecified composite-incidence definition", "needed": "Components/hierarchy of the prespecified primary definition and its relation to the selected definition", "role": "Required", "role_reason": "Preparation item distinguishing Components/hierarchy of the prespecified primary definition and its relation to the selected definition to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Components/hierarchy of the prespecified primary definition and its relation to the selected definition must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish definition/hierarchy and component-specific outcomes; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original 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. It is not replaced by FPG-only results.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original component-specific events, overlap/confirmation procedures and planning/change history are unread. Existing content review remains incomplete.", "missingness": "Original component-specific events, overlap/confirmation procedures and planning/change history are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified definition, component-specific adjudication and original plans" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Original nine-year composite result", "needed": "Between-group outcomes under the other definition, distinguished from selected FPG", "role": "Required", "role_reason": "Preparation item distinguishing Between-group outcomes under the other definition, distinguished from selected FPG to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Between-group outcomes under the other definition, distinguished from selected FPG must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "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; M15 §15.3.1–15.3.3; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish definition-specific outcomes within the same cohort; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Prespecified nine-year composite 125/419 (30%) versus 142/422 (34%), RR 0.88 (0.73-1.08), P=.24 is retained as context. These are not the selected FPG events/estimate.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Correspondence of people/events across definitions and component-specific outcomes/denominators are unverified. No new difference, ratio or interaction is calculated. Existing content review remains incomplete.", "missingness": "Correspondence of people/events across definitions and component-specific outcomes/denominators are unverified. No new difference, ratio or interaction is calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Composite/FPG definition correspondence and original analysis materials" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Multiple definitions, selection and multiplicity", "needed": "Prespecification of the selected positive result and multiplicity/overall-result specification", "role": "Required", "role_reason": "Preparation item distinguishing Prespecification of the selected positive result and multiplicity/overall-result specification to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Prespecification of the selected positive result and multiplicity/overall-result specification must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M15 §15.3.1–15.3.3; CHAMGAP adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine selection/multiplicity and result interpretation; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original note that the positive FPG-only result was not the prespecified primary endpoint is retained. Selecting only the positive definition does not create an overall conclusion or new grade.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Definition list, prespecified hierarchy, multiplicity/adjustment, testing strategy and SAP are unread. Existing content review remains incomplete.", "missingness": "Definition list, prespecified hierarchy, multiplicity/adjustment, testing strategy and SAP are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans, SAP and all definition/testing results" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "1,007·500/507·841", "needed": "Randomized population distinguished from the nine-year available-case analysis population", "role": "Required", "role_reason": "Preparation item distinguishing Randomized population distinguished from the nine-year available-case analysis population to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Randomized population distinguished from the nine-year available-case analysis population must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A follow-up research proposal on analysis populations and omission assumptions; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The 1,007 randomized participants (500/507) and 841 with nine-year outcome data (419/422) are retained separately. They are not described as full ITT or a verified identical denominator for selected FPG.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Group-specific inclusion/exclusion flow, FPG observation, death/withdrawal/missingness and cluster analysis are unverified. Existing content review remains incomplete.", "missingness": "Group-specific inclusion/exclusion flow, FPG observation, death/withdrawal/missingness and cluster analysis are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow from randomization to definition-specific observation/analysis populations" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Loss to follow-up: 144 and 14.3%", "needed": "Original loss-to-follow-up account and its relation to available cases", "role": "Required", "role_reason": "Preparation item distinguishing Original loss-to-follow-up account and its relation to available cases to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Original loss-to-follow-up account and its relation to available cases must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish loss to follow-up from the actual analyzable population; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original loss to follow-up of 144/1,007 (14.3%), below 15%, is retained. The separate 1,007 and 841 analysis accounts are not subtracted/reconciled to create new omission counts.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Stage-specific follow-up/analysis definitions, group-specific reasons, death/unmeasured exclusions and FPG missingness are unverified. Existing content review remains incomplete.", "missingness": "Stage-specific follow-up/analysis definitions, group-specific reasons, death/unmeasured exclusions and FPG missingness are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Stage-specific follow-up, analysis exclusion/missingness flows and reasons" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Cluster analysis, missingness and sensitivity", "needed": "Analysis specification for cluster adjustment, available cases and missingness assumptions", "role": "Required", "role_reason": "Preparation item distinguishing Analysis specification for cluster adjustment, available cases and missingness assumptions to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Analysis specification for cluster adjustment, available cases and missingness assumptions must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M15 §15.3.1–15.3.3; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine uncertainty under cluster/missingness assumptions; no new investigation, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original nine-year available-case account and cluster-randomized structure are retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Selected FPG cluster correlation, adjustment, missingness models, sensitivity and estimates for all randomized participants are unverified. No new model/effect is calculated. Existing content review remains incomplete.", "missingness": "Selected FPG cluster correlation, adjustment, missingness models, sensitivity and estimates for all randomized participants are unverified. No new model/effect is calculated.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original FPG analysis, cluster/missingness handling and sensitivity materials" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Earlier 24-month report of the same trial", "needed": "Population, timing and results of the earlier report and relation to nine years", "role": "Required", "role_reason": "Preparation item distinguishing Population, timing and results of the earlier report and relation to nine years to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Population, timing and results of the earlier report and relation to nine years must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Follow-up proposal to distinguish time/definition-specific outcomes in the same cohort; no new investigation, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S02 is the same K-DPP trial’s earlier 24-month report. Its primary result is retained as 68/456 (14.9%) versus 79/463 (17.1%), RR 0.88 (0.66-1.16), P=.36. It does not become the nine-year FPG-only result or a separate independent trial.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original 24-month definition, clusters/denominators, attrition/missingness, population correspondence to nine years and FPG-specific values are unverified. Existing content review remains incomplete.", "missingness": "Original 24-month definition, clusters/denominators, attrition/missingness, population correspondence to nine years and FPG-specific values are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 24-month report, definition/population/denominators and long-term correspondence" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Paired registration identifiers", "needed": "Registration identity, scope of each identifier and original plans", "role": "Required", "role_reason": "Preparation item distinguishing Registration identity, scope of each identifier and original plans to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Registration identity, scope of each identifier and original plans must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior 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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to link prespecified plans and report/registration relationships; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original ACTRN12611000262909 · CTRI/2021/10/037191 in the registration field is retained. The two identifiers are not counted as separate independent trials.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Each registration’s population/duration, prespecified plans, change history and relation to recruitment/analysis are unread. Existing content review remains incomplete.", "missingness": "Each registration’s population/duration, prespecified plans, change history and relation to recruitment/analysis are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each registration history, protocol/SAP and report correspondence" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Concurrent activity, treatment and contamination", "needed": "Group-specific concurrent exposure, treatment/changes and actual participation", "role": "Required", "role_reason": "Preparation item distinguishing Group-specific concurrent exposure, treatment/changes and actual participation to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Group-specific concurrent exposure, treatment/changes and actual participation must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine concurrent exposure and attribution of program outcomes; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The monthly group-intervention/education-booklet difference is retained within its original scope.", "condition_status": "Unverified", "status_reason": "Currently required information is unverified in the preserved summary. Group-specific diet/activity, expert support, testing/medication, external programs, contamination/crossover, actual adherence and subsequent exposure are unverified. No new lifestyle/treatment instructions are created. Existing content review remains incomplete.", "missingness": "Group-specific diet/activity, expert support, testing/medication, external programs, contamination/crossover, actual adherence and subsequent exposure are unverified. No new lifestyle/treatment instructions are created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific concurrent exposure, participation/adherence, changes and crossover records" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "NHMRC funding and roles", "needed": "Funding provision distinguished from research/analysis/publication roles", "role": "Required", "role_reason": "Preparation item distinguishing Funding provision distinguished from research/analysis/publication roles to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Funding provision distinguished from research/analysis/publication roles must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish support roles and reporting relationships; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account of support from the Australian National Health and Medical Research Council is retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Contracts, involvement in analysis/writing/publication, individual author relationships/COI and time-specific disclosures are unread. Public funding alone does not certify complete independence. Existing content review remains incomplete.", "missingness": "Contracts, involvement in analysis/writing/publication, individual author relationships/COI and time-specific disclosures are unread. Public funding alone does not certify complete independence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/role, author-contribution/COI and publication-related disclosures" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "No commercial product and other support", "needed": "Commercial-product use distinguished from other support/relationships", "role": "Required", "role_reason": "Preparation item distinguishing Commercial-product use distinguished from other support/relationships to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Commercial-product use distinguished from other support/relationships must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish product/other support; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account that no commercial product was used is retained.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Product nonuse does not verify absence of all material/analysis/writing/publication-fee support, employee authors or COI. Individual disclosures are unread. Existing content review remains incomplete.", "missingness": "Product nonuse does not verify absence of all material/analysis/writing/publication-fee support, employee authors or COI. Individual disclosures are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual support, author relationships and disclosure materials" }, { "item_id": "N22", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Nine-year and 24-month safety-reporting scope", "needed": "Time-specific distinction between harms collection, reporting and denominators", "role": "Supplementary", "role_reason": "Preparation item distinguishing Time-specific distinction between harms collection, reporting and denominators to link required and current materials for the selected question.", "application_exception": "Supplements the selected subclaim’s safety-material gap. Incidence results or parent safety wording do not establish safety or generate harm rates or new usage instructions.", "criterion": "Corresponding original materials and analysis scope for Time-specific distinction between harms collection, reporting and denominators must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to examine long-term follow-up and harms-reporting gaps; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account is retained: no separate safety-outcome counts in the nine-year abstract, and no intervention-related adverse events reported at 24 months.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Actual harms collection, population/denominators, events, discontinuation and detailed nine-year originals are unread. Nonreporting/no related events does not establish zero long-term harms or certify safety. Existing content review remains incomplete.", "missingness": "Actual harms collection, population/denominators, events, discontinuation and detailed nine-year originals are unread. Nonreporting/no related events does not establish zero long-term harms or certify safety.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific harms collection, denominators and event/discontinuation materials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Intensive expert programs and other evidence", "needed": "Intervention intensity/components and other trials’ identities/results", "role": "Required", "role_reason": "Preparation item distinguishing Intervention intensity/components and other trials’ identities/results to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Intervention intensity/components and other trials’ identities/results must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; Status distinctions are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details 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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish intervention intensity/components and result applicability; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Only the original context mentioning DPP/DPS and intensive expert-led intervention in 1531 is retained. These are not transferred as the same direct report for the monthly peer-led intervention/selected FPG.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Individual population, intervention, bibliography, estimates and direct correspondence for those trials are not linked in this source and remain unverified. Existing content review remains incomplete.", "missingness": "Individual population, intervention, bibliography, estimates and direct correspondence for those trials are not linked in this source and remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for each trial/intervention/population mentioned in the original account" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Independence, follow-up reports and sibling sheets", "needed": "Relationships among reports, trials, people, time points and definitions", "role": "Required", "role_reason": "Preparation item distinguishing Relationships among reports, trials, people, time points and definitions to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Relationships among reports, trials, people, time points and definitions must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish the same trial from separate evidence; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Jeemon’s 2026 nine-year report and Thankappan’s 2018 24-month report are linked as reports of the same trial. Shared 60 clusters, people/groups, definitions, time points and sibling sheets are not added as new independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Actual people/cluster/time correspondence, unique participants and independent replication have not been checked against external materials. Original R1 is not inherited as new independence certification. Existing content review remains incomplete.", "missingness": "Actual people/cluster/time correspondence, unique participants and independent replication have not been checked against external materials. Original R1 is not inherited as new independence certification.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/registration/population, time/definition relationships and separate replication materials" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Nine years and other durations/populations", "needed": "Other populations, durations/intensity and long-term follow-up beyond this question", "role": "Required", "role_reason": "Preparation item distinguishing Other populations, durations/intensity and long-term follow-up beyond this question to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Other populations, durations/intensity and long-term follow-up beyond this question must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.4; CHAMGAP’s boundary for extensions; M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposal to distinguish the selected question from other conditions; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected positive result concerns the FPG-only definition for a low-cost peer-led program. It is not extended to preventive efficacy or ineffectiveness across all definitions, intensive expert-led interventions or other populations.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Other recruitment criteria, eras, intensity/duration, long-term clinical outcomes/harms and definition-specific correspondence are unverified. Existing content review remains incomplete.", "missingness": "Other recruitment criteria, eras, intensity/duration, long-term clinical outcomes/harms and definition-specific correspondence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional population/intervention/time/definition-specific materials" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Original axes, Korean/English text, dates and corrections", "needed": "Distinction between original subclaim and parent values, original reference date and correction/history", "role": "Required", "role_reason": "Preparation item distinguishing Distinction between original subclaim and parent values, original reference date and correction/history to link required and current materials for the selected question.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Corresponding original materials and analysis scope for Distinction between original subclaim and parent values, original reference date and correction/history must be supplied so unverified matters can be distinguished. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Updating proposal to distinguish changes to original materials from preparation versions; no new investigation, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Subclaim C/note, parent D34, B/H/R1/I2/E0/B1/C0, false/true/false flags, empty overrides, Korean/English, 2026-08-26 and empty corrections/deliberation are preserved in the complete original summary.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Historical cross-checking/research accounts are not current review, original-paper reading or fulfillment of new conditions. Absent subclaim score/status/axes and parent facets keys are not filled. Existing content review remains incomplete.", "missingness": "Historical cross-checking/research accounts are not current review, original-paper reading or fulfillment of new conditions. Absent subclaim score/status/axes and parent facets keys are not filled.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict, correction/change text and user comments" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Actual summary reading and unread external materials", "needed": "Actual reading by material, bibliography/URLs and additional-material gaps", "role": "Required", "role_reason": "A production item distinguishing Actual reading by material, bibliography/URLs and additional-material gaps to connect the selected question’s needed material with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual reading by material, bibliography/URLs and additional-material gaps: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.", "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": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved JSON summary was read for preparation, linking nine-year/24-month bibliographies and URLs. External papers, registration, protocol/SAP and funding/COI originals remain unread, with no access attempted.", "condition_status": "Partly verified", "status_reason": "Only the corresponding preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Bibliographic links or registration identifiers do not upgrade acquisition/reading/review status. No external click/link checks were performed in this preparation. Existing content review remains incomplete.", "missingness": "Bibliographic links or registration identifiers do not upgrade acquisition/reading/review status. No external click/link checks were performed in this preparation.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports, registration/plans, disclosures and user comments" } ], "reports": [ { "report_id": "S01", "title": "Jeemon P et al. 2026 K-DPP nine-year follow-up", "url": "https://pubmed.ncbi.nlm.nih.gov/41997166/", "report_type": "Long-term follow-up of a 60-cluster randomized controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2963-K-DPP", "independent_replication": null, "observed_result": "Selected FPG-only RR 0.72 (95% CI 0.53-0.98), P=.036 retains the original note that this was not the prespecified primary definition. Prespecified nine-year composite results are 125/419 (30%) versus 142/422 (34%), RR 0.88 (95% CI 0.73-1.08), P=.24 under a different definition/estimate. FPG group-specific events/denominators, exact testing/hierarchy and original analysis are unverified.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41997166/" } ] }, { "report_id": "S02", "title": "Thankappan KR, et al. A peer-support lifestyle intervention to prevent type 2 diabetes in India: a cluster-randomized controlled trial. Diabetes Care. 2018. PMID: 29874236.", "url": "https://pubmed.ncbi.nlm.nih.gov/29874236/", "report_type": "Earlier 24-month report of the same cluster trial · Preserved original cross-citation", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2963-K-DPP", "independent_replication": null, "observed_result": "The same trial’s 24-month primary 68/456 (14.9%) versus 79/463 (17.1%), RR 0.88 (95% CI 0.66-1.16), P=.36 is linked through preserved Korean/English and the citation’s one-line account. It is not the nine-year FPG-only result/denominator; there is no existing native evidence-list entry for this report.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29874236/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Jeemon’s 2026 nine-year and S02 Thankappan’s 2018 24-month reports concern the same K-DPP cluster trial. In 60 polling areas in Kerala, India, 1,007 participants aged 30-60 with IDRS at least 60 and no diabetes (500/507) were assigned to a 12-month monthly peer-led program or education booklet. Nine-year available cases of 841 (419/422) and original loss to follow-up of 144/1,007 (14.3%) are separate accounts; no subtraction or new denominators are calculated. Selected FPG-only RR 0.72 (0.53-0.98), P=.036 and the nonprimary note are distinguished from prespecified nine-year composite 125/419 (30%) versus 142/422 (34%), RR 0.88 (0.73-1.08), P=.24, and 24-month primary 68/456 (14.9%) versus 79/463 (17.1%), RR 0.88 (0.66-1.16), P=.36. FPG-only events/denominators, exact definition/testing/hierarchy, cluster/missingness handling and actual population correspondence are unverified. Shared clusters, people/groups, times/definitions, reports/registrations and sibling sheets are not new independent trials/participants. Report/material slot counts are not totals of unique clinical trials, participants or independent replications; no new totals or independence certification are made." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }