{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2976-s1", "verdict_number": "2976", "title": "Multicomponent digital weight management × At least 5% weight loss", "view_version": "1.0", "view_created_date": "2026-10-14", "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": "351 adults aged 21–65 with obesity at US community health centers, with at least one of hypertension, diabetes or hyperlipidemia. Original randomized denominators: 176 intervention/175 usual care. Detailed eligibility, baseline weight/conditions, visit-specific observations/analyses and attrition/missingness remain unverified.", "intervention": "Multicomponent Track: app-based goal self-monitoring, algorithm-tailored feedback, daily cellular smart-scale weighing, 18 dietitian calls and clinician counseling based on electronic-record recommendations. Stand-alone app/scale/counseling effects cannot be separated. Only the research composition is preserved; no implementation instructions or recommendations are created.", "dose": "Only original planned elements such as 18 counseling calls and daily self-monitoring, and the 12-month evaluation, are preserved. Actual component-specific delivery/use, cumulative contacts, adherence and discontinuation remain unverified; completion by all participants is not assumed.", "comparator": "Parallel comparison with usual care. Actual control management, contact/support, use of other programs, concurrent medication/condition/lifestyle management and crossover use remain unverified. Usual care is not converted into no intervention or contact.", "endpoint": "At least 5% weight loss in 40% versus 17%, P<0.001, is a secondary responder result. Reference values/measurements for threshold calculation, exact denominators/events, proportion models, CIs and missing-data handling remain unverified. Attainment rates or event counts are not calculated from primary mean change or the between-group difference, and 5% is not upgraded into a prespecified success threshold or reduced clinical events.", "duration": "Study context for 12-month weight/responder outcomes. Visit windows, changes by time point, continuation/discontinuation beyond 12 months and long-term clinical/harm follow-up remain unverified.", "excluded_extensions": [ "Newly subtracting group-specific −4.0/−0.1 kg to recalculate the original between-group difference of −3.8 kg and CI", "Calculating 5% attainment rates, responder events/denominators or individual outcomes from continuous mean change", "Applying 176/175 to 40%/17% to calculate event counts or new differences/RR/OR/NNT/CIs", "Automatically substituting daily smart-scale/app entries for standardized visit measurements or actual adjudication values for secondary proportions", "Repurposing general ITT/prespecified maximum-likelihood narratives as complete verification of responder missingness/denominator rules", "Upgrading the secondary 5% endpoint into a primary endpoint, prespecified success threshold, validated minimum clinically important difference or reductions in blood pressure/glucose/disease events", "Repurposing the app/smart-scale/counseling bundle result as effects of a stand-alone app, individual components or all products/populations", "Using 351 participants, 176/175, groups, time points, components, bibliography/registration or sibling sheets as new independent trial/participant totals", "Judging non-reporting of pivotal-trial support as actual absence, or retrospectively confirming later WW/Coeus disclosures as original-trial relationships", "Creating unlinked low-intensity null trials or later disclosures as new reports, direct refutations or independent replications", "Inheriting original parent values, axes and historical verification as a subclaim score or current content review/registration/original-source reading", "New calculations, invented quantities, effects/CIs, grades, independence certification, app/product recommendations or weight/diet/exercise/weight-loss/treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected 5% claim and original grade", "needed": "Distinction between the original responder question/grade and the parent mean-weight verdict", "role": "Required", "role_reason": "An applied item distinguishing distinction between the original responder question/grade and the parent mean-weight verdict to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between the original responder question/grade and the parent mean-weight verdict must be available and unverified matters distinguishable. 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": "A proposed follow-up comparison specifying the responder question and hierarchy; 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 selected subclaim is “At least 5% weight loss,” with grade C and a note of a secondary responder result of 40% versus 17%. Subclaim score/status/axes are absent; parent C56 is not used to fill the subclaim score.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score, status and axes are absent. The primary mean endpoint and secondary responder endpoint are not combined. Existing content review remains incomplete.", "missingness": "Subclaim score, status and axes are absent. The primary mean endpoint and secondary responder endpoint are not combined.", "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 selected subclaim and parent verdict, and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Definition of the 5% threshold", "needed": "Threshold, reference weight, calculation/time point and responder-adjudication rules", "role": "Required", "role_reason": "An applied item distinguishing threshold, reference weight, calculation/time point and responder-adjudication rules to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for threshold, reference weight, calculation/time point and responder-adjudication rules must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M04 §4.6.3; 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": "A proposed follow-up study specifying thresholds, measurement and time points; 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 question concerns attaining the threshold of at least 5% weight loss. This is not converted into mean change in kg, individual final weight or change in every participant.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Reference weight/calculation formula, rounding/boundaries, evaluation windows, measurement selection and details of advance definitions remain unverified. Existing content review remains incomplete.", "missingness": "Reference weight/calculation formula, rounding/boundaries, evaluation windows, measurement selection and details of advance definitions 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": "Responder definitions, baseline/final measurements and adjudication rules" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "40% versus 17% and P value", "needed": "Distinction between original proportions, group correspondence, P value and new arithmetic", "role": "Required", "role_reason": "An applied item distinguishing distinction between original proportions, group correspondence, P value and new arithmetic to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between original proportions, group correspondence, P value and new arithmetic must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; CHAMGAP adaptation; 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", "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 proposed study reporting proportions together with uncertainty and denominators; 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 result was at least 5% weight loss in 40% versus 17%, P<0.001. No new proportion difference, RR/OR, NNT, CI or event count is calculated.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Analysis denominators/event counts for each proportion, exact test/model, CI and distinction between observed/estimated values remain unverified. Existing content review remains incomplete.", "missingness": "Analysis denominators/event counts for each proportion, exact test/model, CI and distinction between observed/estimated values 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": "Responder-result tables and original denominator/event/effect/CI data" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Responder denominators and event counts", "needed": "Randomized, observed and model denominators and actual responder counts", "role": "Required", "role_reason": "An applied item distinguishing randomized, observed and model denominators and actual responder counts to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for randomized, observed and model denominators and actual responder counts must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; 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": "A proposed study reporting enrolled, observed and estimated denominators separately; 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": "351 randomized participants (176/175) describe the original population. These are not multiplied by 40%/17% to create event counts or used to fill the effective denominator of each proportion.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Effective denominators for each proportion, responder counts, inclusion/exclusion and measured/estimated criteria remain unverified. Existing content review remains incomplete.", "missingness": "Effective denominators for each proportion, responder counts, inclusion/exclusion and measured/estimated criteria 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": "Responder denominators/events, participant flow and analysis-population data" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Proportion effects, CIs and precision", "needed": "Original proportions, prespecified effect measures, CIs and clinical importance", "role": "Required", "role_reason": "An applied item distinguishing original proportions, prespecified effect measures, CIs and clinical importance to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for original proportions, prespecified effect measures, CIs and clinical importance must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 Table 8.2.a, M04 §4.6.3; 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": "A proposed follow-up study disclosing effect measures and uncertainty; 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 proportions and P value are preserved. Proportion differences, relative effects, CIs or individual success probabilities unlinked in the manuscript are not newly created.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Planned effect measures, exact estimates, CIs and importance/success criteria remain unverified. Existing content review remains incomplete.", "missingness": "Planned effect measures, exact estimates, CIs and importance/success criteria 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": "Original proportion-effect/CI data and prespecified importance criteria" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Mean change is a different endpoint", "needed": "Distinction between continuous means and threshold-attainment distributions/proportions", "role": "Required", "role_reason": "An applied item distinguishing distinction between continuous means and threshold-attainment distributions/proportions to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between continuous means and threshold-attainment distributions/proportions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own 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 proposed follow-up trial distinguishing mean and responder endpoints; 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": "Mean change of −4.0 kg versus −0.1 kg and a between-group difference of −3.8 kg (95% CI −5.0 to −2.5), P<0.001, form a separate primary endpoint. The 5% proportions, event counts or individual weight loss are not calculated from these.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Individual baseline/change distributions and data linking mean and responder outcomes remain unverified. Existing content review remains incomplete.", "missingness": "Individual baseline/change distributions and data linking mean and responder outcomes 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": "Individual/group distributions and results for each endpoint" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Secondary endpoint and prespecified hierarchy", "needed": "Distinction between the primary mean endpoint and secondary 5% responder result", "role": "Required", "role_reason": "An applied item distinguishing distinction between the primary mean endpoint and secondary 5% responder result to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between the primary mean endpoint and secondary 5% responder result must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an 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": "A proposed study distinguishing the primary endpoint from prespecified responder analyses; 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 manuscript identifies at least 5% weight loss as a secondary responder result. This is not upgraded into a new primary endpoint, independent confirmatory trial or prespecified success threshold.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Pre-recruitment specification of responder definitions/analyses, test order, change history and estimation models remain unverified. Existing content review remains incomplete.", "missingness": "Pre-recruitment specification of responder definitions/analyses, test order, change history and estimation models 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": "Responder hierarchy/plans in registration, protocol and SAP" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Measured weight and responder-adjudication values", "needed": "Correspondence between visit weight, self-monitoring/self-report and proportion calculations", "role": "Required", "role_reason": "An applied item distinguishing correspondence between visit weight, self-monitoring/self-report and proportion calculations to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for correspondence between visit weight, self-monitoring/self-report and proportion calculations must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; 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": "A proposed study linking measured/remote measurements with responder calculations; 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": "Primary weight change used standardized measurement at research visits. This is distinguished from daily smart-scale/app entries and self-report; actual values/visit rules used for the 5% proportions are not filled in.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Measurement sources, evaluation windows, equipment/conditions and valid baseline/final values for responder adjudication remain unverified. Existing content review remains incomplete.", "missingness": "Measurement sources, evaluation windows, equipment/conditions and valid baseline/final values for responder adjudication 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": "Responder adjudication/measurement protocols and original weight data" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Population, comorbidities and recruitment", "needed": "Obese population aged 21–65 with baseline conditions and applicability scope", "role": "Required", "role_reason": "An applied item distinguishing obese population aged 21–65 with baseline conditions and applicability scope to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for obese population aged 21–65 with baseline conditions and applicability scope must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details 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": "A proposed follow-up study specifying applicability by population; 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": "351 people aged 21–65 at community health centers had obesity and at least one of hypertension, diabetes or hyperlipidemia. This is not extended into the probability of attaining 5% loss in other populations.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, baseline weight/condition distributions, recruitment/exclusions and group balance remain unverified. Existing content review remains incomplete.", "missingness": "Detailed eligibility, baseline weight/condition distributions, recruitment/exclusions and group balance 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": "Eligibility, baseline-characteristics and recruitment tables" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Attribution within multicomponent Track", "needed": "The full bundle versus individual effects of app/counseling and other components", "role": "Required", "role_reason": "An applied item distinguishing the full bundle versus individual effects of app/counseling and other components to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for the full bundle versus individual effects of app/counseling and other components must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "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 proposed follow-up comparison distinguishing bundle and component attribution; 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 intervention bundled an app, cellular smart scale, 18 dietitian calls and clinician counseling. The proportion attaining 5% loss is not converted into an effect of a stand-alone app or a specific component.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Independent component effects, component-separation/combination designs and contributions of actual use remain unverified. Existing content review remains incomplete.", "missingness": "Independent component effects, component-separation/combination designs and contributions of actual use 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": "Full intervention composition, delivery/use and component-separation designs" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Component plans and actual use", "needed": "Delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration", "role": "Required", "role_reason": "An applied item distinguishing delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own 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 proposed follow-up study distinguishing plans from actual exposure and response; 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 manuscript records app self-monitoring/tailored feedback, daily cellular-scale weighing, 18 calls and counseling based on electronic-record recommendations. Plans are not used to imply actual completion by every participant.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Component-specific delivery/usage, adherence, discontinuation, contact intensity and differences in clinical/concurrent management remain unverified. Existing content review remains incomplete.", "missingness": "Component-specific delivery/usage, adherence, discontinuation, contact intensity and differences in clinical/concurrent management 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": "Delivery, use and contact records for the app/device/counseling/clinical care" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Usual-care control", "needed": "Actual control management, contact and additional-exposure conditions", "role": "Required", "role_reason": "An applied item distinguishing actual control management, contact and additional-exposure conditions to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for actual control management, contact and additional-exposure conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "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": "Proposed follow-up trial disclosing actual comparison conditions; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The comparison involved 176 intervention participants versus 175 receiving usual care. Usual care is not described as no management/contact, and equal support in all respects is not established.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Control content, contact/support, additional programs, crossover use and baseline-condition management remain unverified. Existing content review remains incomplete.", "missingness": "Control content, contact/support, additional programs, crossover use and baseline-condition management 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": "Usual-care and concurrent-exposure/contact records" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "12-month assessment, maintenance and regain", "needed": "Distinction between the selected responder time point and persistence during or beyond follow-up", "role": "Required", "role_reason": "An applied item distinguishing distinction between the selected responder time point and persistence during or beyond follow-up to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between the selected responder time point and persistence during or beyond follow-up must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "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 proposed study reporting threshold attainment separately from maintenance/regain; 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 responder result in the 12-month study context is preserved. Attaining the threshold once during follow-up, sustained attainment and maintenance/regain beyond 12 months are not made into the same outcome.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Exact evaluation windows, earlier responses, maintained attainment/regain and long-term/discontinuation follow-up remain unverified. Existing content review remains incomplete.", "missingness": "Exact evaluation windows, earlier responses, maintained attainment/regain and long-term/discontinuation follow-up 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": "Responder visit/time-point definitions and long-term follow-up materials" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Randomization and allocation concealment", "needed": "Historical allocation-procedure narrative and current access to originals", "role": "Required", "role_reason": "An applied item distinguishing historical allocation-procedure narrative and current access to originals to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for historical allocation-procedure narrative and current access to originals must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications 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": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The manuscript records sequence generation by a statistician and concealment from study staff before allocation. It is not described as current original-source review or verification of allocation records.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Allocation records, implementation/exceptions, baseline balance and correspondence with the original protocol remain unread. Existing content review remains incomplete.", "missingness": "Allocation records, implementation/exceptions, baseline balance and correspondence with the original protocol remain 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 allocation/concealment, baseline and protocol materials" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Assessor masking and participant expectations", "needed": "Scope of masking for outcome assessors and participants", "role": "Required", "role_reason": "An applied item distinguishing scope of masking for outcome assessors and participants to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for scope of masking for outcome assessors and participants must be available and unverified matters distinguishable. 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": "A proposed study distinguishing masking from participant behavior/expectation scope; 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 manuscript records masked measurement staff and unmasked participants. This is not extended into verification of every responder-calculation/analysis role or exclusion of expectation effects.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Original materials on responder-adjudication/analysis roles, maintained masking and expectation/behavior effects remain unread. Existing content review remains incomplete.", "missingness": "Original materials on responder-adjudication/analysis roles, maintained masking and expectation/behavior effects remain 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": "Masking-role materials for measurement, adjudication and analysis" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "ITT and responder-analysis population", "needed": "Overall ITT principle versus actual denominators/populations for secondary proportions", "role": "Required", "role_reason": "An applied item distinguishing overall ITT principle versus actual denominators/populations for secondary proportions to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for overall ITT principle versus actual denominators/populations for secondary proportions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "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 proposed study separately disclosing analysis populations for continuous and responder 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 manuscript’s statement of following ITT is preserved. It is not automatically transferred into details of populations/handling used for the 5% proportions or verification of observation of all participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Responder-analysis inclusion/exclusion, actual population definitions, primary/sensitivity analyses and PPS correspondence remain unverified. Existing content review remains incomplete.", "missingness": "Responder-analysis inclusion/exclusion, actual population definitions, primary/sensitivity analyses and PPS correspondence 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": "Original responder-analysis populations, ITT application and sensitivity materials" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Maximum-likelihood missing data and proportion handling", "needed": "Distinction between primary-analysis missing-data estimation and handling of unobserved responders", "role": "Required", "role_reason": "An applied item distinguishing distinction between primary-analysis missing-data estimation and handling of unobserved responders to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between primary-analysis missing-data estimation and handling of unobserved responders must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; 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": "A proposed study reporting endpoint-specific missing-data handling and effects separately; 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 manuscript’s prespecified-model maximum-likelihood estimation is preserved. This is not used as identical verification of missing-data handling or denominator rules for responder proportions.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Missing-data adjudication, imputation/estimation, nonresponse handling and model/sensitivity for the 5% result remain unverified. Existing content review remains incomplete.", "missingness": "Missing-data adjudication, imputation/estimation, nonresponse handling and model/sensitivity for the 5% result 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": "Continuous/responder missing-data handling, models and sensitivity materials" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Attrition, non-observation and missed visits", "needed": "Group-specific timing, causes and response effects of attrition/missingness", "role": "Required", "role_reason": "An applied item distinguishing group-specific timing, causes and response effects of attrition/missingness to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for group-specific timing, causes and response effects of attrition/missingness must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; 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": "A proposed follow-up study disclosing effects of non-observation and response adjudication; 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": "351 participants and 176/175 describe the randomized population. Without distinguishing observed/unobserved measurements and participant attrition, these are not used as outcomes for everyone or absence of missing-data effects.", "condition_status": "Unverified", "status_reason": "Information currently needed is unverified in the preserved summary. Visit/group-specific observed counts, attrition causes, response-related missingness and follow-up status remain unverified. Existing content review remains incomplete.", "missingness": "Visit/group-specific observed counts, attrition causes, response-related missingness and follow-up status 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": "Flow diagrams, visit/group denominators and attrition/follow-up materials" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Proportion tests, within/between groups and adjustment", "needed": "Proportion contrasts and original model, test and adjustment conditions", "role": "Required", "role_reason": "An applied item distinguishing proportion contrasts and original model, test and adjustment conditions to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for proportion contrasts and original model, test and adjustment conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; 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": "A proposed study clearly reporting proportion estimands and tests; 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 group correspondence of 40% versus 17% and P<0.001 is preserved as recorded. Within-group changes or rounded proportions are not converted into new adjusted effects or event risk ratios.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Exact tests, models/covariates, observed/estimated proportions, adjustment/advance plans and CIs remain unverified. Existing content review remains incomplete.", "missingness": "Exact tests, models/covariates, observed/estimated proportions, adjustment/advance plans and CIs 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": "Original proportion-analysis models, contrasts, adjustments and CIs" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Registration and advance responder plans", "needed": "NCT identifier and scope of advance plans for primary/secondary proportion endpoints", "role": "Required", "role_reason": "An applied item distinguishing nCT identifier and scope of advance plans for primary/secondary proportion endpoints to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for nCT identifier and scope of advance plans for primary/secondary proportion endpoints must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are 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": "A proposed study openly linking registration with actual secondary analyses; 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 NCT01827800, posting on 2013-04-10 and allocation starting on 2013-06-18 are preserved. Prospective registration and agreement with the primary 12-month mean endpoint do not substitute for verification of all 5% analysis conditions.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Secondary responder plans/definitions, pre-recruitment SAP, change history and full registration remain unread. Existing content review remains incomplete.", "missingness": "Secondary responder plans/definitions, pre-recruitment SAP, change history and full registration remain 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": "Responder plans in registration history, protocol and SAP" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Multiple outcomes, hierarchy and time points", "needed": "Multiplicity in testing responders and other time points/endpoints", "role": "Required", "role_reason": "An applied item distinguishing multiplicity in testing responders and other time points/endpoints to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for multiplicity in testing responders and other time points/endpoints must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently 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": "A proposed study separating primary endpoints from secondary proportions and other 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": "5% is a secondary outcome distinct from mean weight. Success at multiple time points, blood-pressure/glucose/other outcomes or independent replication is not newly created.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Complete lists of secondary outcomes/time points, adjustment, hierarchy and analysis/reporting changes remain unverified. Existing content review remains incomplete.", "missingness": "Complete lists of secondary outcomes/time points, adjustment, hierarchy and analysis/reporting changes 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": "Complete results, SAP and hierarchy/multiplicity materials" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Thresholds, importance and disease events", "needed": "Distinction between 5% response, advance success/importance criteria and clinical outcomes", "role": "Required", "role_reason": "An applied item distinguishing distinction between 5% response, advance success/importance criteria and clinical outcomes to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between 5% response, advance success/importance criteria and clinical outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M04 §4.6.3; 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": "A proposed follow-up study distinguishing responders from clinical 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 manuscript records no declared prespecified success threshold or externally validated minimum clinically important difference. The secondary 5% threshold is not repurposed as a trial-success boundary or reductions in blood pressure/glucose/disease events.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Evidence for threshold importance, advance success definitions and patient-important clinical/long-term outcomes remain unverified. Existing content review remains incomplete.", "missingness": "Evidence for threshold importance, advance success definitions and patient-important clinical/long-term outcomes 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": "Threshold/importance criteria and clinical-outcome/follow-up materials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Concurrent management, medication and lifestyle", "needed": "Concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes", "role": "Required", "role_reason": "An applied item distinguishing concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own 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 proposed follow-up study distinguishing concurrent management from responder 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": "This bundled trial involved baseline conditions and clinician counseling. Absence of medication/diet/activity/contact differences or effects on attaining 5% loss is not assumed.", "condition_status": "Unverified", "status_reason": "Information currently needed is unverified in the preserved summary. Group-specific concurrent management/medication changes, lifestyle, additional support and their analyses remain unverified. Existing content review remains incomplete.", "missingness": "Group-specific concurrent management/medication changes, lifestyle, additional support and their analyses 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": "Concurrent-exposure, lifestyle/condition-management and analysis materials" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "NIH public support", "needed": "Distinction between funder/grant, support roles and independence", "role": "Required", "role_reason": "An applied item distinguishing distinction between funder/grant, support roles and independence to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between funder/grant, support roles and independence must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "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": "Proposed follow-up trial disclosing support/research roles; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "NIH NIDDK R01DK093829 provided support. This is not used as absence of all commercial/author relationships or new independence certification.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Funder/researcher roles, agreements, data/publication rights and complete disclosures remain unread. Existing content review remains incomplete.", "missingness": "Funder/researcher roles, agreements, data/publication rights and complete disclosures remain 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": "Funding, support-role and agreement disclosures" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Non-reporting of support in the pivotal paper", "needed": "Category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support", "role": "Required", "role_reason": "An applied item distinguishing category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support must be available and unverified matters distinguishable. 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": "A proposed study disclosing support categories distinctly; 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 manuscript states that commercial sponsorship, donated scales, outsourced analysis, medical writing and publication-fee support were not reported in the pivotal paper. Non-reporting is not judged as actual absence of support.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Actual presence/scope of each support category, agreements, analysis/writing roles and original disclosures remain unread. Existing content review remains incomplete.", "missingness": "Actual presence/scope of each support category, agreements, analysis/writing roles and original disclosures remain 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": "Commercial/in-kind, analysis and writing/publication support disclosures" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Later author relationships and disclosure timing", "needed": "Distinction between later WW/Coeus disclosures and original-trial timing/roles", "role": "Required", "role_reason": "An applied item distinguishing distinction between later WW/Coeus disclosures and original-trial timing/roles to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between later WW/Coeus disclosures and original-trial timing/roles must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Chamgap’s custom independence/attribution conditions. The official methodology sections used in this pilot do not guarantee all these detailed items; M04 §4.5, §4.6.3; current conversion limits reflect review scope and custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is 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 proposed study distinguishing relationship/support attribution by period; 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 record places later-paper disclosures of Gary Bennett’s WW advisory role and equity in Coeus Health after the pivotal trial. Funding/COI during that trial are not retrospectively established.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Specific later bibliography, disclosure timing, relationships/agreements during the original trial and complete COI remain unlinked/unread. Existing content review remains incomplete.", "missingness": "Specific later bibliography, disclosure timing, relationships/agreements during the original trial and complete COI remain unlinked/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": "Later disclosures, dates and relationship materials with original-trial statements" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "References to null results from other programs", "needed": "Directness of Track’s bundle versus app-only/low-intensity programs", "role": "Required", "role_reason": "An applied item distinguishing directness of Track’s bundle versus app-only/low-intensity programs to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for directness of Track’s bundle versus app-only/low-intensity programs must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation 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": "A proposed direct follow-up comparison matching composition and intensity; 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": "References to null trials of app-only or low-intensity technology support limit generalization because composition/intensity differ. Those reports are not newly created or combined as direct refutations or independent replications of Track’s responder result.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Specific bibliography, populations, proportions/endpoints, denominators and results for other programs remain unlinked. Existing content review remains incomplete.", "missingness": "Specific bibliography, populations, proportions/endpoints, denominators and results for other programs remain unlinked.", "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": "Other-program originals and composition/endpoint relationships" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Same report, sibling sheets and independence", "needed": "Mean/responder, report/registration and group/time-point relationships", "role": "Required", "role_reason": "An applied item distinguishing mean/responder, report/registration and group/time-point relationships to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for mean/responder, report/registration and group/time-point relationships must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "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 proposed independent follow-up comparison specifying the same secondary threshold; 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 5% and mean sheets share the same Bennett2018 Track trial of 351 participants. Groups, time points, thresholds, bibliography/registration and sibling sheets are not added as new independent trials or participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Independent reproduction under the same bundle/responder conditions and unique clinical totals are not established. Existing content review remains incomplete.", "missingness": "Independent reproduction under the same bundle/responder conditions and unique clinical totals are not established.", "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/cohort relationships and originals of separate independent trials" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Persistence and applicability to other compositions/populations", "needed": "Distinction between Track responder results and long-term/stand-alone-app/other-population effects", "role": "Required", "role_reason": "An applied item distinguishing distinction between Track responder results and long-term/stand-alone-app/other-population effects to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for distinction between Track responder results and long-term/stand-alone-app/other-population effects must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are custom design; M03 §3.2.4; custom extension boundary; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation 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": "A proposed study distinguishing threshold attainment from persistence/applicability; 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 12-month bundled trial’s responder result is not extended to all apps/products, other populations, maintenance after stopping the intervention or disease treatment. No new recommendations or weight-loss instructions are created.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Long-term/discontinuation follow-up, other compositions/populations and direct single-component comparisons remain unverified. Existing content review remains incomplete.", "missingness": "Long-term/discontinuation follow-up, other compositions/populations and direct single-component comparisons 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": "Long-term follow-up and direct comparisons by composition/population" }, { "item_id": "N30", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Unknown safety and collection gaps", "needed": "Prespecification, collection/denominators and follow-up for adverse events", "role": "Supplementary", "role_reason": "An applied item distinguishing prespecification, collection/denominators and follow-up for adverse events to connect the selected question’s needed materials with current materials.", "application_exception": "Supplements safety-data gaps for the selected subclaim. Mean weight, 5% responder results and parent caution wording are not used to judge safety or generate harm incidence or new use instructions.", "criterion": "Corresponding original materials and analysis scope for prespecification, collection/denominators and follow-up for adverse events must be available and unverified matters distinguishable. 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": "A proposed follow-up study specifying harm collection and follow-up; 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 record states that parent safety is unknown and adverse events from a prespecified safety endpoint were not systematically presented in the pivotal paper. Attaining 5% loss is not converted into absence of harm or treatment safety.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Adverse-event collection/adjudication, group-specific types/frequencies/denominators, discontinuation and vulnerable-population/long-term harms remain unverified. Existing content review remains incomplete.", "missingness": "Adverse-event collection/adjudication, group-specific types/frequencies/denominators, discontinuation and vulnerable-population/long-term harms 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": "Safety plans, adverse events and discontinuation/long-term follow-up" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Parent/subclaim, Korean/English, corrections and history", "needed": "Separate preservation of original values/axes, reference dates and verification narratives", "role": "Required", "role_reason": "An applied item distinguishing separate preservation of original values/axes, reference dates and verification narratives to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for separate preservation of original values/axes, reference dates and verification narratives must be available and unverified matters distinguishable. 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": "Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent C56, B/S/R1/I2/E+/B0, unrecorded precision, three false flags, empty override reasons and subclaim grade C/note are preserved. Korean/English text, 2026-08-26, empty corrections/deliberation and historical cross-checking are not inherited as current review or a subclaim score.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. Absent subclaim score/status/axes are not filled with parent values, and no new certification is created. Existing content review remains incomplete.", "missingness": "Absent subclaim score/status/axes are not filled with parent values, and no new certification is 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": "Original corrections, versions and user correction comments" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Summary reading, external links and updates", "needed": "Actually read scope and access status of external materials", "role": "Required", "role_reason": "An applied item distinguishing actually read scope and access status of external materials to connect the selected question’s needed materials with current materials.", "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.", "criterion": "Corresponding original materials and analysis scope for actually read scope and access status of external materials must be available and unverified matters distinguishable. Preserved wording is linked here; 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 proposed study updating acquisition, timing and scope of materials separately; 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 full preserved JSON summary and bibliography were used for production, and links are retained. Papers, registration, protocol, SAP and original later disclosures/support materials remain unread with no access attempt; links were not tested.", "condition_status": "Partly verified", "status_reason": "Only the relevant information in the preserved summary is recorded; detailed originals remain unread and existing content review incomplete. External originals, exact responder denominators/models and actual accessibility remain unverified. Existing content review remains incomplete.", "missingness": "External originals, exact responder denominators/models and actual accessibility 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": "Originals, registration, protocol, SAP, support/COI materials or user comments" } ], "reports": [ { "report_id": "S01", "title": "Bennett GG et al. 2018 Track", "url": "https://pubmed.ncbi.nlm.nih.gov/30361140/", "report_type": "Community-health-center randomized usual-care-controlled effectiveness trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2976-TRACK-2018", "independent_replication": null, "observed_result": "−4.0 kg versus −0.1 kg; between-group difference −3.8 kg (95% CI −5.0 to −2.5), P<0.001. At least 5% weight loss was 40% versus 17%, P<0.001, but this was a secondary responder criterion rather than the primary endpoint. Null trials of app-only or low-intensity technology support are also noted; this result is limited to the Track bundle including counseling.", "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/30361140/" } ] } ], "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 Bennett2018 Track is one 12-month parallel report comparing bundled Track with usual care in 351 adults (176/175) aged 21–65 with obesity and at least one of hypertension/diabetes/hyperlipidemia at US community health centers. Individual effects of the app, cellular smart scale, 18 dietitian calls and clinician counseling cannot be separated. The two sheets share the same people/report. Standardized research-visit mean changes of −4.0 kg (95% CI −4.9 to −3.0) versus −0.1 kg (−1.0 to 0.8), and between-group difference −3.8 kg (−5.0 to −2.5), P<0.001, are primary continuous results. At least 5% weight loss, 40% versus 17%, P<0.001, is a secondary responder result; proportions or event counts are not calculated from means. Registration, ITT/maximum likelihood, public funding and later author disclosures are preserved historical narratives, not current external reading/content review. Specific bibliographies for other low-intensity null trials and later disclosures are unlinked, so no new report is created. Groups, time points, thresholds, bibliography/registration and sibling sheets are not added as new independent trials or participants; report-item counts are not unique clinical totals." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }