{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Multicomponent digital weight management × Mean weight loss at 12 months",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "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."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected mean-weight claim and original grade",
      "needed": "Distinction between original wording/grade, parent score/axes and responder outcomes",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between original wording/grade, parent score/axes 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 distinction between original wording/grade, parent score/axes and responder outcomes 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 study specifying mean change and responder endpoints separately; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Population, obesity and comorbidities",
      "needed": "Actual eligibility, recruitment, baseline weight/conditions and applicable population",
      "role": "Required",
      "role_reason": "An applied item distinguishing actual eligibility, recruitment, baseline weight/conditions and applicable population 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 eligibility, recruitment, baseline weight/conditions and applicable population 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": "Proposed follow-up comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Attribution within multicomponent Track",
      "needed": "Distinction between the bundled program and effects of individual components",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between the bundled program and effects of individual 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 distinction between the bundled program and effects of individual 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 attribution to a bundle, single components and combinations; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "App and algorithm roles",
      "needed": "Actual study identity of app-based goal self-monitoring and tailored feedback",
      "role": "Required",
      "role_reason": "An applied item distinguishing actual study identity of app-based goal self-monitoring and tailored feedback 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 study identity of app-based goal self-monitoring and tailored feedback 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 study distinguishing the app component from counseling and other elements; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Smart-scale self-monitoring",
      "needed": "Distinction between the connected scale’s intervention role and outcome measurement",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between the connected scale’s intervention role and outcome measurement 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 connected scale’s intervention role and outcome measurement 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 labeling and test adaptation are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; 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 reporting intervention self-monitoring separately from endpoint measurement; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "18 dietitian calls",
      "needed": "Distinction between counseling plans, actual delivery/use and other contacts",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between counseling plans, actual delivery/use and other contacts 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 counseling plans, actual delivery/use and other contacts 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 study distinguishing counseling delivery, actual use and component attribution; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Clinician counseling and record integration",
      "needed": "Research scope of electronic-record recommendations, clinician counseling and concurrent management",
      "role": "Required",
      "role_reason": "An applied item distinguishing research scope of electronic-record recommendations, clinician counseling and concurrent management 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 research scope of electronic-record recommendations, clinician counseling and concurrent management 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 study distinguishing attribution to clinical integration and other elements; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Usual-care comparison conditions",
      "needed": "Actual usual-care management/contact and differences between intervention and control",
      "role": "Required",
      "role_reason": "An applied item distinguishing actual usual-care management/contact and differences between intervention and control 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 usual-care management/contact and differences between intervention and control 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 trial clearly disclosing actual comparison conditions; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "12-month time point and actual exposure",
      "needed": "Distinction between final 12-month analysis and intervention duration/use",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between final 12-month analysis and intervention duration/use 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 final 12-month analysis and intervention duration/use must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study distinguishing the final time point from continuation/discontinuation follow-up; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Random sequence and allocation concealment",
      "needed": "Original allocation-procedure narrative and scope of actual source verification",
      "role": "Required",
      "role_reason": "An applied item distinguishing original allocation-procedure narrative and scope of actual source verification 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 allocation-procedure narrative and scope of actual source verification 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."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Masked outcome assessors and unmasked participants",
      "needed": "Distinction between assessor masking and intervention characteristics",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between assessor masking and intervention characteristics 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 assessor masking and intervention characteristics 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 assessor masking from participant expectation effects; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Standardized measurements and weight-change definition",
      "needed": "Visit measurements, change from baseline, units and measurement windows",
      "role": "Required",
      "role_reason": "An applied item distinguishing visit measurements, change from baseline, units and measurement windows 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 visit measurements, change from baseline, units and measurement windows 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 reporting measured outcomes separately from remote self-monitoring; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Group-specific mean changes and CIs",
      "needed": "Separate estimands for changes within each group and the between-group effect",
      "role": "Required",
      "role_reason": "An applied item distinguishing separate estimands for changes within each group and the between-group effect 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 estimands for changes within each group and the between-group effect 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 study reporting group changes and the between-group estimate distinctly together; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Between-group difference of −3.8 kg",
      "needed": "Exact original 12-month between-group difference, CI and P value",
      "role": "Required",
      "role_reason": "An applied item distinguishing exact original 12-month between-group difference, CI and P value 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 exact original 12-month between-group difference, CI and P value 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; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's 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 disclosing the primary effect estimate and uncertainty; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Mean, individual response and the 5% threshold",
      "needed": "Distinction between continuous mean change and the secondary responder endpoint",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between continuous mean change and the secondary responder endpoint 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 mean change and the secondary responder endpoint 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 Table 8.2.a, M04 §4.6.3; custom application; M15 §15.3.1–15.3.3; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up trial distinguishing mean and prespecified responder outcomes; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "351 participants, 176/175 and denominators",
      "needed": "Randomized population and endpoint-specific analysis/measurement denominators",
      "role": "Required",
      "role_reason": "An applied item distinguishing randomized population and endpoint-specific analysis/measurement denominators 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 population and endpoint-specific analysis/measurement denominators 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 distinguishing randomized, observed and estimated denominators; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "ITT principle and estimand population",
      "needed": "ITT narrative and outcome-specific analysis conditions",
      "role": "Required",
      "role_reason": "An applied item distinguishing iTT narrative and outcome-specific analysis 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 iTT narrative and outcome-specific analysis 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; 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": "A proposed study disclosing ITT separately from other analyses; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Missing data and maximum-likelihood model",
      "needed": "Distinction between missing-data narratives, missingness/attrition and model assumptions",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between missing-data narratives, missingness/attrition and model assumptions 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 missing-data narratives, missingness/attrition and model assumptions 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 distinguishing observations from estimates when reporting missing-data effects; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Registration and prespecified primary endpoint",
      "needed": "Preserved scope of the NCT identifier, advance dates and endpoint plan",
      "role": "Required",
      "role_reason": "An applied item distinguishing preserved scope of the NCT identifier, advance dates and endpoint plan 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 preserved scope of the NCT identifier, advance dates and endpoint plan 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 advance plans and actual primary analysis; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Multiple outcomes, time points and hierarchy",
      "needed": "Advance hierarchy of the primary mean endpoint, responders and other outcomes",
      "role": "Required",
      "role_reason": "An applied item distinguishing advance hierarchy of the primary mean endpoint, responders and other 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 advance hierarchy of the primary mean endpoint, responders and other outcomes 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; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M03 §3.2.4; custom extension boundary",
      "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 secondary results; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Concurrent management, medication and lifestyle",
      "needed": "Group-specific effects of conditions/medication, diet/activity and clinical contact",
      "role": "Required",
      "role_reason": "An applied item distinguishing group-specific effects of conditions/medication, diet/activity and clinical contact 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 effects of conditions/medication, diet/activity and clinical contact 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 intervention components; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Weight, clinical events and importance",
      "needed": "Distinction between weight change, clinical events and success/importance criteria",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between weight change, clinical events and success/importance criteria 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 weight change, clinical events and success/importance criteria 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's own application; M03 §3.2.4; Chamgap's own limits on extension",
      "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 weight from clinical outcomes important to patients; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "NIH public funding",
      "needed": "Distinction between actual funder/grant and other support categories",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between actual funder/grant and other support categories 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 actual funder/grant and other support categories 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": "A proposed follow-up trial disclosing support roles; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Commercial, scale, analysis/writing/publication support",
      "needed": "Scope of category-specific non-reporting in the pivotal paper",
      "role": "Required",
      "role_reason": "An applied item distinguishing scope of category-specific non-reporting in the pivotal paper 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 category-specific non-reporting in the pivotal paper 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 separately; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Later author relationships and historical attribution",
      "needed": "Timing, individuals and relation of later disclosures to the original trial",
      "role": "Required",
      "role_reason": "An applied item distinguishing timing, individuals and relation of later disclosures to the original trial 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 timing, individuals and relation of later disclosures to the original trial 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 reporting support and author relationships separately by period; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Other low-intensity null trials and applicability differences",
      "needed": "Distinction between references to null programs and direct Track comparisons",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between references to null programs and direct Track comparisons 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 references to null programs and direct Track comparisons 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 follow-up study matching composition and intensity for comparison; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Same report, sibling sheets and independent replication",
      "needed": "Report-to-trial-to-group/time-point/denominator relationships",
      "role": "Required",
      "role_reason": "An applied item distinguishing report-to-trial-to-group/time-point/denominator 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 report-to-trial-to-group/time-point/denominator 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 of the same bundle/endpoint; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Persistence and generalization across products/populations",
      "needed": "12-month bundle results versus later effects or other programs",
      "role": "Required",
      "role_reason": "An applied item distinguishing 12-month bundle results versus later effects or other 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 12-month bundle results versus later effects or other programs 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/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4; internal extension boundaries",
      "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 applicability by bundle, population and duration; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Original safety record and reporting gaps",
      "needed": "Prespecification, collection and group-specific denominators/follow-up for adverse events",
      "role": "Supplementary",
      "role_reason": "An applied item distinguishing prespecification, collection and group-specific denominators/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 and group-specific denominators/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 study specifying harm collection and population-specific follow-up; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Parent/subclaim, Korean/English, dates and history",
      "needed": "Separation of original values/axes from corrections and historical verification narratives",
      "role": "Required",
      "role_reason": "An applied item distinguishing separation of original values/axes from corrections and historical 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 separation of original values/axes from corrections and historical 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": "A proposed study distinguishing original values/history from the applicability of later updates; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Actual summary reading and external links",
      "needed": "Reading the preserved JSON versus access to external originals, registration, plans and COI",
      "role": "Required",
      "role_reason": "An applied item distinguishing reading the preserved JSON versus access to external originals, registration, plans and COI 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 reading the preserved JSON versus access to external originals, registration, plans and COI 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 follow-up study updating acquisition, timing and scope separately; no new investigation, calculation or trial was performed."
    }
  ]
}