{ "schema_version": "chamgap-public-criteria-1.0", "title": "Low-free-sugar diet × Long-term liver-disease events: the gap beyond eight-week MRI", "language": "en", "translation_date": "2026-10-15", "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing long-term liver-disease claim is being presented?", "needed": "Separation of selected subclaim wording and grade from the parent surrogate outcome", "role": "Required", "role_reason": "This connects Separation of selected subclaim wording and grade from the parent surrogate outcome with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Separation of selected subclaim wording and grade from the parent surrogate outcome together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Materials directly providing long-term event definitions, comparisons, duration and denominators, and review of the claim boundary. Parent scores are not inserted as subclaim scores. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Were long-term liver-disease events measured directly?", "needed": "Directness of surrogate and clinical liver-disease outcomes", "role": "Required", "role_reason": "This connects Directness of surrogate and clinical liver-disease outcomes with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Directness of surrogate and clinical liver-disease outcomes together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Direct material with prespecified definitions and ascertainment methods for each clinical liver-disease event, actual event counts, group denominators, follow-up duration, comparative effects and CIs. No search or calculation is conducted here. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Which adolescents contributed the short-term findings?", "needed": "Distinction between the original population and populations for long-term application", "role": "Required", "role_reason": "This connects Distinction between the original population and populations for long-term application with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Distinction between the original population and populations for long-term application together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Complete eligibility and exclusion criteria, disease severity, comorbidities and direct long-term results by population. MRI-PDFF criteria and histological diagnosis are not converted into long-term events. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Was the trial intervention simple advice to restrict sugar?", "needed": "The actual intervention including household food provision", "role": "Required", "role_reason": "This connects The actual intervention including household food provision with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning The actual intervention including household food provision together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What were the actual comparator and concurrent changes?", "needed": "Distinction between usual diet, the food environment and weight", "role": "Required", "role_reason": "This connects Distinction between usual diet, the food environment and weight with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Distinction between usual diet, the food environment and weight together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Data on actual food and intake, contact, weight, concurrent behavior or treatment and adherence in both groups, and the effect of interest. Long-term events in the comparator group were not measured directly. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are eight-week results distinguished from long-term follow-up?", "needed": "The intervention endpoint and event observation period", "role": "Required", "role_reason": "This connects The intervention endpoint and event observation period with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning The intervention endpoint and event observation period together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Actual post-treatment follow-up plans and completion, event ascertainment, observation time, attrition and clinical results. Eight weeks is not repurposed as a long-term follow-up denominator. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is the short-term participant denominator also the long-term event denominator?", "needed": "Allocation, completion, endpoint-specific analysis and long-term follow-up denominators", "role": "Required", "role_reason": "This connects Allocation, completion, endpoint-specific analysis and long-term follow-up denominators with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Allocation, completion, endpoint-specific analysis and long-term follow-up denominators together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Group-specific long-term populations at risk, event-specific analysis denominators, follow-up losses and reasons, and analysis populations. No new attrition counts, rates or person-years are calculated. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which question do the MRI-PDFF effect numbers address?", "needed": "Original adjusted between-group MRI-PDFF difference, CI and P value", "role": "Required", "role_reason": "This connects Original adjusted between-group MRI-PDFF difference, CI and P value with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Original adjusted between-group MRI-PDFF difference, CI and P value together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Separate effect estimates, CIs, follow-up and denominators for long-term clinical events. MRI percentage points are not converted into event risk or long-term treatment benefits. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are within-group changes separated from the adjusted between-group difference?", "needed": "Original group MRI values and the comparative estimate", "role": "Required", "role_reason": "This connects Original group MRI values and the comparative estimate with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Original group MRI values and the comparative estimate together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are MRI, histological diagnosis and other liver markers the same outcome?", "needed": "Distinction between diagnosis, imaging surrogates and clinical outcomes", "role": "Required", "role_reason": "This connects Distinction between diagnosis, imaging surrogates and clinical outcomes with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Distinction between diagnosis, imaging surrogates and clinical outcomes together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Original material is needed to establish the actual measurements, time points and material-specific findings for histological follow-up and tests or imaging other than MRI. Unread material is not declared unreported. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Was the prespecified primary endpoint a long-term event?", "needed": "Distinction between the prespecified MRI endpoint and long-term event plans", "role": "Required", "role_reason": "This connects Distinction between the prespecified MRI endpoint and long-term event plans with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Distinction between the prespecified MRI endpoint and long-term event plans together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Endpoint definitions, time points and hierarchy in the original registration, protocol and SAP, and separate plans and findings for long-term event research. External material remains unread. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Does the weight-adjusted sensitivity result establish long-term event benefits?", "needed": "Scope of weight change and sensitivity analysis", "role": "Required", "role_reason": "This connects Scope of weight change and sensitivity analysis with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Scope of weight change and sensitivity analysis together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Weight-adjusted models, estimates, uncertainty, covariate timing and direct comparative long-term event data. Adjustment wording does not certify that all confounding or concurrent changes were resolved. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "At which stage was masking applied?", "needed": "Open-label intervention and masked MRI assessment", "role": "Required", "role_reason": "This connects Open-label intervention and masked MRI assessment with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Open-label intervention and masked MRI assessment together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Original material on allocation concealment, MRI assessment, departures during the open-label intervention, assessment procedures and long-term event adjudication. No formal RoB assessment is produced. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Have intervention intensity and population boundaries been lost?", "needed": "Application limited to the household food environment and adolescent boys", "role": "Required", "role_reason": "This connects Application limited to the household food environment and adolescent boys with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Application limited to the household food environment and adolescent boys together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Direct comparisons by population, implementation intensity and sustainability, and long-term clinical outcomes. No diet, child or adolescent care or treatment-replacement instructions are provided. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N15", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What does the short-term adverse-event wording delimit?", "needed": "Study-related adverse events and long-term safety during growth", "role": "Supplementary", "role_reason": "This connects Study-related adverse events and long-term safety during growth with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original material concerning Study-related adverse events and long-term safety during growth together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Adverse-event collection, group harm denominators and observation, event definitions, relatedness and discontinuation, and long-term follow-up during growth. No new harm counts, rates or management instructions are produced. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Stored summary and access status of external material", "role": "Required", "role_reason": "This is needed to connect stored summary and access status of external material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on stored summary and access status of external material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What does the registration number establish?", "needed": "Registration identifier in references and evidence versus actual registration reading", "role": "Required", "role_reason": "This connects Registration identifier in references and evidence versus actual registration reading with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on registration identifier in references and evidence versus actual registration reading, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Were the protocol and SAP acquired?", "needed": "Separate entries for prespecified plans, amendments and analysis material", "role": "Required", "role_reason": "This connects Separate entries for prespecified plans, amendments and analysis material with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on separate entries for prespecified plans, amendments and analysis material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are funding, support, authors and research involvement separated?", "needed": "Four categories of company involvement versus public and academic support", "role": "Required", "role_reason": "This connects Four categories of company involvement versus public and academic support with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on four categories of company involvement versus public and academic support, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are unmeasured outcomes, unverified details and null results distinguished?", "needed": "Reasons for question-specific result and access statuses", "role": "Required", "role_reason": "This is needed to connect reasons for question-specific result and access statuses with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on reasons for question-specific result and access statuses, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are reports, trials, people, measurements and related sheets separated?", "needed": "Reference linkage and meaning without double counting", "role": "Required", "role_reason": "This is needed to connect reference linkage and meaning without double counting with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on reference linkage and meaning without double counting, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is there evidence of separate independent replication?", "needed": "Report identity versus independent confirmation", "role": "Supplementary", "role_reason": "This is needed to connect report identity versus independent confirmation with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on report identity versus independent confirmation, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are subclaim grades separated from parent scores and axes?", "needed": "Selected-record absences versus the parent verdict", "role": "Required", "role_reason": "This is needed to connect selected-record absences versus the parent verdict with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on selected-record absences versus the parent verdict, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are Korean, English and classification scopes preserved as the same original record?", "needed": "Original Korean and English texts and structured fields", "role": "Required", "role_reason": "This connects Original Korean and English texts and structured fields with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on original Korean and English texts and structured fields, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are reference dates, corrections and historical verification separated?", "needed": "Original reference date versus creation and application times", "role": "Required", "role_reason": "This is needed to connect original reference date versus creation and application times with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on original reference date versus creation and application times, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What material would directly fill this gap?", "needed": "Question-specific direct comparisons, follow-up and denominator material", "role": "Supplementary", "role_reason": "This is needed to connect question-specific direct comparisons, follow-up and denominator material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on question-specific direct comparisons, follow-up and denominator material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Materials needed: Prespecified long-term liver-disease event definitions, actual observations and group denominators, follow-up and attrition, comparative effects and CIs, and long-term adolescent safety data. Only material requests and research needs are recorded; no search or research is conducted in this work." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is production separated from content review and implementation advice?", "needed": "Production request and responsibility for review of existing content", "role": "Supplementary", "role_reason": "This is needed to connect production request and responsibility for review of existing content with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.", "criterion": "Present original data on production request and responsibility for review of existing content, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed. Only the need for material or research is recorded; no new retrieval or research is performed." } ] }