{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2983-s0", "verdict_number": "2983", "title": "Low-free-sugar diet × Eight-week MRI-PDFF liver-fat reduction", "view_version": "1.0", "view_created_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "40 boys aged 11 to 16 with histological NAFLD and MRI-PDFF above 10%, allocated 20/20, all completing eight weeks. Two centers belong to one trial; detailed recruitment, baseline characteristics, endpoint denominators and missing-data handling are unverified.", "intervention": "An intensive eight-week program including professional menu design, whole-household food provision and twice-weekly checks. The original free-sugar target below 3% of total energy is a study condition, not simple advice, a supplement or the isolated effect of free sugars.", "dose": "Only original household food-environment exposure targeting below 3% of energy is retained. Actual diets, energy, nutrients, household and individual exposure, activity, concurrent management and adherence are unverified. No menus, intake amounts, calorie or sugar conversions, child or adolescent diets or weight-management instructions are given.", "comparator": "Usual diet. Equivalence of household food provision, twice-weekly contact, food and contact conditions, activity and concurrent exposure is unverified.", "endpoint": "Original baseline-to-week-eight MRI-PDFF values, intervention 25% to 17% and control 21% to 20%, are retained separately from the adjusted between-group -6.23 percentage points, 95% CI -9.45 to -3.02, P<.001. About 6.2 percentage points is an original summary, not new within-group or relative arithmetic. The retained weight-adjusted sensitivity statement is not assigned the exact primary effect or CI.", "duration": "Eight weeks of food provision and imaging assessment, with complete follow-up. Post-treatment, repeated and long-term imaging, histology, clinical events and long-term restrictive-diet safety during growth are unmeasured or unlinked.", "excluded_extensions": [ "Generalizing findings in 40 boys aged 11 to 16 with histological NAFLD and MRI above 10%, allocated 20/20, to every population or other diseases", "Reducing whole-household food provision, professional design and twice-weekly checks to simple sugar advice or an isolated component effect", "New within-group or relative arithmetic from 25% to 17% and 21% to 20%, or mixing units with adjusted -6.23 percentage points and CI", "Using the retained weight-adjusted sensitivity statement as isolated free-sugar causality or assigning the same primary effect and CI", "Treating complete follow-up and no reported adverse events as established denominators for every endpoint or long-term growth and restrictive-diet safety", "Adding centers, groups, visits, registration or other adult MRS trials as independent evidence, or transferring parent C with 54 points, axes and historical verification into subclaim values", "New effects, CIs, arithmetic, grades, hypothetical figures, product intake, child or adolescent diets, liver-disease or weight management, or treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected eight-week MRI question and original grade", "needed": "Selected wording, note and grade versus the original parent verdict", "role": "Required", "role_reason": "This applied item distinguishes Selected wording, note and grade versus the original parent verdict to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Selected wording, note and grade versus the original parent verdict must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "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": "Record update events while distinguishing the MRI question from parent and long-term questions. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing record concerns eight-week MRI-PDFF liver-fat reduction, grade C and a note of a positive adjusted between-group difference of -6.23 percentage points. Subclaim score, status and axes are absent and are not filled with parent C with 54 points.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Separate subclaim score, status and axes are absent from the original material. Review of existing content remains incomplete.", "missingness": "Separate subclaim score, status and axes are absent from the original material.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected version and user feedback" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Actual age, sex, disease and recruitment", "needed": "Eligibility, histology, baseline MRI, recruitment and denominators", "role": "Required", "role_reason": "This applied item distinguishes Eligibility, histology, baseline MRI, recruitment and denominators to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Eligibility, histology, baseline MRI, recruitment and denominators must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are internally designed. M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations 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": "Propose subsequent material distinguishing diseases and populations. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text describes 40 boys aged 11 to 16 with histological NAFLD and MRI-PDFF above 10%. The scope is not extended to general adolescents, girls, adults, suspected fatty liver or other diseases.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Center-specific recruitment, biopsy and diagnostic timing, detailed eligibility and medical history, and baseline characteristics are unverified. Review of existing content remains incomplete.", "missingness": "Center-specific recruitment, biopsy and diagnostic timing, detailed eligibility and medical history, and baseline characteristics are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 recruitment, eligibility, histology, baseline MRI and characteristics tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Two centers and the randomized population", "needed": "Separation of centers, people, groups and trials", "role": "Required", "role_reason": "This applied item distinguishes Separation of centers, people, groups and trials to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Separation of centers, people, groups and trials must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinctions between studies and reports; cohort and outcome linkage is internal application; M03 §3.2.1; detailed population conditions are internally designed; M08 §8.1–8.2.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing centers from populations within the same trial. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S01 is an open-label two-center randomized food-provision trial. Two centers are not counted as new independent trials, and material from the same 40 people is not added across centers, groups or visits.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Center-specific recruitment and group mapping, baseline differences and analysis stratification are unverified. Review of existing content remains incomplete.", "missingness": "Center-specific recruitment and group mapping, baseline differences and analysis stratification are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 center-specific recruitment, allocation and analysis relationships" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Identity of whole-household food provision", "needed": "Food environment, design, provision, contact and actual exposure", "role": "Required", "role_reason": "This applied item distinguishes Food environment, design, provision, contact and actual exposure to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Food environment, design, provision, contact and actual exposure must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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": "Propose subsequent material linking the whole intervention and actual exposure. No menus or child-diet instructions are created. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The intervention was an intensive eight-week program including professional menu design, whole-household food provision and twice-weekly checks. It is not changed into simple sugar-restriction advice or the isolated effect of a supplement.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Household food-provision specifications, contact, actual food and energy changes, and individual adherence are unverified. Review of existing content remains incomplete.", "missingness": "Household food-provision specifications, contact, actual food and energy changes, and individual adherence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 menus, supply, contact and household and individual exposure records" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Free-sugar targets versus actual implementation", "needed": "Planned energy percentage, actual intake and accompanying dietary changes", "role": "Required", "role_reason": "This applied item distinguishes Planned energy percentage, actual intake and accompanying dietary changes to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Planned energy percentage, actual intake and accompanying dietary changes must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing targets from the actual whole diet. No intake or weight-management implementation instructions are given. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Free sugars below 3% of total energy were the original study target. This is not turned into individual intake, a recommended target, or calorie and sugar conversions.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Actual free-sugar distributions, total energy and nutrients, household and individual adherence, and discontinuation are unverified. Review of existing content remains incomplete.", "missingness": "Actual free-sugar distributions, total energy and nutrients, household and individual adherence, and discontinuation are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 planned and actual intake, nutrients, energy and adherence" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Actual usual-diet comparator conditions", "needed": "Control diet, household and contact, concurrent management and exposure", "role": "Required", "role_reason": "This applied item distinguishes Control diet, household and contact, concurrent management and exposure to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Control diet, household and contact, concurrent management and exposure must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.1–8.2.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing the comparator from the whole intervention. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The direct comparator was usual diet. It is not automatically treated as an active comparator with the same food environment and contact as household food provision and twice-weekly checks, or a condition differing only in free sugars.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Control-diet specifications, contact, intake, activity, management and group-specific food-provision correspondence are unverified. Review of existing content remains incomplete.", "missingness": "Control-diet specifications, contact, intake, activity, management and group-specific food-provision correspondence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 control management, household food environment and contact records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Allocation, 20/20 and concealment", "needed": "Randomization, group denominators and allocation procedures", "role": "Required", "role_reason": "This applied item distinguishes Randomization, group denominators and allocation procedures to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Randomization, group denominators and allocation procedures must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design", "condition_origin": "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": "Propose subsequent material linking allocation and actual denominators. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original states that 40 participants were allocated 1:1, 20/20, and all completed eight weeks. Design and completion information does not establish sequence generation or allocation concealment.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Sequence generation, concealment, responsible personnel, center-specific allocation and processes before and after recruitment are unverified. Review of existing content remains incomplete.", "missingness": "Sequence generation, concealment, responsible personnel, center-specific allocation and processes before and after recruitment are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 allocation methods, flow diagrams and original center-specific records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Open-label design and masked MRI assessment", "needed": "Who was blinded, and assessment and analysis conditions", "role": "Required", "role_reason": "This applied item distinguishes Who was blinded, and assessment and analysis conditions to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Who was blinded, and assessment and analysis conditions must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material separating dietary exposure from imaging-assessment conditions. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The design was open-label with masked MRI assessment. This is not extended into blinding of all participants, households, care staff and analysts, or absence of contact effects.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. MRI-masking procedures and maintenance, analyst masking, recognition of conditions, expectations and contact are unverified. Review of existing content remains incomplete.", "missingness": "MRI-masking procedures and maintenance, analyst masking, recognition of conditions, expectations and contact are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 blinding, MRI assessment, analysis and contact procedures" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "MRI-PDFF definition, measurement and week eight", "needed": "Image acquisition, fat fraction, units and visits", "role": "Required", "role_reason": "This applied item distinguishes Image acquisition, fat fraction, units and visits to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Image acquisition, fat fraction, units and visits must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "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": "Propose subsequent material disclosing measurement methods and endpoint units. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The endpoint was change in MRI-PDFF liver fat from baseline to week eight. It is not substituted with proton MRS, histology or clinical liver-disease events as the same measurement.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Acquisition equipment and protocols, regions, assessment, quality, exact examination timing and reproducibility are unverified. Review of existing content remains incomplete.", "missingness": "Acquisition equipment and protocols, regions, assessment, quality, exact examination timing and reproducibility are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 MRI-PDFF methods, assessment, quality and original tables" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Original baseline and week-eight group percentages", "needed": "Original group values, visits, denominators and distinctions between changes", "role": "Required", "role_reason": "This applied item distinguishes Original group values, visits, denominators and distinctions between changes to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Original group values, visits, denominators and distinctions between changes must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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": "Propose subsequent material separating group percentages from comparative estimands. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Liver fat of 25% to 17% in the intervention group and 21% to 20% in the control group is original wording. No new within-group change, relative reduction, adjusted between-group effect or CI is calculated from these values.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Group-specific variance, exact denominators, baseline differences, period adjustment and summarization of original values are unverified. Review of existing content remains incomplete.", "missingness": "Group-specific variance, exact denominators, baseline differences, period adjustment and summarization of original values are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original baseline and week-eight tables, summaries, denominators and models" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Adjusted between-group -6.23 percentage points, CI and P value", "needed": "Estimand, absolute percentage points, adjustment and denominators", "role": "Required", "role_reason": "This applied item distinguishes Estimand, absolute percentage points, adjustment and denominators to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Estimand, absolute percentage points, adjustment and denominators must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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; M15 §15.3.1–15.3.3; 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": "Propose subsequent material linking original reported estimands and analysis specifications. No new arithmetic or CIs are created. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The adjusted between-group difference of -6.23 percentage points (95% CI -9.45 to -3.02, P<.001) is an original report summary. Absolute percentage points are not converted into relative percentages, within-group changes or new effect sizes.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Exact primary models, adjustment variables, denominators and detailed estimand specifications are unverified. Review of existing content remains incomplete.", "missingness": "Exact primary models, adjustment variables, denominators and detailed estimand specifications are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 primary-analysis models, denominators and original result tables" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Original about 6.2 versus the exact estimate", "needed": "Narrative summary, exact values, units and direction", "role": "Required", "role_reason": "This applied item distinguishes Narrative summary, exact values, units and direction to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Narrative summary, exact values, units and direction must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow the review scope and internal design; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing exact values from summary wording. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original summary of about 6.2 percentage points and exact -6.23 percentage points and CI are retained separately. They are not turned into different trials or visits, or new rounding or calculations.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Individual effects and estimates at other visits or using other measurements are unlinked. Review of existing content remains incomplete.", "missingness": "Individual effects and estimates at other visits or using other measurements are unlinked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 exact original tables and visit-specific material" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Weight changes and additional adjustment", "needed": "Primary analysis, sensitivity analysis, weight and diet", "role": "Required", "role_reason": "This applied item distinguishes Primary analysis, sensitivity analysis, weight and diet to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Primary analysis, sensitivity analysis, weight and diet must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material separating weight changes from attribution to the whole diet. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text records greater intervention-group weight loss and a retained favorable liver-fat finding in sensitivity analysis additionally adjusting for weight change. This is not automatically used as a direct or completely independent effect of free sugars alone, or the same -6.23-percentage-point effect.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Original weight values, sensitivity estimates, CIs, P values, models, concurrent exposure and mediation relationships are unverified. Review of existing content remains incomplete.", "missingness": "Original weight values, sensitivity estimates, CIs, P values, models, concurrent exposure and mediation relationships are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original weight and diet tables, sensitivity models and findings" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Concurrent household, food-environment and activity exposure", "needed": "Household support, energy, nutrients, activity and management", "role": "Required", "role_reason": "This applied item distinguishes Household support, energy, nutrients, activity and management to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Household support, energy, nutrients, activity and management must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations 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": "Propose subsequent material linking concurrent exposure with MRI analyses. No diet or adolescent weight-management instructions are given. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The intervention changed the whole household food environment and included regular checks. It is not reduced to a trial in which only free sugars changed and other nutrients, total energy, activity and household support stayed unchanged.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Household and individual whole diets, activity, concurrent medication and management, contact and adherence are unverified. Review of existing content remains incomplete.", "missingness": "Household and individual whole diets, activity, concurrent medication and management, contact and adherence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 household and food provision, activity, concurrent management and actual-intake records" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Complete follow-up versus endpoint-specific analysis", "needed": "Completion, group and imaging denominators, missingness and analysis populations", "role": "Required", "role_reason": "This applied item distinguishes Completion, group and imaging denominators, missingness and analysis populations to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Completion, group and imaging denominators, missingness and analysis populations must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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": "Propose subsequent material distinguishing completion from actual analysis data. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original strength is that all 40 participants, 20/20, completed eight weeks. This is not extended into verification of completeness for every additional endpoint and MRI assessment, ITT or PP, or missing-data handling.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Endpoint-specific valid images and denominators, exclusions, missingness, ITT and PP, and handling reasons are unverified. Review of existing content remains incomplete.", "missingness": "Endpoint-specific valid images and denominators, exclusions, missingness, ITT and PP, and handling reasons are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 participant and imaging flow, endpoint denominators and analysis populations" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Analysis models, baseline and center, and multiplicity", "needed": "Prespecified estimands, adjustment and complete testing plans", "role": "Required", "role_reason": "This applied item distinguishes Prespecified estimands, adjustment and complete testing plans to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Prespecified estimands, adjustment and complete testing plans must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing prespecified analyses and all findings. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original records an adjusted between-group difference and a positive prespecified primary MRI finding. It is not used as verification of primary models, center and baseline adjustment, or multiplicity plans for all endpoints.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Exact models, covariates, center effects, multiplicity and sensitivity hierarchy are unverified. Review of existing content remains incomplete.", "missingness": "Exact models, covariates, center effects, multiplicity and sensitivity hierarchy are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 SAP, complete analysis tables and primary and sensitivity models" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "NCT identifier and actual registration access", "needed": "Original registration identifier, plans, dates and amendments", "role": "Required", "role_reason": "This applied item distinguishes Original registration identifier, plans, dates and amendments to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Original registration identifier, plans, dates and amendments must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect 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": "Propose subsequent material distinguishing original identifiers from actual access scope. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original evidence and citation identify NCT02513121. The identifier and historical registration verification do not indicate new reading of the original registration or verification of every prespecified condition.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Recruitment and registration dates, original protocol, SAP and amendment history are unread. Review of existing content remains incomplete.", "missingness": "Recruitment and registration dates, original protocol, SAP and amendment history are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original NCT02513121 registration, protocol, SAP and amendments" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Preservation scope of the prespecified MRI endpoint", "needed": "Primary-endpoint statement, original prespecified versions and hierarchy", "role": "Required", "role_reason": "This applied item distinguishes Primary-endpoint statement, original prespecified versions and hierarchy to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Primary-endpoint statement, original prespecified versions and hierarchy must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules 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": "Propose subsequent material distinguishing prespecification statements from original plans. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent records a prespecified primary MRI-PDFF endpoint. This is not inherited as equal hierarchy for other imaging, weight or clinical endpoints, or reading of all pre-recruitment versions.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Exact hierarchy, estimands, amendments and complete outcome specifications in prespecified versions are unverified. Review of existing content remains incomplete.", "missingness": "Exact hierarchy, estimands, amendments and complete outcome specifications in prespecified versions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 pre-recruitment protocol and SAP, registration versions and findings" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Large effects versus clinical importance", "needed": "Relevance, measured changes, and individual and clinical effects", "role": "Required", "role_reason": "This applied item distinguishes Relevance, measured changes, and individual and clinical effects to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Relevance, measured changes, and individual and clinical effects must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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": "Propose subsequent research separating imaging effects from clinical outcomes. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent's large primary MRI effect concerns a surrogate endpoint. It does not establish cure in every participant, histological improvement or reduced long-term clinical events.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Relevance criteria, individual distributions and direct correspondence with histological and clinical effects are unlinked. Review of existing content remains incomplete.", "missingness": "Relevance criteria, individual distributions and direct correspondence with histological and clinical effects are unlinked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 individual imaging and clinical findings and interpretation criteria" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Long-term liver-disease events were not measured", "needed": "Imaging surrogate, eight weeks and clinical follow-up", "role": "Required", "role_reason": "This applied item distinguishes Imaging surrogate, eight weeks and clinical follow-up to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Imaging surrogate, eight weeks and clinical follow-up must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundaries; M04 §4.5, §4.6.3; current material-conversion limits 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": "Propose subsequent research distinguishing imaging at different periods from clinical events. No treatment-replacement advice is created. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The separate long-term-event subclaim grade '?' is an original record that the eight-week surrogate-endpoint trial did not measure this outcome. The selected MRI signal is not transferred into liver-disease treatment, prevention or reduced long-term events.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Long-term clinical events, persistence and post-treatment follow-up are unlinked. Review of existing content remains incomplete.", "missingness": "Long-term clinical events, persistence and post-treatment follow-up are unlinked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct long-term imaging, histology and clinical follow-up material" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Eight weeks versus sustained or repeated intervention", "needed": "Short-term follow-up, intervention end and long-term exposure", "role": "Required", "role_reason": "This applied item distinguishes Short-term follow-up, intervention end and long-term exposure to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Short-term follow-up, intervention end and long-term exposure must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed", "condition_origin": "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": "Propose subsequent research separating questions about other periods and intervention intensities. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The study covered eight weeks of food provision and assessment. The same effect is not generalized to long-term persistence, after household supply ends, repeated programs or programs with less contact.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Post-supply MRI, repeated and long-term exposure, actual adherence and harms are unlinked. Review of existing content remains incomplete.", "missingness": "Post-supply MRI, repeated and long-term exposure, actual adherence and harms are unlinked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit-specific follow-up and material on interventions of other intensities" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Applicability to other populations and simple advice", "needed": "Direct disease-, sex-, age- and intensity-specific material", "role": "Required", "role_reason": "This applied item distinguishes Direct disease-, sex-, age- and intensity-specific material to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Direct disease-, sex-, age- and intensity-specific material must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details 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": "Propose separate material when population and intervention differ. No child or adolescent diets or liver-disease management instructions are given. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The result concerns household food provision for boys aged 11 to 16 with histological NAFLD. The same effect is not transferred to general adolescents, girls, adults, other liver diseases or simple sugar advice.", "condition_status": "Unverified", "status_reason": "Information currently required is unverified in the stored summary. Direct material for other populations and diseases, advice alone or a product alone is unlinked. Review of existing content remains incomplete.", "missingness": "Direct material for other populations and diseases, advice alone or a product alone is unlinked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate direct trials in other populations and at other intensities" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "References, centers, visits and the same cohort", "needed": "Reports, registration, two centers and repeated measurements", "role": "Required", "role_reason": "This applied item distinguishes Reports, registration, two centers and repeated measurements to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Reports, registration, two centers and repeated measurements must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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": "Propose separate research with the same MRI specifications. No independence certification or aggregation is performed. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The one Schwimmer2019 report, NCT02513121, two centers, 40 participants, 20/20, and baseline and week-eight assessments belong to the same trial. They are not combined with other liver-fat sheets or adult trials to create new independent trial or participant totals.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Separate replication with the same food-provision and population specifications and actual study-family independence are unlinked. Review of existing content remains incomplete.", "missingness": "Separate replication with the same food-provision and population specifications and actual study-family independence are unlinked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report, center and registration relationships and separate direct trials" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Funding, support, product and author roles", "needed": "Original funding roles, supply, employment and COI material", "role": "Required", "role_reason": "This applied item distinguishes Original funding roles, supply, employment and COI material to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. Do not substitute figures from other diets, trials or endpoints, or unread external material.", "criterion": "Original material and analysis scope concerning Original funding roles, supply, employment and COI material must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content 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": "Propose subsequent material distinguishing support types and roles. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Funding information records Nutrition Science Initiative plus foundation, academic and NIH support. The parent's independent-funding statement is not extended into verification of all product or food supply, employee authors or COI.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Each support role, food and free support, employee and developer authors, and original COI material are unverified. Review of existing content remains incomplete.", "missingness": "Each support role, food and free support, employee and developer authors, and original COI material are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original funding, food support, affiliations, contributions and COI material" }, { "item_id": "N25", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Scope of complete follow-up and adverse-event statements", "needed": "Harm-event collection, exposure, denominators and follow-up", "role": "Supplementary", "role_reason": "This applied item distinguishes Harm-event collection, exposure, denominators and follow-up to connect required material for the selected question with currently available material.", "application_exception": "Address safety-material gaps for the selected subclaim. Diet, isolated-component or imaging findings, or parent safety wording do not determine safety or create harm incidence rates or new use instructions.", "criterion": "Original material and analysis scope concerning Harm-event collection, exposure, denominators and follow-up must be provided, with unverified points distinguishable. Existing stored wording is linked; review of existing content remains incomplete.", "basis": "M19 §19.1.2–19.2.4; internal application. M19 §19.1.2–19.2.4; detailed distinctions are internally designed. M19 §19.2 covers design-specific harm questions; detailed temporal relationships are internally designed. M19 §19.2.2–19.2.4 and M03 §3.2.3; internal application. M19 §19.1.2–19.2.4; internal application. M19 §19.2.2–19.2.4 considers design; detailed confounding records are internally designed. M19 §19.1.2–19.2.4 and M04 §4.6.3; internal application. M19 §19.1.2–19.2.4; internal application. Interpretation boundaries are internally defined, informed by M19 principles; no official causality tool is executed.", "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": "Propose subsequent material collecting efficacy separately from safety during growth. No restrictive-diet or child-treatment instructions are created. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Parent safety Good, completion by all 40 participants and no reported study-related adverse events are original statements. They are not turned into zero total harms, absence of rare harms or long-term safety of restrictive diets during growth.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Event definitions, systematic collection, group denominators, discontinuation, nutrition, growth and long-term harms are unverified. Review of existing content remains incomplete.", "missingness": "Event definitions, systematic collection, group denominators, discontinuation, nutrition, growth and long-term harms are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 harm events, exposure, nutrition, growth, denominators and long-term material" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Original grades, axes, languages, dates and corrections", "needed": "Parent C with 54 points versus subclaim C, original values and historical judgments", "role": "Required", "role_reason": "This applied item distinguishes Parent C with 54 points versus subclaim C, original values and historical judgments to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. 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This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Historical full-text and registration cross-checking is preserved as history. Current production uses the stored summary and reference; external abstract, full text, registration, protocol, SAP and COI material are unread and access has not been attempted.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Historical verification details, current acquisition of original material, external reading and review of existing content remain incomplete. Review of existing content remains incomplete.", "missingness": "Historical verification details, current acquisition of original material, external reading and review of existing content remain incomplete.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical original versions, report-specific original texts and plans, and user feedback" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Material links, gaps and update conditions", "needed": "Links between summary reading, unread material and additional material", "role": "Required", "role_reason": "This applied item distinguishes Links between summary reading, unread material and additional material to connect required material for the selected question with currently available material.", "application_exception": "Stay within the stored-summary scope of the selected diet, population, endpoint and duration. 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M04 §4.5 and §4.6.3; current evidence-conversion limits reflect 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": "If additional material is provided, record its original form and actual access scope when updating content. This is a proposal; no new investigation, calculation or trial has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Paper links and original records are retained; actual reading is recorded as summary read or unread. A URL or NCT identifier alone does not raise acquisition or reading status, and no separate external-link operation test was performed.", "condition_status": "Partly verified", "status_reason": "Only corresponding stored-summary information is recorded. Detailed original material is unread and review of existing content remains incomplete. Acquisition of original texts, external reading, link verification and review of existing content remain incomplete. Review of existing content remains incomplete.", "missingness": "Acquisition of original texts, external reading, link verification and review of existing content remain incomplete.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific original texts, registration, plans and support material, and user feedback" } ], "reports": [ { "report_id": "S01", "title": "Schwimmer JB et al. 2019", "url": "https://pubmed.ncbi.nlm.nih.gov/30667502/", "report_type": "Open-label two-center randomized food-provision trial with masked MRI assessment", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2983-SCHWIMMER-2019", "independent_replication": null, "observed_result": "Adjusted between-group difference -6.23 percentage points (95% CI -9.45 to -3.02), P<.001", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Only stored-summary and bibliographic content was used for production. 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URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/30667502/" } ] } ], "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. 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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. 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Original group percentages of 25% to 17% versus 21% to 20% differ from adjusted -6.23 percentage points, CI -9.45 to -3.02, P<.001. Favorable weight-adjusted sensitivity findings are an original statement and are not assigned the same primary effect or CI. Complete follow-up and no reported study-related adverse events are not generalized into long-term growth or restrictive-diet safety. Groups, visits, centers, registration, other sheets and people in one report are not added as unique trial, participant or independent-replication totals. No new calculations, judgments, independence certification or diet, intake or treatment instructions are produced." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-15" }