{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2983-s1", "verdict_number": "2983", "title": "Low-free-sugar diet × Long-term liver-disease events: the gap beyond eight-week MRI", "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%; the population and follow-up denominators for long-term events remain directly unverified.", "intervention": "A low-free-sugar diet including whole-household food provision, professional menu design and twice-weekly checks.", "dose": "Identification of the original study: a free-sugar target below 3% of total energy for eight weeks. This is not guidance for implementing diets or managing adolescents or liver disease.", "comparator": "Usual diet, distinguished from other changes in the food environment, weight and contact.", "endpoint": "Selected outcome: reduced long-term liver-disease events, not directly measured. Parent outcome: eight-week change in MRI-PDFF liver fat.", "duration": "An eight-week trial; follow-up, denominators and direct effects for long-term clinical events remain unverified.", "excluded_extensions": [ "Transferring MRI-PDFF effects into reduced risk of long-term liver-disease events or clinical treatment benefits", "Treating histological diagnosis at enrollment as post-treatment histological or clinical improvement", "Certifying household food provision as simple sugar-restriction advice or an isolated free-sugar effect", "Adding the same citation, trial, people, households, measurements or sibling sheets as new independent trials or participants", "New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions for diets, child or adolescent care, liver-disease management or treatment replacement" ] }, "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The selected wording is reduced long-term liver-disease events, and the original subclaim grade is ?. The note states that the eight-week surrogate trial did not measure this outcome. Subclaim score, status and axes are absent and are preserved separately from parent C with 54 points.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original subclaim note and Korean and English text state that the eight-week surrogate trial did not measure long-term liver-disease events and that long-term clinical effects are unconfirmed. Events not measured are not recast as zero events, reduced risk or zero effect.", "condition_status": "Unverified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The trial allocated 40 boys aged 11 to 16 with histological NAFLD and MRI-PDFF above 10% in a 1:1 ratio. Findings are not extended to all adolescents, girls, adults or other liver diseases.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The eight-week intervention provided food for the whole household and lowered free sugars below 3% of total energy. The stored summary includes professional menu design, household food provision and twice-weekly checks. These identify the research intervention and do not instruct readers to implement a diet.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original classification fields identify usual diet as the comparator. The intensive intervention changed the household food environment and contact, and the intervention group also lost more weight. An effect from free sugars alone is not certified.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The efficacy material covers eight weeks. The original material distinguishes this from proof of long-term liver-disease improvement or the long-term safety of restrictive diets during growth. No post-treatment follow-up period is invented.", "condition_status": "Unverified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original evidence list records 40 boys, allocated 20/20, all completing eight weeks. Short-term completion does not establish complete long-term event observation or long-term analysis denominators. People, households, repeated MRI measurements and time points are not added as new participants.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The parent eight-week MRI-PDFF adjusted between-group difference is -6.23 percentage points, 95% CI -9.45 to -3.02, P<.001. This is an effect on a short-term liver-fat surrogate, not a risk difference, RR or HR for long-term clinical events.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original Korean research explanation separately records liver fat changing from 25% to 17%, control from 21% to 20%, and the adjusted between-group difference of -6.23 percentage points. Within-group changes are not used to calculate a new unadjusted difference, ratio or long-term event effect.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Histological NAFLD identifies the population at enrollment; the primary result is change in MRI-PDFF liver fat from baseline to eight weeks. The preserved material does not provide quantitative results for other imaging or histological follow-up, other liver tests or long-term clinical events.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original evidence list records change in MRI-PDFF liver fat from baseline to eight weeks as a positive prespecified primary MRI endpoint. The selected long-term events were not measured directly. Long-term events are not newly labeled as coprimary, secondary or registered outcomes.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original text states that the intervention group lost more weight and that liver-fat findings remained favorable in a sensitivity analysis additionally adjusting for weight change. No separate sensitivity effect or CI, isolated free-sugar causal effect or long-term event effect is created.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original design is an open-label two-center randomized food-provision trial with masked MRI assessment. Masking of participants, intervention providers or long-term event adjudicators is not additionally claimed.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material explains that reducing the intervention to simple sugar-restriction advice or a fatty-liver cure erases its intensity and population. Short-term MRI findings are not extended into implementation evidence for long-term liver-disease management or everyday diets.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material records completion by all 40 participants and no reported study-related adverse events. It states that the trial did not assess long-term safety of restrictive diets during adolescence. This is not recast as zero harm of every kind or proof of long-term safety.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading in material entries refers to the stored summary; external abstract, full text, registration, protocol and SAP were not read. The presence of a URL or PMCID is not promoted into external reading.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original evidence and citation lists contain NCT02513121. The identifier is retained; registration content, versions, timing, posted results and consistency with plans have not been newly read or verified. An official registration URL is not guessed.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Specific protocol and SAP URLs, original text, versions and dates were not newly acquired or read. Parent statements about prespecified endpoints and historical cross-checking are retained as history and are not described as new content review.", "condition_status": "Unverified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Original funding is Nutrition Science Initiative plus foundation, academic and NIH support, which the parent text describes as independent funding. Company funding, food or product support, employee authorship and involvement in analysis or design have not been individually checked against original source material here. Absence of all four is not newly certified.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Long-term events not measured directly and unverified external details are distinct.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Parent verdict 2983 and the MRI and long-term-event sheets share the same Schwimmer2019 report and 40-person trial context. Reports, people, households, repeated measurements and time points are not added as new independent trials or participants. One linked report is not a certified count of unique trials or participants.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Original parent replication and independence axes R1/I2 are preserved. Reusing citations and sibling sheets does not certify new independent replication of efficacy or harms.", "condition_status": "Unverified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The selected subclaim grade and note are preserved; absent score, status and axes remain unrecorded. Parent C with 54 points, safety and axes provide parent context. No new scores, grades or formal RoB2 or GRADE certification are produced.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The complete parent Korean and English texts, classification information, evidence and citations, and selected subclaim wording, grade and note are preserved in the complete stored summary. This is not a new comparison with the English original paper or another verdict.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original reference date 2026-09-07, empty correction array and empty deliberation string are retained. Cross-checking in the historical verdict-decision record is original history, distinct from current production dates, condition-application times or completed content review.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The short-term positive MRI findings are preserved, although long-term events were not observed directly. This direct evidence gap requires research on long-term clinical events and cannot be replaced by another surrogate.", "condition_status": "Unverified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "This is a record of applied conditions based on a stored summary. Existing content and claim-boundary review is incomplete; candidate review-pending and production-eligibility indicators are retained as history. The original review status is recorded unchanged.", "condition_status": "Partly verified", "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "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.", "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "Schwimmer JB, Ugalde-Nicalo P, Welsh JA, et al. Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial. JAMA. 2019;321(3):256-265. PMID: 30667502. PMCID: PMC6440226. DOI: 10.1001/jama.2018.20579. NCT02513121.", "url": "https://pubmed.ncbi.nlm.nih.gov/30667502/", "report_type": "Open-label two-center randomized food-provision trial with masked MRI assessment", "existence": "The original citation contains the report reference; external public availability and access are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registrations and plans unread", "study_family": "F01", "independent_replication": "Review of existing content is incomplete; references and related sheets are not certified as counts of unique trials or independent replications.", "observed_result": "Adjusted between-group difference -6.23 percentage points (95% CI -9.45 to -3.02), P<.001", "result_level": "Parent-endpoint summary in the original evidence list; the scope of the selected direct endpoint and other findings is distinguished through conditions and roles.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "A preserved local copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed." }, { "material_type": "External abstract", "public_status": "An original identifier, reference or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed." }, { "material_type": "External full text", "public_status": "An original identifier, reference or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed." }, { "material_type": "Original registration", "public_status": "An original identifier, reference or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed." }, { "material_type": "Protocol/SAP", "public_status": "An original identifier, reference or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed." } ], "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": "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent verdict 2983 and the MRI and long-term-event sheets share the same Schwimmer2019 report and 40-person trial context. Reports, people, households, repeated measurements and time points are not added as new independent trials or participants. Citation-based linkage is provisional; review of actual cohort and independent-study relationships remains incomplete." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-15" }