{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Psyllium × MRI liver fat: an unmeasured outcome and gaps behind surrogate findings",
  "language": "en",
  "translation_date": "2026-10-16",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which MRI claim is selected?",
      "needed": "The existing MRI liver-fat-reduction claim and verdict record",
      "role": "Required",
      "role_reason": "This condition connects The existing MRI liver-fat-reduction claim and verdict record with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for The existing MRI liver-fat-reduction claim and verdict record must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Was MRI liver fat directly measured?",
      "needed": "Unmeasured MRI and the direct-evidence gap",
      "role": "Required",
      "role_reason": "This condition connects Unmeasured MRI and the direct-evidence gap with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Unmeasured MRI and the direct-evidence gap must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Does ALT P=.006 establish an MRI liver-fat effect?",
      "needed": "Distinguishing liver enzymes from a direct MRI endpoint",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing liver enzymes from a direct MRI endpoint with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing liver enzymes from a direct MRI endpoint must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Is FibroScan P=.001 the same measurement as MRI?",
      "needed": "Distinguishing the actual FibroScan measure from MRI methods",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing the actual FibroScan measure from MRI methods with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing the actual FibroScan measure from MRI methods must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are MRI, MRS, other imaging and histologic outcomes individually verified?",
      "needed": "Actual measurement by each imaging method and histologic indicator",
      "role": "Required",
      "role_reason": "This condition connects Actual measurement by each imaging method and histologic indicator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Actual measurement by each imaging method and histologic indicator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Does the null AST result establish a null MRI fat result?",
      "needed": "Distinguishing AST P=.98 from other unmeasured tests",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing AST P=.98 from other unmeasured tests with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing AST P=.98 from other unmeasured tests must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are clinical liver-disease outcomes and MRI measurements the same endpoint?",
      "needed": "Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence",
      "role": "Required",
      "role_reason": "This condition connects Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Is the MASLD population the same as the separate NAFLD seed trial?",
      "needed": "Distinguishing the overweight/obese MASLD population from another seed trial",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing the overweight/obese MASLD population from another seed trial with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing the overweight/obese MASLD population from another seed trial must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Can common diet advice and comparator conditions substitute for MRI effects?",
      "needed": "The psyllium versus ground-wheat comparison and common lifestyle advice",
      "role": "Required",
      "role_reason": "This condition connects The psyllium versus ground-wheat comparison and common lifestyle advice with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for The psyllium versus ground-wheat comparison and common lifestyle advice must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are 80 randomized and 78 completed MRI measurement denominators?",
      "needed": "Distinguishing randomized/completed counts from an unmeasured endpoint denominator",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing randomized/completed counts from an unmeasured endpoint denominator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing randomized/completed counts from an unmeasured endpoint denominator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Does ten-week study exposure show sustained MRI effects?",
      "needed": "Duration, actual exposure and post-trial follow-up",
      "role": "Required",
      "role_reason": "This condition connects Duration, actual exposure and post-trial follow-up with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Duration, actual exposure and post-trial follow-up must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Did registration or the prespecified endpoint hierarchy include MRI?",
      "needed": "Distinguishing unverified registration/prespecified endpoints from unmeasured MRI",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing unverified registration/prespecified endpoints from unmeasured MRI with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing unverified registration/prespecified endpoints from unmeasured MRI must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Can P values from other tests fill MRI effects or CIs?",
      "needed": "Direct estimates, within/between-group comparisons and unmeasured outcomes",
      "role": "Required",
      "role_reason": "This condition connects Direct estimates, within/between-group comparisons and unmeasured outcomes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Direct estimates, within/between-group comparisons and unmeasured outcomes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What direct evidence would address the MRI gap?",
      "needed": "MRI measurements addressing the same question",
      "role": "Required",
      "role_reason": "This condition connects MRI measurements addressing the same question with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for MRI measurements addressing the same question must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are the same reports, participants or time points counted as independent evidence?",
      "needed": "Links between parent/subclaims and reports/studies",
      "role": "Required",
      "role_reason": "This condition connects Links between parent/subclaims and reports/studies with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Links between parent/subclaims and reports/studies must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read?",
      "needed": "Distinguishing the complete stored parent summary from external material",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing the complete stored parent summary from external material with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing the complete stored parent summary from external material must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Where are citation and registration identifiers recorded?",
      "needed": "PMID, PMCID and DOI for each citation",
      "role": "Required",
      "role_reason": "This condition connects PMID, PMCID and DOI for each citation with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for PMID, PMCID and DOI for each citation must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are historical bilingual and cross-check records distinguished from this review?",
      "needed": "Original bilingual wording, subclaim records and historical verification",
      "role": "Required",
      "role_reason": "This condition connects Original bilingual wording, subclaim records and historical verification with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Original bilingual wording, subclaim records and historical verification must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are the subclaim record and parent C50/axes distinguished?",
      "needed": "Subclaim grade/note and absent score/status/axes",
      "role": "Required",
      "role_reason": "This condition connects Subclaim grade/note and absent score/status/axes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Subclaim grade/note and absent score/status/axes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are the original evidence date and empty corrections distinguished from production?",
      "needed": "Original evidence date and empty correction/deliberation values",
      "role": "Required",
      "role_reason": "This condition connects Original evidence date and empty correction/deliberation values with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Original evidence date and empty correction/deliberation values must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are funding, support, employee authors and analysis roles distinguished?",
      "needed": "Company-related items and report-specific verification scope",
      "role": "Required",
      "role_reason": "This condition connects Company-related items and report-specific verification scope with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Company-related items and report-specific verification scope must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are allocation, measurement, missingness and selective-reporting details verified?",
      "needed": "Boundaries of block randomization, covariate adjustment and completer analysis",
      "role": "Required",
      "role_reason": "This condition connects Boundaries of block randomization, covariate adjustment and completer analysis with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Boundaries of block randomization, covariate adjustment and completer analysis must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Does common lifestyle advice establish actual concurrent exposure?",
      "needed": "Weight-loss diet, physical activity, adherence and co-management",
      "role": "Required",
      "role_reason": "This condition connects Weight-loss diet, physical activity, adherence and co-management with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Weight-loss diet, physical activity, adherence and co-management must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Which formulation or group had withdrawals in the supporting safety citation?",
      "needed": "Links between the 2016 seed intervention, withdrawals and harms",
      "role": "Supplementary",
      "role_reason": "This condition connects Links between the 2016 seed intervention, withdrawals and harms with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Links between the 2016 seed intervention, withdrawals and harms must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are caution statements, observed harms and long-term safety the same?",
      "needed": "Potential harms, collection methods, denominators and specific risk groups",
      "role": "Supplementary",
      "role_reason": "This condition connects Potential harms, collection methods, denominators and specific risk groups with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Potential harms, collection methods, denominators and specific risk groups must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Which new materials would prompt an update to this table?",
      "needed": "Separate records for original materials, conditions, observations and verdict changes",
      "role": "Required",
      "role_reason": "This condition connects Separate records for original materials, conditions, observations and verdict changes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms.",
      "application_exception": "Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created.",
      "criterion": "Material for Separate records for original materials, conditions, observations and verdict changes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created. This records needed materials; no new research was executed."
    }
  ]
}