{ "schema_version": "chamgap-public-criteria-1.0", "title": "Psyllium × Ten-week ALT and FibroScan findings: signals, effect size and measurement gaps", "language": "en", "translation_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the selected ten-week test question?", "needed": "Original ten-week ALT and FibroScan improvement", "role": "Required", "role_reason": "This condition connects Original ten-week ALT and FibroScan improvement 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 ten-week ALT and FibroScan improvement 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 ALT/FibroScan endpoints, population, comparator, time points and denominators, and review of the question boundary. Parent scores or axes are not inserted into subclaim values. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What was the original ALT result?", "needed": "Ten-week covariate-adjusted between-group ALT test", "role": "Required", "role_reason": "This condition connects Ten-week covariate-adjusted between-group ALT test 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 Ten-week covariate-adjusted between-group ALT test 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, units, assay, baseline/follow-up/change values, covariates, model, group denominators, effects and CIs. No effect sizes or normalization rates are derived from P values. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What was the original FibroScan measure?", "needed": "FibroScan fibrosis score P=.001", "role": "Required", "role_reason": "This condition connects FibroScan fibrosis score P=.001 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 FibroScan fibrosis score P=.001 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 actual FibroScan measure and score definition, units, measurement conditions, validity criteria, group tables, denominators, between-group effects and CIs. No particular measurement name or value is invented. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are FibroScan and MRI/MRS liver-fat measurements the same?", "needed": "Distinguishing elastography-related measures from MRI and other tests", "role": "Required", "role_reason": "This condition connects Distinguishing elastography-related measures from MRI and other 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 elastography-related measures from MRI and other 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: Actual FibroScan measures and separately measured or defined MRI/MRS, other imaging or histology, with their denominators and estimates. A device name alone does not establish liver-fat quantity or histologic improvement. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Is the null AST result retained?", "needed": "Separate ALT and AST tests", "role": "Required", "role_reason": "This condition connects Separate ALT and AST 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 Separate ALT and AST 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: AST baseline/follow-up/change values, group denominators, adjustment models, effects, CIs and prespecified hierarchy. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are within-group improvement and adjusted between-group comparison the same?", "needed": "Target effect, covariate adjustment and change estimates", "role": "Required", "role_reason": "This condition connects Target effect, covariate adjustment and change estimates 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 Target effect, covariate adjustment and change estimates 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 ANCOVA or analysis model, covariates, prespecification, baseline/follow-up/change values, direct effects, CIs and denominators. No new within-group or between-group values are calculated. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were the actual comparator and common advice?", "needed": "Psyllium versus ground wheat with common lifestyle advice", "role": "Required", "role_reason": "This condition connects Psyllium versus ground wheat with 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 Psyllium versus ground wheat with 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: Control products and composition, diet/activity advice in both arms, actual intake, activity, weight changes and co-treatment records. Identical advice and identical actual behavior are distinguished. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Who was actually studied?", "needed": "Overweight/obesity, MASLD and eligibility", "role": "Required", "role_reason": "This condition connects Overweight/obesity, MASLD and eligibility 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 Overweight/obesity, MASLD and eligibility 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: Diagnosis, eligibility, baseline liver disease, imaging, metabolic factors, medication, group baselines, subgroups and test denominators. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Do 80 randomized and 78 completers provide every test denominator?", "needed": "Allocation, completion, valid tests and dropout", "role": "Required", "role_reason": "This condition connects Allocation, completion, valid tests and dropout 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 Allocation, completion, valid tests and dropout 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 flow, test- and time-specific denominators, ITT/completer populations, missing-data handling and exposure/withdrawal tables. Overall n is not copied into each group or test. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are ten-week research exposure and actual adherence verified?", "needed": "Oral 10g/day, duration, products and exposure", "role": "Required", "role_reason": "This condition connects Oral 10g/day, duration, products and exposure 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 Oral 10g/day, duration, products and exposure 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 products, formulations, composition, actual exposure, adherence, dropout and changes in diet/activity. No psyllium, product or diet instructions are provided. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Is the prespecified primary-endpoint hierarchy verified?", "needed": "ALT/AST/FibroScan hierarchy, registration and SAP", "role": "Required", "role_reason": "This condition connects ALT/AST/FibroScan hierarchy, registration and SAP 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 ALT/AST/FibroScan hierarchy, registration and SAP 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: Initial and amended registration, protocol/SAP, endpoints, time points, multiplicity and analysis plans. Missing registration identifiers or URLs are not invented. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are exact effect sizes, CIs and clinical importance available?", "needed": "P values, estimates, intervals and surrogate-test importance", "role": "Required", "role_reason": "This condition connects P values, estimates, intervals and surrogate-test importance 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 P values, estimates, intervals and surrogate-test importance 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 models, estimates, CIs, variance, denominators, prespecified importance thresholds and test units. No hypothetical quantitative examples or new effect/CI calculations are produced. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does a FibroScan measure establish histologic fibrosis improvement?", "needed": "Separate directness for test scores, histology and disease stage", "role": "Required", "role_reason": "This condition connects Separate directness for test scores, histology and disease stage 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 directness for test scores, histology and disease stage 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 score definitions and tables, separate direct histology/disease-stage evidence, denominators, timing and CIs. Unrecorded histologic outcomes are not assumed. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are ALT and FibroScan clinical liver-disease outcomes?", "needed": "Clinical outcomes such as cirrhosis/hospitalization versus surrogates", "role": "Required", "role_reason": "This condition connects Clinical outcomes such as cirrhosis/hospitalization versus surrogates 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/hospitalization versus surrogates 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 clinical-event types, definitions, adjudication, group events, time at risk, long-term denominators and CIs. Unverified information is not changed into zero events or zero effect. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Is the separate seed trial an efficacy replication?", "needed": "Akbarian2016 safety support and a different intervention", "role": "Required", "role_reason": "This condition connects Akbarian2016 safety support and a different intervention 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 Akbarian2016 safety support and a different intervention 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 original formulation, duration, population, group effects, harms, denominators and study/cohort relationships. Detailed unverified/unread status is retained. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are test effects after stopping or over other durations available?", "needed": "Ten weeks, persistence and generalization", "role": "Required", "role_reason": "This condition connects Ten weeks, persistence and generalization 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 Ten weeks, persistence and generalization 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, actual exposure, endpoint-specific denominators/CIs and matching comparator/population data. No maintenance-intake, liver-disease-management or treatment-replacement advice is created. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are the same citation, population or time points counted as new independent evidence?", "needed": "Parent/subclaim and report/trial relationships", "role": "Required", "role_reason": "This condition connects Parent/subclaim and report/trial relationships 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 Parent/subclaim and report/trial relationships 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: Mapping efficacy/safety reports, cohorts, actual interventions, analysis populations and time points. Material-slot counts are not unique trials, participants or quality scores. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What was actually read?", "needed": "The complete parent stored summary and external material", "role": "Required", "role_reason": "This condition connects The complete parent stored summary and 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 The complete parent stored summary and 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: Actual acquisition/reading records for full texts, supplements, plans and registration. No separate external-link, screen, web or API checks were performed. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Where are the original citation and registration identifiers?", "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 citations, study/registration identifiers, content and dates. Full-text or registration URLs are not inferred from PMCIDs. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are bilingual and historical checks distinguished from this review?", "needed": "Original bilingual text, subclaims and historical verification", "role": "Required", "role_reason": "This condition connects Original bilingual text, subclaims 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 text, subclaims 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: Original-text, translation, correction and boundary review. Historical checks are not labeled current FULL/QA, new clinical calculation or independent certification. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are subclaim values distinguished from parent C50 and axes?", "needed": "Original subclaim grade/note and absent score/status/axes", "role": "Required", "role_reason": "This condition connects Original 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 Original 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: Review of selected and parent original values. No new scores, axes, efficacy grades or verdict changes. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are the cut-off, empty corrections and production date distinguished?", "needed": "Original cut-off and empty correction/deliberation records", "role": "Required", "role_reason": "This condition connects Original cut-off and empty correction/deliberation records 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 cut-off and empty correction/deliberation records 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: Subsequent/corrected material, complete pre-change originals and case history. Missing dates or correction values are not invented. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are funding, support, employee authors and analysis roles distinguished?", "needed": "Four company-related areas and report-specific scope", "role": "Required", "role_reason": "This condition connects Four company-related areas and report-specific 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 Four company-related areas and report-specific 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: Original funding/COI, product/material support, author affiliations and analysis/publication roles for each report. Parent I2 is not upgraded into new independence certification. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are randomization, measurement, missingness and reporting details available?", "needed": "Block allocation, covariates and completer boundaries", "role": "Required", "role_reason": "This condition connects Block allocation, covariates and completer boundaries 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 Block allocation, covariates and completer boundaries 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, protocol/SAP, registration/amendments, test tables, denominators and models. Design labels or objective tests do not establish official RoB/GRADE completion or completed review. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are identical lifestyle advice and actual concurrent exposure the same?", "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 exposures, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators. No diet, intake or liver-disease-management instructions are provided. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N26", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Which formulation and group had withdrawals in the supporting safety citation?", "needed": "Withdrawals and harms in the 2016 seed intervention", "role": "Supplementary", "role_reason": "This condition connects Withdrawals and harms in the 2016 seed intervention 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 Withdrawals and harms in the 2016 seed intervention 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/materials, group events, withdrawals, reasons, durations, harm collection and exposure denominators. Other safety citations are not transferred into independent efficacy replication or the original trial's harm rate. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are caution statements, observed harms and long-term safety the same?", "needed": "Possible harms, collection, denominators and particular risk groups", "role": "Supplementary", "role_reason": "This condition connects Possible harms, collection, denominators and particular 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 Possible harms, collection, denominators and particular 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 exposures/denominators, discontinuation, dropout and long-term risk-group evidence. Caution is not replaced with safe/no harms or a newly established incidence rate. Only material requests and research needs are recorded; no new search or clinical research is executed here." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What material would trigger a sheet update?", "needed": "Original material, conditions, observations and verdict-change events", "role": "Required", "role_reason": "This condition connects Original material, conditions, observations and verdict-change events 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 material, conditions, observations and verdict-change events 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: Complete pre-change preservation, original material/condition versions, separate application and content-review records. The source records no QA/tests, web/API or link/screen checks, new calculations, regrading, independence certification, product intake, diet, liver-disease-management or treatment-replacement instructions. Only material requests and research needs are recorded; no new search or clinical research is executed here." } ] }