{ "schema_version": "chamgap-public-criteria-1.0", "title": "Berberine hydrochloride tablets × Reduction of colorectal adenoma recurrence after complete polypectomy", "language": "en", "translation_date": "2026-10-27", "criteria_version": "1.0", "criteria_date": "2026-10-05", "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; distinguish intervention variants.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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": "Link studies and reports separately; do not omit studies solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Met": "The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.", "Partly verified": "Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.", "Unverified": "The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.", "Not applicable": "Used only with a reason that an item is outside the actual scope of the selected question. It does not replace unverified or unread status.", "Conflicting data": "Used when incompatible material for the same question, time and analysis has actually been compared. Different review numbers alone do not establish this status.", "Review incomplete": "Original-material comparisons or searches were not performed within the authorized scope.", "Not applicable (alias)": "An alias for not applicable: reasoned nonapplicability, not a replacement for unread status.", "Not read": "External material was not directly read in this work; distinguish this from reading a retained summary." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which adenoma-recurrence question does this checklist address?", "needed": "The exact original claim, population, formulation, endpoint, comparison and canonical URL.", "role": "Required", "role_reason": "Needed to avoid combining effects for separate endpoints and products into a single result.", "application_exception": "An empty subclaim list does not establish the worldwide absence of other claims, and the checklist is not expanded into every combination of assessment axes.", "criterion": "Fix the single question of oral berberine hydrochloride versus matching placebo for adenoma recurrence over 1–2 years in adults after complete polypectomy.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare inclusion and exclusion boundaries to check whether adenoma counts, advanced adenomas, cancer prevention or treatment of existing adenomas have been mixed into the principal effect." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are the tablet ingredient, source and product identity verified?", "needed": "Tablet composition, manufacturer, product standards, plant source and analytical certification material.", "role": "Required", "role_reason": "Needed to avoid transferring trial results to products with similar ingredient names.", "application_exception": "An unverified plant source does not erase the recorded identity as purified berberine hydrochloride.", "criterion": "Identify the berberine hydrochloride tablet separately from unverified information about its plant source and product.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare manufacturing and composition documents with the trial product to establish the limits of identity with hydrochloride, plant extracts, derivatives and combinations." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What oral dose and administration frequency were specified?", "needed": "Formulation, route, content per tablet, frequency, nominal daily amount and administration records.", "role": "Required", "role_reason": "Needed to avoid treating 0.3 g as the total daily amount or changing the administration route.", "application_exception": "Unverified actual intake or adherence does not mean the nominal dose was not recorded.", "criterion": "Retain the nominal oral regimen of a 0.3 g tablet 2 times daily, 0.6 g/day, and distinguish it from actual adherence and exposure.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare tablet content and administration frequency, and link actual intake records separately from the nominal prescription if acquired." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which adults after polypectomy were included?", "needed": "Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment.", "role": "Required", "role_reason": "Needed to avoid extending post-polypectomy recurrence results to general prevention or treatment of existing lesions.", "application_exception": "Verification of eligibility wording does not establish representativeness for all ages or all adenoma-risk groups.", "criterion": "Limit the population to adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separate the population conditions and compare the trial population with treatment of residual adenomas, a general adenoma-free population and cancer patients." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are recruitment, exclusions and baseline balance verified?", "needed": "Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition.", "role": "Required", "role_reason": "Needed to avoid transferring results in selected post-polypectomy patients to all adults.", "application_exception": "Failure to acquire baseline tables does not establish baseline imbalance or lack of representativeness.", "criterion": "Actual recruitment and exclusion conditions at the 7 hospitals, and baseline risks by arm, must be linked to the analysis population.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare the enrollment-to-analysis flow and baseline tables to examine differences between the selected population and the target population." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are differences in co-interventions and adherence beyond matching placebo verified?", "needed": "Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling.", "role": "Required", "role_reason": "Needed to avoid attributing differences in other treatments or intake behaviour to the formulation.", "application_exception": "The matching-placebo label alone does not establish that every actual co-intervention and adherence pattern was identical.", "criterion": "Check co-interventions, rescue treatment, adherence, deviations and their handling beyond the difference between matching placebo and berberine.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare treatment and adherence records by arm to distinguish the assigned formulation difference from contributions of other changes." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What follow-up period and examination times apply to adenoma recurrence?", "needed": "Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result.", "role": "Required", "role_reason": "Needed to distinguish a single fixed endpoint from a conditional examination pathway.", "application_exception": "Do not turn the 1–2-year contract into complete observation of every participant for exactly 2 years or into an effect after stopping.", "criterion": "Retain the contract of 1–2 years of follow-up and a 2-year colonoscopy if the 1-year colonoscopy is negative.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link recurrence results to the examination schedule and separately examine unexamined intervals and persistence after stopping." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How is recurrence distinguished from other adenoma outcomes?", "needed": "Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations.", "role": "Required", "role_reason": "Needed to avoid combining effects on counts, advanced lesions or cancer with the principal recurrence effect.", "application_exception": "The absence of direct values for other endpoints does not erase the recorded recurrence result.", "criterion": "Distinguish at least one recurrent adenoma at follow-up colonoscopy from adenoma counts, advanced adenomas and cancer.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Make an outcome-definition table and check whether each value represents a proportion of people with recurrence or a count of adenomas." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the actual colonoscopy and histological assessment procedures verified?", "needed": "Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm.", "role": "Required", "role_reason": "Needed to distinguish detection conditions from actual recurrence differences.", "application_exception": "The double-blind label alone does not establish that colonoscopy and pathology assessors were blinded.", "criterion": "Adenoma-identification procedures, examination quality, assessor blinding and examination differences by arm must be linked to the selected result.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare endpoint-collection procedures and completed examinations by arm to examine how detection differences limit the recurrence comparison." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are randomization, concealment and blinding methods verified?", "needed": "Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text.", "role": "Required", "role_reason": "Needed to avoid promoting an RCT label into verification of detailed allocation procedures.", "application_exception": "Unverified details do not establish a nonrandomized design, and no new formal risk-of-bias assessment is performed.", "criterion": "Distinguish the multicentre randomized double-blind label from actual sequence generation, allocation concealment and blinding procedures.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare methods sections and allocation records against bias domains for the selected result, retaining unverified domains separately." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Can randomized, efficacy and safety denominators be distinguished?", "needed": "Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm.", "role": "Required", "role_reason": "Needed to avoid calculating event proportions for different analysis populations with a single denominator.", "application_exception": "Do not generate unreported randomized or completed counts by arm through subtraction or reverse calculation.", "criterion": "Retain 1,108 randomized participants, the 891-person mITT population with denominators 429/462, and safety denominators 446/478 for their respective outcomes.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link each denominator to its analysis population in a comparison table and identify displays that substitute randomized counts for efficacy or safety denominators." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are reasons for missing efficacy data and their handling verified?", "needed": "Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram.", "role": "Required", "role_reason": "Needed to avoid interpreting results among analyzed participants as complete follow-up of everyone randomized.", "application_exception": "Do not recalculate the manuscript’s approximate 20% as a new exact percentage or classify all missing observations as treatment failures.", "criterion": "Verify exclusion reasons, losses by arm and sensitivity handling when efficacy data for only 891 of the 1,108 randomized participants were analyzed.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare reasons for missingness and examination status by arm, and check prespecified sensitivity-analysis plans examining assumptions of the original analysis." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are mITT inclusion rules and the analytical model verified?", "needed": "The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations.", "role": "Required", "role_reason": "Needed to avoid automatically interpreting the mITT label as complete ITT or an adherence effect.", "application_exception": "Unverified adjustment or model details do not establish an unadjusted analysis.", "criterion": "Distinguish the actual modified-ITT inclusion rules, adjustment and effect of interest from the effect of original assignment.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare the analysis plan with result tables to examine how mITT inclusion rules differ from the selected assignment effect." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What RR, interval and P value were originally reported for recurrence?", "needed": "Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result.", "role": "Required", "role_reason": "Needed to avoid transferring a precise relative risk to another endpoint or analysis.", "application_exception": "Do not reverse-calculate new event counts, precise proportions or new confidence intervals from displayed percentages.", "criterion": "Attribute 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91 and P=.001 to the same mITT recurrence comparison.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original result tables with retained citation values and check whether labels have changed to another measure such as HR or a within-group test instead of RR." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Can a prespecified clinical-importance threshold be compared with the interval?", "needed": "The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents.", "role": "Required", "role_reason": "Needed to avoid establishing a sufficiently important patient effect from a P value or large sample size alone.", "application_exception": "An unverified threshold does not establish absence of effect or clinical unimportance.", "criterion": "Clinical sufficiency requires verification of the relationship between a prespecified minimum clinically important difference for recurrence and the reported RR interval.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare an acquired prespecified importance threshold with the original interval’s range, without inventing thresholds or new scores." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is the historical 11-percentage-point description distinguished from a new effect calculation?", "needed": "The original absolute-difference wording, its analysis, calculation history and any reported original interval.", "role": "Required", "role_reason": "Needed to avoid promoting a historical rounded description into a new precise estimate or number needed to treat.", "application_exception": "The relative RR and historical absolute difference are different measures; that alone does not establish conflicting data.", "criterion": "Retain the manuscript’s 11-percentage-point absolute difference as a historical description without generating a new absolute difference, NNT or CI.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link the historical description to original reported rates to check whether it is presented as a new calculation; do not fill in an NNT that was not calculated." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Were the trial number and identity compared against original registration material?", "needed": "The original NCT02226185 registration, identity links between paper and registration, and update history.", "role": "Required", "role_reason": "Needed to distinguish the presence of a number string from verification of original registration material.", "application_exception": "Coexistence of a recorded number and not verified does not establish nonregistration or an incorrect number.", "criterion": "Retain NCT02226185 in the citation and not verified in the evidence registration field, and separately check identity against original registration material.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare registration, paper and follow-up report identities to establish whether they concern the same trial before using them for plan comparisons." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Do planned endpoints, timing and analysis agree with the final report?", "needed": "Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records.", "role": "Required", "role_reason": "Needed to expose missing material for checking the possibility of favorable analytical selection.", "application_exception": "Unacquired planning documents do not establish that selective reporting occurred.", "criterion": "Directly compare recurrence definitions, timing and denominators in registration, protocols and analysis plans with the final report.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare planned and actual endpoints, analyses and examination times across document versions and check reasons for changes." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Is follow-up of the same cohort kept separate from independent replication?", "needed": "Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports.", "role": "Required", "role_reason": "Needed to avoid counting the existence of follow-up reports as independent confirmatory trials.", "application_exception": "No separate follow-up bibliography is currently available; do not create new report IDs or unique participant totals.", "criterion": "Link the final paper and follow-up of the same cohort within one trial family, distinguishing report counts from trial counts.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If follow-up material is acquired, compare recruitment, trial numbers and participant overlap, then link it as a separate timepoint within the same family." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Has direct confirmatory material from an independent study family been acquired?", "needed": "Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials.", "role": "Supplementary; required for independent-replication claims", "role_reason": "Needed to avoid treating a single trial’s precision as verification of independent reproducibility.", "application_exception": "Unverified independent confirmation within the retained scope does not establish 0 studies worldwide or treatment ineffectiveness.", "criterion": "Verify results from independent trials and nonoverlapping study families assessing the same formulation, population and recurrence contract.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If further trials are acquired, compare family identity, formulation, population, timing and analysis before examining independent replication." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does heterogeneity between the currently linked study families need comparison?", "needed": "Comparisons of results, formulation, population, duration and analysis if other independent families are added.", "role": "Supplementary; required for application across families", "role_reason": "Needed to avoid inventing a between-study distribution from a single retained family.", "application_exception": "This nonapplicability is limited to comparison within the currently linked single family and does not replace the unverified independent-replication item.", "criterion": "Do not apply a between-study effect-distribution comparison within the current scope of only one linked report family.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Only when an independent family is newly acquired, compare results and contract differences side by side and examine comparability." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are optimal dose, persistence after stopping and subgroup confirmation required here?", "needed": "Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined.", "role": "Supplementary; required for the relevant extension claim", "role_reason": "Needed to avoid extending the principal effect to every dose, persistence after stopping or subpopulation.", "application_exception": "Retain examination of duration and adherence for the original claim; unacquired extension trials do not establish failure of the original recurrence result.", "criterion": "Do not add optimal-dose, persistence-after-stopping or subgroup-confirmation requirements to the original 0.3 g BID principal effect over 1–2 years.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future extension questions should separately design and assess direct dose comparisons, prespecified subgroup interactions and follow-up after stopping." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is the adenoma-recurrence result kept separate from cancer prevention?", "needed": "Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events.", "role": "Required extension boundary", "role_reason": "Needed to avoid promoting a favorable surrogate difference into prevention of cancer events.", "application_exception": "A cancer-event trial is not imposed as a prerequisite for the adenoma-recurrence value.", "criterion": "Distinguish the surrogate nature of adenoma and observation of 0 colorectal cancers from proof of a cancer-prevention effect.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Evaluating cancer prevention requires a comparative trial with a separate clinical cancer endpoint and sufficient follow-up, analyzed separately from the adenoma surrogate result." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are constipation event definitions and collection verified?", "needed": "Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478.", "role": "Supplementary; required for safety descriptions", "role_reason": "Needed to avoid turning efficacy denominators or reported counts into safety incidence rates.", "application_exception": "Retain 6/446 versus 1/478 without calculating a new risk ratio, difference or attributable rate.", "criterion": "Verify the 6/446 versus 1/478 constipation comparison together with person/event definitions, collection and denominators.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original safety tables and collection plans to verify constipation counting units and exposed/control denominators." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are harm timing, severity, discontinuation and missingness verified?", "needed": "Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events.", "role": "Supplementary; required for the safety scope", "role_reason": "Needed to avoid extending limited constipation reporting into complete safety across all periods.", "application_exception": "Do not infer identical exposure and complete follow-up for all safety participants from the 1–2-year efficacy plan.", "criterion": "Verify administration start and stopping, harm onset and recovery, severity, discontinuation and losses to safety follow-up.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine exposure and event timelines and follow-up losses by arm without converting absent reporting into 0 events." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are long-term harms, co-medication and vulnerable-group data verified?", "needed": "Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material.", "role": "Supplementary; required for safety extensions", "role_reason": "Needed to avoid treating a single recurrence trial as evidence of harmlessness for every population.", "application_exception": "Unverified interactions also do not establish that an interaction occurred.", "criterion": "Retain the reported warning and distinguish direct information on long-term clinical safety, drug interactions and use outside the population.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separately examine long-term follow-up and harm-observation designs including co-medication and baseline risks, and compare the limited safety scope of this trial." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is confirmation of independently repeated harm signals required in this checklist?", "needed": "Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added.", "role": "Supplementary; required for repeated-harm claims", "role_reason": "Needed to avoid automatically imposing a separate repeated-harm condition on an efficacy question.", "application_exception": "This nonapplicability does not turn unverified constipation or long-term harms into harmlessness.", "criterion": "Do not add a repeated-harm confirmation requirement to the current adenoma-recurrence checklist; retain limitations of safety reporting.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If a future repeated-harm question is defined, compare unique events and families and link repeated citations to the same signal." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are product support, author identity and patents verified beyond the funding name?", "needed": "Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles.", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid claiming independence or absence of bias from a single funder name.", "application_exception": "Funding is not an automatic exclusion reason, and the original I2 is not inherited as a new independence judgment.", "criterion": "Separately link verification levels for reported funding, product support, author employment, patents and declared conflicts of interest.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separately compare funding, product, author and patent declarations to check funding sources and roles in result analysis." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Which materials were actually read in this work?", "needed": "Actual reading, access, acquisition and locations for each material, safe links and timestamps.", "role": "Required", "role_reason": "Needed to avoid mistaking a blue summary-reading link for actual reading of clinical full text.", "application_exception": "Do not mark unattempted access as inaccessible or successful.", "criterion": "Distinguish actual reading of the retained summary from external PubMed and full-text access that was not attempted, acquired or read.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare action records for each material with retained source locations to check that a summary link is not presented as external full-text reading." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are the current response and identity of the original bibliographic URL verified?", "needed": "Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration.", "role": "Required", "role_reason": "Needed to avoid turning a URL string into successful current access or acquisition of paper full text.", "application_exception": "The PubMed URL is a bibliography and abstract-index entry point. Its current offered scope remains unverified because it was not opened.", "criterion": "Distinguish the Chen 2020, PMID 31926918, DOI and original PubMed URL strings from verification of current response and agreement with the original document.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "In a future authorized material check, compare identifiers and original-document identity and distinguish the material type offered by the link." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can the scope of historical search and retraction/correction checks be traced?", "needed": "Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records.", "role": "Required", "role_reason": "Needed to avoid exaggerating retained descriptions into a current full-literature search or certification of no current retraction.", "application_exception": "No new search does not establish 0 current studies or absence of retractions/corrections.", "criterion": "Distinguish historical descriptions of final, follow-up and retraction/correction review from actual logs and the current checking scope by date.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If historical logs are acquired, compare their scope with the described review and record corrections, new evidence and condition revisions as separate events." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are the original grade and axes kept separate from current condition statuses?", "needed": "Current grade, score, safety, axes, original grade decision and complete originals before and after correction.", "role": "Required", "role_reason": "Needed to avoid promoting historical scores or cross-check wording into current checklist fulfillment or clinical certification.", "application_exception": "The independent-cross-check wording in the original grade decision is quoted only as a historical description.", "criterion": "Preserve C, 54, Warning, S/R1/I2/E+/B2/CX and original Boolean and empty-string values as source material without creating a new verdict.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare typed current-source and preserved values to check that nulls, Booleans, empty strings and historical assessments remain unchanged." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are generic English descriptions kept separate from new specific facts?", "needed": "Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction.", "role": "Required", "role_reason": "Needed to avoid filling gaps in original Korean material with remaining generic English descriptions.", "application_exception": "This conversion does not replace the original source translation; remaining generic descriptions are preserved.", "criterion": "Distinguish specific bilingual contracts from remaining generic placeholders in evidence and citations, preserving the originals unchanged.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare bilingual correspondence without treating generic explanations as additional evidence for specific denominators, funding, confidence intervals or original-document reading." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are empty source values distinguished from absent keys?", "needed": "All current source keys, typed original values and comparisons of access/effect field presence.", "role": "Required", "role_reason": "Needed to avoid automatically turning absent keys, nulls, empty lists and unverified values into the same fact.", "application_exception": "Access records in this new checklist are its own records; do not imply that these access fields existed in the original source.", "criterion": "Distinguish empty subclaim lists and deliberation strings from absent source-list, principal-effect and access fields; do not represent an absent key as an original null value.", "basis": "Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Check key presence and typed values separately; distinguish original structure from added records if subsequent material is acquired." } ] }