{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2937-s1", "verdict_number": "2937", "title": "Antidepressant discontinuation × the claim that depression inevitably relapses: evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Adults in UK primary care with remission and long-term use who were considering stopping; not extended to every individual or setting", "intervention": "Original ANTLER allocation strategy of tapering to placebo; actual restarting and adherence distinguished from complete discontinuation", "dose": null, "comparator": "Original arm results for maintenance versus tapering to placebo; individual inevitability is a separate question", "endpoint": "Existing question ‘discontinuation inevitably causes relapse’, original wording on 44% without relapse within 52 weeks, and the gap in individual prediction", "duration": "Original observation over 52 weeks; not extended to lifelong freedom from relapse or safe discontinuation for an individual", "excluded_extensions": [ "Extending the original reduction in relapse within 52 weeks to complete prevention for every person or period, or inevitable relapse on discontinuation", "Extending the original 44% without relapse to lifelong freedom from relapse, safe discontinuation for an individual, or complete discontinuation without restarting", "Calculating correspondence or overlap by assuming the discontinuation group's 52% adherence, 39% restarting and 44% without relapse refer to the same people", "Calculating new exclusion proportions, denominators, events or individual classifications from 478 randomized, 468 in the time-to-event analysis and 10 with missing timing (6/4)", "Recalculating or converting the original 92/238, 135/240, 39%/56%, 17%p, HR 2.06/CI/P or DESS means and difference into reciprocals, NNT or individual probabilities", "Double-counting NEJM and HTA as independent trials, or adding participants across the two sheets, arms, time points or the 478/8890 participant figures", "Using the 40-study meta-analysis as a new independent replication under ANTLER conditions, or certification of inevitability or individual prediction", "Treating possible withdrawal misclassification or awareness of allocation as the cause of all results, a newly quantified bias, or invalidation of the trial", "Extending 9/8 participants with serious events and 0 deaths or suicide attempts to zero risk, long-term safety or drug selection", "Treating the absence of reported company donations in the original account as absence of support, employee authors or conflicts of interest, or certification of independence", "Inheriting the parent's B70, axes, historical cross-checking, public funding or original-material review statements as subclaim values, review of content in this work or external reading", "New searches or numerical calculations; hypothetical quantitative examples; new effects, CIs, grades or certification of independence; guidance on maintenance, discontinuation, tapering, dosing, drug changes or treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the existing verdict on ‘discontinuation inevitably causes relapse’?", "needed": "Distinguishing the subclaim's D grade/note from parent B70 and the absence of score, status and axes", "role": "Required", "role_reason": "Production item to distinguish Distinguishing the subclaim's D grade/note from parent B70 and the absence of score, status and axes and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Distinguishing the subclaim's D grade/note from parent B70 and the absence of score, status and axes must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate source records for the inevitability claim and the parent's average effect are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question is ‘discontinuation inevitably causes relapse’, originally grade D, with a note that 44% of the discontinuation group did not relapse within 52 weeks. Subclaim score, status and axes are absent and separate from the parent's B70 for average relapse reduction.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Subclaim score, status and axes were originally absent; no new verdict is written. Review of existing content remains incomplete.", "missingness": "Subclaim score, status and axes were originally absent; no new verdict is written.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional materials for the selected question or user feedback" }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "What period, people and exposure does ‘inevitably’ refer to?", "needed": "Distinguishing an all-person or inevitability claim from the actual 52-week taper-to-placebo conditions", "role": "Required", "role_reason": "Production item to distinguish Distinguishing an all-person or inevitability claim from the actual 52-week taper-to-placebo conditions and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Distinguishing an all-person or inevitability claim from the actual 52-week taper-to-placebo conditions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials separating the claim's time, population and exposure scope are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original selected wording is ‘discontinuation inevitably causes relapse’. ANTLER actually compared tapering to placebo in adults with long-term use and remission who were considering stopping, using first-relapse data over 52 weeks. The 52-week period is not extended to a lifetime or every form of discontinuation.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Materials establishing inevitability for every person, period or discontinuation method are absent from this preserved scope. Review of existing content remains incomplete.", "missingness": "Materials establishing inevitability for every person, period or discontinuation method are absent from this preserved scope.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials specifying period, population and actual exposure, if supplied" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the 44% without relapse stated directly in the original text?", "needed": "Preserving the original no-relapse wording, period and unit of the proportion", "role": "Required", "role_reason": "Production item to distinguish Preserving the original no-relapse wording, period and unit of the proportion and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Preserving the original no-relapse wording, period and unit of the proportion must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials linking observed absence of relapse with individual courses are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The value that 44% of the discontinuation group did not relapse within 52 weeks is directly stated in the existing reader answer and subclaim note. It was not generated by calculating a new complementary proportion from 56%, and is not changed to absence of relapse over another period.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Individual adherence, restarting, censoring, clinical characteristics and subsequent course among those without relapse remain unverified. Review of existing content remains incomplete.", "missingness": "Individual adherence, restarting, censoring, clinical characteristics and subsequent course among those without relapse remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials on the no-relapse group, follow-up, actual exposure and timing" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does 56% relapse in the discontinuation group mean ‘inevitably’?", "needed": "Distinguishing original 135/240 (56%), 92/238 (39%) and 17%p from inevitability wording", "role": "Required", "role_reason": "Production item to distinguish Distinguishing original 135/240 (56%), 92/238 (39%) and 17%p from inevitability wording and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Distinguishing original 135/240 (56%), 92/238 (39%) and 17%p from inevitability wording must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate materials on arm comparisons and claims about every person or individual are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ANTLER's original discontinuation result of 135/240 (56%), maintenance result of 92/238 (39%) and absolute difference of 17%p are average between-arm comparisons. They are not transferred to relapse in every individual who discontinues; the subclaim's D grade/note is preserved unchanged.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Individual probabilities, outcomes for all people and inevitability over other periods or populations remain unverified. Review of existing content remains incomplete.", "missingness": "Individual probabilities, outcomes for all people and inevitability over other periods or populations remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual follow-up or prediction, or corresponding direct materials" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do the population and recruitment conditions include every patient with depression?", "needed": "Conditions involving 150 practices, long-term medication, remission and 2 episodes/2 years", "role": "Required", "role_reason": "Production item to distinguish Conditions involving 150 practices, long-term medication, remission and 2 episodes/2 years and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Conditions involving 150 practices, long-term medication, remission and 2 episodes/2 years must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials linking eligibility conditions with individual outcomes are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Adults from 150 UK general practices felt well enough to consider stopping. They had at least 2 previous episodes or at least 2 years of treatment, with specific study conditions involving long-term use of four drugs.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Exact remission criteria, age, baseline risk, exclusions and the course without relapse under other population conditions remain unverified. Review of existing content remains incomplete.", "missingness": "Exact remission criteria, age, baseline risk, exclusions and the course without relapse under other population conditions remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, exclusions, baseline tables and direct materials under other conditions" }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is study ‘discontinuation’ the same as complete or immediate stopping?", "needed": "Historical scope of tapering over 1~2 months, switching to placebo and actual exposure", "role": "Required", "role_reason": "Production item to distinguish Historical scope of tapering over 1~2 months, switching to placebo and actual exposure and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Historical scope of tapering over 1~2 months, switching to placebo and actual exposure must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials linking allocation conditions with actual behavior are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original trial switched users of specified drugs to matching placebo after tapering over 1~2 months. This is not converted into abrupt-stopping exposure, every drug or dose, or outcomes of individuals who completely stopped. Study conditions are not made into tapering or dosing instructions.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Individual actual tapering, exposure, concomitant treatment and stopping or restarting times remain unverified. Review of existing content remains incomplete.", "missingness": "Individual actual tapering, exposure, concomitant treatment and stopping or restarting times remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of actual exposure, tapering and concomitant treatment" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do 39% restarting and 52% adherence identify those without relapse?", "needed": "Relationship between actual exposure or restarting in the discontinuation group and the no-relapse group", "role": "Required", "role_reason": "Production item to distinguish Relationship between actual exposure or restarting in the discontinuation group and the no-relapse group and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Relationship between actual exposure or restarting in the discontinuation group and the no-relapse group must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials separating absence of relapse in the allocated group from actual exposure pathways are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original values state 52% adherence in the discontinuation group and that 39% restarted a clinician-prescribed antidepressant before the trial ended. These people are not assumed to be the same as the 44% without relapse; no new overlap is calculated.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Individual cross-classification of restarting or adherence with relapse or absence of relapse, timing and reasons remains unverified. Review of existing content remains incomplete.", "missingness": "Individual cross-classification of restarting or adherence with relapse or absence of relapse, timing and reasons remains unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual linked materials on relapse, restarting, adherence and time" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can individual outcomes after actual stopping be separated from the allocation effect?", "needed": "Distinguishing the randomized comparison's estimand from individual and actual-exposure effects", "role": "Required", "role_reason": "Production item to distinguish Distinguishing the randomized comparison's estimand from individual and actual-exposure effects and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Distinguishing the randomized comparison's estimand from individual and actual-exposure effects must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials distinguishing allocation effects from actual-exposure effects are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The allocated comparison of 478 participants and original HR are study results for maintenance versus a taper-followed-by-placebo strategy. No new estimate is made of a pure effect among people who completely stopped, inevitable relapse, or the proportion without relapse and without restarting.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Causal or temporal analysis by actual exposure, crossover, rescue treatment and denominators remains unverified. Review of existing content remains incomplete.", "missingness": "Causal or temporal analysis by actual exposure, crossover, rescue treatment and denominators remains unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials on exposure, crossover and event timing, and the prespecified analysis plan" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "How does primary first relapse differ from symptom worsening and withdrawal?", "needed": "Event definitions for first relapse within 52 weeks, symptom instruments and withdrawal", "role": "Required", "role_reason": "Production item to distinguish Event definitions for first relapse within 52 weeks, symptom instruments and withdrawal and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Event definitions for first relapse within 52 weeks, symptom instruments and withdrawal must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials distinguishing events from symptoms and recurrent outcomes are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ANTLER's primary endpoint is time to first depression relapse within 52 weeks, and the parent describes relapse assessed using a symptom scale. Withdrawal symptoms, other transient worsening and recurrent episodes are not merged into the same event as relapse or inevitability.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Details of the relapse instrument, threshold, assessment schedule, withdrawal distinction, first event and censoring remain unverified. Review of existing content remains incomplete.", "missingness": "Details of the relapse instrument, threshold, assessment schedule, withdrawal distinction, first event and censoring remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relapse and withdrawal definitions, assessment and adjudication materials, and SAP" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are 478 randomized, 468 in time-to-event analysis and 10 with missing timing related?", "needed": "238 maintenance/240 discontinuation, missing timing in 6/4, and denominator-specific scope", "role": "Required", "role_reason": "Production item to distinguish 238 maintenance/240 discontinuation, missing timing in 6/4, and denominator-specific scope and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for 238 maintenance/240 discontinuation, missing timing in 6/4, and denominator-specific scope must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials linking relapse or no-relapse observations by denominator are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved wording states 478 randomized and 468 in the primary time-to-event analysis, with 10 lacking timing (6 maintenance/4 discontinuation) excluded from the primary analysis but included in absolute relapse counts. Missing-data participants are not newly classified as all having relapsed or all having had no relapse.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Exact timing, reasons for missingness, individual exposure and censoring for the 10 participants, and follow-up details for those without relapse remain unverified. Review of existing content remains incomplete.", "missingness": "Exact timing, reasons for missingness, individual exposure and censoring for the 10 participants, and follow-up details for those without relapse remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Flow diagram and records of events, missing timing and follow-up" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do best- and worst-case missing-data assumptions test relapse in everyone?", "needed": "Distinguishing the original direction of sensitivity analyses from the inevitability question", "role": "Required", "role_reason": "Production item to distinguish Distinguishing the original direction of sensitivity analyses from the inevitability question and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Distinguishing the original direction of sensitivity analyses from the inevitability question must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate materials on sensitivity of arm comparisons and individual inevitability are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original statement that best- and worst-case missing-data analyses remained in the same direction concerns the arm comparison. It is not converted into relapse in everyone, individual discontinuation outcomes, or resolution of all missing-data bias.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual values, CIs and denominators under each assumption, pathways without relapse and temporal materials remain unverified. Review of existing content remains incomplete.", "missingness": "Actual values, CIs and denominators under each assumption, pathways without relapse and temporal materials remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sensitivity tables, assumptions and prespecified plan" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the discontinuation-versus-maintenance HR 2.06 a probability of inevitability?", "needed": "Separate units for HR, CI, P, event proportions and individual probabilities", "role": "Required", "role_reason": "Production item to distinguish Separate units for HR, CI, P, event proportions and individual probabilities and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Separate units for HR, CI, P, event proportions and individual probabilities must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials linking comparative estimands and individual prediction are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original discontinuation-versus-maintenance HR 2.06 (1.56~2.70), P<.001 is a time-to-event comparison. It is not changed into a value meaning 100% probability of relapse or relapse in a particular person. No maintenance-versus-discontinuation reciprocal, new RR or effect is calculated.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Model, censoring, proportional hazards, individual prediction and CIs for absolute outcomes remain unverified. Review of existing content remains incomplete.", "missingness": "Model, censoring, proportional hazards, individual prediction and CIs for absolute outcomes remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original HR model and SAP, and individual prediction materials" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "What gaps do withdrawal symptoms and awareness of allocation leave in an inevitability interpretation?", "needed": "Original scope of 12-week modified DESS, possible misclassification and allocation awareness", "role": "Required", "role_reason": "Production item to distinguish Original scope of 12-week modified DESS, possible misclassification and allocation awareness and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Original scope of 12-week modified DESS, possible misclassification and allocation awareness must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials distinguishing withdrawal from relapse and recording allocation awareness are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved wording gives 12-week DESS means of 3.1 versus 1.3, the original difference of 1.9 (1.5~2.3), and greater awareness of allocation in the discontinuation group. Some withdrawal may have been misclassified as relapse, but the magnitude is undetermined. No new conclusion is made that all relapse was withdrawal.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Misclassified cases, original model and denominators, allocation-guessing figures, and temporal relationships between withdrawal and relapse remain unverified. Review of existing content remains incomplete.", "missingness": "Misclassified cases, original model and denominators, allocation-guessing figures, and temporal relationships between withdrawal and relapse remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Withdrawal and relapse items, original tables, masking and adjudication records" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is 39% relapse during maintenance a different question from inevitability after discontinuation?", "needed": "Boundary between the other arm's result and the related complete-prevention question", "role": "Required", "role_reason": "Production item to distinguish Boundary between the other arm's result and the related complete-prevention question and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Boundary between the other arm's result and the related complete-prevention question must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials separating average reduction, complete prevention and inevitability claims are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent and related wording that 39% relapsed despite maintenance concerns the complete-prevention question. It is not transferred to the denominator of ‘discontinuation inevitably causes relapse’ or to relapse outcomes for other individuals.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Individual pathways during maintenance or discontinuation and original subgroup prediction materials remain unverified. Review of existing content remains incomplete.", "missingness": "Individual pathways during maintenance or discontinuation and original subgroup prediction materials remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual courses by arm and direct materials for the separate question" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does absence of relapse within 52 weeks certify lifelong freedom from relapse or safe discontinuation?", "needed": "Actual observation period and gaps beyond observation or in individual safety", "role": "Required", "role_reason": "Production item to distinguish Actual observation period and gaps beyond observation or in individual safety and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Actual observation period and gaps beyond observation or in individual safety must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate materials on gaps beyond the time or individual scope are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The 44% without relapse is original observational wording within 52 weeks. It is not extended to lifelong freedom from relapse, safe discontinuation for every person or a guarantee of individual treatment choice. The original account states that the trial did not identify who could discontinue safely.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Long-term follow-up, individual risk, withdrawal, restarting and other safety outcomes remain unverified. Review of existing content remains incomplete.", "missingness": "Long-term follow-up, individual risk, withdrawal, restarting and other safety outcomes remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up beyond observation and individual prediction or safety materials" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can those who will remain without relapse be identified beforehand?", "needed": "Distinguishing group comparisons from validated individual prediction and subgroup information", "role": "Required", "role_reason": "Production item to distinguish Distinguishing group comparisons from validated individual prediction and subgroup information and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Distinguishing group comparisons from validated individual prediction and subgroup information must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate materials linking average effects and individual prediction are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved wording states that ANTLER reported average relapse reduction and did not distinguish people who could discontinue safely. No individual prediction rule is created from original drug, history or duration conditions alone.", "condition_status": "Unverified", "status_reason": "The information currently required remains unverified in the preserved summary. Validated individual models, prespecified subgroups and external validation in other populations remain unverified in these authoring materials. Review of existing content remains incomplete.", "missingness": "Validated individual models, prespecified subgroups and external validation in other populations remain unverified in these authoring materials.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual prediction, prespecified subgroup or external-population materials, if supplied" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the NEJM and HTA citations independent trials?", "needed": "Relationship between the same ANTLER trial, the first evidence record, and the main and detailed reports", "role": "Required", "role_reason": "Production item to distinguish Relationship between the same ANTLER trial, the first evidence record, and the main and detailed reports and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Relationship between the same ANTLER trial, the first evidence record, and the main and detailed reports must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials on multiple-report relationships within the same trial are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "S01 NEJM PMID34587384 and S02 NIHR HTA PMID34842135 report the same ANTLER trial. They share the first evidence record's 478 and 468 participants and withdrawal, adherence and missing-data results. The two reports are not counted as 2 independent trials or two participant populations.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Original tables, analyses and correspondence between the two reports remain externally unread. Review of existing content remains incomplete.", "missingness": "Original tables, analyses and correspondence between the two reports remain externally unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Linkage table for shared results and trial registration across the two reports" }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do average meta-analysis results directly answer ‘inevitably’?", "needed": "Differences between Kato's 40 trials and 8890 participants, proportions or OR, and the actual original question", "role": "Required", "role_reason": "Production item to distinguish Differences between Kato's 40 trials and 8890 participants, proportions or OR, and the actual original question and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Differences between Kato's 40 trials and 8890 participants, proportions or OR, and the actual original question must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.4: in-house extension boundaries.", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials separating pooled averages from claims about every person or individual are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Kato's maintenance result of 20.9% versus placebo 39.7%, OR .38 (.33~.43), P<.00001 synthesizes varied maintenance trials. An average relapse difference is not transferred to direct evidence that every person relapses after stopping. The preserved wording that does not count it as an independent replication of ANTLER's primary-care decision is retained.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Periods, populations, events, inclusion denominators, overlap, individual prediction and heterogeneity remain unverified. Review of existing content remains incomplete.", "missingness": "Periods, populations, events, inclusion denominators, overlap, individual prediction and heterogeneity remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Inclusion and exclusion tables, trial characteristics, periods, denominators and individual materials" }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do people and reports overlap across the review, ANTLER and related sheets?", "needed": "Shared preserved summary, two subclaim sheets, and report, trial and synthesis relationships", "role": "Required", "role_reason": "Production item to distinguish Shared preserved summary, two subclaim sheets, and report, trial and synthesis relationships and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Shared preserved summary, two subclaim sheets, and report, trial and synthesis relationships must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Records of material families and overlap relationships are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This sheet shares the same ANTLER trial and review summary as the 52-week relapse-reduction sheet; NEJM and HTA report the same trial. The 40 trials with 8890 participants, 478 participants and two sheets or reports are not added as independent trials or total participants.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Unique clinical totals and review inclusion or overlap relationships are not established and remain unrecorded. Review of existing content remains incomplete.", "missingness": "Unique clinical totals and review inclusion or overlap relationships are not established and remain unrecorded.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial, report, population and review inclusion lists, if supplied" }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Have registration and prespecified endpoints actually been read?", "needed": "Original ISRCTN/EudraCT identifiers and unread registration or plans", "role": "Required", "role_reason": "Production item to distinguish Original ISRCTN/EudraCT identifiers and unread registration or plans and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Original ISRCTN/EudraCT identifiers and unread registration or plans must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Links between prespecified plans, versions and reports are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ANTLER's ‘ISRCTN15969819 · EudraCT2015-004210-26’ is preserved unchanged. Kato's ‘Not applicable’ is preserved review wording. Identifiers or wording alone do not establish that registration or plans were read, or that prespecified individual prediction was validated.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Registration amendment history, protocol, SAP, subgroup and missing-data plans remain unread; access was not attempted. Review of existing content remains incomplete.", "missingness": "Registration amendment history, protocol, SAP, subgroup and missing-data plans remain unread; access was not attempted.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration or plan copies, or user-supplied materials" }, { "item_id": "N21", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do public support and unreported product or COI information certify independence?", "needed": "NIHR, PRIMENT, UCL, product provision, employees, conflicts of interest and review funding", "role": "Required", "role_reason": "Production item to distinguish NIHR, PRIMENT, UCL, product provision, employees, conflicts of interest and review funding and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for NIHR, PRIMENT, UCL, product provision, employees, conflicts of interest and review funding must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials on funding, support types and actual roles are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "ANTLER's NIHR HTA 13/115/48, PRIMENT core support and UCL sponsor, and Kato's Japanese research grants are preserved unchanged. The historical wording that neither report described donated trial drug or placebo is not changed into actual absence or certification of independence in this work.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Support and product contracts, employee authors, conflicts of interest, study and manuscript roles, and support for included trials in the review remain unverified. Review of existing content remains incomplete.", "missingness": "Support and product contracts, employee authors, conflicts of interest, study and manuscript roles, and support for included trials in the review remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials on support, provision, authors, contributions and conflicts of interest" }, { "item_id": "N22", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are withdrawal, serious events and absence of relapse the same safety outcome?", "needed": "Scope of harm collection, 12-week withdrawal, 9/8 participants and 0 deaths or suicide attempts", "role": "Supplementary", "role_reason": "Production item to distinguish Scope of harm collection, 12-week withdrawal, 9/8 participants and 0 deaths or suicide attempts and link the materials required for the selected question to currently available materials.", "application_exception": "Addresses gaps in withdrawal and safety materials for the selected relapse question. Relapse, absence of relapse or original safety wording is not used to assess overall safety or an individual's ability to discontinue, or to generate harm incidence or guidance on maintenance, discontinuation, tapering, dosing or treatment.", "criterion": "Relevant original materials and analysis scope for Scope of harm collection, 12-week withdrawal, 9/8 participants and 0 deaths or suicide attempts must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. M19 principles are referenced; no official causality tool was executed", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Materials separating absence of relapse from other harm outcomes are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original serious adverse events of 9 maintenance participants (4%)/8 discontinuation participants (3%), 0 deaths or suicide attempts in both groups, and increased withdrawal at 12 weeks are recorded separately. Absence of relapse is not converted into no adverse effects, safe discontinuation or 0 long-term harm.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Event definitions, collection, safety denominators, exposure, follow-up, CIs and long-term or drug-specific harms remain unverified. Review of existing content remains incomplete.", "missingness": "Event definitions, collection, safety denominators, exposure, follow-up, CIs and long-term or drug-specific harms remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific safety, withdrawal, exposure, denominator and follow-up materials" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does this answer questions about other drugs, abrupt stopping or new treatment settings?", "needed": "Original four drugs, study taper, remission, long-term use and questions outside that scope", "role": "Required", "role_reason": "Production item to distinguish Original four drugs, study taper, remission, long-term use and questions outside that scope and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Original four drugs, study taper, remission, long-term use and questions outside that scope must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate questions and material scopes by exposure and population are proposed; no new investigation, calculation or trial was conducted.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original materials' four drugs, specified doses and study taper over 1~2 months are historical exposure. No new verdict is made on inevitability after abrupt stopping, other drugs or doses, acute treatment, other diseases or ages, or every treatment setting.", "condition_status": "Partly verified", "status_reason": "Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Direct relapse and safety materials under conditions outside the scope remain unverified. Review of existing content remains incomplete.", "missingness": "Direct relapse and safety materials under conditions outside the scope remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials under separate conditions, if supplied" }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "What preserved summaries and external materials have actually been read?", "needed": "Preserved summary, original NEJM/HTA/Kato URLs and unread external materials", "role": "Required", "role_reason": "Production item to distinguish Preserved summary, original NEJM/HTA/Kato URLs and unread external materials and link the materials required for the selected question to currently available materials.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original materials and analysis scope for Preserved summary, original NEJM/HTA/Kato URLs and unread external materials must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. 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No new proportions, differences, individual probabilities, reciprocals, effects, CIs or grades are calculated.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. 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Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 NEJM/Lewis2021 PMID34587384 is the main ANTLER report. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S02 NIHR HTA/Duffy2021 PMID34842135 is a detailed report of the same ANTLER trial. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S03 Kato2021 PMID32704061 is a meta-analysis of 40 trials with 8,890 participants comparing maintenance with switching to placebo after various acute treatments. The original wording that does not count it as an independent replication of ANTLER's long-term primary-care discontinuation decision is preserved. Inclusion, overlap, timing and unique trial totals remain unverified; participants in the review, ANTLER and related sheets are not added together. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-10" }