{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2937-s0", "verdict_number": "2937", "title": "Antidepressant maintenance × reduced depression relapse within 52 weeks after remission: 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 or improvement who were considering discontinuation and had at least 2 previous episodes or at least 2 years of treatment", "intervention": "Long-term maintenance of the original four drugs versus a study taper over 1–2 months followed by matching placebo; historical study exposure", "dose": null, "comparator": "ANTLER: 238 participants in maintenance versus 240 in taper followed by placebo; actual exposure, adherence and restarting recorded separately", "endpoint": "Time to first depression relapse within 52 weeks; original absolute relapse counts, proportions and difference recorded separately", "duration": "First relapse within 52 weeks; withdrawal at 12 weeks recorded separately", "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": "How do the selected 52-week relapse-reduction record and parent values differ?", "needed": "Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict.", "role": "Required", "role_reason": "Production item to distinguish Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict 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 preservation of subclaim B/note and absent values, and parent B70, axes and verdict 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 question-clarification principles; detailed separation rules 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. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Separate source records for the selected question and parent verdict; 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 ‘Reduced depression relapse by 52 weeks’, with original grade B and note ‘39% versus 56%, absolute difference 17%p’. Score, status and axes are absent. Parent B70, Caution and original axes including R1/I2 and E+ are parent verdict context.", "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 grade or score is written. Review of existing content remains incomplete.", "missingness": "Subclaim score, status and axes were originally absent; no new grade or score 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 subclaim or user comments." }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "Who were the long-term antidepressant users in ANTLER?", "needed": "Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions.", "role": "Required", "role_reason": "Production item to distinguish Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment 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 Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions 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'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: Linking actual eligibility conditions to relapse materials; 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 who felt well enough to consider stopping were recruited at 150 UK general practices. Original conditions included at least 2 previous depressive episodes or at least 2 years of treatment, and long-term use of four antidepressants.", "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 and eligibility criteria, symptom thresholds, age and baseline characteristics, exclusions and representativeness are unverified. Review of existing content remains incomplete.", "missingness": "Exact remission and eligibility criteria, symptom thresholds, age and baseline characteristics, exclusions and representativeness are 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 recruitment flow" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What study exposure was compared between maintenance and tapering to placebo?", "needed": "Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance.", "role": "Required", "role_reason": "Production item to distinguish Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance 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 the four drugs, maintenance, tapering to placebo and matching appearance 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: Distinguishing study allocation conditions from actual exposure; 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 assigned users of original specified doses of citalopram, fluoxetine, sertraline or mirtazapine to maintenance or matching placebo after a 1–2-month taper. Drugs and periods are historical trial conditions, not instructions for taking or tapering medication.", "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 denominators by drug, adherent exposure, individual taper trajectories and concomitant treatment are unverified. Review of existing content remains incomplete.", "missingness": "Actual denominators by drug, adherent exposure, individual taper trajectories and concomitant treatment are 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": "Actual exposure by arm, concomitant treatment and baseline tables by drug." }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What were the actual randomization and masking procedures?", "needed": "Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking.", "role": "Required", "role_reason": "Production item to distinguish Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking 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 Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; 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: Documenting design, measurement and allocation awareness; 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 multicenter double-blind placebo-controlled superiority RCT randomized 478 participants to maintenance, 238, or tapering to placebo, 240, using matching tablets.", "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. Allocation generation and concealment, assessor masking, and numbers, timing and procedures for allocation guesses are unverified. Review of existing content remains incomplete.", "missingness": "Allocation generation and concealment, assessor masking, and numbers, timing and procedures for allocation guesses are 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": "Allocation and masking procedures, and allocation-guess results." }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "Was the primary endpoint time to first relapse or an event proportion?", "needed": "Time to first relapse within 52 weeks, original events and participants, and separation from repeated events.", "role": "Required", "role_reason": "Production item to distinguish Time to first relapse within 52 weeks, original events and participants, and separation from repeated events 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 Time to first relapse within 52 weeks, original events and participants, and separation from repeated events 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 result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; 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: Separating first events from symptoms and repeated events; 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 primary endpoint was time to first depression relapse within 52 weeks. 92/238 and 135/240 are absolute relapse counts, not total repeated relapses or mean symptom-scale scores.", "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 first-relapse symptom instrument, diagnostic threshold, assessment schedule, repeated events and censoring rules are unverified. Review of existing content remains incomplete.", "missingness": "Details of the first-relapse symptom instrument, diagnostic threshold, assessment schedule, repeated events and censoring rules are 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 definition, assessment schedule, endpoints and SAP." }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which arms do the absolute relapse counts, proportions and difference represent?", "needed": "Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p.", "role": "Required", "role_reason": "Production item to distinguish Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p 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 Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p 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 adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; 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: Linking events, denominators and absolute-effect intervals; 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 maintenance 92/238 (39%) versus discontinuation after tapering 135/240 (56%) and absolute difference 17%p are preserved. No new proportion, difference, NNT or individual risk 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. Original CI for the absolute difference, events and missingness by timepoint, and interval-estimation models are unverified. Review of existing content remains incomplete.", "missingness": "Original CI for the absolute difference, events and missingness by timepoint, and interval-estimation models are 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 absolute results and CI, with populations by timepoint." }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which comparison direction does HR 2.06 represent?", "needed": "Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions.", "role": "Required", "role_reason": "Production item to distinguish Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions 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 Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions 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; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations 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: Distinguishing comparison direction and model; 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": "Discontinuation-versus-maintenance HR 2.06 (95% CI 1.56–2.70), P<.001 is the original time-to-event estimate. 39%/56% and 17%p are different measures. HR is not inverted to maintenance versus discontinuation or renamed a risk ratio or individual probability.", "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 covariates, proportional-hazards assumptions, censoring and the exact analysis specification are unverified. Review of existing content remains incomplete.", "missingness": "Model covariates, proportional-hazards assumptions, censoring and the exact analysis specification are 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": "Time-to-event analysis tables, SAP and censoring records." }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do the 478 randomized participants differ from the 468 in the time-to-event analysis?", "needed": "Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm.", "role": "Required", "role_reason": "Production item to distinguish Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm 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 Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm 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: Linking absolute-event and time-to-event denominators; 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": "Of 478 randomized participants, 10 without relapse timing, 6 maintenance and 4 discontinuation, were excluded from the primary time-to-event analysis, leaving 468. The original statement that they remained in absolute relapse counts is preserved.", "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 timing and status of the 10 participants, missingness reasons, analysis denominators by arm and follow-up ending details are unverified. Review of existing content remains incomplete.", "missingness": "Actual timing and status of the 10 participants, missingness reasons, analysis denominators by arm and follow-up ending details are 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": "Participant flow, missingness and analysis populations, and relapse-timing materials." }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "What scope is supported by missing-data sensitivity analyses?", "needed": "Original direction under best- and worst-case assumptions and specific estimates.", "role": "Required", "role_reason": "Production item to distinguish Original direction under best- and worst-case assumptions and specific estimates 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 direction under best- and worst-case assumptions and specific estimates 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: Documenting results and precision under each missingness assumption; 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 states that best- and worst-case missing-data sensitivity analyses remained directionally consistent. This statement is not substituted for absence of all missingness or censoring bias, or new numbers.", "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. Events, denominators, HR, CI, models and sensitivity values under each assumption are unverified. Review of existing content remains incomplete.", "missingness": "Events, denominators, HR, CI, models and sensitivity values under each assumption are 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-analysis tables, assumptions and SAP." }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do adherence of 70%/52% and restarting of 39% relate to the allocation effect?", "needed": "Definitions and timing of allocation, actual exposure, adherence and restarting.", "role": "Required", "role_reason": "Production item to distinguish Definitions and timing of allocation, actual exposure, adherence and restarting 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 Definitions and timing of allocation, actual exposure, adherence and restarting 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; 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: Linking allocation to actual exposure and rescue treatment; 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 are adherence of 70% in maintenance and 52% in discontinuation, and 39% of the discontinuation group restarting a clinician-prescribed antidepressant before trial end. The allocation comparison is not changed to a pure exposure effect of complete discontinuation versus complete maintenance.", "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. Adherence definition and measurement, restart timing and reasons, treatment–relapse timing and actual-exposure analyses are unverified. Review of existing content remains incomplete.", "missingness": "Adherence definition and measurement, restart timing and reasons, treatment–relapse timing and actual-exposure analyses are 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": "Adherence and restarting records, timing materials and analysis plans." }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "How were withdrawal symptoms distinguished from depression relapse?", "needed": "Instruments, symptom overlap, timing, classification and misclassification scope.", "role": "Required", "role_reason": "Production item to distinguish Instruments, symptom overlap, timing, classification and misclassification 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 Instruments, symptom overlap, timing, classification and misclassification 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, 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: Separating measurement and timing of withdrawal and relapse; 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": "Withdrawal was greater at 12 weeks in the discontinuation group. Original modified DESS means 3.1 versus 1.3 and between-arm difference 1.9 (95% CI 1.5–2.3) are recorded. The original retains possible partial misclassification of withdrawal as relapse and allocation awareness, without establishing their magnitude.", "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. Relapse and withdrawal classification criteria, case assessment, misclassification magnitude and separate analyses are unverified. Review of existing content remains incomplete.", "missingness": "Relapse and withdrawal classification criteria, case assessment, misclassification magnitude and separate analyses are 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": "DESS and relapse items, schedule, original analysis tables and assessment rules." }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can DESS means and the between-arm difference be turned into the same arithmetic value?", "needed": "Estimation specification for original means 3.1/1.3, difference 1.9 and CI.", "role": "Required", "role_reason": "Production item to distinguish Estimation specification for original means 3.1/1.3, difference 1.9 and CI 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 Estimation specification for original means 3.1/1.3, difference 1.9 and CI 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: Linking estimation specifications for each reported value; 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 modified DESS means 3.1/1.3 and between-arm difference 1.9 (1.5–2.3) are preserved unchanged. The difference is not recalculated from the means, and original values are not corrected.", "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. Adjustment, rounding, analysis populations and original-table details for the means and difference are unverified. Review of existing content remains incomplete.", "missingness": "Adjustment, rounding, analysis populations and original-table details for the means and difference are 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 DESS tables, models, denominators and summary-value definitions." }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "How does the difference in allocation awareness relate to relapse assessment?", "needed": "Maintained masking, timing of awareness and unverified measurement-bias magnitude.", "role": "Required", "role_reason": "Production item to distinguish Maintained masking, timing of awareness and unverified measurement-bias magnitude 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 Maintained masking, timing of awareness and unverified measurement-bias magnitude 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", "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: Documenting allocation awareness and outcome measurement; 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 discontinuation participants guessed allocation more often is preserved. It is not newly established as the cause of every relapse difference, a bias magnitude or invalidation of the trial.", "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. Guess proportions, timing, assessor awareness and analyses involving withdrawal and relapse are unverified. Review of existing content remains incomplete.", "missingness": "Guess proportions, timing, assessor awareness and analyses involving withdrawal and relapse are 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": "Allocation-guess results, assessor masking and related analyses." }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does relapse defined by a symptom instrument also answer other clinical-outcome questions?", "needed": "Relapse definition separated from suicide, function, hospitalization and other outcomes.", "role": "Required", "role_reason": "Production item to distinguish Relapse definition separated from suicide, function, hospitalization and other outcomes 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 Relapse definition separated from suicide, function, hospitalization and other outcomes 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; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome 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: Linking selected relapse to separate clinical outcomes; 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 describes relapse assessed through a depression symptom scale as a patient-important treatment target. This is not moved to all depressive symptoms, function, hospitalization or suicide-prevention outcomes.", "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. Scale details, clinical diagnosis, function, hospitalization and effects for other endpoints are unverified. Review of existing content remains incomplete.", "missingness": "Scale details, clinical diagnosis, function, hospitalization and effects for other endpoints are 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 definitions and clinical and functional result tables." }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does the 52-week benefit describe later persistence or lifetime risk?", "needed": "Actual observation period, outcomes outside observation and subgroups by drug.", "role": "Required", "role_reason": "Production item to distinguish Actual observation period, outcomes outside observation and subgroups by drug 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, outcomes outside observation and subgroups by drug 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 follow-up materials by period and condition; 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 question is first relapse within 52 weeks. Original values are not used to fill in long-term remission, later relapse, drug- or episode-specific effects, or lifetime effects of continuing maintenance.", "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. Follow-up beyond 52 weeks, prespecified subgroups and results by drug, episodes or treatment duration are unverified. Review of existing content remains incomplete.", "missingness": "Follow-up beyond 52 weeks, prespecified subgroups and results by drug, episodes or treatment duration are 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": "Long-term follow-up and subgroup plans, with direct results." }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "How does average relapse reduction differ from prevention for everyone or inevitable relapse?", "needed": "Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction.", "role": "Required", "role_reason": "Production item to distinguish Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction 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 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction 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; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundary", "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: Distinguishing individual prediction from arm comparisons; 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 statements are that 39% relapsed despite maintenance and 44% of discontinuation participants did not relapse within 52 weeks. An average between-arm difference is not changed to every individual's outcome or inevitable relapse after 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. Validated individual predictions of who will or will not relapse under which conditions are unverified in these materials. Review of existing content remains incomplete.", "missingness": "Validated individual predictions of who will or will not relapse under which conditions are unverified in these 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 models and validation in external populations or periods, if supplied." }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which reports of the same trial are NEJM and NIHR HTA?", "needed": "Shared relationships among reports, trial, population and the two bibliographic records and URLs.", "role": "Required", "role_reason": "Production item to distinguish Shared relationships among reports, trial, population and the two bibliographic records and URLs 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 relationships among reports, trial, population and the two bibliographic records and URLs 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: Linking main and detailed reports of the same trial; 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": "NEJM PMID 34587384 and NIHR HTA PMID 34842135 report the same ANTLER trial. The first evidence-list record groups them; HTA is an existing citation providing detailed design, missingness, withdrawal and adherence reporting. They are not counted as two separate trials of 478 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. Direct mapping of report-specific tables and analyses to shared results remains externally unread. Review of existing content remains incomplete.", "missingness": "Direct mapping of report-specific tables and analyses to shared results remains 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": "The two original reports, result tables and a trial-registry relationship table." }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the Kato meta-analysis an independent replication of the same question?", "needed": "Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions.", "role": "Required", "role_reason": "Production item to distinguish Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER 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 Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions 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: Linking different maintenance questions to synthesis materials; 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 synthesizes 40 maintenance-versus-placebo-switch trials involving 8,890 participants. Maintenance 20.9% versus 39.7%, OR .38 (95% CI .33–.43), P<.00001 provide directionally consistent context. The original statement that heterogeneous post-acute maintenance trials were not counted as independent replication of the long-term primary-care discontinuation decision is preserved.", "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. Included trial lists, populations, periods, drugs, overlap, timepoint-specific links to ANTLER and heterogeneity are unverified. Review of existing content remains incomplete.", "missingness": "Included trial lists, populations, periods, drugs, overlap, timepoint-specific links to ANTLER and heterogeneity are 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": "Review inclusion and exclusion tables, trial characteristics, endpoints and denominators." }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do the review's proportions and OR differ from ANTLER HR and difference?", "needed": "Endpoints, denominators and directions for proportions, OR, HR and absolute difference.", "role": "Required", "role_reason": "Production item to distinguish Endpoints, denominators and directions for proportions, OR, HR and absolute difference 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 Endpoints, denominators and directions for proportions, OR, HR and absolute difference 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 internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; 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: Separating measures, periods and estimands; 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": "Kato maintenance 20.9%/placebo 39.7%, OR .38 (.33–.43), and ANTLER discontinuation-versus-maintenance HR 2.06 and 17%p are each original estimates. They are not divided, inverted, combined into a new pooled effect or changed to incidence for the same 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. Actual denominators, periods, event definitions, models and weights for each analysis, and absolute-difference CI are unverified. Review of existing content remains incomplete.", "missingness": "Actual denominators, periods, event definitions, models and weights for each analysis, and absolute-difference CI are 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": "Meta-analysis results, denominators and models, and individual trial tables." }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the same participants, two sheets and review kept from being added together?", "needed": "Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review.", "role": "Required", "role_reason": "Production item to distinguish Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review 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 Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review 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: Recording report families and overlap; 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 and the ‘Discontinuation inevitably causes relapse’ sheet share the same parent summary and ANTLER reports and population. NEJM/HTA are not counted as duplicate trials, and 478 and 8,890 participants are not added as a total.", "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 trial, participant and independent-replication totals are unconfirmed and unrecorded. Review of existing content remains incomplete.", "missingness": "Unique trial, participant and independent-replication totals are unconfirmed and 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 and population relationships and review inclusion relationships, if supplied." }, { "item_id": "N21", "question_type": "Efficacy comparison and presentation of stored material", "question": "What public support and sponsor did ANTLER have, and what remains unverified?", "needed": "NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles.", "role": "Required", "role_reason": "Production item to distinguish NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles 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 and UCL, separated from products, employees, conflicts of interest and roles 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: Separating funding from actual research roles; 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 funding was NIHR HTA award 13/115/48 and NIHR core support for PRIMENT CTU; UCL was the sponsor. Public support is not changed to absence of all company involvement, employee authors or conflicts of interest, or current certification of independence.", "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. Specific research, analysis and manuscript roles, authors and conflicts of interest, and other support remain externally unread. Review of existing content remains incomplete.", "missingness": "Specific research, analysis and manuscript roles, authors and conflicts of interest, and other support 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": "Funding and sponsor roles, authors, conflicts of interest and contribution declarations." }, { "item_id": "N22", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does unreported free trial-drug or placebo provision mean no provision occurred?", "needed": "Historical statements of unreported provision, separated from unverified actual product support.", "role": "Required", "role_reason": "Production item to distinguish Historical statements of unreported provision, separated from unverified actual product support 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 statements of unreported provision, separated from unverified actual product support must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules 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: Separately documenting support types and actual roles; 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 states that donated pharmaceutical-company trial drugs or placebo were not described in NEJM or NIHR HTA. Neither external report was read during this work, and non-reporting is not asserted to mean no actual support.", "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. Supply, purchase and manufacturing contracts, free support, companies, employee authors and conflicts of interest are unverified. Review of existing content remains incomplete.", "missingness": "Supply, purchase and manufacturing contracts, free support, companies, employee authors and conflicts of interest are 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": "Drug and placebo supply contracts, product support, authors and conflicts-of-interest materials." }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "What scope of independence information does public funding of the review provide?", "needed": "Japanese research grants for the review, separated from funding and conflicts of interest in included trials.", "role": "Required", "role_reason": "Production item to distinguish Japanese research grants for the review, separated from funding and conflicts of interest in included trials 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 Japanese research grants for the review, separated from funding and conflicts of interest in included trials 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: Linking independence materials for synthesis and individual trials; 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 original Ministry of Health, Labour and Welfare of Japan grants H29-SEISHIN-ippan-001 and 19GC1012 are preserved. Review funding and included trials' funding, products, authors and conflicts of interest are different items.", "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 review roles and conflicts of interest, and company, product and employee relationships in each included trial are unverified. Review of existing content remains incomplete.", "missingness": "Actual review roles and conflicts of interest, and company, product and employee relationships in each included trial are 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": "Funding, roles and conflicts-of-interest materials for the review and included trials." }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "At what level are registry identifiers and actual prespecified endpoints and plans recorded?", "needed": "Original ISRCTN and EudraCT identifiers, plans and amendment histories.", "role": "Required", "role_reason": "Production item to distinguish Original ISRCTN and EudraCT identifiers, plans and amendment histories 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 and EudraCT identifiers, plans and amendment histories must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.", "basis": "Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal 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: Linking registry and plan versions by report; 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": "Original ANTLER registry identifiers are ‘ISRCTN15969819 · EudraCT 2015-004210-26’. Preserving the two identifiers is separate from reading the actual registry, protocol or SAP; Kato's ‘Not applicable’ is original wording.", "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. Registry source text, amendments, prespecified endpoints, analysis and missing-data plans remain unread; access was not attempted. Review of existing content remains incomplete.", "missingness": "Registry source text, amendments, prespecified endpoints, analysis 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": "Registry, protocol and SAP copies or user-provided materials." }, { "item_id": "N25", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What outcomes do serious adverse events, deaths and suicide attempts represent?", "needed": "Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms.", "role": "Supplementary", "role_reason": "Production item to distinguish Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms 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 Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms 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", "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: Linking event-specific safety materials and precision; 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 occurred in 9 maintenance participants (4%) versus 8 discontinuation participants (3%). Deaths and suicide attempts were 0 in both arms. Zero events are not changed to zero risk, long-term safety or treatment guidance.", "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. Safety denominators, collection and assessment, exposure, follow-up, censoring, CI, and rare and long-term harms are unverified. Review of existing content remains incomplete.", "missingness": "Safety denominators, collection and assessment, exposure, follow-up, censoring, CI, and rare and long-term harms are 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": "Safety tables, collection, exposure, follow-up and denominators." }, { "item_id": "N26", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are safety, relapse and withdrawal different measurements?", "needed": "Collection, timepoints and occurrence units for serious events, withdrawal and relapse.", "role": "Supplementary", "role_reason": "Production item to distinguish Collection, timepoints and occurrence units for serious events, withdrawal and relapse 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 Collection, timepoints and occurrence units for serious events, withdrawal and relapse 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; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed; 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: Separating event and symptom measurements by endpoint; 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": "Withdrawal symptoms at 12 weeks, first relapse by 52 weeks, and serious adverse events, deaths and suicide attempts are different endpoints. Statements about increased withdrawal and reduced relapse are not newly combined into a single safety or efficacy score.", "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. Harm-collection definitions, periods, populations and adverse-effect materials by other drugs are unverified. Review of existing content remains incomplete.", "missingness": "Harm-collection definitions, periods, populations and adverse-effect materials by other drugs are 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 original safety, withdrawal and relapse tables and timing materials." }, { "item_id": "N27", "question_type": "Efficacy comparison and presentation of stored material", "question": "To whom can the result generalize, and what lies outside its scope?", "needed": "Boundaries between long-term primary-care users in remission considering discontinuation and other situations.", "role": "Required", "role_reason": "Production item to distinguish Boundaries between long-term primary-care users in remission considering discontinuation and other situations 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 Boundaries between long-term primary-care users in remission considering discontinuation and other situations 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: Recording evidence gaps by population, exposure and period; 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": "Selected materials concern the original 52-week comparison in long-term users, adults in remission considering discontinuation. This trial does not establish effects for newly started acute treatment, other drugs or doses, abrupt stopping, lifetime maintenance or individually safe 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. Direct materials for other populations, exposures, periods and individual prediction are unverified. Review of existing content remains incomplete.", "missingness": "Direct materials for other populations, exposures, periods and individual prediction are 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 for the separate question, if provided" }, { "item_id": "N28", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are actual summary reading and external-material access labeled?", "needed": "Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest.", "role": "Required", "role_reason": "Production item to distinguish Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest 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 Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest 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. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Recording acquisition, reading and versions by material; 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": "The full preserved summary was read for production and labeled ‘Summary read’. External NEJM, HTA, Kato, registry, plan and conflicts-of-interest materials are labeled ‘Unread’. URLs, identifiers and historical statements of full-text review alone do not upgrade reading status.", "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. External abstracts, full texts, registries, protocols and SAP remain unread; external link and click tests were not conducted. Review of existing content remains incomplete.", "missingness": "External abstracts, full texts, registries, protocols and SAP remain unread; external link and click tests were not conducted.", "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": "User-provided original materials and actual reading records." }, { "item_id": "N29", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are original Korean and English texts, dates, corrections and empty values preserved?", "needed": "Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values.", "role": "Required", "role_reason": "Production item to distinguish Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values 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 Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values 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 question-clarification principles; detailed separation rules 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. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Linking original versions and dates to production content; 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": "The full summary's parent B70, original axes with unrecorded precision and false values, Caution, Korean and English texts, 2026-08-26, empty corrections and empty deliberation are preserved. Subclaim B/note and absent score, status and axes are distinguished and not filled from parent values.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed. Existing content review remains incomplete.", "missingness": "At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed.", "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": "User comments and original correction materials." }, { "item_id": "N30", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are condition freezing, application and content review separate events?", "needed": "Condition preservation, freezing, application, case production and incomplete content review", "role": "Required", "role_reason": "This production item distinguishes \"Condition preservation, freezing, application, case production and incomplete content review\" to link materials needed for the selected question with the currently available material.", "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 Condition preservation, freezing, application, case production and incomplete content review 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. This is not a record of running official tools or completing content review", "proposed_research": "Proposal: Recording condition and production versions and user revision comments; 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": "Condition preservation, freezing, application, case production and content review are separate records. Existing content review remains incomplete; production-row, report and material counts are not unique trial or participant totals.", "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. Existing content review remains incomplete. Additional content review, testing, screen checks and link tests were not conducted during the original production. Review of existing content remains incomplete.", "missingness": "Existing content review remains incomplete. Additional content review, testing, screen checks and link tests were not conducted during the original production.", "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": "Content-review comments and additional materials." } ], "reports": [ { "report_id": "S01", "title": "Lewis G, Marston L, Duffy L, et al. Maintenance or Discontinuation of Antidepressants in Primary Care. N Engl J Med. 2021;385:1257-1267. PMID: 34587384. 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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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Publisher", "url": "https://doi.org/10.1056/NEJMoa2106356" }, { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34587384/" } ] }, { "report_id": "S02", "title": "Duffy L, Clarke CS, Lewis G, et al. Antidepressant medication to prevent depression relapse in primary care: the ANTLER RCT. Health Technol Assess. 2021;25(69):1-62. PMID: 34842135. DOI: 10.3310/hta25690.", "url": "https://pubmed.ncbi.nlm.nih.gov/34842135/", "report_type": "Multicenter double-blind placebo-controlled superiority RCT", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2937-ANTLER", "independent_replication": null, "observed_result": "Relapse: 92/238 (39%) versus 135/240 (56%); discontinuation versus maintenance HR 2.06 (95% CI 1.56~2.70), P<0.001; absolute difference 17%p. The existing reader answer and subclaim state that 44% of the discontinuation group had no relapse within 52 weeks and that 39% of the maintenance group relapsed. The 10 participants with missing timing were excluded from the primary analysis but included in absolute counts. Adherence of 70%/52%, restarting in 39% of the discontinuation group, and 12-week DESS means of 3.1/1.3 with the original difference of 1.9 (CI 1.5~2.3) are preserved separately. 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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Publisher", "url": "https://doi.org/10.3310/hta25690" }, { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34842135/" } ] }, { "report_id": "S03", "title": "Kato M, Hori H, Inoue T, et al. Discontinuation of antidepressants after remission with antidepressant medication in major depressive disorder: a systematic review and meta-analysis. Mol Psychiatry. 2021;26:118-133. PMID: 32704061. DOI: 10.1038/s41380-020-0843-0.", "url": "https://pubmed.ncbi.nlm.nih.gov/32704061/", "report_type": "Meta-analysis of 40 trials of antidepressant maintenance versus switching to placebo", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "SYN2937-KATO-2021", "independent_replication": null, "observed_result": "Maintenance 20.9% versus switching to placebo 39.7%, OR 0.38 (95% CI 0.33~0.43), P<0.00001. The original proportions, OR and direction are preserved within the scope of this synthesis. This estimand differs from the ANTLER HR and 17%p; no new reciprocal, pooled effect, period-specific incidence, total participant count or individual prediction is generated.", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "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. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "Publisher", "url": "https://doi.org/10.1038/s41380-020-0843-0" }, { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32704061/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. 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 public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }