{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Antidepressant discontinuation × the claim that depression inevitably relapses: evidence checklist",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "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."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the existing verdict on ‘discontinuation inevitably causes relapse’?",
      "needed": "Distinguishing the subclaim's D grade/note from parent B70 and the absence of score, status and axes",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing the subclaim's D grade/note from parent B70 and the absence of score, status and axes and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Distinguishing the subclaim's D grade/note from parent B70 and the absence of score, status and axes must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate source records for the inevitability claim and the parent's average effect are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What period, people and exposure does ‘inevitably’ refer to?",
      "needed": "Distinguishing an all-person or inevitability claim from the actual 52-week taper-to-placebo conditions",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing an all-person or inevitability claim from the actual 52-week taper-to-placebo conditions and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Distinguishing an all-person or inevitability claim from the actual 52-week taper-to-placebo conditions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials separating the claim's time, population and exposure scope are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the 44% without relapse stated directly in the original text?",
      "needed": "Preserving the original no-relapse wording, period and unit of the proportion",
      "role": "Required",
      "role_reason": "Production item to distinguish Preserving the original no-relapse wording, period and unit of the proportion and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Preserving the original no-relapse wording, period and unit of the proportion must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials linking observed absence of relapse with individual courses are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does 56% relapse in the discontinuation group mean ‘inevitably’?",
      "needed": "Distinguishing original 135/240 (56%), 92/238 (39%) and 17%p from inevitability wording",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing original 135/240 (56%), 92/238 (39%) and 17%p from inevitability wording and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Distinguishing original 135/240 (56%), 92/238 (39%) and 17%p from inevitability wording must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate materials on arm comparisons and claims about every person or individual are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do the population and recruitment conditions include every patient with depression?",
      "needed": "Conditions involving 150 practices, long-term medication, remission and 2 episodes/2 years",
      "role": "Required",
      "role_reason": "Production item to distinguish Conditions involving 150 practices, long-term medication, remission and 2 episodes/2 years and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Conditions involving 150 practices, long-term medication, remission and 2 episodes/2 years must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials linking eligibility conditions with individual outcomes are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is study ‘discontinuation’ the same as complete or immediate stopping?",
      "needed": "Historical scope of tapering over 1~2 months, switching to placebo and actual exposure",
      "role": "Required",
      "role_reason": "Production item to distinguish Historical scope of tapering over 1~2 months, switching to placebo and actual exposure and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Historical scope of tapering over 1~2 months, switching to placebo and actual exposure must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials linking allocation conditions with actual behavior are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do 39% restarting and 52% adherence identify those without relapse?",
      "needed": "Relationship between actual exposure or restarting in the discontinuation group and the no-relapse group",
      "role": "Required",
      "role_reason": "Production item to distinguish Relationship between actual exposure or restarting in the discontinuation group and the no-relapse group and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Relationship between actual exposure or restarting in the discontinuation group and the no-relapse group must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials separating absence of relapse in the allocated group from actual exposure pathways are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can individual outcomes after actual stopping be separated from the allocation effect?",
      "needed": "Distinguishing the randomized comparison's estimand from individual and actual-exposure effects",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing the randomized comparison's estimand from individual and actual-exposure effects and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Distinguishing the randomized comparison's estimand from individual and actual-exposure effects must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials distinguishing allocation effects from actual-exposure effects are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How does primary first relapse differ from symptom worsening and withdrawal?",
      "needed": "Event definitions for first relapse within 52 weeks, symptom instruments and withdrawal",
      "role": "Required",
      "role_reason": "Production item to distinguish Event definitions for first relapse within 52 weeks, symptom instruments and withdrawal and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Event definitions for first relapse within 52 weeks, symptom instruments and withdrawal must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials distinguishing events from symptoms and recurrent outcomes are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are 478 randomized, 468 in time-to-event analysis and 10 with missing timing related?",
      "needed": "238 maintenance/240 discontinuation, missing timing in 6/4, and denominator-specific scope",
      "role": "Required",
      "role_reason": "Production item to distinguish 238 maintenance/240 discontinuation, missing timing in 6/4, and denominator-specific scope and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for 238 maintenance/240 discontinuation, missing timing in 6/4, and denominator-specific scope must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials linking relapse or no-relapse observations by denominator are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do best- and worst-case missing-data assumptions test relapse in everyone?",
      "needed": "Distinguishing the original direction of sensitivity analyses from the inevitability question",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing the original direction of sensitivity analyses from the inevitability question and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Distinguishing the original direction of sensitivity analyses from the inevitability question must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate materials on sensitivity of arm comparisons and individual inevitability are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the discontinuation-versus-maintenance HR 2.06 a probability of inevitability?",
      "needed": "Separate units for HR, CI, P, event proportions and individual probabilities",
      "role": "Required",
      "role_reason": "Production item to distinguish Separate units for HR, CI, P, event proportions and individual probabilities and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Separate units for HR, CI, P, event proportions and individual probabilities must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials linking comparative estimands and individual prediction are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What gaps do withdrawal symptoms and awareness of allocation leave in an inevitability interpretation?",
      "needed": "Original scope of 12-week modified DESS, possible misclassification and allocation awareness",
      "role": "Required",
      "role_reason": "Production item to distinguish Original scope of 12-week modified DESS, possible misclassification and allocation awareness and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Original scope of 12-week modified DESS, possible misclassification and allocation awareness must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials distinguishing withdrawal from relapse and recording allocation awareness are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is 39% relapse during maintenance a different question from inevitability after discontinuation?",
      "needed": "Boundary between the other arm's result and the related complete-prevention question",
      "role": "Required",
      "role_reason": "Production item to distinguish Boundary between the other arm's result and the related complete-prevention question and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Boundary between the other arm's result and the related complete-prevention question must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials separating average reduction, complete prevention and inevitability claims are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does absence of relapse within 52 weeks certify lifelong freedom from relapse or safe discontinuation?",
      "needed": "Actual observation period and gaps beyond observation or in individual safety",
      "role": "Required",
      "role_reason": "Production item to distinguish Actual observation period and gaps beyond observation or in individual safety and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Actual observation period and gaps beyond observation or in individual safety must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate materials on gaps beyond the time or individual scope are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can those who will remain without relapse be identified beforehand?",
      "needed": "Distinguishing group comparisons from validated individual prediction and subgroup information",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing group comparisons from validated individual prediction and subgroup information and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Distinguishing group comparisons from validated individual prediction and subgroup information must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate materials linking average effects and individual prediction are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are the NEJM and HTA citations independent trials?",
      "needed": "Relationship between the same ANTLER trial, the first evidence record, and the main and detailed reports",
      "role": "Required",
      "role_reason": "Production item to distinguish Relationship between the same ANTLER trial, the first evidence record, and the main and detailed reports and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Relationship between the same ANTLER trial, the first evidence record, and the main and detailed reports must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials on multiple-report relationships within the same trial are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do average meta-analysis results directly answer ‘inevitably’?",
      "needed": "Differences between Kato's 40 trials and 8890 participants, proportions or OR, and the actual original question",
      "role": "Required",
      "role_reason": "Production item to distinguish Differences between Kato's 40 trials and 8890 participants, proportions or OR, and the actual original question and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Differences between Kato's 40 trials and 8890 participants, proportions or OR, and the actual original question must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.4: in-house extension boundaries.",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials separating pooled averages from claims about every person or individual are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do people and reports overlap across the review, ANTLER and related sheets?",
      "needed": "Shared preserved summary, two subclaim sheets, and report, trial and synthesis relationships",
      "role": "Required",
      "role_reason": "Production item to distinguish Shared preserved summary, two subclaim sheets, and report, trial and synthesis relationships and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Shared preserved summary, two subclaim sheets, and report, trial and synthesis relationships must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Records of material families and overlap relationships are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Have registration and prespecified endpoints actually been read?",
      "needed": "Original ISRCTN/EudraCT identifiers and unread registration or plans",
      "role": "Required",
      "role_reason": "Production item to distinguish Original ISRCTN/EudraCT identifiers and unread registration or plans and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Original ISRCTN/EudraCT identifiers and unread registration or plans must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Links between prespecified plans, versions and reports are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do public support and unreported product or COI information certify independence?",
      "needed": "NIHR, PRIMENT, UCL, product provision, employees, conflicts of interest and review funding",
      "role": "Required",
      "role_reason": "Production item to distinguish NIHR, PRIMENT, UCL, product provision, employees, conflicts of interest and review funding and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for NIHR, PRIMENT, UCL, product provision, employees, conflicts of interest and review funding must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials on funding, support types and actual roles are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N22",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are withdrawal, serious events and absence of relapse the same safety outcome?",
      "needed": "Scope of harm collection, 12-week withdrawal, 9/8 participants and 0 deaths or suicide attempts",
      "role": "Supplementary",
      "role_reason": "Production item to distinguish Scope of harm collection, 12-week withdrawal, 9/8 participants and 0 deaths or suicide attempts and link the materials required for the selected question to currently available materials.",
      "application_exception": "Addresses gaps in withdrawal and safety materials for the selected relapse question. Relapse, absence of relapse or original safety wording is not used to assess overall safety or an individual's ability to discontinue, or to generate harm incidence or guidance on maintenance, discontinuation, tapering, dosing or treatment.",
      "criterion": "Relevant original materials and analysis scope for Scope of harm collection, 12-week withdrawal, 9/8 participants and 0 deaths or suicide attempts must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. M19 principles are referenced; no official causality tool was executed",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Materials separating absence of relapse from other harm outcomes are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does this answer questions about other drugs, abrupt stopping or new treatment settings?",
      "needed": "Original four drugs, study taper, remission, long-term use and questions outside that scope",
      "role": "Required",
      "role_reason": "Production item to distinguish Original four drugs, study taper, remission, long-term use and questions outside that scope and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Original four drugs, study taper, remission, long-term use and questions outside that scope must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate questions and material scopes by exposure and population are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What preserved summaries and external materials have actually been read?",
      "needed": "Preserved summary, original NEJM/HTA/Kato URLs and unread external materials",
      "role": "Required",
      "role_reason": "Production item to distinguish Preserved summary, original NEJM/HTA/Kato URLs and unread external materials and link the materials required for the selected question to currently available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and analysis scope for Preserved summary, original NEJM/HTA/Kato URLs and unread external materials must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Records of acquisition, reading and versions by material are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are original subclaim D, parent B70, Korean/English texts, dates and empty values preserved?",
      "needed": "Whole original preservation, absence, unrecorded precision, false values and correction history",
      "role": "Required",
      "role_reason": "Production item to distinguish Whole original preservation, absence, unrecorded precision, false values and correction history 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 Whole original preservation, absence, unrecorded precision, false values and correction history 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: Links between original versions, dates and the selected subclaim sheet are proposed; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N26",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do applied conditions and completed production mean existing content review is complete?",
      "needed": "Distinguishing preservation, freezing and application of conditions, case production and incomplete content review",
      "role": "Required",
      "role_reason": "Production item to distinguish Distinguishing preservation, freezing and application of conditions, case production and incomplete content 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 Distinguishing preservation, freezing and application of conditions, 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: A history of production versions, conditions and user corrections is proposed; no new investigation, calculation or trial was conducted."
    }
  ]
}