{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "ESA anemia correction × improved survival during head-and-neck cancer radiotherapy: evidence checklist",
  "language": "en",
  "translation_date": "2026-10-11",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
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    {
      "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"
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    {
      "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 remains 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": "Does the selected question concern improved survival or the parent tumor-control question?",
      "needed": "Preserve the survival subclaim, grade and note separately from the parent tumor-control claim, score and axes",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Preserve the survival subclaim, grade and note separately from the parent tumor-control claim, score and axes.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Preserve the survival subclaim, grade and note separately from the parent tumor-control claim, score and axes. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying questions; Detailed separation rules are a custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Track survival and tumor-control materials separately; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What events and directions do the survival measures represent?",
      "needed": "Exact names and directions of death, survival, event-free survival and tumor control",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Exact names and directions of death, survival, event-free survival and tumor control.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Exact names and directions of death, survival, event-free survival and tumor control. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M03 §3.2.4; Custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link endpoint-specific event coding and comparison directions; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What population, study exposure and comparator did DAHANCA10 use?",
      "needed": "Actual cancer/anemia and radiotherapy population and the two arms' historical study conditions",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Actual cancer/anemia and radiotherapy population and the two arms' historical study conditions.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Actual cancer/anemia and radiotherapy population and the two arms' historical study conditions. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are a custom design; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptation are a custom design; M08 §8.1–8.2.3; Custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link survival materials by population and comparison conditions; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do DAHANCA10 planned, randomized and evaluable denominators differ?",
      "needed": "Roles of planned600, randomized522, evaluable513 and254/259",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Roles of planned600, randomized522, evaluable513 and254/259.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Roles of planned600, randomized522, evaluable513 and254/259. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate analysis populations and exclusion reasons by denominator; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What plan and criteria governed interim stopping?",
      "needed": "Prespecified interim analysis, inferiority stopping threshold and follow-up plan",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Prespecified interim analysis, inferiority stopping threshold and follow-up plan.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Prespecified interim analysis, inferiority stopping threshold and follow-up plan. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M15 §15.3.1–15.3.3; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document the relationship between interim analysis and final survival outcomes; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the hierarchy of the primary tumor-failure endpoint and selected survival outcomes?",
      "needed": "Primary endpoint, secondary survival outcomes, prespecified analysis hierarchy and multiplicity",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Primary endpoint, secondary survival outcomes, prespecified analysis hierarchy and multiplicity.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Primary endpoint, secondary survival outcomes, prespecified analysis hierarchy and multiplicity. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M04 §4.6.3; Custom application; M03 §3.2.4; Custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link endpoint hierarchy and prespecified multiple-comparison plans; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What analysis produced the DAHANCA10 disease-specific death result?",
      "needed": "Cause-of-death definition, denominator, time, HR/CI and handling of competing events",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Cause-of-death definition, denominator, time, HR/CI and handling of competing events.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Cause-of-death definition, denominator, time, HR/CI and handling of competing events. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M15 §15.3.1–15.3.3; Custom application; M19 §19.1.2–19.2.4; Detailed discrimination is a custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link endpoint definitions and competing-event/survival-analysis materials; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What analysis produced the DAHANCA10 overall-death result?",
      "needed": "Overall-death HR/CI, events/people, follow-up duration and analysis population",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Overall-death HR/CI, events/people, follow-up duration and analysis population.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Overall-death HR/CI, events/people, follow-up duration and analysis population. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M15 §15.3.1–15.3.3; Custom application; M19 §19.2 design-specific harm questions; Details of temporal relationships are a custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document overall-death follow-up and analysis in the randomized population; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can EFS be substituted for survival or cancer-specific death?",
      "needed": "Link event-free survival event composition, hierarchy and analysis separately",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Link event-free survival event composition, hierarchy and analysis separately.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Link event-free survival event composition, hierarchy and analysis separately. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M04 §4.6.3; Custom application; M03 §3.2.4; Custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document the composite endpoint and its components separately; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "May the five-year tumor-failure timepoint be assigned to every survival outcome?",
      "needed": "Actual endpoint-specific follow-up and distinction between absolute and time-to-event outcomes",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Actual endpoint-specific follow-up and distinction between absolute and time-to-event outcomes.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Actual endpoint-specific follow-up and distinction between absolute and time-to-event outcomes. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are a custom design; M19 §19.1.2–19.2.4; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate time scopes by endpoint in follow-up materials; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How might an open-label study and outcome assessment affect individual endpoints?",
      "needed": "Record allocation, open-label status, tumor assessment and death ascertainment separately",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Record allocation, open-label status, tumor assessment and death ascertainment separately.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Record allocation, open-label status, tumor assessment and death ascertainment separately. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; Custom application; M08 Table 8.2.a, M03 §3.2.4; Custom application; M19 §19.1.2–19.2.4; Detailed discrimination is a custom design; M19 §19.1.2–19.2.4, M04 §4.6.3; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link endpoint-specific measurement and missingness materials; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How were concurrent treatment and deviations reflected in survival estimates?",
      "needed": "Radiotherapy, concomitant treatment, crossover/adherence, ITT/PP and covariates",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Radiotherapy, concomitant treatment, crossover/adherence, ITT/PP and covariates.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Radiotherapy, concomitant treatment, crossover/adherence, ITT/PP and covariates. Preserved statements are linked here; existing content review 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 considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document concurrent treatment and comparison estimators; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does successful hemoglobin correction imply improved survival?",
      "needed": "Distinguish anemia/hemoglobin surrogates from clinical survival events",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish anemia/hemoglobin surrogates from clinical survival events.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish anemia/hemoglobin surrogates from clinical survival events. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4; Custom extension boundary; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptation are a custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document surrogate measures and clinical events separately; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do the ENHANCE comparison and denominators differ from DAHANCA10?",
      "needed": "Scope of epoetin beta, blinded placebo comparison,351/180/171 and ITT",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Scope of epoetin beta, blinded placebo comparison,351/180/171 and ITT.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Scope of epoetin beta, blinded placebo comparison,351/180/171 and ITT. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are a custom design; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptation are a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M08 §8.1–8.2.3; Custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate population, formulation and comparison differences; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What does ENHANCE survival RR1.39 mean?",
      "needed": "Original 'survival RR' coding, direction and CI, separate from the tumor primary endpoint",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Original 'survival RR' coding, direction and CI, separate from the tumor primary endpoint.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Original 'survival RR' coding, direction and CI, separate from the tumor primary endpoint. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M15 §15.3.1–15.3.3; Custom application; M08 Table 8.2.a, M04 §4.6.3; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document the original estimator name and comparison direction; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do the initial and long-term RTOG99-03 reports concern the same trial?",
      "needed": "Relationship of original trial/follow-up reports,148 participants, bibliography and timepoints",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Relationship of original trial/follow-up reports,148 participants, bibliography and timepoints.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Relationship of original trial/follow-up reports,148 participants, bibliography and timepoints. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; M04 §4.5–4.6 principles for collecting/selecting materials; Separating access from reading and hyperlink specifications is a custom design; M04 §4.6.1–4.6.2, M15 §15.3.1; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document time-specific reports from the same cohort; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the periods and effects for RTOG survival and tumor failure?",
      "needed": "OS, three-/five-year locoregional failure, original P values and limits of nonsignificance",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: OS, three-/five-year locoregional failure, original P values and limits of nonsignificance.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: OS, three-/five-year locoregional failure, original P values and limits of nonsignificance. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptation is a custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptation is a custom design; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is a custom design; M15 §15.3.1–15.3.3; Custom application; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are a custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link time-specific tumor/survival outcomes and precision materials; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the direction and analysis denominators of the Cochrane survival OR?",
      "needed": "Names/coding of5RCT1397 participants, OS Peto OR and other pooled endpoints",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Names/coding of5RCT1397 participants, OS Peto OR and other pooled endpoints.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Names/coding of5RCT1397 participants, OS Peto OR and other pooled endpoints. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Document pooled-endpoint comparison directions and included denominators; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How much do the review and individual reports overlap?",
      "needed": "Cross-links between review-included trials/follow-up reports and the three individual trials",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Cross-links between review-included trials/follow-up reports and the three individual trials.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Cross-links between review-included trials/follow-up reports and the three individual trials. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Describe shared/overlapping relationships between synthesis and direct reports; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do formulation, population and duration differences relate to the selected scope?",
      "needed": "Differences in ESA/arms/periods, denominators and analyses, with independence unverified",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Differences in ESA/arms/periods, denominators and analyses, with independence unverified.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Differences in ESA/arms/periods, denominators and analyses, with independence unverified. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; Custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; CHAMGAP's own independence and attribution conditions. Official method sections in this pilot do not validate all details of this item",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link replication/heterogeneity materials while separating different conditions; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N21",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "How do cancer-survival harm and other safety outcomes differ?",
      "needed": "Separate definitions and analysis scopes for death/cancer outcomes, SAE, cardiovascular events and radiation toxicity",
      "role": "Supplementary",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Separate definitions and analysis scopes for death/cancer outcomes, SAE, cardiovascular events and radiation toxicity.",
      "application_exception": "Supplement gaps in safety/death materials for the selected survival question. Tumor control, hemoglobin correction or other adverse-event statements do not determine overall safety, harm incidence, drug choice/substitution or treatment guidance.",
      "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Separate definitions and analysis scopes for death/cancer outcomes, SAE, cardiovascular events and radiation toxicity. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate cancer outcomes and other safety events; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N22",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are death causes, missingness, vulnerable groups and long-term scope verified?",
      "needed": "Death ascertainment, cause, competing events, follow-up loss and vulnerable-group specifications",
      "role": "Supplementary",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Death ascertainment, cause, competing events, follow-up loss and vulnerable-group specifications.",
      "application_exception": "Supplement gaps in safety/death materials for the selected survival question. Tumor control, hemoglobin correction or other adverse-event statements do not determine overall safety, harm incidence, drug choice/substitution or treatment guidance.",
      "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Death ascertainment, cause, competing events, follow-up loss and vulnerable-group specifications. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Detailed discrimination is a custom design; M19 §19.2 design-specific harm questions; Details of temporal relationships are a custom design; M19 §19.1.2–19.2.4, M04 §4.6.3; Custom application; M19 §19.1.2–19.2.4; Custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate time- and vulnerable-group-specific evidence gaps in follow-up materials; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the scope of DAHANCA10 support and investigator roles?",
      "needed": "Distinguish cash, free products, quality-control costs, study/manuscript roles and COI",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish cash, free products, quality-control costs, study/manuscript roles and COI.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish cash, free products, quality-control costs, study/manuscript roles and COI. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate types of support and study/manuscript roles; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do ENHANCE, RTOG and review support have the same meaning?",
      "needed": "Funding, products, employees and COI for each company/public/review source",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Funding, products, employees and COI for each company/public/review source.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Funding, products, employees and COI for each company/public/review source. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link direct-trial and review support separately; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do registration wording, actual registration identity and plans differ?",
      "needed": "Preserve original registration wording/identifiers separately from unread status",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Preserve original registration wording/identifiers separately from unread status.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Preserve original registration wording/identifiers separately from unread status. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link registration/plan histories by report; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N26",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Does the FDA warning account reflect actual reading of the original label?",
      "needed": "Separate the account's warning history from external FDA label/date/scope",
      "role": "Supplementary",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Separate the account's warning history from external FDA label/date/scope.",
      "application_exception": "Supplement gaps in safety/death materials for the selected survival question. Tumor control, hemoglobin correction or other adverse-event statements do not determine overall safety, harm incidence, drug choice/substitution or treatment guidance.",
      "criterion": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Separate the account's warning history from external FDA label/date/scope. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Custom application; M04 §4.5–4.6 principles for collecting/selecting materials; Separating access from reading and hyperlink specifications is a custom design; M04 §4.5, §4.6.3; Limitations of the current material conversion follow the review scope and custom design; CHAMGAP's own interpretation boundary. M19 principles are referenced; no official causality tool was run",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link the original warning account to version-specific sources; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does the reduced-transfusion account for another indication answer cancer survival?",
      "needed": "Distinguish the preterm-infant2925 citation from the selected head-and-neck cancer survival question",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish the preterm-infant2925 citation from the selected head-and-neck cancer survival question.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish the preterm-infant2925 citation from the selected head-and-neck cancer survival question. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying questions; Detailed separation rules are a custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; M03 §3.2.4; Custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate source relationships for different indications; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N28",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can these findings be extended to CKD, other cancers or anemia conditions?",
      "needed": "Boundary between original head-and-neck cancer radiotherapy scope and other indications",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Boundary between original head-and-neck cancer radiotherapy scope and other indications.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Boundary between original head-and-neck cancer radiotherapy scope and other indications. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Separate condition-specific questions and direct-material scope in follow-up materials; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N29",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are preserved summaries and actual external reading displayed?",
      "needed": "Access status of summaries, external originals, registration, protocol, SAP and COI",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Access status of summaries, external originals, registration, protocol, SAP and COI.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Access status of summaries, external originals, registration, protocol, SAP and COI. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Record actual acquisition/reading levels and versions by material; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N30",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are original Korean/English text, reference date, empty values and correction history retained?",
      "needed": "Preserve original languages,2026-08-26, empty correction/deliberation values, false and unrecorded values",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Preserve original languages,2026-08-26, empty correction/deliberation values, false and unrecorded values.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Preserve original languages,2026-08-26, empty correction/deliberation values, false and unrecorded values. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Link sources/dates of the original version and new production content; the record includes no new search, calculation or trial."
    },
    {
      "item_id": "N31",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are condition application, table production and completed content review separate events?",
      "needed": "Distinguish conditions saved first, freezing, separate application and existing content-review status",
      "role": "Required",
      "role_reason": "This production condition links required and currently available materials for the selected question by distinguishing: Distinguish conditions saved first, freezing, separate application and existing content-review status.",
      "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": "The corresponding original materials and analysis scope must be available, with unverified matters distinguishable, for: Distinguish conditions saved first, freezing, separate application and existing content-review status. Preserved statements are linked here; existing content review 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 the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposal: Record production versions and user correction comments as history; the record includes no new search, calculation or trial."
    }
  ]
}