{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "ESA anemia correction × locoregional tumor control during head-and-neck 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",
  "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Is the selected original question improved locoregional tumor control?",
      "needed": "Link selected and parent claims, disease, exposure and failure direction",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Is the selected original question improved locoregional tumor control?",
      "application_exception": "Do not arbitrarily rename the improvement question as a harm question or create a new verdict or split.",
      "criterion": "Preserve both the original positive question and the actual direction of its original results.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If the question actually changes, separately record its original wording and excluded scope."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are the subclaim's grade F and note separate from parent F12 and axes?",
      "needed": "Locations of actual and absent subclaim fields and original parent values",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are the subclaim's grade F and note separate from parent F12 and axes?",
      "application_exception": "Do not uniformly assign D to subclaims or copy parent 12 points, RX, I1, E-, B2/C0 as distinct subclaim values.",
      "criterion": "Distinguish the actual subclaim grade F from the parent verdict's scope.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If subclaim fields are actually added, distinguish the original version from the new event."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Do repeated refutation, design limitations and cross-checking constitute current review?",
      "needed": "Korean and English wording, axes, verdict, corrections and methodological statements",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Do repeated refutation, design limitations and cross-checking constitute current review?",
      "application_exception": "Do not inherit RX, the true large-hard-endpoint RCT indication or historical independence and cross-checking as current review or independence certification.",
      "criterion": "Separate original history from incomplete current content review.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M08 §8.1–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If new evidence is requested, separate the original version from the new update event."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read, and which external materials remain unread?",
      "needed": "Acquisition and reading scope for preserved summaries and each external material",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Which materials were actually read, and which external materials remain unread?",
      "application_exception": "Do not convert the presence of a URL or a statement about original-paper roles into current full-text reading, link verification or failed access.",
      "criterion": "Keep summary reading and external unread status separate for each material.",
      "basis": "M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If material and reading records are supplied, record only the actual level."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "How are trials, the review and initial and follow-up reports linked?",
      "needed": "Original bibliography, review inclusion, initial and long-term reports and participant relationships",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: How are trials, the review and initial and follow-up reports linked?",
      "application_exception": "Do not add the review, original trials, two RTOG PMIDs or 2925 as new independent trials or participants.",
      "criterion": "Distinguish preserved report groups from undetermined unique totals and other indications.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original lists are supplied, link each report to the same, different or uncertain study family."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What were DAHANCA's population and Hb eligibility conditions?",
      "needed": "Stage, site, inclusion and exclusion, Hb, anemia cause and baseline risk",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What were DAHANCA's population and Hb eligibility conditions?",
      "application_exception": "Do not reuse the Hb eligibility threshold as an effect for all severe-anemia or other-cancer populations.",
      "criterion": "Record original population and Hb eligibility along with gaps in detailed conditions.",
      "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original population tables are supplied, distinguish the actual population from gaps for other cancers and goals."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What were darbepoetin exposure, goals and hematologic response in the trial?",
      "needed": "Nominal and actual drug exposure, Hb target, changes and discontinuation",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What were darbepoetin exposure, goals and hematologic response in the trial?",
      "application_exception": "Do not write the historical weekly exposure as medication, anemia-correction, anticancer or radiotherapy-selection instructions.",
      "criterion": "Distinguish historical drug conditions from gaps in direct exposure and targets.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original exposure records are supplied, record trial conditions and actual use and goals."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What were control radiotherapy and shared or concurrent cancer treatments?",
      "needed": "Trial-specific controls, radiotherapy plans and shared or concomitant cancer and anemia treatment",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What were control radiotherapy and shared or concurrent cancer treatments?",
      "application_exception": "Do not use the review's control label to certify that every trial had no concomitant treatment.",
      "criterion": "Separate original comparison wording from gaps in detailed conditions.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application / M19 §19.2.2–19.2.4 design considerations; detailed confounding records are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original comparison materials are supplied, distinguish the added drug from shared and other treatments."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are planned 600, randomized 522 and evaluable 513 different stages?",
      "needed": "Allocation and evaluation flow by arm, correspondence of 254/259 to arms, exclusions and missingness",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are planned 600, randomized 522 and evaluable 513 different stages?",
      "application_exception": "Do not subtract counts to calculate attrition counts or rates or use planned 600 as the actual analysis population.",
      "criterion": "Distinguish original stage-specific denominators from unverified flow.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original flow diagrams are supplied, record stages and inclusion rules by arm."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are the locoregional-failure time, five-year values and HR?",
      "needed": "Failure definition, timepoint and time, denominator, HR model and interval",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are the locoregional-failure time, five-year values and HR?",
      "application_exception": "Do not calculate new risk differences, CIs or P values from original proportions or HRs.",
      "criterion": "Attribute the original endpoint, 47/34%, HR and 95% CI to the relevant comparison.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M15 §15.3.1–15.3.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original results and methods are supplied, link cumulative values to the time-to-event estimate."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "How should lower-is-better failure and the improvement question be read?",
      "needed": "Endpoint direction and relationship between question and result",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: How should lower-is-better failure and the improvement question be read?",
      "application_exception": "Do not turn increased failure into improved tumor control or a positive benefit.",
      "criterion": "Clearly distinguish the original improvement question from the observed worsening direction.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original definitions are added, record actual directions and interpretations of other endpoints."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are the five-year cumulative proportion and time-to-failure HR the same measure?",
      "needed": "Cumulative estimation, censoring, HR estimand, time and competing events",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are the five-year cumulative proportion and time-to-failure HR the same measure?",
      "application_exception": "Do not convert 47/34 or the HR into a new risk ratio, effect size or individual probability.",
      "criterion": "Distinguish different original measures and gaps in their models.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application / M15 §15.3.1–15.3.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original statistical methods are supplied, distinguish definitions of cumulative estimation and hazard comparisons."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the actual analysis and risk denominators for locoregional outcomes?",
      "needed": "Endpoint-specific analysis and risk populations, events and people, censoring and missingness",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are the actual analysis and risk denominators for locoregional outcomes?",
      "application_exception": "Do not copy evaluable 513 into every timepoint, survival or safety denominator or back-calculate event counts.",
      "criterion": "Record the original evaluation size and gaps in direct outcome denominators.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original risk tables or flow diagrams are supplied, distinguish evaluation from timepoint and endpoint denominators."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What was the actual scope of open-label design and central blinded review?",
      "needed": "Failure diagnosis and adjudication, imaging and clinical pathways and blinding by role",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What was the actual scope of open-label design and central blinded review?",
      "application_exception": "Do not expand the absence of uniform central blinded review into an absence of all adjudication or examinations.",
      "criterion": "Separate original open-label and review limitations from direct details.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; our own application / M08 §8.1–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original adjudication methods are supplied, record actual pathways and limitations by role."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What is known about randomization, allocation concealment and baseline balance?",
      "needed": "Allocation procedures, concealment, baseline and stratification factors and treatment balance",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is known about randomization, allocation concealment and baseline balance?",
      "application_exception": "Do not certify fulfillment of all methodological conditions from the randomized label, B2 or a past verdict.",
      "criterion": "Separate original design from gaps in direct procedures.",
      "basis": "M08 §8.1–8.2.3; our own application / M03 §3.2.1; detailed population conditions are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original methods and baseline data are supplied, distinguish design labels from actual procedures."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What does early stopping at the planned interim analysis preserve?",
      "needed": "Interim timing and thresholds, committee, alpha, stopping and subsequent follow-up",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What does early stopping at the planned interim analysis preserve?",
      "application_exception": "Do not turn the original planned-analysis wording into direct certification of advance planning or an exact bias magnitude.",
      "criterion": "Preserve the original stopping event and direct gaps in planning and follow-up.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; our own application / M08 §8.2.2, M15 §15.3.1; our own application / M15 §15.3.1–15.3.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original plans and stopping records are supplied, record prior rules and actual stopping and follow-up."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Does hematologic correction constitute a tumor-control benefit?",
      "needed": "Hematologic response, achieved Hb, denominator, tumor oxygenation and direct events",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Does hematologic correction constitute a tumor-control benefit?",
      "application_exception": "Do not treat increased Hb as a guarantee of oxygenation, tumor-control or survival improvement.",
      "criterion": "Preserve original hematologic statements separately from direct clinical worsening.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original response data are supplied, record Hb measures and clinical outcomes separately."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What is the original event-free-survival value?",
      "needed": "EFS definition and components, denominator, HR model and interval confidence level",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is the original event-free-survival value?",
      "application_exception": "Do not automatically copy locoregional-failure values or its 95% CI designation into EFS.",
      "criterion": "Keep the original EFS HR, interval and direction separate.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original results and methods are supplied, link EFS components and estimand to that value."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What is the disease-specific-death result?",
      "needed": "Cause-of-death adjudication, events and time, denominator, model and interval",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is the disease-specific-death result?",
      "application_exception": "Do not fill disease-specific death with another endpoint's HR or 95% designation.",
      "criterion": "Separate the original disease-specific HR from gaps in direct definitions.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original mortality outcomes are supplied, record causes, denominators and estimates separately."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What is the original overall-death HR?",
      "needed": "Overall death, risk population and denominator, time, model and interval",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is the original overall-death HR?",
      "application_exception": "Do not calculate death counts, absolute-risk differences or new intervals from the original HR.",
      "criterion": "Preserve original overall-death values and gaps.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original mortality tables are supplied, record the actual overall-death estimate, time and denominator."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Is the sibling survival-improvement question separate from the main tumor question?",
      "needed": "Existing sibling question, endpoint definitions and denominators and original-result links",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Is the sibling survival-improvement question separate from the main tumor question?",
      "application_exception": "Do not count the sibling row as a new trial or participant group or copy failure values into survival outcomes.",
      "criterion": "Distinguish original survival context from the selected question.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If the original question changes, separately record each existing question and its links."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What are the details of follow-up, treatment deviations, missingness and censoring?",
      "needed": "Endpoint-specific flow, follow-up and censoring, treatment deviations and missing-data handling",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are the details of follow-up, treatment deviations, missingness and censoring?",
      "application_exception": "Do not calculate or infer new attrition or analysis rules from differences in allocation and evaluation counts.",
      "criterion": "Record direct gaps in original flow and time.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application / M19 §19.1.2–19.2.4, M04 §4.6.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original flow and analyses are supplied, distinguish allocation, evaluation, risk populations and losses."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What history underlies the original registration-absence statements?",
      "needed": "Original registration, timing, contemporaneous records and plans and changes",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What history underlies the original registration-absence statements?",
      "application_exception": "Do not turn the historical absence wording into current certification of exhaustive registry absence or a new identifier.",
      "criterion": "Distinguish original values from the current unqueried scope.",
      "basis": "M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M08 Table 8.2.a, M04 §4.6.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original registration and planning materials are supplied, distinguish actual existence and contents from original history."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Were prior endpoints, interim plans and the hierarchy of multiple outcomes read?",
      "needed": "Original plans, prior hierarchy, interim and final testing and changes",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Were prior endpoints, interim plans and the hierarchy of multiple outcomes read?",
      "application_exception": "Do not certify every prior definition solely from the original primary-endpoint or planned-analysis labels.",
      "criterion": "Separate original roles from gaps in planning details.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; our own application / M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original plans are supplied, distinguish contemporaneous roles from reports and follow-up."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What are the clinical thresholds, individual effects and subgroups?",
      "needed": "Prior importance thresholds and subgroup hypotheses, interactions, denominators and intervals",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are the clinical thresholds, individual effects and subgroups?",
      "application_exception": "Do not copy original effects into every stage, Hb target, dose or individual outcome.",
      "criterion": "Record overall original results and gaps in subgroup effects and clinical importance.",
      "basis": "M15 §15.3.1–15.3.3; our own application / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original plans or subgroup data are supplied, distinguish overall estimates from separate conditions."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What are ENHANCE's original population, design and RR results?",
      "needed": "PFS and survival definitions, adjusted model, actual denominators, ITT and intervals",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are ENHANCE's original population, design and RR results?",
      "application_exception": "Do not change original RRs into DAHANCA HRs or probabilities of improvement.",
      "criterion": "Preserve each original RR, interval and P value and trial-specific denominator and hierarchy.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M08 §8.1–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original ENHANCE methods and tables are supplied, record RR notation, estimand and endpoint-specific analyses."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "How do epoetin beta, epoetin alfa and darbepoetin exposures differ?",
      "needed": "Drug-specific formulation, amount and targets, shared and different treatments and populations",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: How do epoetin beta, epoetin alfa and darbepoetin exposures differ?",
      "application_exception": "Do not fill different drugs or targets with the same dose or conditions or extend them to every other indication.",
      "criterion": "Record shared claim context together with actual drug and exposure differences.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original intervention data are supplied, record drugs, targets and trial-specific conditions separately."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What are RTOG's initial and long-term endpoint values?",
      "needed": "Timepoint-specific failure and OS, denominators, estimates, CIs and analysis plans",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are RTOG's initial and long-term endpoint values?",
      "application_exception": "Do not turn nonsignificance into zero effect, equivalence or guaranteed individual survival.",
      "criterion": "Keep original timepoints, proportions and P values attached to their respective endpoints.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original RTOG tables are supplied, link each timepoint and endpoint to its original intervals and denominators."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Do the two RTOG PMIDs refer to reports of the same trial?",
      "needed": "Initial and follow-up populations, timepoints and analysis and report relationships",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Do the two RTOG PMIDs refer to reports of the same trial?",
      "application_exception": "Do not add two PMIDs or timepoints as two groups of 148 participants or independent replications.",
      "criterion": "Preserve the original report group, bibliography and same-population relationship.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original reports are supplied, distinguish same-cohort follow-up from separate trials."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Can the five-RCT, 1,397-participant review be added to original trials?",
      "needed": "Inclusion and contribution lists, trial identities, populations and timepoints and overlap",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Can the five-RCT, 1,397-participant review be added to original trials?",
      "application_exception": "Do not add review 1,397 and individual trials or follow-up to create new participant or trial totals.",
      "criterion": "Distinguish original review counts from undetermined unique totals.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original inclusion tables are supplied, link the review to unique original study families."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What is the event direction of the review's ORs?",
      "needed": "Review event and success coding, models and endpoint-specific contributions and intervals",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is the event direction of the review's ORs?",
      "application_exception": "Do not reverse OR<1 into reduced death or failure with ESA or convert it into an HR or RR.",
      "criterion": "Preserve the original review direction, measures and intervals at their stated level.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M15 §15.3.1–15.3.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original review tables are supplied, record OR coding, estimands and contributions."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What are the review's timing, subsets, heterogeneity and direct comparisons?",
      "needed": "Review version, inclusion timing, endpoint subsets, synthesis, heterogeneity and conditions",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are the review's timing, subsets, heterogeneity and direct comparisons?",
      "application_exception": "Do not assume every recent report was included in the review or arbitrarily correct years or identities.",
      "criterion": "Preserve original dates and bibliography and gaps in actual inclusion.",
      "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; our own application / M08 §8.2.2, M15 §15.3.1; our own application / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original review tables are supplied, record versions and actual included families and conditions."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are repeated refutation in the same indication and other goals distinguished?",
      "needed": "Direct questions, exposures and endpoints for each indication and goal",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are repeated refutation in the same indication and other goals distinguished?",
      "application_exception": "Do not merge 2925 as tumor-control benefit, safety evidence or a separate anticancer trial here.",
      "criterion": "Preserve only the original link context for another goal and do not create treatment-selection instructions.",
      "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If materials for another requested question are supplied, record its original unit and population separately."
    },
    {
      "item_id": "N34",
      "question_type": "Harm information",
      "question": "What is the original statement of no differences in ancillary safety?",
      "needed": "Safety definitions and collection, individual events and denominators, estimates and intervals",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is the original statement of no differences in ancillary safety?",
      "application_exception": "Do not turn unverified differences into zero events, equivalence of all safety outcomes or harmlessness.",
      "criterion": "Preserve both original ancillary-safety statements and direct clinical worsening.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are our own design / M19 §19.2.2–19.2.4, M03 §3.2.3; our own application / M19 §19.1.2–19.2.4; our own application / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original safety tables are supplied, record original observations and intervals for each item."
    },
    {
      "item_id": "N35",
      "question_type": "Harm information",
      "question": "Are major tumor and survival harms separate from safety collection?",
      "needed": "Clinical-harm and safety endpoints, collection and adjudication, severity and discontinuation",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are major tumor and survival harms separate from safety collection?",
      "application_exception": "Do not erase demonstrated tumor or survival harm based on no differences in ancillary safety.",
      "criterion": "Distinguish endpoint-specific harm from gaps in complete collection.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are our own design / CHAMGAP's own interpretation boundary. M19 principles are referenced; no official causality tool was run / M19 §19.1.2–19.2.4; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original safety and endpoint data are supplied, distinguish actual clinical outcomes from separate collection."
    },
    {
      "item_id": "N36",
      "question_type": "Harm information",
      "question": "What are harm-event, participant and time denominators and timepoints?",
      "needed": "Safety-specific denominators and durations, event timing and treatment and follow-up discontinuation",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are harm-event, participant and time denominators and timepoints?",
      "application_exception": "Do not copy 513/522 or five-year figures as actual denominators or duration for every harm.",
      "criterion": "Separate original clinical context from gaps in safety time and denominators.",
      "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are our own design / M19 §19.1.2–19.2.4; our own application / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original safety flow is supplied, record efficacy evaluation separately from safety exposure and time."
    },
    {
      "item_id": "N37",
      "question_type": "Harm information",
      "question": "What is known about baseline cancer risk, concurrent treatments and alternative attribution?",
      "needed": "Baseline and concurrent exposures, event attribution, adjustment and alternative explanations",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is known about baseline cancer risk, concurrent treatments and alternative attribution?",
      "application_exception": "Do not turn population-level harmful direction into established causes or mechanisms for individual patients.",
      "criterion": "Separate original comparisons from gaps in attribution and mechanisms.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original methods and event data are supplied, distinguish randomized comparisons from individual causes and mechanisms."
    },
    {
      "item_id": "N38",
      "question_type": "Harm information",
      "question": "What is known about missing and complete safety and clinical follow-up?",
      "needed": "Safety and clinical flow, losses and omissions, reporting and censoring and sensitivity",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is known about missing and complete safety and clinical follow-up?",
      "application_exception": "Do not turn allocation and evaluation differences into absence of safety events or an exact bias magnitude.",
      "criterion": "Record original outcome limitations in follow-up and reporting.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; our own application / M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original flow and surveillance records are supplied, distinguish observed outcomes from uncaptured and missing data."
    },
    {
      "item_id": "N39",
      "question_type": "Harm information",
      "question": "What is the scope of FDA warnings, original harm, current verification and causality?",
      "needed": "Original regulatory text and versions, indications and clinical-outcome and judgment scope",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What is the scope of FDA warnings, original harm, current verification and causality?",
      "application_exception": "Do not create new regulatory links, certify current approval or provide treatment, medication, radiotherapy-selection or dosing instructions.",
      "criterion": "Separate original warnings and clinical harm from the current unqueried regulatory scope.",
      "basis": "CHAMGAP's own interpretation boundary. M19 principles are referenced; no official causality tool was run / M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original regulatory materials are supplied, distinguish historical statements from direct contents and current updates."
    },
    {
      "item_id": "N40",
      "question_type": "Harm information",
      "question": "Does this answer questions about other cancers, Hb targets, populations or long-term and rare harms?",
      "needed": "Direct population-, target- and exposure-specific materials and safety follow-up",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Does this answer questions about other cancers, Hb targets, populations or long-term and rare harms?",
      "application_exception": "Do not extend original repeated refutation to identical harm for every ESA indication and exposure.",
      "criterion": "Record original limits and gaps in safety and effect extensions.",
      "basis": "M19 §19.1.2–19.2.4; our own application / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design / M03 §3.2.1; detailed population conditions are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If direct materials are supplied, distinguish the selected claim from other indication and harm questions."
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "What were DAHANCA's mixed support, device or drug supply and roles?",
      "needed": "Original sponsorship and supply, roles, contracts and data access and COI declarations",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What were DAHANCA's mixed support, device or drug supply and roles?",
      "application_exception": "Do not remove free-drug/GCP-cost or noninvolvement statements or upgrade I1 to current independence certification.",
      "criterion": "Separate original support, supply and role context from currently unread declarations.",
      "basis": "CHAMGAP's own independence and attribution conditions. Official methodological sections used in this pilot do not guarantee every detail of this item / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original declarations are supplied, distinguish support and supply from each actual operational role."
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "What are funding and author relationships in other trials and the review?",
      "needed": "Report-specific sponsorship and supply, author, analysis and manuscript roles and review declarations",
      "role": "Supplementary",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: What are funding and author relationships in other trials and the review?",
      "application_exception": "Do not certify current investigator or population independence solely from different supporting institutions.",
      "criterion": "Preserve report-specific original funding and relationship gaps.",
      "basis": "CHAMGAP's own independence and attribution conditions. Official methodological sections used in this pilot do not guarantee every detail of this item / M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original declarations and inclusion tables are supplied, record roles, families and funding by report."
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "Are original repeated refutation and unique trial and repeated-harm counts established?",
      "needed": "Unique families, inclusion and follow-up, investigators and funding and event and population lists",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are original repeated refutation and unique trial and repeated-harm counts established?",
      "application_exception": "Do not add review, follow-up, the same population or endpoints as new independent trials or repeated events.",
      "criterion": "Distinguish original history from unrecorded, undetermined unique counts.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application / M04 §4.6.1–4.6.2; harm-material adaptations are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If original lists are supplied, link same, different and uncertain families and repeated citations."
    },
    {
      "item_id": "N44",
      "question_type": "Evidence condition",
      "question": "Are original dates, corrections, Korean and English texts and empty values preserved?",
      "needed": "Original dates, corrections and languages and current input and update scope",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Are original dates, corrections, Korean and English texts and empty values preserved?",
      "application_exception": "Do not borrow historical dates or cross-checking as current clinical-verification dates or certify exhaustive absence from empty corrections.",
      "criterion": "Record original history together with current production and incomplete content review.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "Proposal: If actual update materials are supplied, distinguish the complete original version from the correction event."
    }
  ]
}