{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Preoperative red-cell transfusion × Reduced clinically important surgical complications in sickle cell disease",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "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": "Awaiting user review, or actual review remains 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": "What are the selected question and existing complete verdict record?",
      "needed": "The relationship between the original complete verdict and selected question.",
      "role": "Required",
      "role_reason": "What are the selected question and existing complete verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The existing complete verdict is not converted to a subquestion, and nonexistent subclaims are not created.",
      "criterion": "What are the selected question and existing complete verdict record? Distinguish The relationship between the original complete verdict and selected question in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "If the original question is corrected, the complete pre-change text, current verdict linkage and historical candidate records are preserved separately."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What are the verdict’s actual grade, score, status and axes?",
      "needed": "Existing verdict values, original wording and history.",
      "role": "Required",
      "role_reason": "What are the verdict’s actual grade, score, status and axes? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The verdict’s original values are preserved; this is not a new grade or score judgment.",
      "criterion": "What are the verdict’s actual grade, score, status and axes? Distinguish Existing verdict values, original wording and history in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "If a correction occurs, actual before/after values and reasons are preserved as a separate event."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What is the scope of null, false, empty values and the historical B0 decision?",
      "needed": "Versions of original axes, study assessment and correction history.",
      "role": "Required",
      "role_reason": "What is the scope of null, false, empty values and the historical B0 decision? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Historical rules on fewer than 200 participants and stopping classification are not run as current automated checks.",
      "criterion": "What is the scope of null, false, empty values and the historical B0 decision? Distinguish Versions of original axes, study assessment and correction history in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "A separate reassessment request must distinguish original history from current production status."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How are Korean/English, the reference date, corrections and empty arrays preserved?",
      "needed": "Original wording, dates, corrections, structure and additional versions in each language.",
      "role": "Required",
      "role_reason": "How are Korean/English, the reference date, corrections and empty arrays preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How are Korean/English, the reference date, corrections and empty arrays preserved? Distinguish Original wording, dates, corrections, structure and additional versions in each language in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "When original text or corrections are added, the complete pre-change text and a separate event are retained."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What was actually read, and which external materials remain unread?",
      "needed": "Acquisition/reading level for each material and locations of original results/plans.",
      "role": "Required",
      "role_reason": "What was actually read, and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Only URLs were written in the original preparation; no separate link/content checks were performed.",
      "criterion": "What was actually read, and which external materials remain unread? Distinguish Acquisition/reading level for each material and locations of original results/plans in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Any later direct reading must record its scope, time and version."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How are the TAPS bibliography and two registration identifiers linked?",
      "needed": "Bibliography, paper/registration versions and material linking them to the same trial.",
      "role": "Required",
      "role_reason": "How are the TAPS bibliography and two registration identifiers linked? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The two registration identifiers are not counted as two independent trials.",
      "criterion": "How are the TAPS bibliography and two registration identifiers linked? Distinguish Bibliography, paper/registration versions and material linking them to the same trial in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "New reports/registration must distinguish identity, populations and relationships using source material."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "How is sharing across the trial, reports, populations and multiple outcomes maintained?",
      "needed": "Relationships/overlap between each outcome, trial, population, analysis set and follow-up.",
      "role": "Required",
      "role_reason": "How is sharing across the trial, reports, populations and multiple outcomes maintained? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "A direct report entry does not certify independent unique trial or participant totals.",
      "criterion": "How is sharing across the trial, reports, populations and multiple outcomes maintained? Distinguish Relationships/overlap between each outcome, trial, population, analysis set and follow-up in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added follow-up/related reports must distinguish population sharing within the existing TAPS family."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What are the population and surgical risk scope?",
      "needed": "Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.",
      "role": "Required",
      "role_reason": "What are the population and surgical risk scope? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Ages, genotypes and risk criteria absent from the original are not filled in.",
      "criterion": "What are the population and surgical risk scope? Distinguish Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Other surgery/risk populations require direct comparison material for their own question."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "How much is verified about baseline disease risk, representativeness and clinical setting?",
      "needed": "Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.",
      "role": "Supplementary; required for general application",
      "role_reason": "How much is verified about baseline disease risk, representativeness and clinical setting? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How much is verified about baseline disease risk, representativeness and clinical setting? Distinguish Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "General application requires direct material showing actual population differences."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What was the original study exposure to preoperative red-cell transfusion?",
      "needed": "Trial transfusion strategy, actual implementation, products, exposure and change records.",
      "role": "Required",
      "role_reason": "What was the original study exposure to preoperative red-cell transfusion? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "No new Hb targets, exchange/simple transfusion methods, administration schedules or doses are written.",
      "criterion": "What was the original study exposure to preoperative red-cell transfusion? Distinguish Trial transfusion strategy, actual implementation, products, exposure and change records in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Effects of other transfusion strategies must be distinguished using direct comparison material."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What are the no-transfusion control and concurrent surgical/care conditions?",
      "needed": "Original control, concurrent care, surgery, actual transfusion changes and timing material.",
      "role": "Required",
      "role_reason": "What are the no-transfusion control and concurrent surgical/care conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "No transfusion is not extended to no lifetime transfusion history or to waiting/treatment recommendations.",
      "criterion": "What are the no-transfusion control and concurrent surgical/care conditions? Distinguish Original control, concurrent care, surgery, actual transfusion changes and timing material in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Actual strategy implementation material is required to address exposure differences and concurrent-care effects."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What were the actual procedures of the multicentre randomized sequential superiority trial?",
      "needed": "Original allocation, concealment, assessor, centre and sequential-design plans/procedures.",
      "role": "Required",
      "role_reason": "What were the actual procedures of the multicentre randomized sequential superiority trial? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What were the actual procedures of the multicentre randomized sequential superiority trial? Distinguish Original allocation, concealment, assessor, centre and sequential-design plans/procedures in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added design details must distinguish original reports/historical assessments from actual verification."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "How do planned 405, enrolled 70 and ITT 67 differ?",
      "needed": "Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.",
      "role": "Required",
      "role_reason": "How do planned 405, enrolled 70 and ITT 67 differ? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "No new lost/excluded participant counts or recruitment completion rates are calculated from current numbers.",
      "criterion": "How do planned 405, enrolled 70 and ITT 67 differ? Distinguish Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "An original flow diagram showing actual analysis-population pathways is needed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What are the events, groups and denominators in 13/33 and 5/34?",
      "needed": "Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.",
      "role": "Required",
      "role_reason": "What are the events, groups and denominators in 13/33 and 5/34? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What are the events, groups and denominators in 13/33 and 5/34? Distinguish Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added direct outcome material must link each event to its group denominator."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What are the direction and interval of the no-transfusion versus transfusion OR?",
      "needed": "Details of the original OR model, analysis population, adjustment and interval.",
      "role": "Required",
      "role_reason": "What are the direction and interval of the no-transfusion versus transfusion OR? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The OR is not converted to its reciprocal, a risk ratio or a new relative reduction.",
      "criterion": "What are the direction and interval of the no-transfusion versus transfusion OR? Distinguish Details of the original OR model, analysis population, adjustment and interval in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "The original explanation of the estimand, direction and scale is needed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What is the original comparison behind the absolute difference of -24 percentage points?",
      "needed": "Original absolute-effect population, time, analysis and interval.",
      "role": "Required",
      "role_reason": "What is the original comparison behind the absolute difference of -24 percentage points? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original absolute values are not copied to long-term survival or effects in other surgery.",
      "criterion": "What is the original comparison behind the absolute difference of -24 percentage points? Distinguish Original absolute-effect population, time, analysis and interval in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added original explanations should link the absolute effect to its relevant scope."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What is the observation window for clinically important complications?",
      "needed": "Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.",
      "role": "Required",
      "role_reason": "What is the observation window for clinically important complications? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What is the observation window for clinically important complications? Distinguish Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Outcomes at each timepoint must be linked to their relevant analysis windows."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "How much is known about important complication definitions, components and adjudication?",
      "needed": "Complication components, severity, adjudication, overlap, original outcomes and plans.",
      "role": "Required",
      "role_reason": "How much is known about important complication definitions, components and adjudication? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How much is known about important complication definitions, components and adjudication? Distinguish Complication components, severity, adjudication, overlap, original outcomes and plans in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Direct material presenting the composite and individual components side by side is needed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What separate outcome is acute chest syndrome in 9 versus 1 participants?",
      "needed": "The event definition, original tables, denominators, periods and between-group analyses.",
      "role": "Required",
      "role_reason": "What separate outcome is acute chest syndrome in 9 versus 1 participants? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The 9 and 1 participants are not added independently to SAEs or total complications as separate events/people.",
      "criterion": "What separate outcome is acute chest syndrome in 9 versus 1 participants? Distinguish The event definition, original tables, denominators, periods and between-group analyses in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Direct material for each component must be linked separately from the composite outcome."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What are the original serious adverse event counts, denominators and proportions?",
      "needed": "SAE definitions, periods, calculation, overlap, group tables and plans.",
      "role": "Required",
      "role_reason": "What are the original serious adverse event counts, denominators and proportions? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "SAEs and important complication events are not independently added together.",
      "criterion": "What are the original serious adverse event counts, denominators and proportions? Distinguish SAE definitions, periods, calculation, overlap, group tables and plans in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Direct material on the reason for safety stopping and original SAE analysis is needed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "How did the first planned interim analysis differ from the later unplanned safety analysis?",
      "needed": "Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.",
      "role": "Required",
      "role_reason": "How did the first planned interim analysis differ from the later unplanned safety analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The trial is not re-described as stopping for efficacy after crossing the first planned boundary.",
      "criterion": "How did the first planned interim analysis differ from the later unplanned safety analysis? Distinguish Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added original decision material must separately record plans, actual events and interpretation."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "How are safety stopping and the original B0/sample-size defect treatment related?",
      "needed": "Stopping circumstances, original verdict rationale and actual plans/analyses.",
      "role": "Required",
      "role_reason": "How are safety stopping and the original B0/sample-size defect treatment related? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "No new sample-size criteria, bias grades or defect scores are calculated.",
      "criterion": "How are safety stopping and the original B0/sample-size defect treatment related? Distinguish Stopping circumstances, original verdict rationale and actual plans/analyses in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "A separate correction to the original decision must preserve before/after wording and reasons."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What effect-size uncertainty arises from the small sample and early termination?",
      "needed": "Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.",
      "role": "Required",
      "role_reason": "What effect-size uncertainty arises from the small sample and early termination? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Uncertainty is not converted into deletion of the original positive result or a new null verdict.",
      "criterion": "What effect-size uncertainty arises from the small sample and early termination? Distinguish Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Direct comparison material with independent replication and sufficient events/follow-up is needed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What are the details of ITT, missingness, changes and follow-up?",
      "needed": "Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.",
      "role": "Required",
      "role_reason": "What are the details of ITT, missingness, changes and follow-up? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What are the details of ITT, missingness, changes and follow-up? Distinguish Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Material linking the planned estimand to the actual analysis population is needed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons?",
      "needed": "Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.",
      "role": "Required",
      "role_reason": "What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons? Distinguish Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Any later comparison of prespecified plans with reports must retain its actual scope."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What is the scope of 0 versus 0 clinically important transfusion-related complications?",
      "needed": "Event definitions, collection, periods, denominators, testing plans and follow-up material.",
      "role": "Required",
      "role_reason": "What is the scope of 0 versus 0 clinically important transfusion-related complications? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Zero observed events are not changed into zero risk or safety noninferiority.",
      "criterion": "What is the scope of 0 versus 0 clinically important transfusion-related complications? Distinguish Event definitions, collection, periods, denominators, testing plans and follow-up material in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Rare transfusion harms require material with sufficient exposure, collection and follow-up."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What separate harm is the three-month anti-S alloantibody observation?",
      "needed": "Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.",
      "role": "Required",
      "role_reason": "What separate harm is the three-month anti-S alloantibody observation? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "One participant is not converted into a new 1/34 proportion or long-term disease value.",
      "criterion": "What separate harm is the three-month anti-S alloantibody observation? Distinguish Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Long-term alloimmunization effects require direct ascertainment, comparison and follow-up material."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What remains unverified about acute/delayed haemolytic reactions and alloimmunization?",
      "needed": "Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.",
      "role": "Required",
      "role_reason": "What remains unverified about acute/delayed haemolytic reactions and alloimmunization? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What remains unverified about acute/delayed haemolytic reactions and alloimmunization? Distinguish Definitions, collection, denominators, ascertainment and long-term follow-up for each harm in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Material documenting actual harm collection/ascertainment and direct clinical impact is needed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "How much is known about harm collection, ascertainment, recurrence and causality adjudication?",
      "needed": "Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.",
      "role": "Required",
      "role_reason": "How much is known about harm collection, ascertainment, recurrence and causality adjudication? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How much is known about harm collection, ascertainment, recurrence and causality adjudication? Distinguish Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Harm signals must be supplemented by actual exposure, timing, ascertainment and alternative-factor material."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are a safety imbalance and long-term harmlessness the same conclusion?",
      "needed": "Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.",
      "role": "Required",
      "role_reason": "Are a safety imbalance and long-term harmlessness the same conclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "Are a safety imbalance and long-term harmlessness the same conclusion? Distinguish Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Long-term/rare transfusion harms and clinical benefits each require direct material."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What were NHSBT public sponsorship, author employment and research roles?",
      "needed": "Original sponsorship, employment, research-role, data-access and COI disclosures.",
      "role": "Required",
      "role_reason": "What were NHSBT public sponsorship, author employment and research roles? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Public funding is not changed into absence of research involvement.",
      "criterion": "What were NHSBT public sponsorship, author employment and research roles? Distinguish Original sponsorship, employment, research-role, data-access and COI disclosures in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added role disclosures must record actual involvement and analysis/data relationships."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What are the details of contracts, data access, publication and other COI?",
      "needed": "Original COI, contract, data-access, analysis and publication-role disclosures.",
      "role": "Required",
      "role_reason": "What are the details of contracts, data access, publication and other COI? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What are the details of contracts, data access, publication and other COI? Distinguish Original COI, contract, data-access, analysis and publication-role disclosures in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Claims of broader independence require actual data-sharing, involvement and analysis-relationship material."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "How is a single confirmatory report distinguished from additional independent replication?",
      "needed": "Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.",
      "role": "Required",
      "role_reason": "How is a single confirmatory report distinguished from additional independent replication? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How is a single confirmatory report distinguished from additional independent replication? Distinguish Linkage material for new bibliography, registration, populations, designs, exposures and outcomes in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Added independent results must first distinguish population/report sharing with existing TAPS."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Is the related case 1485 hydroxyurea verdict the same question?",
      "needed": "Disease, population, purpose, timepoint and intervention differences, with direct material.",
      "role": "Supplementary; required for the boundary of the related question",
      "role_reason": "Is the related case 1485 hydroxyurea verdict the same question? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "The citation’s JSON-path verification label is historical; it does not mean the link was checked or read here.",
      "criterion": "Is the related case 1485 hydroxyurea verdict the same question? Distinguish Disease, population, purpose, timepoint and intervention differences, with direct material in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Related questions are not combined solely because they name the same disease; differences in conditions and purpose are retained."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies?",
      "needed": "Direct comparison material showing population, surgery and exposure-strategy differences.",
      "role": "Supplementary; required for extending applicability",
      "role_reason": "Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "No recommendations on transfusion suitability, methods, products, doses or surgical choice are made.",
      "criterion": "Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies? Distinguish Direct comparison material showing population, surgery and exposure-strategy differences in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Clinical outcomes under other conditions must be distinguished using their relevant populations, strategies and follow-up."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "Does a reduction in complications answer survival, quality of life and every long-term outcome?",
      "needed": "Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.",
      "role": "Supplementary; required to extend to other outcomes",
      "role_reason": "Does a reduction in complications answer survival, quality of life and every long-term outcome? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "Does a reduction in complications answer survival, quality of life and every long-term outcome? Distinguish Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Broader clinical-outcome scope requires direct outcome material for each question."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "What remains unverified about prespecified subgroup, component and multiple-outcome effects?",
      "needed": "Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.",
      "role": "Required",
      "role_reason": "What remains unverified about prespecified subgroup, component and multiple-outcome effects? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "What remains unverified about prespecified subgroup, component and multiple-outcome effects? Distinguish Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Direct material answering each outcome/subgroup and prespecified plans are needed."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "How much is verified about transfusion/event timing and alternative factors?",
      "needed": "Baseline risk, actual exposure, care, changes, event timing and adjudication material.",
      "role": "Required",
      "role_reason": "How much is verified about transfusion/event timing and alternative factors? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How much is verified about transfusion/event timing and alternative factors? Distinguish Baseline risk, actual exposure, care, changes, event timing and adjudication material in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Interpreting harms and clinical course requires direct records, ascertainment and comparisons."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "How are direct clinical outcomes, a large original effect and uncertainty preserved together?",
      "needed": "Relevant original outcome, design, follow-up, uncertainty and independent-material scope.",
      "role": "Required",
      "role_reason": "How are direct clinical outcomes, a large original effect and uncertainty preserved together? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.",
      "criterion": "How are direct clinical outcomes, a large original effect and uncertainty preserved together? Distinguish Relevant original outcome, design, follow-up, uncertainty and independent-material scope in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Additional material directly addressing clinical benefits and harms is separately needed."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "What is preserved when material, corrections or record-location displays are updated?",
      "needed": "Version relationships between new material, corrections, changed text, questions, conditions and observations.",
      "role": "Required (update boundaries)",
      "role_reason": "What is preserved when material, corrections or record-location displays are updated? This is needed to distinguish the relevant outcome, population and design from other scopes.",
      "application_exception": "No new searches, calculations, grades or treatment/procedural guidance are created in this production.",
      "criterion": "What is preserved when material, corrections or record-location displays are updated? Distinguish Version relationships between new material, corrections, changed text, questions, conditions and observations in the original material and retain the limits of direct verification.",
      "basis": "Study-family condition definitions linked to the stored original; no official clinical method assessment was run.",
      "condition_origin": "Application conditions for the current question; review of the existing content is incomplete",
      "proposed_research": "Separately added follow-up material must retain report/population sharing and the user-review scope."
    }
  ]
}