{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2920-main", "verdict_number": "2920", "title": "Preoperative red-cell transfusion × Reduced clinically important surgical complications in sickle cell disease", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Only the stored summary was read for production; external papers, registration, plans and original tables remain unread. Partial verification in this presentation does not mean clinical confirmation or completed review. Existing verdict values are distinguished from historical candidate records. Original results, uncertainty, harms, design and denominators are kept distinct; no procedural guidance is provided.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Reduced clinically important complications in low- and medium-risk surgery in sickle cell disease", "intervention": "Preoperative red-cell transfusion", "dose": "The current article lacks details of the actual transfusion method, dose, targets and schedule; no new procedural guidance is created", "comparator": "No transfusion. The reported OR is in the no-transfusion versus transfusion direction", "endpoint": "Clinically important complications from randomization through 30 days after surgery", "duration": "Important complications from randomization through 30 days after surgery; the three-month anti-S observation is a separate timepoint", "excluded_extensions": [ "Generalizing effects/safety to other populations, diseases, surgical risks, formulations or timepoints", "Adding the same report, population, groups, timepoints or outcomes as new independent trials/participants", "Recommending individual treatments, procedures, doses, suitability or usage choices" ] }, "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The selected stored summary concerns reduced clinically important complications in low- and medium-risk surgery in sickle cell disease. The selected question and complete existing verdict record are distinguished. Candidate history is preserved without creating nonexistent subclaims.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The relationship between the original complete verdict and selected question remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; The relationship between the original complete verdict and selected question.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The relationship between the original complete verdict and selected question." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Original grade B, score 76, axes B/H/R1/I2/E+/B0 and safety caution are used. An existing verification-status field is absent from the stored summary; that absence is recorded. A statement of absent subclaim scores is not applied to a verdict with its own score and axes.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Existing verdict values, original wording and history remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Existing verdict values, original wording and history.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing verdict values, original wording and history." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Original precision null, coprimary_split/big_hard_rct/no_human_study false and empty override_reason/override_reason_en strings are preserved. The original B0/B76 decision not to count safety stopping or the 70-person sample as defects is historical. No new criteria or review are run.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Versions of original axes, study assessment and correction history remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Versions of original axes, study assessment and correction history.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Versions of original axes, study assessment and correction history." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Complete Korean/English articles, reference date 2026-08-26 and existing empty correction/subclaim/deliberation values are preserved. Stored cross-check/Primary-source cross-check wording is historical, not completed current review.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original wording, dates, corrections, structure and additional versions in each language remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original wording, dates, corrections, structure and additional versions in each language.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wording, dates, corrections, structure and additional versions in each language." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The complete designated stored JSON was read for production. Abstracts, full texts, NCT/ISRCTN registration, protocols, SAPs, DSMC records and original tables were not accessed. Links, stored citations and historical review do not certify current external reading.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Acquisition/reading level for each material and locations of original results/plans remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Acquisition/reading level for each material and locations of original results/plans.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Acquisition/reading level for each material and locations of original results/plans." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The direct report is TAPS, Howard J et al., Lancet 2013, PMID 23352054. Stored registration text is NCT00512577 · ISRCTN00862331; both identifiers link to one stored report. DOI, PMCID and registration content are unverified.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Bibliography, paper/registration versions and material linking them to the same trial remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Bibliography, paper/registration versions and material linking them to the same trial.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Bibliography, paper/registration versions and material linking them to the same trial." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "One direct TAPS report contains clinically important complications, acute chest syndrome, SAEs, transfusion-related complications and alloantibodies. Shared people, groups, events or timepoints are not added as new independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Relationships/overlap between each outcome, trial, population, analysis set and follow-up remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Relationships/overlap between each outcome, trial, population, analysis set and follow-up.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships/overlap between each outcome, trial, population, analysis set and follow-up." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The verdict question concerns low-/medium-risk surgery in sickle cell disease. The stored summary lacks detailed ages, genotypes, surgical types, risk classification and eligibility/exclusions, so it is not automatically extended to all sickle cell disease or high-risk surgery.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The current summary lacks disease severity, baseline haemoglobin, previous transfusions, antibodies, comorbidities, recruitment setting and group distributions. The population name and original effect do not guide transfusion suitability for an individual patient.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The intervention is preoperative red-cell transfusion. The current summary lacks actual methods, units, targets, timing, antigen matching, changes and adherence. No transfusion procedure, dose, target or suitability recommendations are created.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Trial transfusion strategy, actual implementation, products, exposure and change records remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Trial transfusion strategy, actual implementation, products, exposure and change records.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial transfusion strategy, actual implementation, products, exposure and change records." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The stored comparison is transfusion versus no transfusion, while the reported OR is no transfusion versus transfusion. Actual surgery, anaesthesia, concurrent care, transfusion changes and rescue treatment details are unverified.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original control, concurrent care, surgery, actual transfusion changes and timing material remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original control, concurrent care, surgery, actual transfusion changes and timing material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original control, concurrent care, surgery, actual transfusion changes and timing material." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original design is a multicentre randomized sequential superiority trial. The current summary lacks sequence generation, concealment, stratification, centre implementation and assessment blinding details. Original B0 is not inherited as direct procedural verification.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Original allocation, concealment, assessor, centre and sequential-design plans/procedures remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original allocation, concealment, assessor, centre and sequential-design plans/procedures.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation, concealment, assessor, centre and sequential-design plans/procedures." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Of a planned 405 participants, 70 were enrolled and 67 analyzed by ITT. Original planned, enrolled and analyzed counts are distinguished. Enrolled 70 is not changed to a completed-randomization count beyond the stored summary, and no differences or proportions are calculated.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Clinically important complications were no transfusion 13/33 (39%) versus transfusion 5/34 (15%). These are original group values for the same verdict, not mixed with separate acute chest syndrome or SAE measures.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Reported no-transfusion versus transfusion OR: 3.8 (95% CI 1.2–12.2). Its direction is retained, without conversion to a transfusion versus no-transfusion OR, RR, HR or survival outcome. No P value or other effect absent from the stored summary is calculated.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Details of the original OR model, analysis population, adjustment and interval remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Details of the original OR model, analysis population, adjustment and interval.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Details of the original OR model, analysis population, adjustment and interval." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original absolute difference of -24 percentage points is preserved in the context of important surgical complications: no transfusion 39% versus transfusion 15%. No new absolute difference, NNT, treated-person example or interval is calculated.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original absolute-effect population, time, analysis and interval remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original absolute-effect population, time, analysis and interval.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original absolute-effect population, time, analysis and interval." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The endpoint runs from randomization through 30 days after surgery. Thirty days after surgery is distinguished from the transfusion group’s three-month alloantibody observation; the complication window is not changed to simply 30 days after enrollment.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original important-complication definition and some acute chest syndrome/SAE values are available, but full components, overlap, first events, severity, assessors, blinding and ascertainment details are unverified. Equal reductions in all components are not newly established.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Complication components, severity, adjudication, overlap, original outcomes and plans remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Complication components, severity, adjudication, overlap, original outcomes and plans.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complication components, severity, adjudication, overlap, original outcomes and plans." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Original acute chest syndrome counts are 9 versus 1 participants. The no-transfusion versus transfusion context is retained; absent denominators, proportions, effects, CIs or P values for that outcome are not calculated from other outcome numbers.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The event definition, original tables, denominators, periods and between-group analyses remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; The event definition, original tables, denominators, periods and between-group analyses.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The event definition, original tables, denominators, periods and between-group analyses." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "SAEs were no transfusion 10/33 (30%) versus transfusion 1/34 (3%). These outcomes come from the same trial as complications and acute chest syndrome; detailed overlap is unverified. No new effect, CI or P value is created.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. SAE definitions, periods, calculation, overlap, group tables and plans remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; SAE definitions, periods, calculation, overlap, group tables and plans.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAE definitions, periods, calculation, overlap, group tables and plans." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "At the first planned interim analysis, no stopping boundaries had been crossed and the trial continued. The original sequence is retained: an unexpected SAE imbalance later led the DSMC to request an unscheduled interim analysis and recommend stopping for safety.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The historical assessment says stopping was not at a prespecified primary-endpoint boundary and the safety stop was unavoidable, so early stopping and fewer than 200 participants were not counted as defects. This history is preserved alongside the facts: enrolled 70, ITT 67 and planned 405.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Stopping circumstances, original verdict rationale and actual plans/analyses remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Stopping circumstances, original verdict rationale and actual plans/analyses.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Stopping circumstances, original verdict rationale and actual plans/analyses." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original counterpoint says the small sample and early termination may have overestimated the effect size. The original OR 95% CI width, 1.2–12.2, is preserved without new precision-axis or reliability scores.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "ITT 67 and group counts 33/34 are preserved. Enrollment, analysis inclusion, surgery not performed, treatment changes, missingness, follow-up and analysis handling details are unverified. Group results are not assigned a denominator of all enrollees.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Historical explanations of the randomized sequential superiority trial and interim analyses are preserved. Actual registration/protocol/SAP details of primary-outcome hierarchy, stopping rules, multiple comparisons, adjustment and analysis versions remain unread.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original description of zero clinically important transfusion-related complications in both TAPS groups is preserved. The stored summary did not test this comparison, so no between-group significance wording is used and not all transfusion harms are established as absent or harmless.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Event definitions, collection, periods, denominators, testing plans and follow-up material remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Event definitions, collection, periods, denominators, testing plans and follow-up material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event definitions, collection, periods, denominators, testing plans and follow-up material." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "One participant in the transfusion group developed an anti-S red-cell alloantibody at three months. This is separate from the primary complication window through 30 days after surgery. Incidence, between-group effects, P values or CIs absent from the summary are not calculated.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original counterview explains alloimmunization and acute/delayed haemolytic transfusion reaction risks. Beyond TAPS important complications 0 versus 0 and one anti-S participant, detailed frequencies, ascertainment and long-term results for each harm are unverified.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Definitions, collection, denominators, ascertainment and long-term follow-up for each harm remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions, collection, denominators, ascertainment and long-term follow-up for each harm." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Some original transfusion-harm/SAE values are available, but collection, assessors, severity, recurrence, event relatedness, risk periods and safety-denominator details are unverified. Observed events are distinguished from established causality.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The historical recommendation to stop for safety following an SAE imbalance in the no-transfusion group is retained alongside harms of transfusion itself. A signal of comparative advantage does not establish harmlessness for every patient/long-term transfusion or suitability for every surgery.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "NHS Blood and Transplant sponsored the trial; five authors were employed by NHSBT. Original information that NHSBT and the MRC Clinical Studies Unit performed design, data collection, analysis and interpretation is retained. Public funding and actual involvement are shown together.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original sponsorship, employment, research-role, data-access and COI disclosures remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original sponsorship, employment, research-role, data-access and COI disclosures.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sponsorship, employment, research-role, data-access and COI disclosures." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The summary describes sponsorship, author employment, design, collection, analysis and interpretation, but contract, data-access, publication-decision and other conflict details are unverified. Original I2 is not inherited as new analysis-independence certification.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Original COI, contract, data-access, analysis and publication-role disclosures remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original COI, contract, data-access, analysis and publication-role disclosures.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original COI, contract, data-access, analysis and publication-role disclosures." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The evidence weight describes a single small confirmatory trial, and the original overall summary says independent replication is needed. One direct report, two registrations and multiple outcomes are not added as new independent replications. Additional direct trials are unverified in the current input.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Linkage material for new bibliography, registration, populations, designs, exposures and outcomes remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Linkage material for new bibliography, registration, populations, designs, exposures and outcomes." }, { "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.", "current_reports": [], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Case 1485 concerns routine prevention of vaso-occlusive complications in adults with sickle cell anaemia, linked with historical B77. Its population and purpose differ from preparation for low-/medium-risk surgery here. That page was not read and is not counted as a direct TAPS report or new trial.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Disease, population, purpose, timepoint and intervention differences, with direct material remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Disease, population, purpose, timepoint and intervention differences, with direct material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Disease, population, purpose, timepoint and intervention differences, with direct material." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The current verdict preserves the original preoperative transfusion comparison in low-/medium-risk surgery. Benefits/harms for other surgical risks, disease types, ages, baseline antibodies or transfusion strategies are not automatically established as identical. Relevant direct material is unverified.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Direct comparison material showing population, surgery and exposure-strategy differences remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Direct comparison material showing population, surgery and exposure-strategy differences.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparison material showing population, surgery and exposure-strategy differences." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Original results for actual clinically important surgical complications are preserved. Direct long-term survival, quality-of-life, all-complication and routine disease-control values are absent, so they do not substitute for those separate questions.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Total important complications and some event counts are preserved, but group-specific subgroup/component plans, precision, interactions and multiple-comparison details are unverified. The overall OR is not copied to every component/population.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Detailed timing between underlying disease, previous transfusions, concurrent care, surgery type, changes and events is unverified. Randomized strategy comparisons are distinguished from attributing every individual event to a single cause.", "condition_status": "Unverified", "status_reason": "Required direct details are unverified within the current summary and unread external material. Baseline risk, actual exposure, care, changes, event timing and adjudication material remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Baseline risk, actual exposure, care, changes, event timing and adjudication material.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline risk, actual exposure, care, changes, event timing and adjudication material." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Original B76 and wording of a large important-complication reduction, actual events 13/33 versus 5/34 and the OR direction/interval are preserved. Small sample, safety stopping, transfusion harms and the need for independent replication remain limitations.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Relevant original outcome, design, follow-up, uncertainty and independent-material scope remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Relevant original outcome, design, follow-up, uncertainty and independent-material scope.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relevant original outcome, design, follow-up, uncertainty and independent-material scope." }, { "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.", "current_reports": [ "R01" ], "existence": "Stored summary/bibliography distinguished from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The existing complete verdict, selected question, candidate history, Korean/English articles, dates and empty correction-history values are retained. New material must separate the complete pre-change stored summary, version/reason, condition changes and separate application of observations.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Version relationships between new material, corrections, changed text, questions, conditions and observations remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Version relationships between new material, corrections, changed text, questions, conditions and observations.", "uncertainty": "Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Version relationships between new material, corrections, changed text, questions, conditions and observations." } ], "reports": [ { "report_id": "R01", "title": "Howard J, et al. Lancet. 2013. PMID: 23352054.", "url": "https://pubmed.ncbi.nlm.nih.gov/23352054/", "report_type": "Multicentre randomized sequential superiority trial", "existence": "Direct report linked in the existing review summary’s evidence/citation lists", "acquired_read": "Summary read; external papers and registration unread", "study_family": "F01", "independent_replication": false, "observed_result": "13/33 (39%) versus 5/34 (15%); absolute difference -24 percentage points; no-transfusion versus transfusion OR 3.8 (95% CI 1.2–12.2)", "result_level": "Reported values from the existing review summary. The original paper was not directly verified in this work.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Stored summary", "access_status": "Locally stored existing review summary read for preparation", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T19:16:28.810965+09:00", "qualification": "The existing complete review summary was read for production; the original paper was not acquired or read." }, { "material_type": "Paper abstract", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the bibliographic PMID link was connected. The actual abstract and result locations were not directly verified." }, { "material_type": "Full paper", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The URL is a bibliographic link; full-text acquisition and accessibility were not verified." }, { "material_type": "Clinical trial registration", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only original registration-identifier text is preserved. Registration content, versions, first date, changes and comparison with reports are unverified." }, { "material_type": "Study protocol", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original sequential-design, hypothesis, transfusion-strategy, outcome-component, interim-analysis and DSMC stopping-plan documents have not been acquired." }, { "material_type": "Statistical analysis plan", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Direct plans for analysis populations, estimands, adjustment, missingness, sensitivity, hierarchy and precision have not been acquired." }, { "material_type": "Original results and safety tables", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original definitions, group outcomes, timing and denominators are needed for important complications, acute chest syndrome, SAEs, transfusion harms, alloantibodies and stopping." }, { "material_type": "Sponsorship and interest disclosures", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Beyond stored funding/role information, original contract, data-access, publication-decision and author-specific COI documents have not been acquired." }, { "material_type": "Verdict on a different related question", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "A historical link distinguishing routine prevention in the same disease from original preoperative preparation. It is not a direct TAPS report or independent replication; that page was not read." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23352054/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Original functional/clinical outcomes, analyses, harms and related timepoints share one TAPS report/population; they are not added as new independent replications." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }