{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2932-s0", "verdict_number": "2932", "title": "Evidence sheet: liberal transfusion thresholds × overall 180-day neurologic outcome in acute brain injury", "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": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "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": "TRAIN's anemic mixed TBI/SAH/ICH population; HEMOTION's traumatic-injury-only population; not extended to effects in every patient or subgroup", "intervention": "Historical assigned strategies of 9 versus 7 g/dL in TRAIN and 10 versus 7 g/dL in HEMOTION; not transfusion, threshold or suitability recommendations", "dose": null, "comparator": "Each trial's liberal/restrictive thresholds and actual transfusion/concomitant treatment; causes of population/threshold differences remain unverified", "endpoint": "TRAIN's unfavorable GOS-E 1~5 at 180 days and HEMOTION's unfavorable outcome at six months; different definitions, denominators and estimates", "duration": "Each 180-day/six-month assessment specification; not extended to other durations or lifelong outcomes", "excluded_extensions": [ "Certifying TRAIN's overall result as equal effects across all brain injuries, anemia levels, individuals or each TBI/SAH/ICH subgroup", "Repurposing HEMOTION's traumatic-injury 10-versus-7 strategy as identical direct replication of TRAIN's mixed-population 9-versus-7 strategy or hemorrhage subgroups", "Calculating new exclusion/missingness counts or rates, total participants or events from 850/806/393/413, 742/722 or safety denominators 397/423", "Copying TRAIN's GOS-E 1~5 as HEMOTION's exact cutoff/baseline-specific adjudication, or equating 180-day and six-month windows without verification", "Converting original unfavorable-outcome rates into favorable-outcome rates or individual probabilities, or recalculating/reversing signs/reciprocals/new RRs for difference −10.0/RR .86 or difference 5.4/CI", "Repurposing original positive/null or opposing-conclusion wording as reversed effect signs, proven interaction under identical conditions, zero HEMOTION effect, equivalence or exclusion of important effects", "Presenting population/threshold differences alone as proof of conflict causes or effect modification", "Changing original Korean core-summary size wording/English differences into new trial-size judgments or corrections, or deleting current numbers/history", "Repurposing transfusion medians of 2/0 as total exposure, every individual's exposure or a new dose-response effect", "Changing safety cerebral ischemia of 35/397 versus 57/423 and RR .65/CI into primary-outcome denominators, overall safety, zero other harm or individual suitability", "Changing public/nonprofit funding or CIHR 'and others' into absence of all product/company/staff/COI involvement or certified independence", "Extending research thresholds, blood exposure or 180-day outcomes into transfusion/threshold/individual-suitability, treatment-administration or replacement guidance", "Adding the same reports/trials/populations or different questions/groups/timepoints/denominators as new independent trials or total participants", "Inheriting parent scores/axes, historical cross-checks, registration matches or full-text review accounts as subclaim values, current content review or external reading", "New search/API use, numerical calculations, hypothetical numbers, new effects/CIs/grades, independent certification or treatment/suitability/administration guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the existing subclaim and parent values for the overall acute-brain-injury question?", "needed": "Separate the subclaim C grade and note, absent score/status/axes, and parent C56/axes", "role": "Required", "role_reason": "This item distinguishes Separate the subclaim C grade and note, absent score/status/axes, and parent C56/axes to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate the subclaim C grade and note, absent score/status/axes, and parent C56/axes must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record separate sources for the overall question and original verdict. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question is improved 180-day neurologic outcome across acute brain injury. Its C grade and note describe positive TRAIN and null HEMOTION findings as conflicting. Subclaim score, status and axes are absent; parent C56, Caution and H/R0/I2/E+/B1 remain parent context.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Absent subclaim values are not filled with parent scores or axes, and no new grade is created. Existing content review remains incomplete.", "missingness": "Absent subclaim values are not filled with parent scores or axes, and no new grade is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional materials for the selected question or user feedback" }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which brain-injury populations does TRAIN's overall population include?", "needed": "Anemia, TBI/SAH/ICH, 22 countries and 72 ICUs, and eligibility scope", "role": "Required", "role_reason": "This item distinguishes Anemia, TBI/SAH/ICH, 22 countries and 72 ICUs, and eligibility scope to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Anemia, TBI/SAH/ICH, 22 countries and 72 ICUs, and eligibility scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link materials on the mixed overall population and eligibility conditions. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN studied anemic acute brain injury including traumatic brain injury, subarachnoid hemorrhage and intracerebral hemorrhage, randomizing 850 participants across 72 ICUs in 22 countries. This is not extended to universal effects across all brain injuries, anemia levels or treatment settings.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact stage/severity, age, anemia and eligibility criteria, and baseline characteristics and denominators by injury remain unverified. Existing content review remains incomplete.", "missingness": "Exact stage/severity, age, anemia and eligibility criteria, and baseline characteristics and denominators by injury remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusions, baseline and injury-specific tables, and recruitment materials" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What historical trial strategy does the 9 versus 7 g/dL comparison represent?", "needed": "Separate assigned thresholds, actual exposure, and baseline/concomitant treatment", "role": "Required", "role_reason": "This item distinguishes Separate assigned thresholds, actual exposure, and baseline/concomitant treatment to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate assigned thresholds, actual exposure, and baseline/concomitant treatment must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link assigned strategies and actual exposure. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's 9 versus 7 g/dL thresholds are historical trial conditions. Assigned liberal/restrictive strategies are distinguished from actual transfusion volume/timing and individual suitability; no transfusion, threshold or treatment instructions are created.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Actual threshold adherence, crossover/deviations, blood exposure/timing and concomitant treatment details remain unverified. Existing content review remains incomplete.", "missingness": "Actual threshold adherence, crossover/deviations, blood exposure/timing and concomitant treatment details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual transfusion, adherence and concomitant treatment records, and protocol" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about allocation and assessment in the open-label randomized design?", "needed": "Allocation generation/concealment, open-label status, and 180-day assessment/masking", "role": "Required", "role_reason": "This item distinguishes Allocation generation/concealment, open-label status, and 180-day assessment/masking to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Allocation generation/concealment, open-label status, and 180-day assessment/masking must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record separate materials for design and outcome measurement. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN was a multinational open-label randomized trial. Open treatment and masking/measurement of the 180-day neurologic assessor are kept separate; the original H/B1 axes do not establish actual assessor blinding.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Allocation generation/concealment, assessor/patient awareness and assessment conditions remain unverified. Existing content review remains incomplete.", "missingness": "Allocation generation/concealment, assessor/patient awareness and assessment conditions remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation/assessment guidance, masking and original collection materials" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do the 850 randomized participants differ from the 806 in the primary analysis?", "needed": "Observed-outcome/completer analysis, group denominators 393/413, and missingness/exclusions", "role": "Required", "role_reason": "This item distinguishes Observed-outcome/completer analysis, group denominators 393/413, and missingness/exclusions to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Observed-outcome/completer analysis, group denominators 393/413, and missingness/exclusions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link randomized and observed populations and missingness. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved statement says TRAIN included only the 806 participants with observed primary outcomes among 850 randomized. The unfavorable-outcome denominators are 246/393 versus 300/413; no new exclusion counts or rates are calculated.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Reasons for unobserved/excluded outcomes, group follow-up/missingness and original ITT/sensitivity plans remain unverified. Existing content review remains incomplete.", "missingness": "Reasons for unobserved/excluded outcomes, group follow-up/missingness and original ITT/sensitivity plans remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, missingness/analysis populations and sensitivity analyses/SAP" }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "How was unfavorable GOS-E 1~5 outcome at 180 days defined?", "needed": "The scale, 1~5 cutoff, timing/adjudication and original component scope", "role": "Required", "role_reason": "This item distinguishes The scale, 1~5 cutoff, timing/adjudication and original component scope to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering The scale, 1~5 cutoff, timing/adjudication and original component scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link the unfavorable-outcome definition and individual functional materials. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's endpoint was unfavorable GOS-E 1~5 outcome at 180 days. Descriptions of scale levels, components/death, other functional scales or continuous scores are not added where absent from the summary.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Adjudication/questions, assessment window, scale/component results and original collection details remain unverified. Existing content review remains incomplete.", "missingness": "Adjudication/questions, assessment window, scale/component results and original collection details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "GOS-E assessment/endpoint definitions, original outcome tables and prespecified plans" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which groups and analysis population underlie TRAIN's unfavorable-outcome counts and rates?", "needed": "Original group labels and denominators for 246/393 (62.6%) and 300/413 (72.6%)", "role": "Required", "role_reason": "This item distinguishes Original group labels and denominators for 246/393 (62.6%) and 300/413 (72.6%) to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Original group labels and denominators for 246/393 (62.6%) and 300/413 (72.6%) must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document event/person and overall/subgroup denominators. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's original unfavorable outcomes are preserved as 246/393 (62.6%) with the liberal strategy versus 300/413 (72.6%) with the restrictive strategy. They are not converted into rates among all 850 participants, injury-specific response rates or favorable-outcome rates.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original group/denominator flow, subgroup events, missingness/censoring and exact assessment timing remain unverified. Existing content review remains incomplete.", "missingness": "Original group/denominator flow, subgroup events, missingness/censoring and exact assessment timing remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original outcome/group-denominator tables and subgroup/follow-up tables" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the interval, direction and analysis specifications for adjusted RR .86?", "needed": "Unfavorable-outcome RR/CI/P, adjustment and distinction from absolute effects", "role": "Required", "role_reason": "This item distinguishes Unfavorable-outcome RR/CI/P, adjustment and distinction from absolute effects to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Unfavorable-outcome RR/CI/P, adjustment and distinction from absolute effects must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link comparison direction and adjusted estimates. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's adjusted RR .86 (95% CI .79~.94), P=.002 is recorded in the original unfavorable-outcome comparison direction. It is not changed into a favorable-outcome RR, individual prediction or effect of transfusion exposure alone; no reciprocal or new effect is calculated.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Covariates, model/assumptions, missing-data handling and exact contrast/population remain unverified. Existing content review remains incomplete.", "missingness": "Covariates, model/assumptions, missing-data handling and exact contrast/population remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adjusted model/SAP and original result/interval tables" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do TRAIN's absolute difference of −10%p and RR differ?", "needed": "Original absolute difference −10.0 (−16.5~−3.6), RR, scales and directions", "role": "Required", "role_reason": "This item distinguishes Original absolute difference −10.0 (−16.5~−3.6), RR, scales and directions to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Original absolute difference −10.0 (−16.5~−3.6), RR, scales and directions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record the sign and interval specifications for each estimate. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's original absolute difference −10.0%p (95% CI −16.5~−3.6) and adjusted RR .86 are different estimates. No new difference is calculated from 62.6/72.6, and the sign is not changed to match HEMOTION's positive-difference coding.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The exact absolute-difference contrast/adjustment, denominators, covariates and original tables remain unverified. Existing content review remains incomplete.", "missingness": "The exact absolute-difference contrast/adjustment, denominators, covariates and original tables remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original absolute/relative-effect tables and contrast/model definitions" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about primary timing/outcome, prespecified analysis and multiplicity?", "needed": "The 180-day primary outcome, prespecified plan, and subgroup/safety hierarchy", "role": "Required", "role_reason": "This item distinguishes The 180-day primary outcome, prespecified plan, and subgroup/safety hierarchy to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering The 180-day primary outcome, prespecified plan, and subgroup/safety hierarchy must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link plans for primary, secondary and subgroup analyses. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's original primary endpoint was unfavorable GOS-E outcome at 180 days, analyzed in 806 with observed outcomes. Injury-specific, safety and other-timepoint results are not promoted to new primary endpoints or independent confirmation.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Protocol/SAP, prespecified multiplicity/subgroup/missingness plans and amendment history remain unverified. Existing content review remains incomplete.", "missingness": "Protocol/SAP, prespecified multiplicity/subgroup/missingness plans and amendment history remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol/SAP and endpoint hierarchy" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "What exposure information is represented by median transfusion volume of 2 versus 0 units?", "needed": "Separate actual transfusion volume, assigned strategy, distribution/denominator/time", "role": "Required", "role_reason": "This item distinguishes Separate actual transfusion volume, assigned strategy, distribution/denominator/time to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate actual transfusion volume, assigned strategy, distribution/denominator/time must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link assigned strategies and actual blood exposure. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's original median transfusion volume of 2 versus 0 units is preserved. The median is not repurposed as every individual's exposure, total transfusion volume or a dose-response effect.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Timing, analysis population, distribution/blood types, crossover/additional transfusion and concomitant treatment remain unverified. Existing content review remains incomplete.", "missingness": "Timing, analysis population, distribution/blood types, crossover/additional transfusion and concomitant treatment remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual exposure/distribution, adherence/crossover and concomitant treatment records" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "Did HEMOTION test the same question as TRAIN's overall population?", "needed": "Traumatic injury only and thresholds of 10 versus 7, versus mixed injuries and 9 versus 7", "role": "Required", "role_reason": "This item distinguishes Traumatic injury only and thresholds of 10 versus 7, versus mixed injuries and 9 versus 7 to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Traumatic injury only and thresholds of 10 versus 7, versus mixed injuries and 9 versus 7 must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record population/threshold differences and their relationship to results. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "HEMOTION included traumatic brain injury only and compared 10 versus 7 g/dL; TRAIN included TBI/SAH/ICH and compared 9 versus 7. The populations and liberal thresholds are not treated as identical, and HEMOTION is not transferred as direct replication in SAH/ICH.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact eligibility/severity, baseline characteristics, treatment/exposure and comparability by injury remain unverified. Existing content review remains incomplete.", "missingness": "Exact eligibility/severity, baseline characteristics, treatment/exposure and comparability by injury remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both trials' characteristics/baseline and strategy/exposure tables" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "What do HEMOTION's 742 randomized and 722 analyzed participants represent?", "needed": "Randomized/analysis denominators, group-level missingness and actual outcomes", "role": "Required", "role_reason": "This item distinguishes Randomized/analysis denominators, group-level missingness and actual outcomes to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Randomized/analysis denominators, group-level missingness and actual outcomes must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link randomized/analysis populations and outcome denominators. No new research, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "HEMOTION's 742 randomized and 722 analyzed participants are preserved. Its 68.4% versus 73.5% rates are not transferred to all 742 participants or TRAIN's 393/413 denominators; no new exclusion counts or rates are calculated.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Group analysis denominators, follow-up/missingness/exclusions and sensitivity/ITT plans remain unverified. Existing content review remains incomplete.", "missingness": "Group analysis denominators, follow-up/missingness/exclusions and sensitivity/ITT plans remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "HEMOTION flow, original group outcomes/denominators and SAP" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "What do HEMOTION's unfavorable outcomes, adjusted difference and CI estimate?", "needed": "68.4/73.5%, adjusted 5.4%p (−2.9~13.7), and the original null-result wording", "role": "Required", "role_reason": "This item distinguishes 68.4/73.5%, adjusted 5.4%p (−2.9~13.7), and the original null-result wording to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering 68.4/73.5%, adjusted 5.4%p (−2.9~13.7), and the original null-result wording must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document original intervals and estimation specifications. No new research, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "HEMOTION's original 68.4% versus 73.5%, adjusted absolute difference 5.4%p (95% CI −2.9~13.7) and null-result wording are preserved. No new difference, CI or RR is calculated from the rates, and nonsignificance is not changed into equivalence, zero effect or exclusion of important effects.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact group/coding of the adjusted difference, model, original P value, denominators and important-difference threshold remain unverified. Existing content review remains incomplete.", "missingness": "Exact group/coding of the adjusted difference, model, original P value, denominators and important-difference threshold remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "HEMOTION original tables, contrast/model and prespecified importance threshold" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are assessment and GOS-E definitions identical at 180 days and six months?", "needed": "TRAIN's 180-day 1~5 definition and HEMOTION's actual six-month definition/assessment window", "role": "Required", "role_reason": "This item distinguishes TRAIN's 180-day 1~5 definition and HEMOTION's actual six-month definition/assessment window to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering TRAIN's 180-day 1~5 definition and HEMOTION's actual six-month definition/assessment window must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; own application; M04 §4.6.1–4.6.2, M15 §15.3.1; own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Compare timing and scale specifications. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN is preserved as 180-day GOS-E 1~5 and HEMOTION as six-month unfavorable GOS-E outcome. HEMOTION's exact cutoff/adjudication rules and assessment window are not filled with TRAIN's definition.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Both assessment windows/collection, HEMOTION's unfavorable-outcome definition and baseline-specific classification/weighting remain unverified. Existing content review remains incomplete.", "missingness": "Both assessment windows/collection, HEMOTION's unfavorable-outcome definition and baseline-specific classification/weighting remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both trials' endpoint/assessment guidance and prespecified plans" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "How does the original positive/null conflict wording relate to the numbers?", "needed": "Preserve original verdict/conflict wording alongside each rate, effect and interval", "role": "Required", "role_reason": "This item distinguishes Preserve original verdict/conflict wording alongside each rate, effect and interval to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Preserve original verdict/conflict wording alongside each rate, effect and interval must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design; M15 §15.3.1–15.3.3; own application; M04 §4.6.1–4.6.2, M15 §15.3.1; own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link original conclusion wording and quantitative results separately. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes TRAIN as positive and HEMOTION as null/opposing, and the subclaim C note describes conflict. Original rates, estimates and CIs are recorded together; the wording alone does not newly establish opposite effect signs or a proven difference under identical conditions.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The cause of conflict, direct between-trial interaction, comparability and important-effect threshold remain unverified. Existing content review remains incomplete.", "missingness": "The cause of conflict, direct between-trial interaction, comparability and important-effect threshold remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both trials' original results/characteristics and prespecified comparison/interaction materials" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are the original Korean/English descriptions of trial size and conclusions preserved?", "needed": "History of the original 'larger contemporaneous' wording, actual 850/742 counts and English account", "role": "Required", "role_reason": "This item distinguishes History of the original 'larger contemporaneous' wording, actual 850/742 counts and English account to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering History of the original 'larger contemporaneous' wording, actual 850/742 counts and English account must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record version-specific sources for original wording and numbers. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The Korean core summary's original 'larger contemporaneous HEMOTION' wording and the English description of a contemporaneous large trial remain in the full preserved source. Original 850/806 and 742/722 counts are used separately; that wording is not adopted as a new trial-size comparison/verdict fact, and the original is not corrected.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. New original-text review or correction of the wording/numeric context was not performed here. Existing content review remains incomplete.", "missingness": "New original-text review or correction of the wording/numeric context was not performed here.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original correction materials or user feedback" }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do population/threshold differences explain the cause of the conflict?", "needed": "Differences in 9/10 versus 7 thresholds and mixed/traumatic populations, with cause unverified", "role": "Required", "role_reason": "This item distinguishes Differences in 9/10 versus 7 thresholds and mixed/traumatic populations, with cause unverified to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Differences in 9/10 versus 7 thresholds and mixed/traumatic populations, with cause unverified must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record the unverified relationship between condition differences and causes of conflict. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original counterview says populations and liberal thresholds differ, but these differences alone cannot explain the opposing conclusions and the cause is unknown. Differences are not newly confirmed as proven effect modification or causes.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Prespecified interactions, standardized comparisons, covariates/exposure and causal analyses remain unverified. Existing content review remains incomplete.", "missingness": "Prespecified interactions, standardized comparisons, covariates/exposure and causal analyses remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial characteristics, prespecified interactions and comparative analysis materials" }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can the overall acute-brain-injury effect be transferred separately to TBI, SAH and ICH?", "needed": "Mixed-population overall results, subgroup events/denominators and interaction", "role": "Required", "role_reason": "This item distinguishes Mixed-population overall results, subgroup events/denominators and interaction to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Mixed-population overall results, subgroup events/denominators and interaction must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record overall/subgroup estimates and conditions separately. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's overall result does not certify equal effect size separately in TBI/SAH/ICH. HEMOTION's traumatic-injury result is not transferred to hemorrhage subgroups, and subgroups are not counted as new independent trials.", "condition_status": "Unverified", "status_reason": "Required information is unverified in the preserved summary. Injury-specific denominators/events, effects/CIs, prespecified subgroups and interactions remain unverified. Existing content review remains incomplete.", "missingness": "Injury-specific denominators/events, effects/CIs, prespecified subgroups and interactions remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Injury-specific results, prespecified plans and interaction materials" }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are trials, questions, timepoints and denominators kept separate when counting?", "needed": "Report/trial/population links, shared denominators/endpoints and unverified unique totals", "role": "Required", "role_reason": "This item distinguishes Report/trial/population links, shared denominators/endpoints and unverified unique totals to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Report/trial/population links, shared denominators/endpoints and unverified unique totals must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record study families and shared/duplicate relationships. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN and HEMOTION have separate original reports/conditions and their own randomized, analysis and safety denominators and 180-day/six-month outcomes. The parent/current sheet, questions and timepoints are not added as new independent trials or total participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unique trial, participant and independent-replication totals have not been confirmed and remain unrecorded. Existing content review remains incomplete.", "missingness": "Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/trial/population/endpoint linkage materials, if supplied" }, { "item_id": "N21", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are TRAIN's funding, sponsorship and administrative roles?", "needed": "ESICM NeXT, Fondation and Brussels, distinguished from products/staff/COI", "role": "Required", "role_reason": "This item distinguishes ESICM NeXT, Fondation and Brussels, distinguished from products/staff/COI to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering ESICM NeXT, Fondation and Brussels, distinguished from products/staff/COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document funding and actual roles. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's original ESICM NeXT grant, La Fondation des Gueules Cassées, and University Hospital Brussels sponsorship/administrative support are preserved. Public/nonprofit support is not changed into absence of all product/company/staff-author/COI involvement or certification of independence.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Support agreements, product/blood support, authors/contributions, study/analysis/manuscript decision rights and COI remain unverified. Existing content review remains incomplete.", "missingness": "Support agreements, product/blood support, authors/contributions, study/analysis/manuscript decision rights and COI remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support/sponsorship roles, contributions/products and author/COI materials" }, { "item_id": "N22", "question_type": "Efficacy comparison and presentation of stored material", "question": "What funding scope is covered by HEMOTION's CIHR 'and others' wording?", "needed": "Listed funding and 'and others', with products/staff and actual roles unverified", "role": "Required", "role_reason": "This item distinguishes Listed funding and 'and others', with products/staff and actual roles unverified to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Listed funding and 'and others', with products/staff and actual roles unverified must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link funding wording and actual support/roles. No new research, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original HEMOTION record names support from the Canadian Institutes of Health Research and others. Unlisted total funding, in-kind support or company roles are not newly filled in or inherited as verified independence.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Specific other funding, product support, staff/contributions/author COI and analysis/manuscript roles remain unverified. Existing content review remains incomplete.", "missingness": "Specific other funding, product support, staff/contributions/author COI and analysis/manuscript roles remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original total-support/in-kind and author/contribution/COI materials" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were registration identifiers and actual prespecified plans read?", "needed": "NCT02968654/03260478 identifiers, protocol/SAP and amendments", "role": "Required", "role_reason": "This item distinguishes NCT02968654/03260478 identifiers, protocol/SAP and amendments to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering NCT02968654/03260478 identifiers, protocol/SAP and amendments must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link registration versions by report and endpoint. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Both original registration identifiers are preserved. Identifiers and historical prespecification accounts are not inherited as registration/plan reading here or as fulfilled endpoint/missingness/subgroup conditions.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Original registration/amendment history, protocol/SAP and multiplicity/subgroup/missingness plans remain unread. Existing content review remains incomplete.", "missingness": "Original registration/amendment history, protocol/SAP and multiplicity/subgroup/missingness plans remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/plan copies or user-supplied materials" }, { "item_id": "N24", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "How do TRAIN's cerebral-ischemia safety denominators differ from the primary outcome?", "needed": "Prespecified serious events, 35/397 and 57/423, and separate RR .65/CI specifications", "role": "Supplementary", "role_reason": "This item distinguishes Prespecified serious events, 35/397 and 57/423, and separate RR .65/CI specifications to link the materials needed for the selected question with those currently available.", "application_exception": "Address gaps in harm materials for the selected kidney-replacement independence/neurologic outcome. Survival dependence and original mortality/neurologic/safety wording are not used to judge overall safety or create harm rates, treatment-initiation/transfusion/threshold/suitability guidance.", "criterion": "Original materials and analysis scope covering Prespecified serious events, 35/397 and 57/423, and separate RR .65/CI specifications must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; own application; M19 §19.1.2–19.2.4; detailed distinctions are our own design; M19 §19.1.2–19.2.4; own application; M08 Table 8.2.a, M04 §4.6.3; own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record primary endpoints and cerebral-ischemia events/denominators separately. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original cerebral ischemia of 35/397 (8.8%) versus 57/423 (13.5%), RR .65 (95% CI .44~.97), belongs to prespecified serious-adverse-event context. It is not transferred to the 246/393 and 300/413 primary-outcome denominators or overall neurologic improvement.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Safety denominators/collection, cerebral-ischemia definition/adjudication, timing and multiplicity/CI details remain unverified. Existing content review remains incomplete.", "missingness": "Safety denominators/collection, cerebral-ischemia definition/adjudication, timing and multiplicity/CI details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety tables, prespecified plans and event collection/denominators" }, { "item_id": "N25", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Do increased transfusion exposure and cerebral-ischemia findings establish overall safety?", "needed": "Blood exposure, individual serious events and rare/long-term harms", "role": "Supplementary", "role_reason": "This item distinguishes Blood exposure, individual serious events and rare/long-term harms to link the materials needed for the selected question with those currently available.", "application_exception": "Address gaps in harm materials for the selected kidney-replacement independence/neurologic outcome. Survival dependence and original mortality/neurologic/safety wording are not used to judge overall safety or create harm rates, treatment-initiation/transfusion/threshold/suitability guidance.", "criterion": "Original materials and analysis scope covering Blood exposure, individual serious events and rare/long-term harms must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; own application; M19 §19.1.2–19.2.4; detailed distinctions are our own design; M19 §19.2 design-specific harm questions; timing details are our own design; M19 §19.1.2–19.2.4; own application; Chamgap's own interpretation boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link blood exposure and endpoint-specific harms. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "TRAIN's original median transfusion volume of 2 versus 0 units and cerebral-ischemia results are preserved separately. The no-increase wording for one cerebral-ischemia outcome is not changed into zero transfusion harm, long-term safety or certified individual suitability.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Other safety-event definitions/collection, groups/exposure/denominators, rare/long-term harms and COI details remain unverified. Existing content review remains incomplete.", "missingness": "Other safety-event definitions/collection, groups/exposure/denominators, rare/long-term harms and COI details remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete safety tables, actual exposure/follow-up and collection materials" }, { "item_id": "N26", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can 180-day unfavorable outcomes be extended to lifelong function or other patients/thresholds?", "needed": "Actual 180-day/six-month assessments, eligibility/exposure and out-of-scope conditions", "role": "Required", "role_reason": "This item distinguishes Actual 180-day/six-month assessments, eligibility/exposure and out-of-scope conditions to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Actual 180-day/six-month assessments, eligibility/exposure and out-of-scope conditions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record evidence gaps by duration, population and exposure. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original materials cover each trial's 180-day/six-month outcomes. They do not create recommendations on lifelong function/mortality, other brain injuries/anemia/exposures, individual thresholds or transfusion selection/administration.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Long-term follow-up, individual prediction/vulnerable groups and direct evidence for other thresholds/populations remain unverified. Existing content review remains incomplete.", "missingness": "Long-term follow-up, individual prediction/vulnerable groups and direct evidence for other thresholds/populations remain unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct long-term or separate-condition materials, if supplied" }, { "item_id": "N27", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was actually read in the preserved summaries, URLs and external materials?", "needed": "Preserved summaries, TRAIN/HEMOTION URLs/registration and unread external materials", "role": "Required", "role_reason": "This item distinguishes Preserved summaries, TRAIN/HEMOTION URLs/registration and unread external materials to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Preserved summaries, TRAIN/HEMOTION URLs/registration and unread external materials must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record acquisition, reading and versions by material. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Both original bibliographic records/URLs and registration identifiers are retained, and the full preserved summary was read for production and marked as summary reading. External papers/plans and COI remain unread; historical review accounts or identifiers do not upgrade reading status.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External access, abstract/full-text/registration reading and link/click tests were not performed. Existing content review remains incomplete.", "missingness": "External access, abstract/full-text/registration reading and link/click tests were not performed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-supplied materials and actual reading records" }, { "item_id": "N28", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are original Korean/English text, verdicts/axes, dates and absent values preserved?", "needed": "Subclaim C, parent C56, 2026-08-26, null/false and correction history", "role": "Required", "role_reason": "This item distinguishes Subclaim C, parent C56, 2026-08-26, null/false and correction history to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Subclaim C, parent C56, 2026-08-26, null/false and correction history must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link original versions/dates and the selected question. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The full source's Korean/English text, parent C56/Caution, unrecorded precision/false flags, empty corrections/deliberation, 2026-08-26 and original conflict/cross-check wording are preserved. Subclaim C/note and absent score/status/axes are not filled with parent values.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The earlier production record performed no verdict-text translation, clinical full-text review, reassessment, correction or external update. Existing content review remains incomplete.", "missingness": "The earlier production record performed no verdict-text translation, clinical full-text review, reassessment, correction or external update.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original correction materials or user feedback" }, { "item_id": "N29", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are condition preservation, application and sheet production distinguished from content review?", "needed": "Separate condition preservation/freezing/application, case production and incomplete content review", "role": "Required", "role_reason": "This item distinguishes Separate condition preservation/freezing/application, case production and incomplete content review to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate condition preservation/freezing/application, case production and incomplete content review must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record condition/production versions and user correction history. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Condition preservation, freezing, application, case production and content review are separate records. Existing content review remains incomplete; counts of rows, reports and materials are not unique clinical-trial or participant totals.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Existing content review remains incomplete, and original clinical materials have not been newly verified. Existing content review remains incomplete.", "missingness": "Review of the existing content is incomplete and clinical source material was not newly verified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User review feedback and additional preserved materials" } ], "reports": [ { "report_id": "S01", "title": "TRAIN", "url": "https://pubmed.ncbi.nlm.nih.gov/39382241/", "report_type": "Multinational open-label randomized trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2932-TRAIN", "independent_replication": null, "observed_result": "62.6% versus 72.6%, adjusted RR 0.86 (0.79~0.94), P=.002. Original absolute difference −10.0%p (CI −16.5~−3.6), adjusted RR and denominators 246/393 versus 300/413 are preserved separately. Safety cerebral-ischemia denominators, transfusion medians and overall/subgroup results are not merged, and no new favorable-outcome rates, differences/CIs or individual effects are calculated.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39382241/" } ] }, { "report_id": "S02", "title": "HEMOTION", "url": "https://pubmed.ncbi.nlm.nih.gov/38869931/", "report_type": "Multinational open-label randomized trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2932-HEMOTION", "independent_replication": null, "observed_result": "68.4% versus 73.5%, adjusted absolute difference 5.4%p (95% CI −2.9~13.7), null. Original rates and adjusted difference/interval are preserved separately. Signs are not changed to match TRAIN's absolute-difference coding, and no new RR, difference/CI, between-trial interaction or identical overall/subgroup effect is created.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38869931/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 TRAIN/PMID39382241 is a 9-versus-7 g/dL strategy trial in a mixed TBI/SAH/ICH population across 72 ICUs in 22 countries, with 850 randomized and 806 analyzed with observed outcomes. Overall results, subgroups and safety denominators 397/423 are distinguished; equal effects across every brain-injury patient/subgroup are not established. The same report/groups/people, timepoints/endpoints and different questions/denominators are not added as new independent trials or participants. Report/material counts are not unique clinical totals; unique trial, participant and independent-replication totals remain unrecorded. S02 HEMOTION/PMID38869931 is a 10-versus-7 g/dL strategy trial in traumatic brain injury only, with 742 randomized and 722 analyzed. It differs from TRAIN's mixed-population 9-versus-7 strategy; the exact six-month GOS-E cutoff/adjudication specification is unverified in this summary. The same report/groups/people, timepoints/endpoints and different questions/denominators are not added as new independent trials or participants. Report/material counts are not unique clinical totals; unique trial, participant and independent-replication totals remain unrecorded." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }