{ "schema_version": "chamgap-public-criteria-1.0", "title": "Evidence sheet: liberal transfusion thresholds × overall 180-day neurologic outcome in acute brain injury", "language": "en", "translation_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }