{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Early Kidney Replacement Therapy × Freedom from Kidney Replacement Therapy at 90 Days — Evidence Checklist",
  "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": "Does the selected KRT-independence question differ from the parent mortality verdict?",
      "needed": "Distinguish the subclaim D grade/note and absent points/status/axes from parent D34/axes",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguish the subclaim D grade/note and absent points/status/axes from parent D34/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 Distinguish the subclaim D grade/note and absent points/status/axes from parent D34/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: Separate the sources of the independence question and mortality verdict. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What values are provided for the original 'independence' question?",
      "needed": "Distinguish KRT independence from the survivor dependence actually reported",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguish KRT independence from the survivor dependence actually reported 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 Distinguish KRT independence from the survivor dependence actually reported 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 §8.2.2, M15 §15.3.1; our 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 the independence question with the reported dependence values. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What denominators are survivor 814/815 and mortality-analysis 1465/1462?",
      "needed": "Separate the survival condition/dependence analysis from the overall mortality analysis",
      "role": "Required",
      "role_reason": "This item distinguishes Separate the survival condition/dependence analysis from the overall mortality analysis 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 survival condition/dependence analysis from the overall mortality analysis 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 the entire assigned/mortality population and survivor-conditional outcomes. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What comparison direction is represented by dependence RR1.74 and its CI?",
      "needed": "Distinguish early versus standard dependence RR/CI from independence/absolute effects",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguish early versus standard dependence RR/CI from independence/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 Distinguish early versus standard dependence RR/CI from independence/absolute effects 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 the original comparison direction, interval and endpoint specification. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is a survivor-conditional result the same as kidney recovery in all patients?",
      "needed": "Survivor selection, death as a competing event and randomized/conditional estimation",
      "role": "Required",
      "role_reason": "This item distinguishes Survivor selection, death as a competing event and randomized/conditional estimation 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 Survivor selection, death as a competing event and randomized/conditional estimation must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution",
      "proposed_research": "Proposal: Document conditional and whole-population outcomes separately. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were the actual STARRT-AKI population and initiation strategies?",
      "needed": "Severe AKI, early/standard initiation before absolute indications and eligibility/exclusions",
      "role": "Required",
      "role_reason": "This item distinguishes Severe AKI, early/standard initiation before absolute indications and eligibility/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 Severe AKI, early/standard initiation before absolute indications and eligibility/exclusions 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 in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house; M03 §3.2.3 and M08 §8.2.2–8.2.3: in-house 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 population and strategy conditions. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do 3019 randomized and 2927 analyzed participants differ?",
      "needed": "Postrandomization ineligibility/consent withdrawal, denominators and modified ITT scope",
      "role": "Required",
      "role_reason": "This item distinguishes Postrandomization ineligibility/consent withdrawal, denominators and modified ITT 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 Postrandomization ineligibility/consent withdrawal, denominators and modified ITT scope 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, mortality and survivor analysis populations. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were the 90-day dependence assessment and discontinuation/restart rules?",
      "needed": "Definitions of KRT status, assessment timing/duration and collection/follow-up",
      "role": "Required",
      "role_reason": "This item distinguishes Definitions of KRT status, assessment timing/duration and collection/follow-up 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 Definitions of KRT status, assessment timing/duration and collection/follow-up must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M08 Table 8.2.a and M03 §3.2.4: in-house application; M19 §19.1.2–19.2.4: detailed distinctions are in-house.",
      "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution",
      "proposed_research": "Proposal: Document KRT status and the timing/assessment specification. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How does the open-label design relate to dependence assessment?",
      "needed": "Distinguish allocation concealment/openness from mortality/KRT decisions",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguish allocation concealment/openness from mortality/KRT decisions 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 Distinguish allocation concealment/openness from mortality/KRT decisions 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: Link design with endpoint-specific measurement/decisions. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was the prespecified endpoint hierarchy for dependence?",
      "needed": "Primary mortality, dependence/safety and multiplicity/prespecified analysis",
      "role": "Required",
      "role_reason": "This item distinguishes Primary mortality, dependence/safety and multiplicity/prespecified analysis 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 Primary mortality, dependence/safety and multiplicity/prespecified analysis 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 the primary timepoint/endpoint and secondary dependence analysis. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does overall 90-day mortality differ from the selected independence outcome?",
      "needed": "Separate context of original 643/1465, 639/1462 and RR1.00/CI/P",
      "role": "Required",
      "role_reason": "This item distinguishes Separate context of original 643/1465, 639/1462 and RR1.00/CI/P 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 context of original 643/1465, 639/1462 and RR1.00/CI/P must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.3 and M15 §15.3.1–15.3.3: status separation is in-house; M15 §15.3.1–15.3.3: in-house 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 hard mortality and survivor-conditional dependence separately. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do actual treatment exposure/crossover relate to dependence?",
      "needed": "Greater early-group exposure, indication-based standard initiation and actual pathways",
      "role": "Required",
      "role_reason": "This item distinguishes Greater early-group exposure, indication-based standard initiation and actual pathways 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 Greater early-group exposure, indication-based standard initiation and actual pathways must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3 and M08 §8.2.2–8.2.3: in-house application; M08 §8.2.2 and M15 §15.3.1: in-house application; M19 §19.2: design-specific harm questions, with timing details in-house; M19 §19.2.2–19.2.4: design considerations, with detailed confounding records in-house.",
      "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 with actual exposure/dependence. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does ELAIN's positive mortality result directly answer 90-day independence?",
      "needed": "Context of 231 participants, one center, mortality 39.3/54.7% and HR/P",
      "role": "Required",
      "role_reason": "This item distinguishes Context of 231 participants, one center, mortality 39.3/54.7% and HR/P 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 Context of 231 participants, one center, mortality 39.3/54.7% and HR/P must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.4: in-house extension boundaries.",
      "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution",
      "proposed_research": "Proposal: Separate mortality context from the selected independence endpoint. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does AKIKI 60-day survival directly answer 90-day independence?",
      "needed": "Scope of 620 randomized/619 analyzed, 31 ICUs and 60-day survival",
      "role": "Required",
      "role_reason": "This item distinguishes Scope of 620 randomized/619 analyzed, 31 ICUs and 60-day survival 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 Scope of 620 randomized/619 analyzed, 31 ICUs and 60-day survival must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.1–3.2.4: dosage, persistence and effect-modification details are in-house.",
      "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution",
      "proposed_research": "Proposal: Document differences in timing/endpoints. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do different early definitions and populations across the three trials relate?",
      "needed": "Institutions/patients/timing, strategy definitions and the history of conflicting original results",
      "role": "Required",
      "role_reason": "This item distinguishes Institutions/patients/timing, strategy definitions and the history of conflicting original results 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 Institutions/patients/timing, strategy definitions and the history of conflicting original results 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 and M15 §15.3.1: in-house application; M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house.",
      "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution",
      "proposed_research": "Proposal: Document relationships across different strategies/populations/endpoints. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are the same trial and parent mortality/independence questions and reports kept from being summed?",
      "needed": "Shared reports/trials/populations, different endpoints and units",
      "role": "Required",
      "role_reason": "This item distinguishes Shared reports/trials/populations, different endpoints and units 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 Shared reports/trials/populations, different endpoints and units 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 shared/overlapping relationships separately. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were STARRT's mixed support and Alere's in-kind contribution?",
      "needed": "Distinguish public/industry partnership and in-kind measurement devices from actual roles/COI",
      "role": "Required",
      "role_reason": "This item distinguishes Distinguish public/industry partnership and in-kind measurement devices from actual roles/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 Distinguish public/industry partnership and in-kind measurement devices from actual roles/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/measurement-device support and actual roles. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does ELAIN/AKIKI support verify independence for the dependence question?",
      "needed": "Institutional/nonprofit support, French Ministry of Health and detailed roles",
      "role": "Required",
      "role_reason": "This item distinguishes Institutional/nonprofit support, French Ministry of Health and detailed roles 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 Institutional/nonprofit support, French Ministry of Health and detailed roles 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: Separate each trial's funding from actual roles. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were registry IDs and prespecified independence/dependence analyses actually read?",
      "needed": "Original DRKS00004367, NCT01932190/02568722 identifiers and plans",
      "role": "Required",
      "role_reason": "This item distinguishes Original DRKS00004367, NCT01932190/02568722 identifiers and plans 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 DRKS00004367, NCT01932190/02568722 identifiers and plans 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 endpoint-specific prespecified plans with report versions. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "How do KRT complications and dependence represent different harm information?",
      "needed": "Hypotension/infection/bleeding/access complications and actual event reports",
      "role": "Supplementary",
      "role_reason": "This item distinguishes Hypotension/infection/bleeding/access complications and actual event reports 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 Hypotension/infection/bleeding/access complications and actual event reports 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; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap 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: Document dependence separately from other safety events. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What is the scope of survivor follow-up/missingness and long-term dependence?",
      "needed": "90 days, survival conditions, discharge/long-term outcomes, vulnerable groups and observation loss",
      "role": "Supplementary",
      "role_reason": "This item distinguishes 90 days, survival conditions, discharge/long-term outcomes, vulnerable groups and observation loss 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 90 days, survival conditions, discharge/long-term outcomes, vulnerable groups and observation loss 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 and M04 §4.6.3: in-house application; M19 §19.1.2–19.2.4: in-house application; M03 §3.2.1–3.2.4: dosage, persistence and effect-modification details are in-house.",
      "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution",
      "proposed_research": "Proposal: Link dependence gaps across time/conditions. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can findings be generalized to other patients, absolute indications or treatment choices?",
      "needed": "Severe-AKI study strategies, actual eligibility and questions outside scope",
      "role": "Required",
      "role_reason": "This item distinguishes Severe-AKI study strategies, actual eligibility and questions outside 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 Severe-AKI study strategies, actual eligibility and questions outside 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 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 population/strategy-specific evidence gaps. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What reading level applies to summaries, external reports/plans and URLs?",
      "needed": "The complete preserved summary, three original URLs/registrations and unread external materials",
      "role": "Required",
      "role_reason": "This item distinguishes The complete preserved summary, three original URLs/registrations 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 The complete preserved summary, three original URLs/registrations 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 for each material. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are original Korean/English text, axis-evidence wording, empty values and dates preserved?",
      "needed": "Subclaim D, parent D34, 2026-08-26, false and empty arrays/strings",
      "role": "Required",
      "role_reason": "This item distinguishes Subclaim D, parent D34, 2026-08-26, false and empty arrays/strings 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 D, parent D34, 2026-08-26, false and empty arrays/strings 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 with the selected independence question. No new research, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are condition preservation/application, case preparation and content review distinguished?",
      "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."
    }
  ]
}