{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Early Kidney Replacement Therapy · Severe Acute Kidney Injury · Reduced 90-Day Mortality — 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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Existing content review is pending or remains incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What are the selected question/record and parent/related-outcome context?",
      "needed": "Separate links for the original question, record and parent/related outcomes",
      "role": "Required",
      "role_reason": "Required to separately document 'What are the selected question/record and parent/related-outcome context?' for the selected reduced-90-day-mortality question.",
      "application_exception": "The original candidate's pending boundary review is historical; existing content and question-boundary review remain incomplete. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are the selected question/record and parent/related-outcome context?' to their original records. The original candidate's pending boundary review is historical; existing content and question-boundary review remain incomplete.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If new materials for the same question are supplied, link them while retaining the original question and verdict text."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How do the original subclaim D grade/note differ from parent D34 and absent subclaim score/axes?",
      "needed": "Preserve subclaim grade/note separately from parent scores/axes and absent values",
      "role": "Required",
      "role_reason": "Required to separately document 'How do the original subclaim D grade/note differ from parent D34 and absent subclaim score/axes?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not copy grades uniformly, inherit the parent 34 points/axes or make a new verdict; do not extend the note's 'exactly' into an exact zero effect.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How do the original subclaim D grade/note differ from parent D34 and absent subclaim score/axes?' to their original records. Direct original values for the selected subclaim's score/status/axes are absent.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01, C09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If an actual correction is supplied, record full original text, event/version and change decision separately."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "How are ELAIN, AKIKI and STARRT-AKI reports related to trials?",
      "needed": "Table linking reports/registration/study families, timing/outcomes and shared populations",
      "role": "Required",
      "role_reason": "Required to separately document 'How are ELAIN, AKIKI and STARRT-AKI reports related to trials?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not sum the three report records, bibliographic entries, institution counts or individual sample sizes into a new independent-trial or participant total.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How are ELAIN, AKIKI and STARRT-AKI reports related to trials?' to their original records. Early/follow-up report versions, duplicate people/trials and current unique totals have not been confirmed.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, E07, H07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If additional materials are supplied, record same/separate/unclear report relationships and outcome-specific scope."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What is the scope of actual reading and external links?",
      "needed": "Material-specific status, reading scope and original records for preserved summaries and external materials",
      "role": "Required",
      "role_reason": "Required to separately document 'What is the scope of actual reading and external links?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not upgrade summary reading into paper/registry reading or describe unattempted access as failure or zero existence.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is the scope of actual reading and external links?' to their original records. External availability/acquisition, accessibility, current content and URL operation were not checked here.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "In a follow-up permitting material acquisition, record actual reading, access attempts and dates separately."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What are the severe-AKI eligibility, severity and institutional settings?",
      "needed": "Trial-specific eligibility/exclusions, severity/baseline kidney function and recruitment settings",
      "role": "Required",
      "role_reason": "Required to separately document 'What are the severe-AKI eligibility, severity and institutional settings?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Age, AKI definition/stage, baseline kidney function, other organs/causes, eligibility/exclusions and each population's severity composition remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are the severe-AKI eligibility, severity and institutional settings?' to their original records. Age, AKI definition/stage, baseline kidney function, other organs/causes, eligibility/exclusions and each population's severity composition remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C04, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If direct materials specify the same strategy/population or other conditions, distinguish them by trial."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are actual definitions of early, standard and delayed strategies identical across trials?",
      "needed": "Trial-specific protocols, early/standard/delayed definitions and actual implementation",
      "role": "Required",
      "role_reason": "Required to separately document 'Are actual definitions of early, standard and delayed strategies identical across trials?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not fill timing/thresholds with invented numbers or declare the early strategies of different trials identical.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'Are actual definitions of early, standard and delayed strategies identical across trials?' to their original records. Trial-specific time origins, initiation criteria/thresholds, permitted waiting and actual initiation times/adherence remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02, E07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link each trial's directly described definitions/exposure conditions to the same or different question."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What scope is covered by the standard arm's initiation after absolute indications?",
      "needed": "Original standard-strategy initiation/rescue criteria and implementation materials",
      "role": "Required",
      "role_reason": "Required to separately document 'What scope is covered by the standard arm's initiation after absolute indications?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not turn historical initiation conditions into action recommendations on individual treatment initiation/waiting, emergency assessment or suitability.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What scope is covered by the standard arm's initiation after absolute indications?' to their original records. Protocol numerical thresholds, actual timing, decisions/adherence, rescue initiation and individual suitability remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link historical strategy descriptions to original protocol and implementation materials."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Which kidney-replacement methods and actual exposures are described?",
      "needed": "Original treatment methods, devices/exposure, changes and implementation tables",
      "role": "Required",
      "role_reason": "Required to separately document 'Which kidney-replacement methods and actual exposures are described?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not turn the original treatment types into modality selection, dosage conversion or treatment instructions.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'Which kidney-replacement methods and actual exposures are described?' to their original records. Group-specific techniques/devices, actual amounts/intensity, frequency/duration, anticoagulation, switching/stopping and concomitant treatment remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link treatment content/actual exposure and results within each trial's strategy conditions."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What quantitative information supports increased treatment exposure in the early arm?",
      "needed": "Group actual exposure, initiation/stopping and adherence/crossover tables",
      "role": "Required",
      "role_reason": "Required to separately document 'What quantitative information supports increased treatment exposure in the early arm?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not calculate initiation rates, exposure time, treatment counts or causal-pathway quantities from increased-exposure wording without original materials.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What quantitative information supports increased treatment exposure in the early arm?' to their original records. Counts/denominators actually treated, initiation/duration, group exposure intensity and adherence/crossover quantities are absent from the summary.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, C05, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original implementation materials distinguishing exposure and each outcome within the same assigned population."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are STARRT-AKI's randomized, analysis and group denominators?",
      "needed": "Group tables and flow from allocation through postrandomization exclusions, analysis and exposure/follow-up",
      "role": "Required",
      "role_reason": "Required to separately document 'What are STARRT-AKI's randomized, analysis and group denominators?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not calculate 3,019−2,927 as a new dropout count or alter the original reader wording.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are STARRT-AKI's randomized, analysis and group denominators?' to their original records. Original tables are needed for randomized group counts, exclusions by reason/group, actual exposure and follow-up/endpoint denominators.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link original flow and analysis definitions to each denominator within the same trial."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What is known about STARRT-AKI allocation/concealment and baseline balance?",
      "needed": "Original allocation/concealment, baseline characteristics, operational roles and postrandomization exclusions",
      "role": "Required",
      "role_reason": "Required to separately document 'What is known about STARRT-AKI allocation/concealment and baseline balance?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Stratification, sequence access, allocation operations, baseline balance and group distribution of subsequent exclusions remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is known about STARRT-AKI allocation/concealment and baseline balance?' to their original records. Stratification, sequence access, allocation operations, baseline balance and group distribution of subsequent exclusions remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E01.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original materials describing allocation and baseline information in plans/reports."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "How was all-cause mortality ascertained in the open-label trial?",
      "needed": "Endpoint-specific ascertainment, follow-up, masking/access and missing records",
      "role": "Required",
      "role_reason": "Required to separately document 'How was all-cause mortality ascertained in the open-label trial?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not certify absence of missing measurements or all bias from a hard mortality endpoint/parent B0 alone, or reassess the verdict as null solely because the trial was open-label.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How was all-cause mortality ascertained in the open-label trial?' to their original records. Mortality ascertainment sources, assessors/data access, loss to follow-up, group ascertainment differences and adjudication procedures remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E01, E03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use reports from the same trial specifying actual mortality ascertainment and analysis limits."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What do modified ITT and postrandomization exclusions represent?",
      "needed": "Analysis populations, timing/reasons for exclusions, original flow and SAP/sensitivity analyses",
      "role": "Required",
      "role_reason": "Required to separately document 'What do modified ITT and postrandomization exclusions represent?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not substitute complete ITT for everyone or complete observation for modified ITT, or estimate exclusion counts/reasons.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What do modified ITT and postrandomization exclusions represent?' to their original records. Counts by reason/group, planned versus later changes, complete-ITT alternatives and missingness/sensitivity details remain unread in original materials.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E04, C07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link original modified ITT and postrandomization exclusions to each group/outcome."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What is recorded about 90-day all-cause death, registration and prespecification?",
      "needed": "Original registration/plan/report records for endpoint, timing and analysis",
      "role": "Required",
      "role_reason": "Required to separately document 'What is recorded about 90-day all-cause death, registration and prespecification?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not upgrade the original registry-agreement wording into registry access or prespecification verification performed here.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is recorded about 90-day all-cause death, registration and prespecification?' to their original records. Current registration versions, protocol/SAP, amendment timing, time origins and testing plans remain externally unread.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E06, C09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual plan documents are supplied, link prespecification/amendment and reporting scope."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What are the original STARRT-AKI 90-day mortality events, denominators and rates?",
      "needed": "90-day mortality counts, denominators/duration, follow-up and counting rules",
      "role": "Required",
      "role_reason": "Required to separately document 'What are the original STARRT-AKI 90-day mortality events, denominators and rates?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not add mortality counts or newly calculate non-deaths/losses, risk differences, NNT or relative ratios.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are the original STARRT-AKI 90-day mortality events, denominators and rates?' to their original records. Group ascertainment completeness, missingness, differences from allocation denominators, time origins/cutoffs and original counting-rule details remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link mortality events and original denominators/follow-up in materials from the same trial."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What are the original mortality RR, 95% CI and P values?",
      "needed": "Original RR/CI/P results tables and statistical methods/SAP",
      "role": "Required",
      "role_reason": "Required to separately document 'What are the original mortality RR, 95% CI and P values?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not label RR as HR or treat the rounded RR 1.00 as proof of exactly zero for every effect.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are the original mortality RR, 95% CI and P values?' to their original records. RR model, adjustment/stratification, testing method, assumptions, sensitivity analyses and prespecified importance details remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E04, E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link original estimation/testing plans and mortality RR in statistical materials."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "How is the original 'exactly null' wording distinguished from zero effect or equivalence?",
      "needed": "Original intervals, testing purpose/importance and design limitations",
      "role": "Required",
      "role_reason": "Required to separately document 'How is the original 'exactly null' wording distinguished from zero effect or equivalence?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not alter the original record or extend null wording into an exact zero effect, equivalence, harmlessness or conclusions about all strategies.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How is the original 'exactly null' wording distinguished from zero effect or equivalence?' to their original records. Equivalence/noninferiority objectives, justified margins and plans excluding all effect sizes have not been verified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C08, E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use materials describing original justified criteria and interval interpretation."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What denominators apply to 90-day follow-up, missingness/censoring and mortality ascertainment?",
      "needed": "90-day follow-up/ascertainment, missingness/censoring and original analysis handling",
      "role": "Required",
      "role_reason": "Required to separately document 'What denominators apply to 90-day follow-up, missingness/censoring and mortality ascertainment?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Complete/incomplete follow-up, missingness/censoring, original cutoffs, later deaths and sensitivity details are absent from the summary. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What denominators apply to 90-day follow-up, missingness/censoring and mortality ascertainment?' to their original records. Complete/incomplete follow-up, missingness/censoring, original cutoffs, later deaths and sensitivity details are absent from the summary.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04, E03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original materials separating actual observation/loss from mortality denominators."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "How does the mortality effect of assignment strategies differ from effects of actual treatment?",
      "needed": "Strategy estimands, actual exposure and analysis/adjustment/SAP materials",
      "role": "Required",
      "role_reason": "Required to separately document 'How does the mortality effect of assignment strategies differ from effects of actual treatment?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not invent efficacy among recipients/non-recipients or attribute the strategy RR to treatment itself or a particular technique.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How does the mortality effect of assignment strategies differ from effects of actual treatment?' to their original records. Original RR adjustment, crossover/non-treatment, rescue initiation, later therapy and estimand/SAP remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original reports separating assignment comparisons from actual-treatment/adherence analyses."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What are the original interval and important mortality-difference criteria?",
      "needed": "Original plan importance/power and interval/judgment criteria",
      "role": "Required",
      "role_reason": "Required to separately document 'What are the original interval and important mortality-difference criteria?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not make a new judgment that all small or important effects are excluded because of a large sample/C0.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are the original interval and important mortality-difference criteria?' to their original records. Prespecified important differences, power, planned events/sample and justified clinical margins are absent from the summary.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual plan criteria are supplied, describe boundaries alongside reported intervals."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "How does survivor-conditioned 90-day dependence differ from the selected mortality outcome?",
      "needed": "Original survivor condition/dependence definition, denominators, assessment/missingness and tables",
      "role": "Required",
      "role_reason": "Required to separately document 'How does survivor-conditioned 90-day dependence differ from the selected mortality outcome?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not transfer the dependence RR 1.74 to mortality RR or convert it into a value for reduced mortality or improved kidney replacement therapy independence.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How does survivor-conditioned 90-day dependence differ from the selected mortality outcome?' to their original records. Dependence definition, assessable survivors, missingness/selection and timing/denominator details remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, E09, E10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use same-trial materials reporting mortality and survivor-conditioned dependence for their respective populations."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are 814/815 identical to randomized or mortality denominators?",
      "needed": "Original flow from mortality denominators through survivors/assessable survivors to dependence denominators",
      "role": "Required",
      "role_reason": "Required to separately document 'Are 814/815 identical to randomized or mortality denominators?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not calculate total survivors by subtracting mortality counts or substitute 814/815 for the entire assigned-population denominators.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'Are 814/815 identical to randomized or mortality denominators?' to their original records. Relationships between all and assessable survivors, missingness reasons/group counts and changes in flow remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04, H04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original reports/appendices specifying conditional denominators and missingness."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "How do dependence definition, timing and duration relate to independence?",
      "needed": "Original dependence/independence definitions, measurement, timing and analysis population",
      "role": "Required",
      "role_reason": "Required to separately document 'How do dependence definition, timing and duration relate to independence?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not calculate the complement of dependence proportions to create independence rates or turn them into conclusions about long-term recovery or an individual's dialysis need.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How do dependence definition, timing and duration relate to independence?' to their original records. Use on the assessment day, persistence/restart, recovery/baseline kidney failure, ascertainment/cutoff and original P value remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E03, E09, H02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use same-trial materials reporting kidney recovery/dependence by definition and timepoint."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What is the interpretive scope of survivor conditioning, mortality and missingness?",
      "needed": "Mortality and conditional-dependence analysis definitions, selection/missingness and alternative analyses",
      "role": "Required",
      "role_reason": "Required to separately document 'What is the interpretive scope of survivor conditioning, mortality and missingness?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not automatically establish increased conditional dependence as the same causal harm or individual outcome for every assigned patient.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is the interpretive scope of survivor conditioning, mortality and missingness?' to their original records. Mortality/dependence composites, conditional selection, assessment missingness/sensitivity and original analysis assumptions remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E04, C07, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use same-trial materials distinguishing original conditional analyses and mortality/missingness handling."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What actually occurred in concomitant treatment, rescue initiation and strategy deviations?",
      "needed": "Group concomitant/rescue therapy, implementation/deviations, later interventions and estimands",
      "role": "Required",
      "role_reason": "Required to separately document 'What actually occurred in concomitant treatment, rescue initiation and strategy deviations?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Supportive care, initiation/rescue thresholds, crossover, medication/device changes, actual adherence and analysis handling remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What actually occurred in concomitant treatment, rescue initiation and strategy deviations?' to their original records. Supportive care, initiation/rescue thresholds, crossover, medication/device changes, actual adherence and analysis handling remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, H05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original implementation materials separating strategy execution from concomitant care."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What are ELAIN's single-center population, denominators and comparison?",
      "needed": "Original ELAIN baseline/flow, protocol and strategy/design materials",
      "role": "Required",
      "role_reason": "Required to separately document 'What are ELAIN's single-center population, denominators and comparison?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Group counts, analysis/completion/exposure, eligibility/severity, detailed early/delayed definitions and allocation/masking remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are ELAIN's single-center population, denominators and comparison?' to their original records. Group counts, analysis/completion/exposure, eligibility/severity, detailed early/delayed definitions and allocation/masking remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C04, E01, C07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Link original ELAIN eligibility, implementation and denominators."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What original ELAIN 90-day mortality rates, HR and P are preserved?",
      "needed": "Original ELAIN mortality tables, HR interval/model, denominators and SAP",
      "role": "Required",
      "role_reason": "Required to separately document 'What original ELAIN 90-day mortality rates, HR and P are preserved?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not delete the small positive result, back-calculate confidence intervals/events/risk differences or substitute RR for HR.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What original ELAIN 90-day mortality rates, HR and P are preserved?' to their original records. ELAIN CI, events/group denominators, model/adjustment, missingness and original testing plan remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, C08, E05.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use ELAIN reports linking rates and time-to-event results to original denominators/models."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What is known about ELAIN registration, strategy timing and follow-up reports?",
      "needed": "DRKS/protocol, report versions and actual early/delayed timing",
      "role": "Required",
      "role_reason": "Required to separately document 'What is known about ELAIN registration, strategy timing and follow-up reports?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not upgrade original registry IDs into access or prespecification verification, or invent follow-up/initial reports for the same bibliographic entry.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is known about ELAIN registration, strategy timing and follow-up reports?' to their original records. Registration versions, original plans/timing, initial/follow-up reports and kidney-injury/exposure details remain externally unread.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E06, C09, E08.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If original materials are supplied, record definitions and registration/report versions/timing separately."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What are AKIKI's randomized/analysis counts and 60-day survival outcome?",
      "needed": "AKIKI flow, 60-day survival/mortality definitions and denominators/analysis",
      "role": "Required",
      "role_reason": "Required to separately document 'What are AKIKI's randomized/analysis counts and 60-day survival outcome?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not calculate 620−619 as a dropout count or change 60-day survival into 90-day mortality.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are AKIKI's randomized/analysis counts and 60-day survival outcome?' to their original records. Group counts, exclusion/missingness reasons, exposure, follow-up and analysis/design details remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, E04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If original AKIKI materials are supplied, link endpoint/denominator and wording scope to each original record."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What scope is covered by AKIKI's no-difference wording and unverified numbers/intervals?",
      "needed": "Original outcome tables, intervals, design/SAP and registration/report versions",
      "role": "Required",
      "role_reason": "Required to separately document 'What scope is covered by AKIKI's no-difference wording and unverified numbers/intervals?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not turn no difference into an exact zero effect/equivalence or insert STARRT-AKI/ELAIN values.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What scope is covered by AKIKI's no-difference wording and unverified numbers/intervals?' to their original records. Actual 60-day rates, effect measure/CI/P, importance, model, definitions/timing and plan versions are absent from the summary.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C08, E05, E06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original materials directly reporting AKIKI quantitative results and testing purpose."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "How do trial-specific 60/90-day timing, HR/RR, strategies and populations differ?",
      "needed": "Trial-specific definitions/populations/exposure/comparisons, timepoints/measures and original results",
      "role": "Required",
      "role_reason": "Required to separately document 'How do trial-specific 60/90-day timing, HR/RR, strategies and populations differ?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not combine the three results as the same timepoint/effect measure or entirely identical strategies, or calculate a new pooled effect, ranking or independent total.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How do trial-specific 60/90-day timing, HR/RR, strategies and populations differ?' to their original records. Direct condition matching, heterogeneity, prespecified effect modification, detailed recruitment/intervention differences and synthesis plans remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E07, C08, C06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If permitted original materials are supplied, link conditions while specifying same/different estimands."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What is shared or historical across early-positive, large-trial and other reports?",
      "needed": "Report versions, initial/follow-up relationships, bibliography/registration and shared populations/outcomes",
      "role": "Required",
      "role_reason": "Required to separately document 'What is shared or historical across early-positive, large-trial and other reports?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not mistake 'early positive' for a follow-up report of the same cohort or create unprovided pilot/follow-up report records.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is shared or historical across early-positive, large-trial and other reports?' to their original records. Initial/pilot/follow-up papers, recitation, within-family duplicates and version amendments remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, E07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If additional reports are supplied, distinguish between-trial and within-trial relationships."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Do results answer subgroup, other-severity, duration and method questions?",
      "needed": "Direct evidence for expanded populations/exposure/duration and prespecified subgroups/SAP",
      "role": "Supplementary; required for extension",
      "role_reason": "Required to separately document 'Do results answer subgroup, other-severity, duration and method questions?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Direct prespecified subgroup/interaction, baseline kidney function, other method/exposure, cessation and long-term follow-up results remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'Do results answer subgroup, other-severity, duration and method questions?' to their original records. Direct prespecified subgroup/interaction, baseline kidney function, other method/exposure, cessation and long-term follow-up results remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E08, E07, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual materials are supplied, link them while specifying differences in original strategy, application and question."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are parent RX/I1 and repeated-null history being inherited as current independence?",
      "needed": "Additional original study/report-family, interests and outcome/population-relationship materials",
      "role": "Required",
      "role_reason": "Required to separately document 'Are parent RX/I1 and repeated-null history being inherited as current independence?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not declare historical RX/I1 or the three report records a currently verified independent replication or an exact trial/participant total.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'Are parent RX/I1 and repeated-null history being inherited as current independence?' to their original records. Current independent listings of same/different reports, data access, participant overlap and source/family conditions were not newly verified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, C10, E07, H07.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual additional materials are supplied, record same/different/unclear relationships by verification level."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "What is the trial-specific scope of plans, registration and selective reporting?",
      "needed": "Trial-specific registration versions, plans and endpoint/analysis/amendment reporting",
      "role": "Required",
      "role_reason": "Required to separately document 'What is the trial-specific scope of plans, registration and selective reporting?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not portray the presence of registry IDs/original agreement wording as completed review here or absence of all selective reporting.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What is the trial-specific scope of plans, registration and selective reporting?' to their original records. Original registration/SAP/protocol, amendment events, hierarchy/multiplicity and complete secondary-outcome lists remain externally unread.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E06, C09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual plans are supplied, link compared, unexamined and amended scope to each trial record."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What level of information describes ELAIN's institutional/nonprofit funding?",
      "needed": "Original funding/COI, product provision and sponsor/author-role declarations",
      "role": "Required",
      "role_reason": "Required to separately document 'What level of information describes ELAIN's institutional/nonprofit funding?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not upgrade nonprofit support into verification of current non-involvement, absence of all conflicts of interest or independence.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What level of information describes ELAIN's institutional/nonprofit funding?' to their original records. Institutions/supporters, monetary/in-kind support, author employment/COI and design/data/analysis/publication roles remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If original declarations are supplied, distinguish verified funding/roles from unverified scope."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "What original report describes AKIKI's public funding?",
      "needed": "Original funding/COI, sponsor/author roles and data-access declarations",
      "role": "Required",
      "role_reason": "Required to separately document 'What original report describes AKIKI's public funding?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Specific grants/product provision, sponsor design/collection/analysis/submission roles and author COI remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What original report describes AKIKI's public funding?' to their original records. Specific grants/product provision, sponsor design/collection/analysis/submission roles and author COI remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If original declarations are supplied, record AKIKI funding/roles separately from other trials."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "What are STARRT-AKI's public and industry-partnership funding sources?",
      "needed": "Original funding/industry partnerships, agreements/roles and declared COI",
      "role": "Required",
      "role_reason": "Required to separately document 'What are STARRT-AKI's public and industry-partnership funding sources?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not reduce public funding to absence of company involvement or reassess the effect/bias grade solely from industry partnership.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are STARRT-AKI's public and industry-partnership funding sources?' to their original records. Each grant/agreement, sponsor design/collection/analysis/submission roles, all author COI and data access remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual declarations are supplied, record the verified scope of mixed funding and roles."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What research condition does Alere's in-kind NGAL device provision represent?",
      "needed": "Original in-kind support/measurement methods, actual data use and provider-role declarations",
      "role": "Required",
      "role_reason": "Required to separately document 'What research condition does Alere's in-kind NGAL device provision represent?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not infer NGAL as an early-initiation criterion/threshold or equate the measurement device with a treatment product.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What research condition does Alere's in-kind NGAL device provision represent?' to their original records. NGAL eligibility/measurement roles, exact samples/adjudication/analysis use, supply agreements and independence roles remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10, E03, E02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If original declarations/methods are supplied, distinguish device provision from treatment/analysis contributions."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "What original results describe hypotension, infection, bleeding and vascular-access harms?",
      "needed": "Trial-specific original harm tables, definitions/collection, populations/duration and attribution",
      "role": "Required",
      "role_reason": "Required to separately document 'What original results describe hypotension, infection, bleeding and vascular-access harms?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not turn possible-harm examples into verified events/rates from the original trials or write individual-management/treatment instructions.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What original results describe hypotension, infection, bleeding and vascular-access harms?' to their original records. Event definitions, severity/discontinuation, collection, denominators/exposure time, group counts/CI/P and attribution remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E10, H01, H04.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original materials linking each harm to denominators/duration in the same exposure/population."
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "How do harm occurrence, recovery and stopping relate to the 90-day timepoint?",
      "needed": "Group exposure/harms/stopping, collection/follow-up timing and original flow",
      "role": "Required",
      "role_reason": "Required to separately document 'How do harm occurrence, recovery and stopping relate to the 90-day timepoint?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Exposure/event times, discontinuation/re-exposure, recovery, safety-collection windows and follow-up durations remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How do harm occurrence, recovery and stopping relate to the 90-day timepoint?' to their original records. Exposure/event times, discontinuation/re-exposure, recovery, safety-collection windows and follow-up durations remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H02, H04, E10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use trial-specific materials separating original temporal sequence from each safety window."
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "What denominators, conditions and background apply to actual harm comparisons?",
      "needed": "Harm-specific denominators/events/time and original controls/statistical materials",
      "role": "Required",
      "role_reason": "Required to separately document 'What denominators, conditions and background apply to actual harm comparisons?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not copy efficacy denominators or survivor denominators 814/815 into all harm denominators, or extrapolate background rates.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What denominators, conditions and background apply to actual harm comparisons?' to their original records. Exposed/at-risk populations, individual/recurrent events, safety analyses/comparisons and background risks remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H03, H04, E10.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use original reports distinguishing safety populations from efficacy denominators and survivor conditioning."
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "What scope do underlying disease, concomitant care and missingness/follow-up have in harm interpretation?",
      "needed": "Baseline/concurrent exposure, event attribution and original missingness/follow-up/sensitivity materials",
      "role": "Required",
      "role_reason": "Required to separately document 'What scope do underlying disease, concomitant care and missingness/follow-up have in harm interpretation?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not turn missing alternative-explanation information into absence of other causes, complete observation of everything or established causality.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What scope do underlying disease, concomitant care and missingness/follow-up have in harm interpretation?' to their original records. Baseline kidney disease, hemodynamics/other diseases, medications/procedures, alternative causes, missingness/death selection and detection differences remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H05, H06, E02.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Use each trial's safety materials specifying alternative causes and collection/missingness scope."
    },
    {
      "item_id": "N44",
      "question_type": "Evidence condition",
      "question": "What scope covers long-term kidney function, rare harms and vulnerable populations?",
      "needed": "Direct exposure/duration evidence on long-term and population-specific kidney function/harms",
      "role": "Supplementary; required for extension",
      "role_reason": "Required to separately document 'What scope covers long-term kidney function, rare harms and vulnerable populations?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Long-term follow-up, direct effects by baseline kidney function/age, rare events and actual long-term exposure remain unverified. Absent values are not filled by new calculations, estimation or reassessment; retain them alongside the original material scope.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What scope covers long-term kidney function, rare harms and vulnerable populations?' to their original records. Long-term follow-up, direct effects by baseline kidney function/age, rare events and actual long-term exposure remain unverified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H08, E08, E09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If direct materials in that scope are supplied, specify differences from original 90-day results."
    },
    {
      "item_id": "N45",
      "question_type": "Evidence condition",
      "question": "Are parent axes, Korean/English text and false/empty values being inherited by the subclaim?",
      "needed": "Separate parent/subclaim values, Korean/English text, absent values/axes and historical verdicts",
      "role": "Required",
      "role_reason": "Required to separately document 'Are parent axes, Korean/English text and false/empty values being inherited by the subclaim?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not copy parent points/axes/B0/cross-checking to the subclaim or declare new clinical approval.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'Are parent axes, Korean/English text and false/empty values being inherited by the subclaim?' to their original records. Original historical verdict/axes were not reused to establish a current subclaim score, fulfilled conditions or completed review.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01, C09, E06.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual verdict corrections are supplied, preserve full original text, events/versions and decisions within each scope."
    },
    {
      "item_id": "N46",
      "question_type": "Evidence condition",
      "question": "What are the historical date, corrections/empty values and absence of current searching/review?",
      "needed": "Publication/registration/search/correction history and current production timing/scope",
      "role": "Required",
      "role_reason": "Required to separately document 'What are the historical date, corrections/empty values and absence of current searching/review?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not reuse the historical verified date as the review date here, or portray an empty correction history/no new search as verification of zero current corrections/research reports.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'What are the historical date, corrections/empty values and absence of current searching/review?' to their original records. Evidence-cutoff/classification fields are absent; registration/corrections/retractions and additional literature were not checked here.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C09, C03.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If new materials/corrections are supplied, distinguish original scope, full before/after text and additional events."
    },
    {
      "item_id": "N47",
      "question_type": "Evidence condition",
      "question": "How are current mortality, survivor-dependence and harm descriptions bounded from treatment decisions?",
      "needed": "Direct evidence for original conditions/estimands and expanded populations, timepoints, efficacy and harms",
      "role": "Required",
      "role_reason": "Required to separately document 'How are current mortality, survivor-dependence and harm descriptions bounded from treatment decisions?' for the selected reduced-90-day-mortality question.",
      "application_exception": "Do not extend null early-versus-standard results into all kidney replacement therapy being unnecessary, individual initiation/waiting recommendations, emergency/treatment suitability judgments or harmlessness verification.",
      "criterion": "Link preserved values, denominators, timing, material scope and unverified matters for 'How are current mortality, survivor-dependence and harm descriptions bounded from treatment decisions?' to their original records. Current guidelines/individual status, initiation/waiting, method suitability and direct long-term benefit/harm conclusions were not verified.",
      "basis": "An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H09, E09, E10, E08, C09.",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If materials are supplied and scope permits, update evidence gaps while separating other application questions from the current original table."
    }
  ]
}