# Early Kidney Replacement Therapy · Severe Acute Kidney Injury · Reduced 90-Day Mortality — Evidence Checklist Verdict 2933 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-10 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: Severe acute kidney injury in critical care; trial-specific eligibility, severity and baseline kidney-function details are unverified. - Ingredient, formulation and route: The original strategy of starting kidney replacement therapy early, before absolute indications; trial-specific definitions and actual timing differences are unverified. - Dose: Only the original dialysis/hemofiltration scope; modality, device, intensity, duration and actual exposure are unverified. No initiation or dosage instructions. - Comparator: The STARRT-AKI standard strategy and the original early-versus-delayed context of ELAIN/AKIKI; rescue initiation for absolute indications is a historical study condition. - Measured outcome: Selected 90-day mortality; distinguish STARRT 90-day all-cause mortality, ELAIN 90-day mortality and AKIKI 60-day survival. - Duration: The selected 90-day outcome, AKIKI 60-day outcome and survivor-conditional 90-day dependence each have their own endpoint window; actual exposure, safety follow-up and long-term duration are unverified. - Questions outside this scope: Extending the original 'null'/'exactly' wording into an exact zero effect, equivalence or harmlessness; Substituting survivor-conditional dependence for the same effect on overall mortality or the entire assigned population; Mixing the timing and effect measures of ELAIN HR, the qualitative AKIKI 60-day result and STARRT RR; New totals, trial/participant aggregation, missing-data calculations, confidence-interval calculations or hypothetical values; Instructions on treatment initiation/waiting, acute or emergency situations, RRT modality selection, dosage, suitability or substitution ## Checklist items ### N01 · What are the selected question/record and parent/related-outcome context? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected question is reduced 90-day mortality, with the question and existing verdict record kept separate. It concerns the same mortality outcome as the parent effect; the related question concerns freedom from kidney-replacement therapy at 90 days, a different outcome. - Why unverified: Some information in the stored summary was linked for preparation. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials. - Reason for missing information: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. - Required materials and conditions: Separate links for the original question, record and parent/related outcomes - Materials to obtain first: Separate links for the original question, record and parent/related outcomes - Further research: If new materials for the same question are supplied, link them while retaining the original question and verdict text. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are the selected question/record and parent/related-outcome context?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01. - Related sources: R03 ### N02 · How do the original subclaim D grade/note differ from parent D34 and absent subclaim score/axes? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original subclaim D grade and note that STARRT-AKI was exactly null are preserved. Subclaim score/status/axes are absent; parent D34, Caution and axes remain parent history. - Why unverified: Some information from the preserved summary is linked. Direct original values for the selected subclaim's score/status/axes are absent. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Direct original values for the selected subclaim's score/status/axes are absent. - Required materials and conditions: Preserve subclaim grade/note separately from parent scores/axes and absent values - Materials to obtain first: Preserve subclaim grade/note separately from parent scores/axes and absent values - Further research: If an actual correction is supplied, record full original text, event/version and change decision separately. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Direct original values for the selected subclaim's score/status/axes are absent. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01, C09. - Related sources: R03 ### N03 · How are ELAIN, AKIKI and STARRT-AKI reports related to trials? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The preserved evidence and citation lists each contain three report entries linked to ELAIN, AKIKI and STARRT-AKI. Original bibliographic/registration records form provisional families; mortality/dependence, sites/countries and early-positive/large-trial results are kept separate. - Why unverified: Some information from the preserved summary is linked. Early/follow-up report versions, duplicate people/trials and current unique totals have not been confirmed. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Early/follow-up report versions, duplicate people/trials and current unique totals have not been confirmed. - Required materials and conditions: Table linking reports/registration/study families, timing/outcomes and shared populations - Materials to obtain first: Table linking reports/registration/study families, timing/outcomes and shared populations - Further research: If additional materials are supplied, record same/separate/unclear report relationships and outcome-specific scope. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'How are ELAIN, AKIKI and STARRT-AKI reports related to trials?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not sum the three report records, bibliographic entries, institution counts or individual sample sizes into a new independent-trial or participant total. - Remaining uncertainty: Early/follow-up report versions, duplicate people/trials and current unique totals have not been confirmed. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, E07, H07. - Related sources: R01, R02, R03 ### N04 · What is the scope of actual reading and external links? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The full designated preserved summary was read for production and original bytes preserved. Original PubMed citation URLs are retained; abstracts, full texts, registrations and plans remain externally unread. - Why unverified: Some information from the preserved summary is linked. External availability/acquisition, accessibility, current content and URL operation were not checked here. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: External availability/acquisition, accessibility, current content and URL operation were not checked here. - Required materials and conditions: Material-specific status, reading scope and original records for preserved summaries and external materials - Materials to obtain first: Material-specific status, reading scope and original records for preserved summaries and external materials - Further research: In a follow-up permitting material acquisition, record actual reading, access attempts and dates separately. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What is the scope of actual reading and external links?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not upgrade summary reading into paper/registry reading or describe unattempted access as failure or zero existence. - Remaining uncertainty: External availability/acquisition, accessibility, current content and URL operation were not checked here. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C03. - Related sources: R01, R02, R03 ### N05 · What are the severe-AKI eligibility, severity and institutional settings? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original question concerns 90-day mortality in severe acute kidney injury in critical-care settings. Original designs are preserved: STARRT-AKI at 168 sites in 15 countries, AKIKI in 31 French ICUs and ELAIN at one German center. - Why unverified: Some information from the preserved summary is linked. Age, AKI definition/stage, baseline kidney function, other organs/causes, eligibility/exclusions and each population's severity composition remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Age, AKI definition/stage, baseline kidney function, other organs/causes, eligibility/exclusions and each population's severity composition remain unverified. - Required materials and conditions: Trial-specific eligibility/exclusions, severity/baseline kidney function and recruitment settings - Materials to obtain first: Trial-specific eligibility/exclusions, severity/baseline kidney function and recruitment settings - Further research: If direct materials specify the same strategy/population or other conditions, distinguish them by trial. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are the severe-AKI eligibility, severity and institutional settings?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Age, AKI definition/stage, baseline kidney function, other organs/causes, eligibility/exclusions and each population's severity composition remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C04, E08. - Related sources: R01, R02, R03 ### N06 · Are actual definitions of early, standard and delayed strategies identical across trials? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The parent intervention describes early initiation before absolute indications. STARRT-AKI compares early versus standard strategies; other trials retain early-versus-delayed context. The original counterpoint records different definitions and severity. - Why unverified: Some information from the preserved summary is linked. Trial-specific time origins, initiation criteria/thresholds, permitted waiting and actual initiation times/adherence remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Trial-specific time origins, initiation criteria/thresholds, permitted waiting and actual initiation times/adherence remain unverified. - Required materials and conditions: Trial-specific protocols, early/standard/delayed definitions and actual implementation - Materials to obtain first: Trial-specific protocols, early/standard/delayed definitions and actual implementation - Further research: Link each trial's directly described definitions/exposure conditions to the same or different question. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not fill timing/thresholds with invented numbers or declare the early strategies of different trials identical. - Remaining uncertainty: Trial-specific time origins, initiation criteria/thresholds, permitted waiting and actual initiation times/adherence remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02, E07. - Related sources: R01, R02, R03 ### N07 · What scope is covered by the standard arm's initiation after absolute indications? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original advertising interpretation and study-condition account say STARRT-AKI's standard arm also initiated therapy when absolute indications occurred and was not simply withholding treatment. Hyperkalemia, acidosis and pulmonary edema are examples from the original research-condition account. - Why unverified: Some information from the preserved summary is linked. Protocol numerical thresholds, actual timing, decisions/adherence, rescue initiation and individual suitability remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Protocol numerical thresholds, actual timing, decisions/adherence, rescue initiation and individual suitability remain unverified. - Required materials and conditions: Original standard-strategy initiation/rescue criteria and implementation materials - Materials to obtain first: Original standard-strategy initiation/rescue criteria and implementation materials - Further research: Link historical strategy descriptions to original protocol and implementation materials. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not turn historical initiation conditions into action recommendations on individual treatment initiation/waiting, emergency assessment or suitability. - Remaining uncertainty: Protocol numerical thresholds, actual timing, decisions/adherence, rescue initiation and individual suitability remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02. - Related sources: R03 ### N08 · Which kidney-replacement methods and actual exposures are described? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original study-condition account describes kidney-replacement therapy as critical-care treatment including dialysis and hemofiltration. It does not separately establish specific-device, method or dose effects. - Why unverified: Some information from the preserved summary is linked. Group-specific techniques/devices, actual amounts/intensity, frequency/duration, anticoagulation, switching/stopping and concomitant treatment remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Group-specific techniques/devices, actual amounts/intensity, frequency/duration, anticoagulation, switching/stopping and concomitant treatment remain unverified. - Required materials and conditions: Original treatment methods, devices/exposure, changes and implementation tables - Materials to obtain first: Original treatment methods, devices/exposure, changes and implementation tables - Further research: Link treatment content/actual exposure and results within each trial's strategy conditions. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'Which kidney-replacement methods and actual exposures are described?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not turn the original treatment types into modality selection, dosage conversion or treatment instructions. - Remaining uncertainty: Group-specific techniques/devices, actual amounts/intensity, frequency/duration, anticoagulation, switching/stopping and concomitant treatment remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02, E08. - Related sources: R03 ### N09 · What quantitative information supports increased treatment exposure in the early arm? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original study-condition account says treatment exposure and 90-day dependence were greater in the early arm. Increased exposure is recorded separately from survivor-conditioned dependence outcomes. - Why unverified: Some information from the preserved summary is linked. Counts/denominators actually treated, initiation/duration, group exposure intensity and adherence/crossover quantities are absent from the summary. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Counts/denominators actually treated, initiation/duration, group exposure intensity and adherence/crossover quantities are absent from the summary. - Required materials and conditions: Group actual exposure, initiation/stopping and adherence/crossover tables - Materials to obtain first: Group actual exposure, initiation/stopping and adherence/crossover tables - Further research: Use original implementation materials distinguishing exposure and each outcome within the same assigned population. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What quantitative information supports increased treatment exposure in the early arm?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not calculate initiation rates, exposure time, treatment counts or causal-pathway quantities from increased-exposure wording without original materials. - Remaining uncertainty: Counts/denominators actually treated, initiation/duration, group exposure intensity and adherence/crossover quantities are absent from the summary. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, C05, E04. - Related sources: R03 ### N10 · What are STARRT-AKI's randomized, analysis and group denominators? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original research/evidence account records 3,019 randomized, 2,927 analyzed and mortality denominators of 1,465/1,462. The original reader-answer wording describing a '2,927 randomized analysis' is preserved, with detailed allocation and analysis records linked separately. - Why unverified: Some information from the preserved summary is linked. Original tables are needed for randomized group counts, exclusions by reason/group, actual exposure and follow-up/endpoint denominators. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Original tables are needed for randomized group counts, exclusions by reason/group, actual exposure and follow-up/endpoint denominators. - Required materials and conditions: Group tables and flow from allocation through postrandomization exclusions, analysis and exposure/follow-up - Materials to obtain first: Group tables and flow from allocation through postrandomization exclusions, analysis and exposure/follow-up - Further research: Link original flow and analysis definitions to each denominator within the same trial. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are STARRT-AKI's randomized, analysis and group denominators?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not calculate 3,019−2,927 as a new dropout count or alter the original reader wording. - Remaining uncertainty: Original tables are needed for randomized group counts, exclusions by reason/group, actual exposure and follow-up/endpoint denominators. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04. - Related sources: R03 ### N11 · What is known about STARRT-AKI allocation/concealment and baseline balance? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original research account quotes a 'centralized, computer-generated randomization schedule'. This allocation statement is distinguished from unverified actual original procedures. - Why unverified: Some information from the preserved summary is linked. Stratification, sequence access, allocation operations, baseline balance and group distribution of subsequent exclusions remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Stratification, sequence access, allocation operations, baseline balance and group distribution of subsequent exclusions remain unverified. - Required materials and conditions: Original allocation/concealment, baseline characteristics, operational roles and postrandomization exclusions - Materials to obtain first: Original allocation/concealment, baseline characteristics, operational roles and postrandomization exclusions - Further research: Use original materials describing allocation and baseline information in plans/reports. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What is known about STARRT-AKI allocation/concealment and baseline balance?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Stratification, sequence access, allocation operations, baseline balance and group distribution of subsequent exclusions remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E01. - Related sources: R03 ### N12 · How was all-cause mortality ascertained in the open-label trial? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: STARRT-AKI's original design was open-label and its primary endpoint was all-cause mortality at 90 days. Open-label status and ascertainment/missingness of objective events require separate information. - Why unverified: Some information from the preserved summary is linked. Mortality ascertainment sources, assessors/data access, loss to follow-up, group ascertainment differences and adjudication procedures remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Mortality ascertainment sources, assessors/data access, loss to follow-up, group ascertainment differences and adjudication procedures remain unverified. - Required materials and conditions: Endpoint-specific ascertainment, follow-up, masking/access and missing records - Materials to obtain first: Endpoint-specific ascertainment, follow-up, masking/access and missing records - Further research: Use reports from the same trial specifying actual mortality ascertainment and analysis limits. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'How was all-cause mortality ascertained in the open-label trial?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Mortality ascertainment sources, assessors/data access, loss to follow-up, group ascertainment differences and adjudication procedures remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E01, E03. - Related sources: R03 ### N13 · What do modified ITT and postrandomization exclusions represent? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original account says a 'modified intention-to-treat principle' analyzed 2,927 participants and reported exclusions including postrandomization ineligibility and consent withdrawal. - Why unverified: Some information from the preserved summary is linked. Counts by reason/group, planned versus later changes, complete-ITT alternatives and missingness/sensitivity details remain unread in original materials. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Counts by reason/group, planned versus later changes, complete-ITT alternatives and missingness/sensitivity details remain unread in original materials. - Required materials and conditions: Analysis populations, timing/reasons for exclusions, original flow and SAP/sensitivity analyses - Materials to obtain first: Analysis populations, timing/reasons for exclusions, original flow and SAP/sensitivity analyses - Further research: Link original modified ITT and postrandomization exclusions to each group/outcome. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What do modified ITT and postrandomization exclusions represent?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not substitute complete ITT for everyone or complete observation for modified ITT, or estimate exclusion counts/reasons. - Remaining uncertainty: Counts by reason/group, planned versus later changes, complete-ITT alternatives and missingness/sensitivity details remain unread in original materials. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E04, C07. - Related sources: R03 ### N14 · What is recorded about 90-day all-cause death, registration and prespecification? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original citation quotes 'death from any cause at 90 days' and agreement with NCT02568722. The selected question concerns reduced 90-day mortality; AKIKI's 60-day result is a different timepoint. - Why unverified: Some information from the preserved summary is linked. Current registration versions, protocol/SAP, amendment timing, time origins and testing plans remain externally unread. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Current registration versions, protocol/SAP, amendment timing, time origins and testing plans remain externally unread. - Required materials and conditions: Original registration/plan/report records for endpoint, timing and analysis - Materials to obtain first: Original registration/plan/report records for endpoint, timing and analysis - Further research: If actual plan documents are supplied, link prespecification/amendment and reporting scope. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not upgrade the original registry-agreement wording into registry access or prespecification verification performed here. - Remaining uncertainty: Current registration versions, protocol/SAP, amendment timing, time origins and testing plans remain externally unread. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E06, C09. - Related sources: R03 ### N15 · What are the original STARRT-AKI 90-day mortality events, denominators and rates? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original mortality is early 643/1,465 (43.9%) versus standard 639/1,462 (43.7%). Person denominators, events and rates are retained together and distinguished from other outcomes/timepoints. - Why unverified: Some information from the preserved summary is linked. Group ascertainment completeness, missingness, differences from allocation denominators, time origins/cutoffs and original counting-rule details remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Group ascertainment completeness, missingness, differences from allocation denominators, time origins/cutoffs and original counting-rule details remain unverified. - Required materials and conditions: 90-day mortality counts, denominators/duration, follow-up and counting rules - Materials to obtain first: 90-day mortality counts, denominators/duration, follow-up and counting rules - Further research: Link mortality events and original denominators/follow-up in materials from the same trial. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not add mortality counts or newly calculate non-deaths/losses, risk differences, NNT or relative ratios. - Remaining uncertainty: Group ascertainment completeness, missingness, differences from allocation denominators, time origins/cutoffs and original counting-rule details remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07. - Related sources: R03 ### N16 · What are the original mortality RR, 95% CI and P values? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original mortality RR is 1.00 (95% CI 0.93~1.09), P=0.92; the English/evidence account writes P=.92. Interval labels and original Korean/English records are preserved separately. - Why unverified: Some information from the preserved summary is linked. RR model, adjustment/stratification, testing method, assumptions, sensitivity analyses and prespecified importance details remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: RR model, adjustment/stratification, testing method, assumptions, sensitivity analyses and prespecified importance details remain unverified. - Required materials and conditions: Original RR/CI/P results tables and statistical methods/SAP - Materials to obtain first: Original RR/CI/P results tables and statistical methods/SAP - Further research: Link original estimation/testing plans and mortality RR in statistical materials. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are the original mortality RR, 95% CI and P values?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not label RR as HR or treat the rounded RR 1.00 as proof of exactly zero for every effect. - Remaining uncertainty: RR model, adjustment/stratification, testing method, assumptions, sensitivity analyses and prespecified importance details remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E04, E05. - Related sources: R03 ### N17 · How is the original 'exactly null' wording distinguished from zero effect or equivalence? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original note/counterpoint calls STARRT-AKI exactly null, retaining mortality RR 1.00 and its interval. This is the original failure-to-reproduce-survival-benefit account; CI 0.93~1.09 remains alongside it. - Why unverified: Some information from the preserved summary is linked. Equivalence/noninferiority objectives, justified margins and plans excluding all effect sizes have not been verified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Equivalence/noninferiority objectives, justified margins and plans excluding all effect sizes have not been verified. - Required materials and conditions: Original intervals, testing purpose/importance and design limitations - Materials to obtain first: Original intervals, testing purpose/importance and design limitations - Further research: Use materials describing original justified criteria and interval interpretation. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not alter the original record or extend null wording into an exact zero effect, equivalence, harmlessness or conclusions about all strategies. - Remaining uncertainty: Equivalence/noninferiority objectives, justified margins and plans excluding all effect sizes have not been verified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C08, E05. - Related sources: R03 ### N18 · What denominators apply to 90-day follow-up, missingness/censoring and mortality ascertainment? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original account records 90-day mortality and modified ITT denominators. Analysis inclusion differs from 90-day ascertainment and observation loss. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Complete/incomplete follow-up, missingness/censoring, original cutoffs, later deaths and sensitivity details are absent from the summary. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Complete/incomplete follow-up, missingness/censoring, original cutoffs, later deaths and sensitivity details are absent from the summary. - Required materials and conditions: 90-day follow-up/ascertainment, missingness/censoring and original analysis handling - Materials to obtain first: 90-day follow-up/ascertainment, missingness/censoring and original analysis handling - Further research: Use original materials separating actual observation/loss from mortality denominators. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Complete/incomplete follow-up, missingness/censoring, original cutoffs, later deaths and sensitivity details are absent from the summary. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04, E03. - Related sources: R03 ### N19 · How does the mortality effect of assignment strategies differ from effects of actual treatment? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original mortality values compare assigned early versus standard strategies. Effects among actual kidney-replacement recipients and PP/adherence effects are separate questions. - Why unverified: Some information from the preserved summary is linked. Original RR adjustment, crossover/non-treatment, rescue initiation, later therapy and estimand/SAP remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Original RR adjustment, crossover/non-treatment, rescue initiation, later therapy and estimand/SAP remain unverified. - Required materials and conditions: Strategy estimands, actual exposure and analysis/adjustment/SAP materials - Materials to obtain first: Strategy estimands, actual exposure and analysis/adjustment/SAP materials - Further research: Use original reports separating assignment comparisons from actual-treatment/adherence analyses. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not invent efficacy among recipients/non-recipients or attribute the strategy RR to treatment itself or a particular technique. - Remaining uncertainty: Original RR adjustment, crossover/non-treatment, rescue initiation, later therapy and estimand/SAP remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, E04. - Related sources: R03 ### N20 · What are the original interval and important mortality-difference criteria? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Original RR/95% CI and the large hard mortality endpoint are preserved. Parent precision/C0 statements are history and do not constitute current importance/equivalence criteria. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Prespecified important differences, power, planned events/sample and justified clinical margins are absent from the summary. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Prespecified important differences, power, planned events/sample and justified clinical margins are absent from the summary. - Required materials and conditions: Original plan importance/power and interval/judgment criteria - Materials to obtain first: Original plan importance/power and interval/judgment criteria - Further research: If actual plan criteria are supplied, describe boundaries alongside reported intervals. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are the original interval and important mortality-difference criteria?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not make a new judgment that all small or important effects are excluded because of a large sample/C0. - Remaining uncertainty: Prespecified important differences, power, planned events/sample and justified clinical margins are absent from the summary. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E05. - Related sources: R03 ### N21 · How does survivor-conditioned 90-day dependence differ from the selected mortality outcome? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original research account records survivor-conditioned 90-day kidney-replacement dependence in the same STARRT-AKI report: 85/814 (10.4%) versus 49/815 (6.0%), RR 1.74 (95% CI 1.24~2.43). The related sheet asks about independence, a separate question. - Why unverified: Some information from the preserved summary is linked. Dependence definition, assessable survivors, missingness/selection and timing/denominator details remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Dependence definition, assessable survivors, missingness/selection and timing/denominator details remain unverified. - Required materials and conditions: Original survivor condition/dependence definition, denominators, assessment/missingness and tables - Materials to obtain first: Original survivor condition/dependence definition, denominators, assessment/missingness and tables - Further research: Use same-trial materials reporting mortality and survivor-conditioned dependence for their respective populations. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Dependence definition, assessable survivors, missingness/selection and timing/denominator details remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, E09, E10. - Related sources: R03 ### N22 · Are 814/815 identical to randomized or mortality denominators? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original dependence denominators 814/815 are described as survivor-conditioned and differ from mortality denominators 1,465/1,462. Allocation, analysis, mortality and assessable-survivor populations are kept separate. - Why unverified: Some information from the preserved summary is linked. Relationships between all and assessable survivors, missingness reasons/group counts and changes in flow remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Relationships between all and assessable survivors, missingness reasons/group counts and changes in flow remain unverified. - Required materials and conditions: Original flow from mortality denominators through survivors/assessable survivors to dependence denominators - Materials to obtain first: Original flow from mortality denominators through survivors/assessable survivors to dependence denominators - Further research: Use original reports/appendices specifying conditional denominators and missingness. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'Are 814/815 identical to randomized or mortality denominators?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not calculate total survivors by subtracting mortality counts or substitute 814/815 for the entire assigned-population denominators. - Remaining uncertainty: Relationships between all and assessable survivors, missingness reasons/group counts and changes in flow remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04, H04. - Related sources: R03 ### N23 · How do dependence definition, timing and duration relate to independence? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original account records 90-day kidney-replacement dependence as a survivor-conditioned outcome; the related note says dependence increased in the early arm. Its conditions/units differ from mortality. - Why unverified: Some information from the preserved summary is linked. Use on the assessment day, persistence/restart, recovery/baseline kidney failure, ascertainment/cutoff and original P value remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Use on the assessment day, persistence/restart, recovery/baseline kidney failure, ascertainment/cutoff and original P value remain unverified. - Required materials and conditions: Original dependence/independence definitions, measurement, timing and analysis population - Materials to obtain first: Original dependence/independence definitions, measurement, timing and analysis population - Further research: Use same-trial materials reporting kidney recovery/dependence by definition and timepoint. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'How do dependence definition, timing and duration relate to independence?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Use on the assessment day, persistence/restart, recovery/baseline kidney failure, ascertainment/cutoff and original P value remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E03, E09, H02. - Related sources: R03 ### N24 · What is the interpretive scope of survivor conditioning, mortality and missingness? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Original dependence compares survivors; mortality is a 90-day outcome in the full analysis population. Separate materials are needed to establish whether conditional selection targets the same estimand. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Mortality/dependence composites, conditional selection, assessment missingness/sensitivity and original analysis assumptions remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Mortality/dependence composites, conditional selection, assessment missingness/sensitivity and original analysis assumptions remain unverified. - Required materials and conditions: Mortality and conditional-dependence analysis definitions, selection/missingness and alternative analyses - Materials to obtain first: Mortality and conditional-dependence analysis definitions, selection/missingness and alternative analyses - Further research: Use same-trial materials distinguishing original conditional analyses and mortality/missingness handling. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What is the interpretive scope of survivor conditioning, mortality and missingness?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not automatically establish increased conditional dependence as the same causal harm or individual outcome for every assigned patient. - Remaining uncertainty: Mortality/dependence composites, conditional selection, assessment missingness/sensitivity and original analysis assumptions remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E04, C07, E09. - Related sources: R03 ### N25 · What actually occurred in concomitant treatment, rescue initiation and strategy deviations? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original account says standard-arm treatment began when absolute indications occurred and early-arm exposure was greater. Concomitant critical-care treatment is distinguished from strategy implementation. - Why unverified: Some information from the preserved summary is linked. Supportive care, initiation/rescue thresholds, crossover, medication/device changes, actual adherence and analysis handling remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Supportive care, initiation/rescue thresholds, crossover, medication/device changes, actual adherence and analysis handling remain unverified. - Required materials and conditions: Group concomitant/rescue therapy, implementation/deviations, later interventions and estimands - Materials to obtain first: Group concomitant/rescue therapy, implementation/deviations, later interventions and estimands - Further research: Use original implementation materials separating strategy execution from concomitant care. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What actually occurred in concomitant treatment, rescue initiation and strategy deviations?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Supportive care, initiation/rescue thresholds, crossover, medication/device changes, actual adherence and analysis handling remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, H05. - Related sources: R03 ### N26 · What are ELAIN's single-center population, denominators and comparison? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: ELAIN's original design/count is a German single-center randomized trial with 231 participants. It is described as an early positive trial but is not the same trial or population as STARRT-AKI. - Why unverified: Some information from the preserved summary is linked. Group counts, analysis/completion/exposure, eligibility/severity, detailed early/delayed definitions and allocation/masking remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Group counts, analysis/completion/exposure, eligibility/severity, detailed early/delayed definitions and allocation/masking remain unverified. - Required materials and conditions: Original ELAIN baseline/flow, protocol and strategy/design materials - Materials to obtain first: Original ELAIN baseline/flow, protocol and strategy/design materials - Further research: Link original ELAIN eligibility, implementation and denominators. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are ELAIN's single-center population, denominators and comparison?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Group counts, analysis/completion/exposure, eligibility/severity, detailed early/delayed definitions and allocation/masking remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C04, E01, C07. - Related sources: R01 ### N27 · What original ELAIN 90-day mortality rates, HR and P are preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: ELAIN's original positive 90-day mortality result is preserved: 39.3% versus 54.7%, HR 0.66, P=.03. HR is a different measure from STARRT-AKI's RR. - Why unverified: Some information from the preserved summary is linked. ELAIN CI, events/group denominators, model/adjustment, missingness and original testing plan remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: ELAIN CI, events/group denominators, model/adjustment, missingness and original testing plan remain unverified. - Required materials and conditions: Original ELAIN mortality tables, HR interval/model, denominators and SAP - Materials to obtain first: Original ELAIN mortality tables, HR interval/model, denominators and SAP - Further research: Use ELAIN reports linking rates and time-to-event results to original denominators/models. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not delete the small positive result, back-calculate confidence intervals/events/risk differences or substitute RR for HR. - Remaining uncertainty: ELAIN CI, events/group denominators, model/adjustment, missingness and original testing plan remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, C08, E05. - Related sources: R01 ### N28 · What is known about ELAIN registration, strategy timing and follow-up reports? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original ELAIN registration identifier is DRKS00004367 and citation is 2016 JAMA/PMID27209269. These bibliographic/registration records are linked as originally recorded. - Why unverified: Some information from the preserved summary is linked. Registration versions, original plans/timing, initial/follow-up reports and kidney-injury/exposure details remain externally unread. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Registration versions, original plans/timing, initial/follow-up reports and kidney-injury/exposure details remain externally unread. - Required materials and conditions: DRKS/protocol, report versions and actual early/delayed timing - Materials to obtain first: DRKS/protocol, report versions and actual early/delayed timing - Further research: If original materials are supplied, record definitions and registration/report versions/timing separately. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not upgrade original registry IDs into access or prespecification verification, or invent follow-up/initial reports for the same bibliographic entry. - Remaining uncertainty: Registration versions, original plans/timing, initial/follow-up reports and kidney-injury/exposure details remain externally unread. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E06, C09, E08. - Related sources: R01 ### N29 · What are AKIKI's randomized/analysis counts and 60-day survival outcome? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: AKIKI was a randomized trial in 31 French ICUs with 620 assigned and 619 analyzed; its endpoint was 60-day survival. The parent counterview describes no 60-day mortality difference, so each original direction/label is preserved. - Why unverified: Some information from the preserved summary is linked. Group counts, exclusion/missingness reasons, exposure, follow-up and analysis/design details remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Group counts, exclusion/missingness reasons, exposure, follow-up and analysis/design details remain unverified. - Required materials and conditions: AKIKI flow, 60-day survival/mortality definitions and denominators/analysis - Materials to obtain first: AKIKI flow, 60-day survival/mortality definitions and denominators/analysis - Further research: If original AKIKI materials are supplied, link endpoint/denominator and wording scope to each original record. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not calculate 620−619 as a dropout count or change 60-day survival into 90-day mortality. - Remaining uncertainty: Group counts, exclusion/missingness reasons, exposure, follow-up and analysis/design details remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, E04. - Related sources: R02 ### N30 · What scope is covered by AKIKI's no-difference wording and unverified numbers/intervals? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: AKIKI's original result qualitatively says no difference between early and delayed strategies. NCT01932190 and PMID27181456 are linked to original registration/citation records. - Why unverified: Some information from the preserved summary is linked. Actual 60-day rates, effect measure/CI/P, importance, model, definitions/timing and plan versions are absent from the summary. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Actual 60-day rates, effect measure/CI/P, importance, model, definitions/timing and plan versions are absent from the summary. - Required materials and conditions: Original outcome tables, intervals, design/SAP and registration/report versions - Materials to obtain first: Original outcome tables, intervals, design/SAP and registration/report versions - Further research: Use original materials directly reporting AKIKI quantitative results and testing purpose. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not turn no difference into an exact zero effect/equivalence or insert STARRT-AKI/ELAIN values. - Remaining uncertainty: Actual 60-day rates, effect measure/CI/P, importance, model, definitions/timing and plan versions are absent from the summary. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C08, E05, E06. - Related sources: R02 ### N31 · How do trial-specific 60/90-day timing, HR/RR, strategies and populations differ? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: ELAIN's positive 90-day mortality HR, AKIKI's no-difference 60-day survival and STARRT-AKI's null 90-day mortality RR remain within their trial conditions. The original account explicitly records differences in early/delayed definitions and severity. - Why unverified: Some information from the preserved summary is linked. Direct condition matching, heterogeneity, prespecified effect modification, detailed recruitment/intervention differences and synthesis plans remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Direct condition matching, heterogeneity, prespecified effect modification, detailed recruitment/intervention differences and synthesis plans remain unverified. - Required materials and conditions: Trial-specific definitions/populations/exposure/comparisons, timepoints/measures and original results - Materials to obtain first: Trial-specific definitions/populations/exposure/comparisons, timepoints/measures and original results - Further research: If permitted original materials are supplied, link conditions while specifying same/different estimands. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Direct condition matching, heterogeneity, prespecified effect modification, detailed recruitment/intervention differences and synthesis plans remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E07, C08, C06. - Related sources: R01, R02, R03 ### N32 · What is shared or historical across early-positive, large-trial and other reports? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The parent describes failure to reproduce ELAIN's small single-center survival benefit in AKIKI and STARRT-AKI. The current preserved source has one bibliographic record per trial; STARRT mortality/dependence and related questions share the same report. - Why unverified: Some information from the preserved summary is linked. Initial/pilot/follow-up papers, recitation, within-family duplicates and version amendments remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Initial/pilot/follow-up papers, recitation, within-family duplicates and version amendments remain unverified. - Required materials and conditions: Report versions, initial/follow-up relationships, bibliography/registration and shared populations/outcomes - Materials to obtain first: Report versions, initial/follow-up relationships, bibliography/registration and shared populations/outcomes - Further research: If additional reports are supplied, distinguish between-trial and within-trial relationships. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not mistake 'early positive' for a follow-up report of the same cohort or create unprovided pilot/follow-up report records. - Remaining uncertainty: Initial/pilot/follow-up papers, recitation, within-family duplicates and version amendments remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, E07. - Related sources: R01, R02, R03 ### N33 · Do results answer subgroup, other-severity, duration and method questions? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original counterpoint acknowledges severity/definition differences, and results retain trial-specific scope. The selected question is severe-AKI 90-day mortality; other populations, kidney recovery and long-term disease are separate. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Direct prespecified subgroup/interaction, baseline kidney function, other method/exposure, cessation and long-term follow-up results remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Direct prespecified subgroup/interaction, baseline kidney function, other method/exposure, cessation and long-term follow-up results remain unverified. - Required materials and conditions: Direct evidence for expanded populations/exposure/duration and prespecified subgroups/SAP - Materials to obtain first: Direct evidence for expanded populations/exposure/duration and prespecified subgroups/SAP - Further research: If actual materials are supplied, link them while specifying differences in original strategy, application and question. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'Do results answer subgroup, other-severity, duration and method questions?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Direct prespecified subgroup/interaction, baseline kidney function, other method/exposure, cessation and long-term follow-up results remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E08, E07, E09. - Related sources: R01, R02, R03 ### N34 · Are parent RX/I1 and repeated-null history being inherited as current independence? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Parent RX/I1 axes and repeated-null grade rationale are historical verdict records. The current table preserves original results/conditions from three reports and does not certify unique trials/participants or independence. - Why unverified: Some information from the preserved summary is linked. Current independent listings of same/different reports, data access, participant overlap and source/family conditions were not newly verified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Current independent listings of same/different reports, data access, participant overlap and source/family conditions were not newly verified. - Required materials and conditions: Additional original study/report-family, interests and outcome/population-relationship materials - Materials to obtain first: Additional original study/report-family, interests and outcome/population-relationship materials - Further research: If actual additional materials are supplied, record same/different/unclear relationships by verification level. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not declare historical RX/I1 or the three report records a currently verified independent replication or an exact trial/participant total. - Remaining uncertainty: Current independent listings of same/different reports, data access, participant overlap and source/family conditions were not newly verified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, C10, E07, H07. - Related sources: R01, R02, R03 ### N35 · What is the trial-specific scope of plans, registration and selective reporting? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original registrations are ELAIN DRKS00004367, AKIKI NCT01932190 and STARRT-AKI NCT02568722. STARRT's prespecified-primary agreement and modified ITT quotation remain historical records. - Why unverified: Some information from the preserved summary is linked. Original registration/SAP/protocol, amendment events, hierarchy/multiplicity and complete secondary-outcome lists remain externally unread. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Original registration/SAP/protocol, amendment events, hierarchy/multiplicity and complete secondary-outcome lists remain externally unread. - Required materials and conditions: Trial-specific registration versions, plans and endpoint/analysis/amendment reporting - Materials to obtain first: Trial-specific registration versions, plans and endpoint/analysis/amendment reporting - Further research: If actual plans are supplied, link compared, unexamined and amended scope to each trial record. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not portray the presence of registry IDs/original agreement wording as completed review here or absence of all selective reporting. - Remaining uncertainty: Original registration/SAP/protocol, amendment events, hierarchy/multiplicity and complete secondary-outcome lists remain externally unread. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E06, C09. - Related sources: R01, R02, R03 ### N36 · What level of information describes ELAIN's institutional/nonprofit funding? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: ELAIN's original funding wording is institutional/nonprofit support. Public funding or company in-kind support from other trials is not transferred here. - Why unverified: Some information from the preserved summary is linked. Institutions/supporters, monetary/in-kind support, author employment/COI and design/data/analysis/publication roles remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Institutions/supporters, monetary/in-kind support, author employment/COI and design/data/analysis/publication roles remain unverified. - Required materials and conditions: Original funding/COI, product provision and sponsor/author-role declarations - Materials to obtain first: Original funding/COI, product provision and sponsor/author-role declarations - Further research: If original declarations are supplied, distinguish verified funding/roles from unverified scope. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What level of information describes ELAIN's institutional/nonprofit funding?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not upgrade nonprofit support into verification of current non-involvement, absence of all conflicts of interest or independence. - Remaining uncertainty: Institutions/supporters, monetary/in-kind support, author employment/COI and design/data/analysis/publication roles remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10. - Related sources: R01 ### N37 · What original report describes AKIKI's public funding? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: AKIKI's original funding record names the French Ministry of Health. This is the original funding description and differs from currently verified roles. - Why unverified: Some information from the preserved summary is linked. Specific grants/product provision, sponsor design/collection/analysis/submission roles and author COI remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Specific grants/product provision, sponsor design/collection/analysis/submission roles and author COI remain unverified. - Required materials and conditions: Original funding/COI, sponsor/author roles and data-access declarations - Materials to obtain first: Original funding/COI, sponsor/author roles and data-access declarations - Further research: If original declarations are supplied, record AKIKI funding/roles separately from other trials. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What original report describes AKIKI's public funding?' for the selected reduced-90-day-mortality question. - Application exceptions: 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. - Remaining uncertainty: Specific grants/product provision, sponsor design/collection/analysis/submission roles and author COI remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10. - Related sources: R02 ### N38 · What are STARRT-AKI's public and industry-partnership funding sources? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original Korean account names two CIHR grants, a CIHR-Baxter industry-partnered grant, NHMRC, New Zealand HRC and UK NIHR HTA. Original English/evidence funding accounts are preserved as their respective records. - Why unverified: Some information from the preserved summary is linked. Each grant/agreement, sponsor design/collection/analysis/submission roles, all author COI and data access remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Each grant/agreement, sponsor design/collection/analysis/submission roles, all author COI and data access remain unverified. - Required materials and conditions: Original funding/industry partnerships, agreements/roles and declared COI - Materials to obtain first: Original funding/industry partnerships, agreements/roles and declared COI - Further research: If actual declarations are supplied, record the verified scope of mixed funding and roles. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What are STARRT-AKI's public and industry-partnership funding sources?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not reduce public funding to absence of company involvement or reassess the effect/bias grade solely from industry partnership. - Remaining uncertainty: Each grant/agreement, sponsor design/collection/analysis/submission roles, all author COI and data access remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10. - Related sources: R03 ### N39 · What research condition does Alere's in-kind NGAL device provision represent? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original record says Alere supplied Triage MeterPro devices for NGAL measurement in kind. This is product-provision/measurement context, not efficacy of a kidney-replacement device or specific treatment. - Why unverified: Some information from the preserved summary is linked. NGAL eligibility/measurement roles, exact samples/adjudication/analysis use, supply agreements and independence roles remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: NGAL eligibility/measurement roles, exact samples/adjudication/analysis use, supply agreements and independence roles remain unverified. - Required materials and conditions: Original in-kind support/measurement methods, actual data use and provider-role declarations - Materials to obtain first: Original in-kind support/measurement methods, actual data use and provider-role declarations - Further research: If original declarations/methods are supplied, distinguish device provision from treatment/analysis contributions. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not infer NGAL as an early-initiation criterion/threshold or equate the measurement device with a treatment product. - Remaining uncertainty: NGAL eligibility/measurement roles, exact samples/adjudication/analysis use, supply agreements and independence roles remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10, E03, E02. - Related sources: R03 ### N40 · What original results describe hypotension, infection, bleeding and vascular-access harms? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The original safety account says kidney-replacement therapy can involve hypotension, infection, bleeding and vascular-access complications. Actual trial-specific event counts/comparisons are absent from this summary. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Event definitions, severity/discontinuation, collection, denominators/exposure time, group counts/CI/P and attribution remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Event definitions, severity/discontinuation, collection, denominators/exposure time, group counts/CI/P and attribution remain unverified. - Required materials and conditions: Trial-specific original harm tables, definitions/collection, populations/duration and attribution - Materials to obtain first: Trial-specific original harm tables, definitions/collection, populations/duration and attribution - Further research: Use original materials linking each harm to denominators/duration in the same exposure/population. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What original results describe hypotension, infection, bleeding and vascular-access harms?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not turn possible-harm examples into verified events/rates from the original trials or write individual-management/treatment instructions. - Remaining uncertainty: Event definitions, severity/discontinuation, collection, denominators/exposure time, group counts/CI/P and attribution remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E10, H01, H04. - Related sources: R03 ### N41 · How do harm occurrence, recovery and stopping relate to the 90-day timepoint? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Original 90-day dependence and mortality timepoints are endpoint assessment windows. They are not automatically actual treatment initiation/duration, complication occurrence/recovery or stopping times. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Exposure/event times, discontinuation/re-exposure, recovery, safety-collection windows and follow-up durations remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Exposure/event times, discontinuation/re-exposure, recovery, safety-collection windows and follow-up durations remain unverified. - Required materials and conditions: Group exposure/harms/stopping, collection/follow-up timing and original flow - Materials to obtain first: Group exposure/harms/stopping, collection/follow-up timing and original flow - Further research: Use trial-specific materials separating original temporal sequence from each safety window. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exposure/event times, discontinuation/re-exposure, recovery, safety-collection windows and follow-up durations remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H02, H04, E10. - Related sources: R03 ### N42 · What denominators, conditions and background apply to actual harm comparisons? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Survivor-conditioned dependence RR/denominators are original values; group safety populations/comparisons for other complications are separate. Original clinical exposure conditions of early/standard strategies are retained. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Exposed/at-risk populations, individual/recurrent events, safety analyses/comparisons and background risks remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Exposed/at-risk populations, individual/recurrent events, safety analyses/comparisons and background risks remain unverified. - Required materials and conditions: Harm-specific denominators/events/time and original controls/statistical materials - Materials to obtain first: Harm-specific denominators/events/time and original controls/statistical materials - Further research: Use original reports distinguishing safety populations from efficacy denominators and survivor conditioning. - Conditions for verification: 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. - Why this condition is needed: Required to separately document 'What denominators, conditions and background apply to actual harm comparisons?' for the selected reduced-90-day-mortality question. - Application exceptions: Do not copy efficacy denominators or survivor denominators 814/815 into all harm denominators, or extrapolate background rates. - Remaining uncertainty: Exposed/at-risk populations, individual/recurrent events, safety analyses/comparisons and background risks remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H03, H04, E10. - Related sources: R03 ### N43 · What scope do underlying disease, concomitant care and missingness/follow-up have in harm interpretation? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Severe AKI, critical-care treatment and original early/standard exposure share a context. Dependence and possible complications differ in collection/conditions, requiring separate examination of direct attribution. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Baseline kidney disease, hemodynamics/other diseases, medications/procedures, alternative causes, missingness/death selection and detection differences remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Baseline kidney disease, hemodynamics/other diseases, medications/procedures, alternative causes, missingness/death selection and detection differences remain unverified. - Required materials and conditions: Baseline/concurrent exposure, event attribution and original missingness/follow-up/sensitivity materials - Materials to obtain first: Baseline/concurrent exposure, event attribution and original missingness/follow-up/sensitivity materials - Further research: Use each trial's safety materials specifying alternative causes and collection/missingness scope. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not turn missing alternative-explanation information into absence of other causes, complete observation of everything or established causality. - Remaining uncertainty: Baseline kidney disease, hemodynamics/other diseases, medications/procedures, alternative causes, missingness/death selection and detection differences remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H05, H06, E02. - Related sources: R03 ### N44 · What scope covers long-term kidney function, rare harms and vulnerable populations? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The selected question concerns 90-day mortality; survivor-conditioned 90-day dependence is a separate original outcome. Longer kidney recovery/chronic disease and rare/special-population harms are other questions. - Why unverified: The required direct details are unverified within the preserved summary and unread external materials. Long-term follow-up, direct effects by baseline kidney function/age, rare events and actual long-term exposure remain unverified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Long-term follow-up, direct effects by baseline kidney function/age, rare events and actual long-term exposure remain unverified. - Required materials and conditions: Direct exposure/duration evidence on long-term and population-specific kidney function/harms - Materials to obtain first: Direct exposure/duration evidence on long-term and population-specific kidney function/harms - Further research: If direct materials in that scope are supplied, specify differences from original 90-day results. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Long-term follow-up, direct effects by baseline kidney function/age, rare events and actual long-term exposure remain unverified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H08, E08, E09. - Related sources: R03 ### N45 · Are parent axes, Korean/English text and false/empty values being inherited by the subclaim? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Parent D34/Caution, axes B/H/RX/I1/E0/B0/C0, false coprimary-split flag, true large-hard-endpoint RCT flag, false no-human-study flag and empty override reasons are preserved. Synthesis/grade decisions and cross-check accounts remain parent history. - Why unverified: Some information from the preserved summary is linked. Original historical verdict/axes were not reused to establish a current subclaim score, fulfilled conditions or completed review. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Original historical verdict/axes were not reused to establish a current subclaim score, fulfilled conditions or completed review. - Required materials and conditions: Separate parent/subclaim values, Korean/English text, absent values/axes and historical verdicts - Materials to obtain first: Separate parent/subclaim values, Korean/English text, absent values/axes and historical verdicts - Further research: If actual verdict corrections are supplied, preserve full original text, events/versions and decisions within each scope. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Do not copy parent points/axes/B0/cross-checking to the subclaim or declare new clinical approval. - Remaining uncertainty: Original historical verdict/axes were not reused to establish a current subclaim score, fulfilled conditions or completed review. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01, C09, E06. - Related sources: R01, R02, R03 ### N46 · What are the historical date, corrections/empty values and absence of current searching/review? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original 2026-08-26, empty corrections and empty deliberation are retained. Original ELAIN/AKIKI publication in 2016, STARRT in 2020, registration identifiers and verification accounts are history; current timing records production events. - Why unverified: Some information from the preserved summary is linked. Evidence-cutoff/classification fields are absent; registration/corrections/retractions and additional literature were not checked here. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Evidence-cutoff/classification fields are absent; registration/corrections/retractions and additional literature were not checked here. - Required materials and conditions: Publication/registration/search/correction history and current production timing/scope - Materials to obtain first: Publication/registration/search/correction history and current production timing/scope - Further research: If new materials/corrections are supplied, distinguish original scope, full before/after text and additional events. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Evidence-cutoff/classification fields are absent; registration/corrections/retractions and additional literature were not checked here. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C09, C03. - Related sources: R01, R02, R03 ### N47 · How are current mortality, survivor-dependence and harm descriptions bounded from treatment decisions? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original null mortality, positive ELAIN/no-difference AKIKI, increased conditional dependence and possible harms retain their questions/populations/timing. The standard strategy is a research condition including original rescue initiation; individual treatment actions are outside production scope. - Why unverified: Some information from the preserved summary is linked. Current guidelines/individual status, initiation/waiting, method suitability and direct long-term benefit/harm conclusions were not verified. Existing content review remains incomplete; this record does not establish clinical-condition fulfillment, zero effect or absence of materials. - Reason for missing information: Current guidelines/individual status, initiation/waiting, method suitability and direct long-term benefit/harm conclusions were not verified. - Required materials and conditions: Direct evidence for original conditions/estimands and expanded populations, timepoints, efficacy and harms - Materials to obtain first: Direct evidence for original conditions/estimands and expanded populations, timepoints, efficacy and harms - Further research: If materials are supplied and scope permits, update evidence gaps while separating other application questions from the current original table. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Current guidelines/individual status, initiation/waiting, method suitability and direct long-term benefit/harm conclusions were not verified. - Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H09, E09, E10, E08, C09. - Related sources: R03 ## Evidence and sources ### R01 Zarbock A, et al. JAMA. 2016;315:2190-2199. PMID: 27209269. [PubMed](https://pubmed.ncbi.nlm.nih.gov/27209269/) Materials actually read: Summary read; external abstracts, full papers and registries unread Findings recorded in the summary: 39.3% versus 54.7%, HR 0.66, P=.03 Record level: Not recorded Independent replication: ELAIN is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; distinguish other trials' definitions, timing and denominators, with no current unique/independent-total verification or participant aggregation. AKIKI is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; distinguish other trials' definitions, timing and denominators, with no current unique/independent-total verification or participant aggregation. STARRT-AKI is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; STARRT mortality, survivor-conditional dependence and the related question share the same report/population, with no current unique/independent-total verification or participant aggregation. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Complete preserved copy of the original summary | Preserved summary copy acquired; summary read | Summary read | The complete parent record and trial-specific report, timing, original values, registry and funding statements were read for production; external papers/registries were not read. | | External abstract | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Only the original PubMed bibliographic URL was linked; no abstract acquisition/reading or link verification. | | External full text | External materials unread; access not attempted | Access not attempted; not acquired | Not read | The URL identifies the original bibliographic record; it does not verify full-text access, acquisition or reading. | | External registration | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Original ID records preserved; registry URLs/dates unsupported by original materials were neither invented nor accessed. | | Required protocol | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original definitions of early/comparator strategies, eligibility/severity, timing/endpoints and actual exposure are needed for each trial. | | Required analysis plan | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original materials on timing/effect measures, models, denominators/exclusions/missingness, importance and the plan-versus-report comparison are needed. | | Required result tables and safety material | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original tables of endpoint-specific events, measurement/follow-up, exposure and safety populations/time are needed. STARRT requires separate mortality and survivor-conditional denominators. | | Required funding and interests | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | The complete original declarations of trial funding/in-kind support, design/collection/analysis/submission roles and author conflicts of interest remain unread. | ### R02 Gaudry S, et al. N Engl J Med. 2016;375:122-133. PMID: 27181456. [PubMed](https://pubmed.ncbi.nlm.nih.gov/27181456/) Materials actually read: Summary read; external abstracts, full papers and registries unread Findings recorded in the summary: No difference between early and delayed strategies Record level: Not recorded Independent replication: ELAIN is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; distinguish other trials' definitions, timing and denominators, with no current unique/independent-total verification or participant aggregation. AKIKI is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; distinguish other trials' definitions, timing and denominators, with no current unique/independent-total verification or participant aggregation. STARRT-AKI is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; STARRT mortality, survivor-conditional dependence and the related question share the same report/population, with no current unique/independent-total verification or participant aggregation. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Complete preserved copy of the original summary | Preserved summary copy acquired; summary read | Summary read | The complete parent record and trial-specific report, timing, original values, registry and funding statements were read for production; external papers/registries were not read. | | External abstract | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Only the original PubMed bibliographic URL was linked; no abstract acquisition/reading or link verification. | | External full text | External materials unread; access not attempted | Access not attempted; not acquired | Not read | The URL identifies the original bibliographic record; it does not verify full-text access, acquisition or reading. | | External registration | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Original ID records preserved; registry URLs/dates unsupported by original materials were neither invented nor accessed. | | Required protocol | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original definitions of early/comparator strategies, eligibility/severity, timing/endpoints and actual exposure are needed for each trial. | | Required analysis plan | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original materials on timing/effect measures, models, denominators/exclusions/missingness, importance and the plan-versus-report comparison are needed. | | Required result tables and safety material | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original tables of endpoint-specific events, measurement/follow-up, exposure and safety populations/time are needed. STARRT requires separate mortality and survivor-conditional denominators. | | Required funding and interests | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | The complete original declarations of trial funding/in-kind support, design/collection/analysis/submission roles and author conflicts of interest remain unread. | ### R03 STARRT-AKI Investigators. N Engl J Med. 2020;383:240-251. PMID: 32668114. [PubMed](https://pubmed.ncbi.nlm.nih.gov/32668114/) Materials actually read: Summary read; external abstracts, full papers and registries unread Findings recorded in the summary: 43.9% versus 43.7%, RR 1.00(0.93~1.09), P=.92 Record level: Not recorded Independent replication: ELAIN is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; distinguish other trials' definitions, timing and denominators, with no current unique/independent-total verification or participant aggregation. AKIKI is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; distinguish other trials' definitions, timing and denominators, with no current unique/independent-total verification or participant aggregation. STARRT-AKI is a provisional family based on its original bibliography/registration and trial-specific eligibility, timing and strategy; STARRT mortality, survivor-conditional dependence and the related question share the same report/population, with no current unique/independent-total verification or participant aggregation. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Complete preserved copy of the original summary | Preserved summary copy acquired; summary read | Summary read | The complete parent record and trial-specific report, timing, original values, registry and funding statements were read for production; external papers/registries were not read. | | External abstract | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Only the original PubMed bibliographic URL was linked; no abstract acquisition/reading or link verification. | | External full text | External materials unread; access not attempted | Access not attempted; not acquired | Not read | The URL identifies the original bibliographic record; it does not verify full-text access, acquisition or reading. | | External registration | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Original ID records preserved; registry URLs/dates unsupported by original materials were neither invented nor accessed. | | Required protocol | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original definitions of early/comparator strategies, eligibility/severity, timing/endpoints and actual exposure are needed for each trial. | | Required analysis plan | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original materials on timing/effect measures, models, denominators/exclusions/missingness, importance and the plan-versus-report comparison are needed. | | Required result tables and safety material | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original tables of endpoint-specific events, measurement/follow-up, exposure and safety populations/time are needed. STARRT requires separate mortality and survivor-conditional denominators. | | Required funding and interests | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | The complete original declarations of trial funding/in-kind support, design/collection/analysis/submission roles and author conflicts of interest remain unread. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. ## What the statuses mean - 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. ## Change history 2026-10-10 · Public page/materials 1.0. Reader-facing pages and materials were prepared from the existing 47 items. No new clinical search, confirmation-status change or scoring was performed.