Early Kidney Replacement Therapy · Severe Acute Kidney Injury · Reduced 90-Day Mortality — Evidence Checklist

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat are the selected question/record and parent/related-outcome context?Required	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. R03	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.	Separate links for the original question, record and parent/related outcomes	If new materials for the same question are supplied, link them while retaining the original question and verdict text.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow do the original subclaim D grade/note differ from parent D34 and absent subclaim score/axes?Required	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. R03	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.	Preserve subclaim grade/note separately from parent scores/axes and absent values	If an actual correction is supplied, record full original text, event/version and change decision separately.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionHow are ELAIN, AKIKI and STARRT-AKI reports related to trials?Required	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. R01 R02 R03	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.	Table linking reports/registration/study families, timing/outcomes and shared populations	If additional materials are supplied, record same/separate/unclear report relationships and outcome-specific scope.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat is the scope of actual reading and external links?Required	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. R01 R02 R03	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.	Material-specific status, reading scope and original records for preserved summaries and external materials	In a follow-up permitting material acquisition, record actual reading, access attempts and dates separately.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat are the severe-AKI eligibility, severity and institutional settings?Required	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. R01 R02 R03	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.	Trial-specific eligibility/exclusions, severity/baseline kidney function and recruitment settings	If direct materials specify the same strategy/population or other conditions, distinguish them by trial.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre actual definitions of early, standard and delayed strategies identical across trials?Required	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. R01 R02 R03	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.	Trial-specific protocols, early/standard/delayed definitions and actual implementation	Link each trial's directly described definitions/exposure conditions to the same or different question.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat scope is covered by the standard arm's initiation after absolute indications?Required	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. R03	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.	Original standard-strategy initiation/rescue criteria and implementation materials	Link historical strategy descriptions to original protocol and implementation materials.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhich kidney-replacement methods and actual exposures are described?Required	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. R03	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.	Original treatment methods, devices/exposure, changes and implementation tables	Link treatment content/actual exposure and results within each trial's strategy conditions.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat quantitative information supports increased treatment exposure in the early arm?Required	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. R03	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.	Group actual exposure, initiation/stopping and adherence/crossover tables	Use original implementation materials distinguishing exposure and each outcome within the same assigned population.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat are STARRT-AKI's randomized, analysis and group denominators?Required	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. R03	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.	Group tables and flow from allocation through postrandomization exclusions, analysis and exposure/follow-up	Link original flow and analysis definitions to each denominator within the same trial.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat is known about STARRT-AKI allocation/concealment and baseline balance?Required	The original research account quotes a 'centralized, computer-generated randomization schedule'. This allocation statement is distinguished from unverified actual original procedures. R03	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.	Original allocation/concealment, baseline characteristics, operational roles and postrandomization exclusions	Use original materials describing allocation and baseline information in plans/reports.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow was all-cause mortality ascertained in the open-label trial?Required	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. R03	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.	Endpoint-specific ascertainment, follow-up, masking/access and missing records	Use reports from the same trial specifying actual mortality ascertainment and analysis limits.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat do modified ITT and postrandomization exclusions represent?Required	The original account says a 'modified intention-to-treat principle' analyzed 2,927 participants and reported exclusions including postrandomization ineligibility and consent withdrawal. R03	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.	Analysis populations, timing/reasons for exclusions, original flow and SAP/sensitivity analyses	Link original modified ITT and postrandomization exclusions to each group/outcome.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat is recorded about 90-day all-cause death, registration and prespecification?Required	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. R03	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.	Original registration/plan/report records for endpoint, timing and analysis	If actual plan documents are supplied, link prespecification/amendment and reporting scope.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat are the original STARRT-AKI 90-day mortality events, denominators and rates?Required	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. R03	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.	90-day mortality counts, denominators/duration, follow-up and counting rules	Link mortality events and original denominators/follow-up in materials from the same trial.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat are the original mortality RR, 95% CI and P values?Required	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. R03	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.	Original RR/CI/P results tables and statistical methods/SAP	Link original estimation/testing plans and mortality RR in statistical materials.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionHow is the original 'exactly null' wording distinguished from zero effect or equivalence?Required	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. R03	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.	Original intervals, testing purpose/importance and design limitations	Use materials describing original justified criteria and interval interpretation.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionWhat denominators apply to 90-day follow-up, missingness/censoring and mortality ascertainment?Required	The original account records 90-day mortality and modified ITT denominators. Analysis inclusion differs from 90-day ascertainment and observation loss. R03	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.	90-day follow-up/ascertainment, missingness/censoring and original analysis handling	Use original materials separating actual observation/loss from mortality denominators.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionHow does the mortality effect of assignment strategies differ from effects of actual treatment?Required	Original mortality values compare assigned early versus standard strategies. Effects among actual kidney-replacement recipients and PP/adherence effects are separate questions. R03	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.	Strategy estimands, actual exposure and analysis/adjustment/SAP materials	Use original reports separating assignment comparisons from actual-treatment/adherence analyses.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWhat are the original interval and important mortality-difference criteria?Required	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. R03	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.	Original plan importance/power and interval/judgment criteria	If actual plan criteria are supplied, describe boundaries alongside reported intervals.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionHow does survivor-conditioned 90-day dependence differ from the selected mortality outcome?Required	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. R03	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.	Original survivor condition/dependence definition, denominators, assessment/missingness and tables	Use same-trial materials reporting mortality and survivor-conditioned dependence for their respective populations.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre 814/815 identical to randomized or mortality denominators?Required	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. R03	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.	Original flow from mortality denominators through survivors/assessable survivors to dependence denominators	Use original reports/appendices specifying conditional denominators and missingness.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionHow do dependence definition, timing and duration relate to independence?Required	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. R03	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.	Original dependence/independence definitions, measurement, timing and analysis population	Use same-trial materials reporting kidney recovery/dependence by definition and timepoint.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWhat is the interpretive scope of survivor conditioning, mortality and missingness?Required	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. R03	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.	Mortality and conditional-dependence analysis definitions, selection/missingness and alternative analyses	Use same-trial materials distinguishing original conditional analyses and mortality/missingness handling.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat actually occurred in concomitant treatment, rescue initiation and strategy deviations?Required	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. R03	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.	Group concomitant/rescue therapy, implementation/deviations, later interventions and estimands	Use original implementation materials separating strategy execution from concomitant care.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhat are ELAIN's single-center population, denominators and comparison?Required	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. R01	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.	Original ELAIN baseline/flow, protocol and strategy/design materials	Link original ELAIN eligibility, implementation and denominators.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhat original ELAIN 90-day mortality rates, HR and P are preserved?Required	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. R01	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.	Original ELAIN mortality tables, HR interval/model, denominators and SAP	Use ELAIN reports linking rates and time-to-event results to original denominators/models.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhat is known about ELAIN registration, strategy timing and follow-up reports?Required	The original ELAIN registration identifier is DRKS00004367 and citation is 2016 JAMA/PMID27209269. These bibliographic/registration records are linked as originally recorded. R01	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.	DRKS/protocol, report versions and actual early/delayed timing	If original materials are supplied, record definitions and registration/report versions/timing separately.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat are AKIKI's randomized/analysis counts and 60-day survival outcome?Required	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. R02	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.	AKIKI flow, 60-day survival/mortality definitions and denominators/analysis	If original AKIKI materials are supplied, link endpoint/denominator and wording scope to each original record.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat scope is covered by AKIKI's no-difference wording and unverified numbers/intervals?Required	AKIKI's original result qualitatively says no difference between early and delayed strategies. NCT01932190 and PMID27181456 are linked to original registration/citation records. R02	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.	Original outcome tables, intervals, design/SAP and registration/report versions	Use original materials directly reporting AKIKI quantitative results and testing purpose.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionHow do trial-specific 60/90-day timing, HR/RR, strategies and populations differ?Required	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. R01 R02 R03	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.	Trial-specific definitions/populations/exposure/comparisons, timepoints/measures and original results	If permitted original materials are supplied, link conditions while specifying same/different estimands.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat is shared or historical across early-positive, large-trial and other reports?Required	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. R01 R02 R03	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.	Report versions, initial/follow-up relationships, bibliography/registration and shared populations/outcomes	If additional reports are supplied, distinguish between-trial and within-trial relationships.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionDo results answer subgroup, other-severity, duration and method questions?Supplementary; required for extension	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. R01 R02 R03	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.	Direct evidence for expanded populations/exposure/duration and prespecified subgroups/SAP	If actual materials are supplied, link them while specifying differences in original strategy, application and question.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionAre parent RX/I1 and repeated-null history being inherited as current independence?Required	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. R01 R02 R03	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.	Additional original study/report-family, interests and outcome/population-relationship materials	If actual additional materials are supplied, record same/different/unclear relationships by verification level.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionWhat is the trial-specific scope of plans, registration and selective reporting?Required	Original registrations are ELAIN DRKS00004367, AKIKI NCT01932190 and STARRT-AKI NCT02568722. STARRT's prespecified-primary agreement and modified ITT quotation remain historical records. R01 R02 R03	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.	Trial-specific registration versions, plans and endpoint/analysis/amendment reporting	If actual plans are supplied, link compared, unexamined and amended scope to each trial record.
36	Partly verified	Full text not readStored summary read	N36 · Evidence conditionWhat level of information describes ELAIN's institutional/nonprofit funding?Required	ELAIN's original funding wording is institutional/nonprofit support. Public funding or company in-kind support from other trials is not transferred here. R01	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.	Original funding/COI, product provision and sponsor/author-role declarations	If original declarations are supplied, distinguish verified funding/roles from unverified scope.
37	Partly verified	Full text not readStored summary read	N37 · Evidence conditionWhat original report describes AKIKI's public funding?Required	AKIKI's original funding record names the French Ministry of Health. This is the original funding description and differs from currently verified roles. R02	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.	Original funding/COI, sponsor/author roles and data-access declarations	If original declarations are supplied, record AKIKI funding/roles separately from other trials.
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionWhat are STARRT-AKI's public and industry-partnership funding sources?Required	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. R03	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.	Original funding/industry partnerships, agreements/roles and declared COI	If actual declarations are supplied, record the verified scope of mixed funding and roles.
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionWhat research condition does Alere's in-kind NGAL device provision represent?Required	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. R03	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.	Original in-kind support/measurement methods, actual data use and provider-role declarations	If original declarations/methods are supplied, distinguish device provision from treatment/analysis contributions.
40	Unverified	Full text not readStored summary read	N40 · Evidence conditionWhat original results describe hypotension, infection, bleeding and vascular-access harms?Required	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. R03	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.	Trial-specific original harm tables, definitions/collection, populations/duration and attribution	Use original materials linking each harm to denominators/duration in the same exposure/population.
41	Unverified	Full text not readStored summary read	N41 · Evidence conditionHow do harm occurrence, recovery and stopping relate to the 90-day timepoint?Required	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. R03	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.	Group exposure/harms/stopping, collection/follow-up timing and original flow	Use trial-specific materials separating original temporal sequence from each safety window.
42	Unverified	Full text not readStored summary read	N42 · Evidence conditionWhat denominators, conditions and background apply to actual harm comparisons?Required	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. R03	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.	Harm-specific denominators/events/time and original controls/statistical materials	Use original reports distinguishing safety populations from efficacy denominators and survivor conditioning.
43	Unverified	Full text not readStored summary read	N43 · Evidence conditionWhat scope do underlying disease, concomitant care and missingness/follow-up have in harm interpretation?Required	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. R03	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.	Baseline/concurrent exposure, event attribution and original missingness/follow-up/sensitivity materials	Use each trial's safety materials specifying alternative causes and collection/missingness scope.
44	Unverified	Full text not readStored summary read	N44 · Evidence conditionWhat scope covers long-term kidney function, rare harms and vulnerable populations?Supplementary; required for extension	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. R03	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.	Direct exposure/duration evidence on long-term and population-specific kidney function/harms	If direct materials in that scope are supplied, specify differences from original 90-day results.
45	Partly verified	Full text not readStored summary read	N45 · Evidence conditionAre parent axes, Korean/English text and false/empty values being inherited by the subclaim?Required	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. R01 R02 R03	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.	Separate parent/subclaim values, Korean/English text, absent values/axes and historical verdicts	If actual verdict corrections are supplied, preserve full original text, events/versions and decisions within each scope.
46	Partly verified	Full text not readStored summary read	N46 · Evidence conditionWhat are the historical date, corrections/empty values and absence of current searching/review?Required	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. R01 R02 R03	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.	Publication/registration/search/correction history and current production timing/scope	If new materials/corrections are supplied, distinguish original scope, full before/after text and additional events.
47	Partly verified	Full text not readStored summary read	N47 · Evidence conditionHow are current mortality, survivor-dependence and harm descriptions bounded from treatment decisions?Required	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. R03	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.	Direct evidence for original conditions/estimands and expanded populations, timepoints, efficacy and harms	If materials are supplied and scope permits, update evidence gaps while separating other application questions from the current original table.

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47 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Zarbock A, et al. JAMA. 2016;315:2190-2199. PMID: 27209269.

PubMed

Material type: Original-report summary of a German single-center randomized trial
Materials actually read: Summary read; external abstracts, full papers and registries unread
Findings recorded in the stored summary: 39.3% versus 54.7%, HR 0.66, P=.03
Record level: Not recorded
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Original-report summary of a randomized trial in 31 French ICUs
Materials actually read: Summary read; external abstracts, full papers and registries unread
Findings recorded in the stored summary: No difference between early and delayed strategies
Record level: Not recorded
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Original-report summary of an open-label randomized trial at 168 sites in 15 countries
Materials actually read: Summary read; external abstracts, full papers and registries unread
Findings recorded in the stored summary: 43.9% versus 43.7%, RR 1.00(0.93~1.09), P=.92
Record level: Not recorded
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the selected question/record and parent/related-outcome context?

Required materials and conditions: Separate links for the original question, record and parent/related outcomes
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01.

N02 · How do the original subclaim D grade/note differ from parent D34 and absent subclaim score/axes?

Required materials and conditions: Preserve subclaim grade/note separately from parent scores/axes and absent values
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01, C09.

N03 · How are ELAIN, AKIKI and STARRT-AKI reports related to trials?

Required materials and conditions: Table linking reports/registration/study families, timing/outcomes and shared populations
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, E07, H07.

N04 · What is the scope of actual reading and external links?

Required materials and conditions: Material-specific status, reading scope and original records for preserved summaries and external materials
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.
Requirement and applicability: Required
Application exceptions: Do not upgrade summary reading into paper/registry reading or describe unattempted access as failure or zero existence.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C03.

N05 · What are the severe-AKI eligibility, severity and institutional settings?

Required materials and conditions: Trial-specific eligibility/exclusions, severity/baseline kidney function and recruitment settings
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C04, E08.

N06 · Are actual definitions of early, standard and delayed strategies identical across trials?

Required materials and conditions: Trial-specific protocols, early/standard/delayed definitions and actual implementation
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.
Requirement and applicability: Required
Application exceptions: Do not fill timing/thresholds with invented numbers or declare the early strategies of different trials identical.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02, E07.

N07 · What scope is covered by the standard arm's initiation after absolute indications?

Required materials and conditions: Original standard-strategy initiation/rescue criteria 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.
Requirement and applicability: Required
Application exceptions: Do not turn historical initiation conditions into action recommendations on individual treatment initiation/waiting, emergency assessment or suitability.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02.

N08 · Which kidney-replacement methods and actual exposures are described?

Required materials and conditions: Original treatment methods, devices/exposure, changes and implementation tables
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.
Requirement and applicability: Required
Application exceptions: Do not turn the original treatment types into modality selection, dosage conversion or treatment instructions.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C05, E02, E08.

N09 · What quantitative information supports increased treatment exposure in the early arm?

Required materials and conditions: Group actual exposure, initiation/stopping and adherence/crossover tables
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.
Requirement and applicability: Required
Application exceptions: Do not calculate initiation rates, exposure time, treatment counts or causal-pathway quantities from increased-exposure wording without original materials.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, C05, E04.

N10 · What are STARRT-AKI's randomized, analysis and group denominators?

Required materials and conditions: Group tables and flow from allocation through postrandomization exclusions, analysis and exposure/follow-up
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.
Requirement and applicability: Required
Application exceptions: Do not calculate 3,019−2,927 as a new dropout count or alter the original reader wording.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04.

N11 · What is known about STARRT-AKI allocation/concealment and baseline balance?

Required materials and conditions: Original allocation/concealment, baseline characteristics, operational roles and postrandomization exclusions
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E01.

N12 · How was all-cause mortality ascertained in the open-label trial?

Required materials and conditions: Endpoint-specific ascertainment, follow-up, masking/access and missing records
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E01, E03.

N13 · What do modified ITT and postrandomization exclusions represent?

Required materials and conditions: Analysis populations, timing/reasons for exclusions, original flow and SAP/sensitivity analyses
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.
Requirement and applicability: Required
Application exceptions: Do not substitute complete ITT for everyone or complete observation for modified ITT, or estimate exclusion counts/reasons.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E04, C07.

N14 · What is recorded about 90-day all-cause death, registration and prespecification?

Required materials and conditions: Original registration/plan/report records for endpoint, timing and analysis
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.
Requirement and applicability: Required
Application exceptions: Do not upgrade the original registry-agreement wording into registry access or prespecification verification performed here.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E06, C09.

N15 · What are the original STARRT-AKI 90-day mortality events, denominators and rates?

Required materials and conditions: 90-day mortality counts, denominators/duration, follow-up and counting rules
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.
Requirement and applicability: Required
Application exceptions: Do not add mortality counts or newly calculate non-deaths/losses, risk differences, NNT or relative ratios.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07.

N16 · What are the original mortality RR, 95% CI and P values?

Required materials and conditions: Original RR/CI/P results tables and statistical methods/SAP
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.
Requirement and applicability: Required
Application exceptions: Do not label RR as HR or treat the rounded RR 1.00 as proof of exactly zero for every effect.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E04, E05.

N17 · How is the original 'exactly null' wording distinguished from zero effect or equivalence?

Required materials and conditions: Original intervals, testing purpose/importance and design limitations
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.
Requirement and applicability: Required
Application exceptions: Do not alter the original record or extend null wording into an exact zero effect, equivalence, harmlessness or conclusions about all strategies.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C08, E05.

N18 · What denominators apply to 90-day follow-up, missingness/censoring and mortality ascertainment?

Required materials and conditions: 90-day follow-up/ascertainment, missingness/censoring and original analysis handling
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04, E03.

N19 · How does the mortality effect of assignment strategies differ from effects of actual treatment?

Required materials and conditions: Strategy estimands, actual exposure and analysis/adjustment/SAP materials
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.
Requirement and applicability: Required
Application exceptions: Do not invent efficacy among recipients/non-recipients or attribute the strategy RR to treatment itself or a particular technique.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, E04.

N20 · What are the original interval and important mortality-difference criteria?

Required materials and conditions: Original plan importance/power and interval/judgment criteria
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.
Requirement and applicability: Required
Application exceptions: Do not make a new judgment that all small or important effects are excluded because of a large sample/C0.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E05.

N21 · How does survivor-conditioned 90-day dependence differ from the selected mortality outcome?

Required materials and conditions: Original survivor condition/dependence definition, denominators, assessment/missingness and tables
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, E09, E10.

N22 · Are 814/815 identical to randomized or mortality denominators?

Required materials and conditions: Original flow from mortality denominators through survivors/assessable survivors to dependence denominators
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.
Requirement and applicability: Required
Application exceptions: Do not calculate total survivors by subtracting mortality counts or substitute 814/815 for the entire assigned-population denominators.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C07, E04, H04.

N23 · How do dependence definition, timing and duration relate to independence?

Required materials and conditions: Original dependence/independence definitions, measurement, timing and analysis population
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, E03, E09, H02.

N24 · What is the interpretive scope of survivor conditioning, mortality and missingness?

Required materials and conditions: Mortality and conditional-dependence analysis definitions, selection/missingness and alternative analyses
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.
Requirement and applicability: Required
Application exceptions: Do not automatically establish increased conditional dependence as the same causal harm or individual outcome for every assigned patient.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E04, C07, E09.

N25 · What actually occurred in concomitant treatment, rescue initiation and strategy deviations?

Required materials and conditions: Group concomitant/rescue therapy, implementation/deviations, later interventions and estimands
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E02, H05.

N26 · What are ELAIN's single-center population, denominators and comparison?

Required materials and conditions: Original ELAIN baseline/flow, protocol and strategy/design materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C04, E01, C07.

N27 · What original ELAIN 90-day mortality rates, HR and P are preserved?

Required materials and conditions: Original ELAIN mortality tables, HR interval/model, denominators and SAP
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.
Requirement and applicability: Required
Application exceptions: Do not delete the small positive result, back-calculate confidence intervals/events/risk differences or substitute RR for HR.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, C08, E05.

N28 · What is known about ELAIN registration, strategy timing and follow-up reports?

Required materials and conditions: DRKS/protocol, report versions and actual early/delayed timing
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.
Requirement and applicability: Required
Application exceptions: Do not upgrade original registry IDs into access or prespecification verification, or invent follow-up/initial reports for the same bibliographic entry.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E06, C09, E08.

N29 · What are AKIKI's randomized/analysis counts and 60-day survival outcome?

Required materials and conditions: AKIKI flow, 60-day survival/mortality definitions and denominators/analysis
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.
Requirement and applicability: Required
Application exceptions: Do not calculate 620−619 as a dropout count or change 60-day survival into 90-day mortality.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C06, C07, E04.

N30 · What scope is covered by AKIKI's no-difference wording and unverified numbers/intervals?

Required materials and conditions: Original outcome tables, intervals, design/SAP and registration/report versions
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.
Requirement and applicability: Required
Application exceptions: Do not turn no difference into an exact zero effect/equivalence or insert STARRT-AKI/ELAIN values.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C08, E05, E06.

N31 · How do trial-specific 60/90-day timing, HR/RR, strategies and populations differ?

Required materials and conditions: Trial-specific definitions/populations/exposure/comparisons, timepoints/measures and original results
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E07, C08, C06.

N32 · What is shared or historical across early-positive, large-trial and other reports?

Required materials and conditions: Report versions, initial/follow-up relationships, bibliography/registration and shared populations/outcomes
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.
Requirement and applicability: Required
Application exceptions: Do not mistake 'early positive' for a follow-up report of the same cohort or create unprovided pilot/follow-up report records.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, E07.

N33 · Do results answer subgroup, other-severity, duration and method questions?

Required materials and conditions: Direct evidence for expanded populations/exposure/duration and prespecified subgroups/SAP
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.
Requirement and applicability: Supplementary; required for extension
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E08, E07, E09.

N34 · Are parent RX/I1 and repeated-null history being inherited as current independence?

Required materials and conditions: Additional original study/report-family, interests and outcome/population-relationship materials
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.
Requirement and applicability: Required
Application exceptions: Do not declare historical RX/I1 or the three report records a currently verified independent replication or an exact trial/participant total.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C02, C10, E07, H07.

N35 · What is the trial-specific scope of plans, registration and selective reporting?

Required materials and conditions: Trial-specific registration versions, plans and endpoint/analysis/amendment reporting
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.
Requirement and applicability: Required
Application exceptions: Do not portray the presence of registry IDs/original agreement wording as completed review here or absence of all selective reporting.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E06, C09.

N36 · What level of information describes ELAIN's institutional/nonprofit funding?

Required materials and conditions: Original funding/COI, product provision and sponsor/author-role declarations
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.
Requirement and applicability: Required
Application exceptions: Do not upgrade nonprofit support into verification of current non-involvement, absence of all conflicts of interest or independence.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10.

N37 · What original report describes AKIKI's public funding?

Required materials and conditions: Original funding/COI, sponsor/author roles and data-access declarations
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10.

N38 · What are STARRT-AKI's public and industry-partnership funding sources?

Required materials and conditions: Original funding/industry partnerships, agreements/roles and declared COI
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.
Requirement and applicability: Required
Application exceptions: Do not reduce public funding to absence of company involvement or reassess the effect/bias grade solely from industry partnership.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10.

N39 · What research condition does Alere's in-kind NGAL device provision represent?

Required materials and conditions: Original in-kind support/measurement methods, actual data use and provider-role declarations
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.
Requirement and applicability: Required
Application exceptions: Do not infer NGAL as an early-initiation criterion/threshold or equate the measurement device with a treatment product.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C10, E03, E02.

N40 · What original results describe hypotension, infection, bleeding and vascular-access harms?

Required materials and conditions: Trial-specific original harm tables, definitions/collection, populations/duration and attribution
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.
Requirement and applicability: Required
Application exceptions: Do not turn possible-harm examples into verified events/rates from the original trials or write individual-management/treatment instructions.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions E10, H01, H04.

N41 · How do harm occurrence, recovery and stopping relate to the 90-day timepoint?

Required materials and conditions: Group exposure/harms/stopping, collection/follow-up timing and original flow
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H02, H04, E10.

N42 · What denominators, conditions and background apply to actual harm comparisons?

Required materials and conditions: Harm-specific denominators/events/time and original controls/statistical materials
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.
Requirement and applicability: Required
Application exceptions: Do not copy efficacy denominators or survivor denominators 814/815 into all harm denominators, or extrapolate background rates.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H03, H04, E10.

N43 · What scope do underlying disease, concomitant care and missingness/follow-up have in harm interpretation?

Required materials and conditions: Baseline/concurrent exposure, event attribution and original missingness/follow-up/sensitivity materials
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.
Requirement and applicability: Required
Application exceptions: Do not turn missing alternative-explanation information into absence of other causes, complete observation of everything or established causality.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H05, H06, E02.

N44 · What scope covers long-term kidney function, rare harms and vulnerable populations?

Required materials and conditions: Direct exposure/duration evidence on long-term and population-specific kidney function/harms
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.
Requirement and applicability: Supplementary; required for extension
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions H08, E08, E09.

N45 · Are parent axes, Korean/English text and false/empty values being inherited by the subclaim?

Required materials and conditions: Separate parent/subclaim values, Korean/English text, absent values/axes and historical verdicts
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.
Requirement and applicability: Required
Application exceptions: Do not copy parent points/axes/B0/cross-checking to the subclaim or declare new clinical approval.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C01, C09, E06.

N46 · What are the historical date, corrections/empty values and absence of current searching/review?

Required materials and conditions: Publication/registration/search/correction history and current production timing/scope
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.
Requirement and applicability: Required
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.
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.
Referenced methods: An independently written condition for this question, referring to the relevant preserved-summary record and family application conditions C09, C03.

N47 · How are current mortality, survivor-dependence and harm descriptions bounded from treatment decisions?

Required materials and conditions: Direct evidence for original conditions/estimands and expanded populations, timepoints, efficacy and harms
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.
Requirement and applicability: Required
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.
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.
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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 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.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the selected question/record and parent/related-outcome context?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Direct original values for the selected subclaim's score/status/axes are absent.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Early/follow-up report versions, duplicate people/trials and current unique totals have not been confirmed.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: External availability/acquisition, accessibility, current content and URL operation were not checked here.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Age, AKI definition/stage, baseline kidney function, other organs/causes, eligibility/exclusions and each population's severity composition remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Trial-specific time origins, initiation criteria/thresholds, permitted waiting and actual initiation times/adherence remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Protocol numerical thresholds, actual timing, decisions/adherence, rescue initiation and individual suitability remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Group-specific techniques/devices, actual amounts/intensity, frequency/duration, anticoagulation, switching/stopping and concomitant treatment remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Counts/denominators actually treated, initiation/duration, group exposure intensity and adherence/crossover quantities are absent from the summary.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Original tables are needed for randomized group counts, exclusions by reason/group, actual exposure and follow-up/endpoint denominators.
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.
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?

Current findings: The original research account quotes a 'centralized, computer-generated randomization schedule'. This allocation statement is distinguished from unverified actual original procedures.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Stratification, sequence access, allocation operations, baseline balance and group distribution of subsequent exclusions remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Mortality ascertainment sources, assessors/data access, loss to follow-up, group ascertainment differences and adjudication procedures remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Counts by reason/group, planned versus later changes, complete-ITT alternatives and missingness/sensitivity details remain unread in original materials.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Current registration versions, protocol/SAP, amendment timing, time origins and testing plans remain externally unread.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Group ascertainment completeness, missingness, differences from allocation denominators, time origins/cutoffs and original counting-rule details remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: RR model, adjustment/stratification, testing method, assumptions, sensitivity analyses and prespecified importance details remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Equivalence/noninferiority objectives, justified margins and plans excluding all effect sizes have not been verified.
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.
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?

Current findings: The original account records 90-day mortality and modified ITT denominators. Analysis inclusion differs from 90-day ascertainment and observation loss.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Complete/incomplete follow-up, missingness/censoring, original cutoffs, later deaths and sensitivity details are absent from the summary.
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.
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?

Current findings: Original mortality values compare assigned early versus standard strategies. Effects among actual kidney-replacement recipients and PP/adherence effects are separate questions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Original RR adjustment, crossover/non-treatment, rescue initiation, later therapy and estimand/SAP remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Prespecified important differences, power, planned events/sample and justified clinical margins are absent from the summary.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Dependence definition, assessable survivors, missingness/selection and timing/denominator details remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Relationships between all and assessable survivors, missingness reasons/group counts and changes in flow remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Use on the assessment day, persistence/restart, recovery/baseline kidney failure, ascertainment/cutoff and original P value remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Mortality/dependence composites, conditional selection, assessment missingness/sensitivity and original analysis assumptions remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Supportive care, initiation/rescue thresholds, crossover, medication/device changes, actual adherence and analysis handling remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Group counts, analysis/completion/exposure, eligibility/severity, detailed early/delayed definitions and allocation/masking remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: ELAIN CI, events/group denominators, model/adjustment, missingness and original testing plan remain unverified.
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.
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?

Current findings: The original ELAIN registration identifier is DRKS00004367 and citation is 2016 JAMA/PMID27209269. These bibliographic/registration records are linked as originally recorded.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Registration versions, original plans/timing, initial/follow-up reports and kidney-injury/exposure details remain externally unread.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Group counts, exclusion/missingness reasons, exposure, follow-up and analysis/design details remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Actual 60-day rates, effect measure/CI/P, importance, model, definitions/timing and plan versions are absent from the summary.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Direct condition matching, heterogeneity, prespecified effect modification, detailed recruitment/intervention differences and synthesis plans remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Initial/pilot/follow-up papers, recitation, within-family duplicates and version amendments remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Direct prespecified subgroup/interaction, baseline kidney function, other method/exposure, cessation and long-term follow-up results remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Current independent listings of same/different reports, data access, participant overlap and source/family conditions were not newly verified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Original registration/SAP/protocol, amendment events, hierarchy/multiplicity and complete secondary-outcome lists remain externally unread.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Institutions/supporters, monetary/in-kind support, author employment/COI and design/data/analysis/publication roles remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Specific grants/product provision, sponsor design/collection/analysis/submission roles and author COI remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Each grant/agreement, sponsor design/collection/analysis/submission roles, all author COI and data access remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: NGAL eligibility/measurement roles, exact samples/adjudication/analysis use, supply agreements and independence roles remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Event definitions, severity/discontinuation, collection, denominators/exposure time, group counts/CI/P and attribution remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Exposure/event times, discontinuation/re-exposure, recovery, safety-collection windows and follow-up durations remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Exposed/at-risk populations, individual/recurrent events, safety analyses/comparisons and background risks remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Baseline kidney disease, hemodynamics/other diseases, medications/procedures, alternative causes, missingness/death selection and detection differences remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Long-term follow-up, direct effects by baseline kidney function/age, rare events and actual long-term exposure remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Original historical verdict/axes were not reused to establish a current subclaim score, fulfilled conditions or completed review.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Evidence-cutoff/classification fields are absent; registration/corrections/retractions and additional literature were not checked here.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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.
Remaining uncertainty: Current guidelines/individual status, initiation/waiting, method suitability and direct long-term benefit/harm conclusions were not verified.
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.
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