{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2933-s1", "verdict_number": "2933", "title": "Early Kidney Replacement Therapy × Freedom from Kidney Replacement Therapy at 90 Days — Evidence Checklist", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Distinguish STARRT-AKI survivor 90-day dependence analysis denominators 814/815 from overall randomization/mortality denominators.", "intervention": "Historical early/standard KRT-initiation strategies before absolute indications in severe AKI; no initiation/delay instructions.", "dose": null, "comparator": "Early versus standard strategy; different ELAIN/AKIKI mortality results provide context.", "endpoint": "Selected original 90-day KRT-independence question; the actual original report gives survivor dependence 85/814 versus 49/815, RR1.74.", "duration": "Survivor-conditional dependence at 90 days, separate from ELAIN 90-day mortality, AKIKI 60-day survival and overall 90-day mortality.", "excluded_extensions": [ "Calculating independence rates, independence RR, kidney-recovery rates, reciprocals or composite outcomes from dependence 10.4%/6.0% and RR1.74/CI", "Calculating new survivor/missing/exclusion counts or rates from survivor 814/815, overall mortality 1465/1462 or 3019/2927", "Establishing a 90-day survivor-conditional result as a causal effect in the whole population, permanent dependence, discharge independence or individual recovery", "Repurposing positive ELAIN mortality or null AKIKI 60-day survival as direct values, replication or equivalence for 90-day independence", "Repurposing historical null mortality RR1.00 wording as zero independence effect, equivalence or overall safety verification", "Transferring centralized allocation/open design, a hard mortality endpoint or B0 wording to dependence-assessor blinding or content review here", "Changing CIHR-Baxter partnership or Alere's in-kind measurement devices into free treatment equipment, absence of company relationships or independence verification", "Creating new event counts/rates or established causality from possible hypotension, infection, bleeding or access complications", "Extending severe-AKI study strategies into treatment initiation/delay, absolute-indication, procedure-modality/suitability or treatment instructions", "Adding the same reports/trials/populations or different questions/groups/timepoints/denominators as new independent trials or total participants", "Inheriting parent scores/axes, historical cross-checks, registration matches or full-text review accounts as subclaim values, current content review or external reading", "New search/API use, numerical calculations, hypothetical numbers, new effects/CIs/grades, independent certification or treatment/suitability/administration guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does the selected KRT-independence question differ from the parent mortality verdict?", "needed": "Distinguish the subclaim D grade/note and absent points/status/axes from parent D34/axes", "role": "Required", "role_reason": "This item distinguishes Distinguish the subclaim D grade/note and absent points/status/axes from parent D34/axes to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Distinguish the subclaim D grade/note and absent points/status/axes from parent D34/axes must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Separate the sources of the independence question and mortality verdict. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected question is 'freedom from kidney replacement therapy at 90 days'; its original D grade/note says dependence among survivors was higher in the early group. Subclaim points, status and axes are absent; parent D34, Caution and the 90-day mortality verdict/axes are separate.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Do not fill absent subclaim values with parent values or create a new grade. Existing content review remains incomplete.", "missingness": "Do not fill absent subclaim values with parent values or create a new grade.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional materials for the selected question or user feedback" }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "What values are provided for the original 'independence' question?", "needed": "Distinguish KRT independence from the survivor dependence actually reported", "role": "Required", "role_reason": "This item distinguishes Distinguish KRT independence from the survivor dependence actually reported to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Distinguish KRT independence from the survivor dependence actually reported must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link the independence question with the reported dependence values. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original STARRT-AKI research description reports 90-day dependence among survivors as 85/814 (10.4%) versus 49/815 (6.0%), RR1.74 (95% CI1.24~2.43). Do not newly convert dependence values into independence rates, independence RR or recovery rates.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Direct independence events, proportions and definitions, and details of the original dependence endpoint, are unverified. Existing content review remains incomplete.", "missingness": "Direct independence events, proportions and definitions, and details of the original dependence endpoint, are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "90-day dependence/independence definitions and original outcome/denominator tables" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "What denominators are survivor 814/815 and mortality-analysis 1465/1462?", "needed": "Separate the survival condition/dependence analysis from the overall mortality analysis", "role": "Required", "role_reason": "This item distinguishes Separate the survival condition/dependence analysis from the overall mortality analysis to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate the survival condition/dependence analysis from the overall mortality analysis must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link the entire assigned/mortality population and survivor-conditional outcomes. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Dependence 85/814 versus 49/815 uses the original survivor-conditional denominators. Mortality 643/1465 versus 639/1462 uses different analysis denominators; do not newly calculate survivors/missing counts from them to replace the dependence denominators.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Eligibility/exclusions, missingness/follow-up and reasons connecting the survivor-dependence denominators are unverified. Existing content review remains incomplete.", "missingness": "Eligibility/exclusions, missingness/follow-up and reasons connecting the survivor-dependence denominators are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population flow by denominator, survival/dependence follow-up and original outcome tables" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What comparison direction is represented by dependence RR1.74 and its CI?", "needed": "Distinguish early versus standard dependence RR/CI from independence/absolute effects", "role": "Required", "role_reason": "This item distinguishes Distinguish early versus standard dependence RR/CI from independence/absolute effects to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Distinguish early versus standard dependence RR/CI from independence/absolute effects must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document the original comparison direction, interval and endpoint specification. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original survivor dependence increased from standard 6.0% to early 10.4%, RR1.74 (1.24~2.43). Do not turn it into an effect improving independence, mortality RR, a reciprocal or an absolute risk difference.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. The original dependence P value, model/adjustment and event-definition/timing details are unverified. Existing content review remains incomplete.", "missingness": "The original dependence P value, model/adjustment and event-definition/timing details are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dependence outcome tables and model/SAP" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is a survivor-conditional result the same as kidney recovery in all patients?", "needed": "Survivor selection, death as a competing event and randomized/conditional estimation", "role": "Required", "role_reason": "This item distinguishes Survivor selection, death as a competing event and randomized/conditional estimation to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Survivor selection, death as a competing event and randomized/conditional estimation must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document conditional and whole-population outcomes separately. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original report concerns KRT dependence at 90 days among survivors. Do not calculate kidney recovery in all randomized patients, a pure causal dependence effect independent of death or a new survival/independence composite outcome.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Survivor-conditional selection, handling of death, composite/competing-event analyses and individual trajectories are unverified. Existing content review remains incomplete.", "missingness": "Survivor-conditional selection, handling of death, composite/competing-event analyses and individual trajectories are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time records of survival/death and KRT status, with the prespecified analysis plan" }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "What were the actual STARRT-AKI population and initiation strategies?", "needed": "Severe AKI, early/standard initiation before absolute indications and eligibility/exclusions", "role": "Required", "role_reason": "This item distinguishes Severe AKI, early/standard initiation before absolute indications and eligibility/exclusions to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Severe AKI, early/standard initiation before absolute indications and eligibility/exclusions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house; M03 §3.2.3 and M08 §8.2.2–8.2.3: in-house application.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link population and strategy conditions. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original STARRT-AKI compares initiation strategies before absolute indications in severe acute kidney injury. The standard group also started when indications arose; this is a historical condition, with no treatment initiation/delay or suitability instructions.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact severity/eligibility, early/standard timing and exclusion/concomitant-treatment details are unverified. Existing content review remains incomplete.", "missingness": "Exact severity/eligibility, early/standard timing and exclusion/concomitant-treatment details are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, baseline/eligibility information and actual initiation records" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do 3019 randomized and 2927 analyzed participants differ?", "needed": "Postrandomization ineligibility/consent withdrawal, denominators and modified ITT scope", "role": "Required", "role_reason": "This item distinguishes Postrandomization ineligibility/consent withdrawal, denominators and modified ITT scope to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Postrandomization ineligibility/consent withdrawal, denominators and modified ITT scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link randomized, mortality and survivor analysis populations. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account states that STARRT-AKI randomized 3019 at 168 sites in 15 countries and analyzed 2927 by modified ITT after postrandomization ineligibility, consent withdrawal and other exclusions. Do not newly calculate exclusion counts/proportions.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Arm-specific exclusions/missingness, dependence-analysis inclusion criteria and the entire follow-up path are unverified. Existing content review remains incomplete.", "missingness": "Arm-specific exclusions/missingness, dependence-analysis inclusion criteria and the entire follow-up path are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, analysis populations/exclusions and consent/follow-up materials" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "What were the 90-day dependence assessment and discontinuation/restart rules?", "needed": "Definitions of KRT status, assessment timing/duration and collection/follow-up", "role": "Required", "role_reason": "This item distinguishes Definitions of KRT status, assessment timing/duration and collection/follow-up to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Definitions of KRT status, assessment timing/duration and collection/follow-up must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M08 Table 8.2.a and M03 §3.2.4: in-house application; M19 §19.1.2–19.2.4: detailed distinctions are in-house.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document KRT status and the timing/assessment specification. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original reports dependence among 90-day survivors. Do not newly attach definitions involving treatment on a specific day, a preceding period, discharge status or long-term dependence.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Dependence/independence assessment rules, treatment discontinuation/restart and follow-up methods/missingness are unverified. Existing content review remains incomplete.", "missingness": "Dependence/independence assessment rules, treatment discontinuation/restart and follow-up methods/missingness are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dependence endpoint definitions, original collection/follow-up and status records" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "How does the open-label design relate to dependence assessment?", "needed": "Distinguish allocation concealment/openness from mortality/KRT decisions", "role": "Required", "role_reason": "This item distinguishes Distinguish allocation concealment/openness from mortality/KRT decisions to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Distinguish allocation concealment/openness from mortality/KRT decisions must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link design with endpoint-specific measurement/decisions. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original describes centralized computer-generated allocation, an open-label design, a primary 90-day all-cause mortality endpoint and B0 evidence. Do not transfer the nature of mortality measurement to blinding of KRT continuation/discontinuation decisions.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Dependence assessors/blinding, actual treatment decisions and follow-up procedures are unverified. Existing content review remains incomplete.", "missingness": "Dependence assessors/blinding, actual treatment decisions and follow-up procedures are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation/dependence assessment, treatment-decision procedures and original records" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was the prespecified endpoint hierarchy for dependence?", "needed": "Primary mortality, dependence/safety and multiplicity/prespecified analysis", "role": "Required", "role_reason": "This item distinguishes Primary mortality, dependence/safety and multiplicity/prespecified analysis to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Primary mortality, dependence/safety and multiplicity/prespecified analysis must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link the primary timepoint/endpoint and secondary dependence analysis. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original prespecified primary endpoint was all-cause mortality at 90 days. Do not upgrade survivor KRT dependence to the primary endpoint or newly assign a different independence objective or power.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Prespecification/hierarchy of the dependence endpoint, multiple comparisons and model/plan are unverified. Existing content review remains incomplete.", "missingness": "Prespecification/hierarchy of the dependence endpoint, multiple comparisons and model/plan are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol/SAP and endpoint hierarchy" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does overall 90-day mortality differ from the selected independence outcome?", "needed": "Separate context of original 643/1465, 639/1462 and RR1.00/CI/P", "role": "Required", "role_reason": "This item distinguishes Separate context of original 643/1465, 639/1462 and RR1.00/CI/P to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate context of original 643/1465, 639/1462 and RR1.00/CI/P must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.3 and M15 §15.3.1–15.3.3: status separation is in-house; M15 §15.3.1–15.3.3: in-house application.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document hard mortality and survivor-conditional dependence separately. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original mortality values are 643/1465 (43.9%) versus 639/1462 (43.7%), RR1.00 (.93~1.09), P=.92. Do not turn them into dependence incidence, zero independence effect, equivalence or conditional kidney-recovery verification.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Individual mortality/dependence linkage, joint estimation and precision details of the selected analysis are unverified. Existing content review remains incomplete.", "missingness": "Individual mortality/dependence linkage, joint estimation and precision details of the selected analysis are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Linked mortality/KRT-status tables and prespecified analysis" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do actual treatment exposure/crossover relate to dependence?", "needed": "Greater early-group exposure, indication-based standard initiation and actual pathways", "role": "Required", "role_reason": "This item distinguishes Greater early-group exposure, indication-based standard initiation and actual pathways to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Greater early-group exposure, indication-based standard initiation and actual pathways must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.3 and M08 §8.2.2–8.2.3: in-house application; M08 §8.2.2 and M15 §15.3.1: in-house application; M19 §19.2: design-specific harm questions, with timing details in-house; M19 §19.2.2–19.2.4: design considerations, with detailed confounding records in-house.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link assigned strategies with actual exposure/dependence. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original study-condition description states that the early group had more treatment exposure and 90-day dependence. Do not arbitrarily fill exposure quantity/timing, procedure type/discontinuation or establish dependence causality from increased exposure alone.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Denominators/timing of actual exposure/crossover, procedure types, concomitant treatment and discontinuation/restart are unverified. Existing content review remains incomplete.", "missingness": "Denominators/timing of actual exposure/crossover, procedure types, concomitant treatment and discontinuation/restart are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific actual/concomitant treatment and timed status records" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does ELAIN's positive mortality result directly answer 90-day independence?", "needed": "Context of 231 participants, one center, mortality 39.3/54.7% and HR/P", "role": "Required", "role_reason": "This item distinguishes Context of 231 participants, one center, mortality 39.3/54.7% and HR/P to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Context of 231 participants, one center, mortality 39.3/54.7% and HR/P must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.4: in-house extension boundaries.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Separate mortality context from the selected independence endpoint. No new research, calculation or trial was performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original ELAIN context is a German single-center trial of 231 reporting 90-day mortality of 39.3% versus 54.7%, HR.66, P=.03. Do not transfer it to direct values or a replication trial for the selected KRT-independence question.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. ELAIN 90-day independence/dependence definitions, values, denominators, CI and conditions are unverified in this preserved summary. Existing content review remains incomplete.", "missingness": "ELAIN 90-day independence/dependence definitions, values, denominators, CI and conditions are unverified in this preserved summary.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ELAIN KRT-status materials and protocol" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does AKIKI 60-day survival directly answer 90-day independence?", "needed": "Scope of 620 randomized/619 analyzed, 31 ICUs and 60-day survival", "role": "Required", "role_reason": "This item distinguishes Scope of 620 randomized/619 analyzed, 31 ICUs and 60-day survival to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Scope of 620 randomized/619 analyzed, 31 ICUs and 60-day survival must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3: question-specific outcome adaptation is in-house; M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.1–3.2.4: dosage, persistence and effect-modification details are in-house.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document differences in timing/endpoints. No new research, calculation or trial was performed.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original AKIKI context is no 60-day survival difference among 620 randomized/619 analyzed at 31 French ICUs. Do not change 60-day survival into 90-day KRT independence or a replicated dependence RR1.74.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. AKIKI independence/dependence timing, values, denominators and precision are unverified. Existing content review remains incomplete.", "missingness": "AKIKI independence/dependence timing, values, denominators and precision are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original AKIKI status/timing materials and plan" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do different early definitions and populations across the three trials relate?", "needed": "Institutions/patients/timing, strategy definitions and the history of conflicting original results", "role": "Required", "role_reason": "This item distinguishes Institutions/patients/timing, strategy definitions and the history of conflicting original results to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Institutions/patients/timing, strategy definitions and the history of conflicting original results must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document relationships across different strategies/populations/endpoints. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account says early/delayed definitions and severity differed across trials. Do not certify ELAIN/AKIKI/STARRT mortality context as unique replication of the same dependence endpoint.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Exact strategy/eligibility/timing differences, dependence outcomes, effect modification and reasons for conflicting results are unverified. Existing content review remains incomplete.", "missingness": "Exact strategy/eligibility/timing differences, dependence outcomes, effect modification and reasons for conflicting results are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific characteristics, KRT status and analysis plans" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the same trial and parent mortality/independence questions and reports kept from being summed?", "needed": "Shared reports/trials/populations, different endpoints and units", "role": "Required", "role_reason": "This item distinguishes Shared reports/trials/populations, different endpoints and units to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Shared reports/trials/populations, different endpoints and units must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record shared/overlapping relationships separately. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This sheet's STARRT survivor data and parent mortality context are different conditions/endpoints of the same trial/population. Do not sum the three bibliographic entries, analysis denominators, timepoints or different questions into new independent trials/total participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Unique trial, participant and independent-replication totals have not been confirmed and remain unrecorded. Existing content review remains incomplete.", "missingness": "Unique clinical trial, participant and independent replication totals have not been verified and are not recorded.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report↔trial↔population↔endpoint linkage materials, if provided" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "What were STARRT's mixed support and Alere's in-kind contribution?", "needed": "Distinguish public/industry partnership and in-kind measurement devices from actual roles/COI", "role": "Required", "role_reason": "This item distinguishes Distinguish public/industry partnership and in-kind measurement devices from actual roles/COI to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Distinguish public/industry partnership and in-kind measurement devices from actual roles/COI must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document funding/measurement-device support and actual roles. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original describes two CIHR grants, CIHR-Baxter industry partnership, NHMRC, New Zealand HRC, NIHR HTA and Alere's in-kind Triage MeterPro devices for NGAL. Do not turn this into free treatment equipment, absence of company roles/COI or independence verification.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Support contracts, company/employee authors, analysis/manuscript decision rights and COI are unverified. Existing content review remains incomplete.", "missingness": "Support contracts, company/employee authors, analysis/manuscript decision rights and COI are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Support/in-kind contributions, authorship/contributions/COI and research-role contracts" }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does ELAIN/AKIKI support verify independence for the dependence question?", "needed": "Institutional/nonprofit support, French Ministry of Health and detailed roles", "role": "Required", "role_reason": "This item distinguishes Institutional/nonprofit support, French Ministry of Health and detailed roles to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Institutional/nonprofit support, French Ministry of Health and detailed roles must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Separate each trial's funding from actual roles. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve original ELAIN institutional/nonprofit support and AKIKI French Ministry of Health funding. Funding names alone do not verify absence of product/company/employee authors or COI, or independent replication of the dependence endpoint.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Specific funding/product support, contributions, employees/COI and dependence outcomes are unverified. Existing content review remains incomplete.", "missingness": "Specific funding/product support, contributions, employees/COI and dependence outcomes are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support/contribution/authorship/COI materials for each trial" }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were registry IDs and prespecified independence/dependence analyses actually read?", "needed": "Original DRKS00004367, NCT01932190/02568722 identifiers and plans", "role": "Required", "role_reason": "This item distinguishes Original DRKS00004367, NCT01932190/02568722 identifiers and plans to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Original DRKS00004367, NCT01932190/02568722 identifiers and plans must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link endpoint-specific prespecified plans with report versions. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve each original registry ID. Do not transfer the historical account of the STARRT primary mortality endpoint agreeing with its registry into registry/plan reading here or prespecified dependence fulfillment.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Registry-change history, protocols/SAP and dependence hierarchy/missing-data plans remain unread. Existing content review remains incomplete.", "missingness": "Registry-change history, protocols/SAP and dependence hierarchy/missing-data plans remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registry/plan copies or user-provided materials" }, { "item_id": "N20", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "How do KRT complications and dependence represent different harm information?", "needed": "Hypotension/infection/bleeding/access complications and actual event reports", "role": "Supplementary", "role_reason": "This item distinguishes Hypotension/infection/bleeding/access complications and actual event reports to link the materials needed for the selected question with those currently available.", "application_exception": "Address gaps in harm materials for the selected kidney-replacement independence/neurologic outcome. Survival dependence and original mortality/neurologic/safety wording are not used to judge overall safety or create harm rates, treatment-initiation/transfusion/threshold/suitability guidance.", "criterion": "Original materials and analysis scope covering Hypotension/infection/bleeding/access complications and actual event reports must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Document dependence separately from other safety events. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original safety description discusses possible hypotension, infection, bleeding and vascular-access complications, alongside increased survivor dependence. Do not turn these into actual individual event counts/cause verification or zero overall risk.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Definitions/collection, denominators, exposure/timing, CI and relatedness of each complication are unverified. Existing content review remains incomplete.", "missingness": "Definitions/collection, denominators, exposure/timing, CI and relatedness of each complication are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific safety tables and collection/exposure/follow-up materials" }, { "item_id": "N21", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is the scope of survivor follow-up/missingness and long-term dependence?", "needed": "90 days, survival conditions, discharge/long-term outcomes, vulnerable groups and observation loss", "role": "Supplementary", "role_reason": "This item distinguishes 90 days, survival conditions, discharge/long-term outcomes, vulnerable groups and observation loss to link the materials needed for the selected question with those currently available.", "application_exception": "Address gaps in harm materials for the selected kidney-replacement independence/neurologic outcome. Survival dependence and original mortality/neurologic/safety wording are not used to judge overall safety or create harm rates, treatment-initiation/transfusion/threshold/suitability guidance.", "criterion": "Original materials and analysis scope covering 90 days, survival conditions, discharge/long-term outcomes, vulnerable groups and observation loss must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4 and M04 §4.6.3: in-house application; M19 §19.1.2–19.2.4: in-house application; M03 §3.2.1–3.2.4: dosage, persistence and effect-modification details are in-house.", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link dependence gaps across time/conditions. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original selection is 90-day survivor-dependence data. Do not newly establish long-term permanent dependence, discharge independence, baseline chronic kidney disease/vulnerable groups or individual kidney recovery.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Dependence follow-up losses, later courses, vulnerable/subgroups and prespecified definitions are unverified. Existing content review remains incomplete.", "missingness": "Dependence follow-up losses, later courses, vulnerable/subgroups and prespecified definitions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "KRT follow-up/missingness and long-term/subgroup plans" }, { "item_id": "N22", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can findings be generalized to other patients, absolute indications or treatment choices?", "needed": "Severe-AKI study strategies, actual eligibility and questions outside scope", "role": "Required", "role_reason": "This item distinguishes Severe-AKI study strategies, actual eligibility and questions outside scope to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Severe-AKI study strategies, actual eligibility and questions outside scope must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record population/strategy-specific evidence gaps. No new research, calculation or trial was performed.", "current_reports": [ "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original is a historical comparison of severe-AKI strategies before absolute indications. Do not create individual judgments on absolute indications, treatment initiation/delay, dialysis modality/suitability or treatment recommendations for other diseases/severity levels.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Direct dependence/safety materials for populations/strategies outside scope are unverified. Existing content review remains incomplete.", "missingness": "Direct dependence/safety materials for populations/strategies outside scope are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials for the separate question, if provided" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "What reading level applies to summaries, external reports/plans and URLs?", "needed": "The complete preserved summary, three original URLs/registrations and unread external materials", "role": "Required", "role_reason": "This item distinguishes The complete preserved summary, three original URLs/registrations and unread external materials to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering The complete preserved summary, three original URLs/registrations and unread external materials must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record acquisition, reading and versions for each material. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete preserved summary was read for production and marked 'summary read', with three original URLs/registry identifiers preserved. External papers/registries/plans/COI remain 'unread'; historical review/axis-evidence wording is not transferred into new reading/content review.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. External access, abstracts/full papers/plans and link/click verification were not performed. Existing content review remains incomplete.", "missingness": "External access, abstracts/full papers/plans and link/click verification were not performed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided materials and records of actual reading" }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are original Korean/English text, axis-evidence wording, empty values and dates preserved?", "needed": "Subclaim D, parent D34, 2026-08-26, false and empty arrays/strings", "role": "Required", "role_reason": "This item distinguishes Subclaim D, parent D34, 2026-08-26, false and empty arrays/strings to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Subclaim D, parent D34, 2026-08-26, false and empty arrays/strings must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Link original versions/dates with the selected independence question. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve original Korean/English text, B0 axis-evidence wording, parent D34/Caution, false/empty values, 2026-08-26 and empty correction/deliberation values in the complete summary. Do not fill the subclaim D grade/note or absent points/status/axes with parent values.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At the historical production stage, verdict-prose translation, clinical-original review, grade changes, corrections and external updates were not performed. Existing content review remains incomplete.", "missingness": "At the historical production stage, verdict-prose translation, clinical-original review, grade changes, corrections and external updates were not performed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original correction materials or user comments" }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are condition preservation/application, case preparation and content review distinguished?", "needed": "Separate condition preservation/freezing/application, case production and incomplete content review", "role": "Required", "role_reason": "This item distinguishes Separate condition preservation/freezing/application, case production and incomplete content review to link the materials needed for the selected question with those currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original materials and analysis scope covering Separate condition preservation/freezing/application, case production and incomplete content review must be available, with unverified matters distinguished. Preserved statements are linked here; existing content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting preserved text in a table; existing content review incomplete; no official tool or QA execution", "proposed_research": "Proposal: Record condition/production versions and user correction history. No new research, calculation or trial was performed.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Condition preservation, freezing, application, case production and content review are separate records. Review of the existing content is incomplete; record counts are not totals of unique clinical trials/participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. Existing content review remains incomplete, and original clinical materials have not been newly verified. Existing content review remains incomplete.", "missingness": "Review of the existing content is incomplete and clinical source material was not newly verified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User review feedback and additional preserved materials" } ], "reports": [ { "report_id": "S01", "title": "ELAIN", "url": "https://pubmed.ncbi.nlm.nih.gov/27209269/", "report_type": "German single-center randomized trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2933-ELAIN", "independent_replication": null, "observed_result": "39.3% versus 54.7%, HR 0.66, P=.03. Preserve only the relevant mortality result and original positive wording; do not repurpose them as independence rates, dependence, kidney-recovery effects or a new replication count.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27209269/" } ] }, { "report_id": "S02", "title": "AKIKI", "url": "https://pubmed.ncbi.nlm.nih.gov/27181456/", "report_type": "Randomized trial in 31 French ICUs", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2933-AKIKI", "independent_replication": null, "observed_result": "No difference between early and delayed strategies. Preserve original null wording as the history of the mortality/survival question; do not fill 90-day independence/dependence values, equivalence or precision from it.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27181456/" } ] }, { "report_id": "S03", "title": "STARRT-AKI", "url": "https://pubmed.ncbi.nlm.nih.gov/32668114/", "report_type": "Open-label randomized trial at 168 sites in 15 countries", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2933-STARRT-AKI", "independent_replication": null, "observed_result": "Preserve increased survivor 90-day dependence in the original direction: 85/814 (10.4%) versus 49/815 (6.0%), RR1.74 (95%CI1.24~2.43). Original 90-day mortality 43.9%/43.7% and RR1.00/CI/P are different outcomes. Dependence definitions/follow-up, survivor-conditional selection and denominator linkage are unverified; do not calculate independence rates, composites or new differences.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32668114/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 ELAIN/PMID27209269 reports 90-day mortality among 231 at one German center. Direct independence/dependence values are absent from this preserved summary; different early definitions, populations and endpoints do not verify replication of the selected independence question. S02 AKIKI/PMID27181456 reports 60-day survival among 620 randomized/619 analyzed at 31 French ICUs; timing/endpoints differ from selected 90-day KRT independence, and new dependence values/CI are not created. S03 STARRT-AKI/PMID32668114 is the same trial with 3019 randomized/2927 modified-ITT participants at 168 sites in 15 countries. Overall mortality denominators 1465/1462 differ from survivor-dependence denominators 814/815. Original B0 and prespecified mortality/registry-agreement wording are not transferred into dependence assessment/content review here. Across these records, do not sum the same reports, arms, people, timepoints, endpoints, other questions or denominators into new independent trials/participants. Report/material record counts are not unique clinical totals; unique-trial, participant and independent-replication totals remain null." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }