{ "schema_version": "chamgap-public-criteria-1.0", "title": "High-ferritin-target intravenous iron × Reduced dialysis, death or cardiovascular events in nondialysis CKD", "language": "en", "translation_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Awaiting user review, or actual review remains incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing subclaim and question direction does this sheet preserve?", "needed": "Material retaining the selected subclaim-parent relationship, original question and verdict record.", "role": "Required", "role_reason": "Which existing subclaim and question direction does this sheet preserve? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "Which existing subclaim and question direction does this sheet preserve? Distinguish Material retaining the selected subclaim-parent relationship, original question and verdict record in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "When additional material becomes available, the existing question scope is recorded separately from other questions." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are subclaim grade/note and absent score, status and axes distinguished?", "needed": "Actual selected-subclaim fields and separately retained parent fields.", "role": "Required", "role_reason": "How are subclaim grade/note and absent score, status and axes distinguished? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "How are subclaim grade/note and absent score, status and axes distinguished? Distinguish Actual selected-subclaim fields and separately retained parent fields in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "If the original subclaim is corrected, the complete pre-change text and change event are preserved." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What historical context do parent C, 50 points, axes, safety and empty values represent?", "needed": "Complete parent verdict, axes, safety labels and actual change history.", "role": "Required", "role_reason": "What historical context do parent C, 50 points, axes, safety and empty values represent? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Parent scores/axes are historical context and do not fill absent selected-subclaim values.", "criterion": "What historical context do parent C, 50 points, axes, safety and empty values represent? Distinguish Complete parent verdict, axes, safety labels and actual change history in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Even if a new verdict is requested, original grades and production status remain separately preserved." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How are original Korean/English, reference dates and correction histories retained?", "needed": "Complete original text, language-specific explanations, reference dates and additional correction records.", "role": "Required", "role_reason": "How are original Korean/English, reference dates and correction histories retained? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Historical cross-check and research-assessment wording does not mean newly completed review.", "criterion": "How are original Korean/English, reference dates and correction histories retained? Distinguish Complete original text, language-specific explanations, reference dates and additional correction records in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added language-specific text or corrections preserve the complete existing version and link as a new event." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which materials were actually read for this production and which external materials remain unread?", "needed": "Acquisition/reading levels and relevant result locations in original source material.", "role": "Required", "role_reason": "Which materials were actually read for this production and which external materials remain unread? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "URLs link sources without being upgraded to reading, link testing or content verification.", "criterion": "Which materials were actually read for this production and which external materials remain unread? Distinguish Acquisition/reading levels and relevant result locations in original source material in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Separate additional reading must record its scope and time as a new event." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What are the FIND-CKD report bibliography and registration identity?", "needed": "Paper bibliography, original full text, registration content and their actual links.", "role": "Required", "role_reason": "What are the FIND-CKD report bibliography and registration identity? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "A registration identifier does not verify registration content or certify a unique trial.", "criterion": "What are the FIND-CKD report bibliography and registration identity? Distinguish Paper bibliography, original full text, registration content and their actual links in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added report identities must be distinguished as the same trial or separate trials using original material." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How do two subclaim sheets share one trial, report and population?", "needed": "Original material distinguishing trial, report, population, group, outcome links and overlap.", "role": "Required", "role_reason": "How do two subclaim sheets share one trial, report and population? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "New-unit increment remains 0 and the final independent count remains null.", "criterion": "How do two subclaim sheets share one trial, report and population? Distinguish Original material distinguishing trial, report, population, group, outcome links and overlap in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "New follow-up/related reports link to the existing family; independent replication requires separate material." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which nondialysis chronic kidney disease anemia population was studied?", "needed": "Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.", "role": "Required", "role_reason": "Which nondialysis chronic kidney disease anemia population was studied? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Eligibility thresholds or disease stages absent from the current summary are not invented.", "criterion": "Which nondialysis chronic kidney disease anemia population was studied? Distinguish Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Population differences require direct comparison material for the relevant populations." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How much is verified about baseline risk and representativeness?", "needed": "Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.", "role": "Supplementary; required for general application", "role_reason": "How much is verified about baseline risk and representativeness? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "How much is verified about baseline risk and representativeness? Distinguish Group baseline tables, recruitment pathways, exclusions, severity and comorbidities in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Application to different risk populations must be distinguished using direct studies with follow-up." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose?", "needed": "Intervention strategy, product identity, target-adjustment rules and group achieved values.", "role": "Required", "role_reason": "What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Historical targets are not written as treatment, dose or suitability guidance.", "criterion": "What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? Distinguish Intervention strategy, product identity, target-adjustment rules and group achieved values in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Differences by formulation or target require direct strategy-comparison material." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What is the original research exposure of the oral ferrous sulfate control?", "needed": "Oral formulation, research exposure, actual use, discontinuation and adherence material.", "role": "Required", "role_reason": "What is the original research exposure of the oral ferrous sulfate control? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Only original exposure values are retained; no new totals, conversions or use recommendations are calculated.", "criterion": "What is the original research exposure of the oral ferrous sulfate control? Distinguish Oral formulation, research exposure, actual use, discontinuation and adherence material in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material with different control conditions is linked separately with those differences specified." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How are the selected comparison and other-group information separated in the three-arm design?", "needed": "Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.", "role": "Required", "role_reason": "How are the selected comparison and other-group information separated in the three-arm design? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Other-group targets, denominators or effects are not inferred or back-calculated from totals.", "criterion": "How are the selected comparison and other-group information separated in the three-arm design? Distinguish Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added other-group results retain separate attribution from the current comparison." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How much is known about actual intravenous administration, achieved ferritin, adherence and changes?", "needed": "Actual group administration, achieved values, adherence, changes and discontinuation records.", "role": "Required", "role_reason": "How much is known about actual intravenous administration, achieved ferritin, adherence and changes? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "No new administered doses, schedules or unit conversions are created.", "criterion": "How much is known about actual intravenous administration, achieved ferritin, adherence and changes? Distinguish Actual group administration, achieved values, adherence, changes and discontinuation records in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Exposure differences require material linking actual strategy implementation with outcomes." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are starting ESA, transfusions or other iron concurrent care or outcome components?", "needed": "Additional-management initiation criteria, group use/timing and outcome-counting rules.", "role": "Required", "role_reason": "Are starting ESA, transfusions or other iron concurrent care or outcome components? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Treatment switches are not presented as the same outcome as patient events.", "criterion": "Are starting ESA, transfusions or other iron concurrent care or outcome components? Distinguish Additional-management initiation criteria, group use/timing and outcome-counting rules in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Interpreting additional management requires plans alongside actual courses." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are 56-week follow-up and the weeks 8~52 composite window the same period?", "needed": "Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.", "role": "Required", "role_reason": "Are 56-week follow-up and the weeks 8~52 composite window the same period? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "Are 56-week follow-up and the weeks 8~52 composite window the same period? Distinguish Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added timepoint-specific material links each outcome to its relevant period separately." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the randomized, ITT and completed denominators?", "needed": "Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.", "role": "Required", "role_reason": "What are the randomized, ITT and completed denominators? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "No new differences, proportions or participant totals are created from current numbers.", "criterion": "What are the randomized, ITT and completed denominators? Distinguish Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added actual analysis inclusion/missingness rules supplement outcome-specific links." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How are group-denominator differences for the primary composite, death and infection recorded?", "needed": "Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.", "role": "Required", "role_reason": "How are group-denominator differences for the primary composite, death and infection recorded? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "One denominator is not used to recalculate other outcomes or certify common ITT.", "criterion": "How are group-denominator differences for the primary composite, death and infection recorded? Distinguish Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Original explanations of outcome-specific denominators link only to the corresponding rows." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What effects remain uncertain from noncompletion and missingness?", "needed": "Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.", "role": "Required", "role_reason": "What effects remain uncertain from noncompletion and missingness? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Attrition effects, new bias grades or lost-person counts are not calculated.", "criterion": "What effects remain uncertain from noncompletion and missingness? Distinguish Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Changes under missingness assumptions must be distinguished using original analyses/additional material." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What is the verification scope of central randomization?", "needed": "Detailed allocation methods, protocols and implementation material.", "role": "Required", "role_reason": "What is the verification scope of central randomization? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Central-allocation wording alone does not certify all randomization procedures as appropriate.", "criterion": "What is the verification scope of central randomization? Distinguish Detailed allocation methods, protocols and implementation material in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added allocation procedures must retain known levels separately from unverified details." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What distinctions does open-label design require for treatment decisions and laboratory measurement?", "needed": "Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.", "role": "Required", "role_reason": "What distinctions does open-label design require for treatment decisions and laboratory measurement? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "The original three-defect, avoidability and common bias-category wording remains historical only.", "criterion": "What distinctions does open-label design require for treatment decisions and laboratory measurement? Distinguish Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material separating component measurement from decision procedures is needed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Was NCT00994318 registration content actually verified?", "needed": "Original registration text, versions, endpoints, analyses and changes.", "role": "Required", "role_reason": "Was NCT00994318 registration content actually verified? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "A registration number is not displayed as actual reading or trial certification.", "criterion": "Was NCT00994318 registration content actually verified? Distinguish Original registration text, versions, endpoints, analyses and changes in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Separately acquired registration material must retain its version and relationship to reports." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "At what level are primary/secondary endpoint and analysis hierarchies known?", "needed": "Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.", "role": "Required", "role_reason": "At what level are primary/secondary endpoint and analysis hierarchies known? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Parent primary-endpoint wording is not upgraded to direct external-plan verification.", "criterion": "At what level are primary/secondary endpoint and analysis hierarchies known? Distinguish Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added plans link prespecified and post hoc distinctions to each outcome." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What original information describes Vifor Pharma sponsorship and oral-iron supply?", "needed": "Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.", "role": "Required", "role_reason": "What original information describes Vifor Pharma sponsorship and oral-iron supply? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "What original information describes Vifor Pharma sponsorship and oral-iron supply? Distinguish Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added sponsorship, data-access or analysis-involvement information is recorded separately from interpretation limits." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What are the detailed author conflicts, data-access and publication roles?", "needed": "COI, sponsorship contracts, analysis, data-access and publication-role disclosures.", "role": "Supplementary; required for independence claims", "role_reason": "What are the detailed author conflicts, data-access and publication roles? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "What are the detailed author conflicts, data-access and publication roles? Distinguish COI, sponsorship contracts, analysis, data-access and publication-role disclosures in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Added independent reports first distinguish actual parties, data sharing and analysis relationships." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What safety scope do stored infection observations cover?", "needed": "Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.", "role": "Required", "role_reason": "What safety scope do stored infection observations cover? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "No differences, ratios, P values or CIs beyond original values are calculated.", "criterion": "What safety scope do stored infection observations cover? Distinguish Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Clinically important infection harms require appropriate event collection, follow-up and comparisons." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are detailed safety collection, sparse events and attrition verified?", "needed": "Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.", "role": "Required", "role_reason": "Are detailed safety collection, sparse events and attrition verified? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "Are detailed safety collection, sparse events and attrition verified? Distinguish Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Safety signals require material with definitions, ascertainment, denominators and follow-up." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors?", "needed": "Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.", "role": "Supplementary; required for long-term/safety extension", "role_reason": "What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? Distinguish Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Long-term/rare clinical harms need separate material with sufficient follow-up and appropriate comparisons." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Is preoperative verdict 2560 for the same drug direct evidence here?", "needed": "Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.", "role": "Supplementary; required for limits of extension to other settings", "role_reason": "Is preoperative verdict 2560 for the same drug direct evidence here? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Another verdict grade is not inherited by this subclaim.", "criterion": "Is preoperative verdict 2560 for the same drug direct evidence here? Distinguish Direct material and application limits for different use settings, populations, timepoints and clinical outcomes in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material from other settings is not merged by drug name alone; question/population differences remain recorded." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What separate questions concern reduced dialysis, death and cardiovascular events?", "needed": "Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.", "role": "Required", "role_reason": "What separate questions concern reduced dialysis, death and cardiovascular events? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Parent C/Hb improvement is not inherited as positive effects or scores for the selected clinical events.", "criterion": "What separate questions concern reduced dialysis, death and cardiovascular events? Distinguish Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "The three outcomes need material with individual definitions and adequate power." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What are the original dialysis-initiation events and denominators?", "needed": "Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.", "role": "Required", "role_reason": "What are the original dialysis-initiation events and denominators? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "The overall 16 people are not copied as group-specific values or added as participants.", "criterion": "What are the original dialysis-initiation events and denominators? Distinguish Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Dialysis initiation requires sufficient follow-up and direct between-group comparisons." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How does no-group-difference wording differ from dialysis effects and precision?", "needed": "Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.", "role": "Required", "role_reason": "How does no-group-difference wording differ from dialysis effects and precision? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Historical nonsignificance/no-group-difference wording is not changed to zero effect.", "criterion": "How does no-group-difference wording differ from dialysis effects and precision? Distinguish Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Reduced dialysis must be answered directly by clinical comparisons with sufficient precision." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the original group mortality events, denominators and proportions?", "needed": "Original mortality tables, group analysis populations, follow-up, effects and precision.", "role": "Required", "role_reason": "What are the original group mortality events, denominators and proportions? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Mortality is not recalculated using primary-composite denominators 153/308.", "criterion": "What are the original group mortality events, denominators and proportions? Distinguish Original mortality tables, group analysis populations, follow-up, effects and precision in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Direct mortality-reduction comparisons need sufficient events and follow-up." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Were deaths defined as all-cause or cause-specific mortality?", "needed": "Death counting, cause ascertainment, adjudication, classification and relatedness material.", "role": "Required", "role_reason": "Were deaths defined as all-cause or cause-specific mortality? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "Were deaths defined as all-cause or cause-specific mortality? Distinguish Death counting, cause ascertainment, adjudication, classification and relatedness material in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Cause-specific mortality requires direct definitions and event adjudication." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are cardiovascular-event definitions, components, counts and denominators verified?", "needed": "Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.", "role": "Required", "role_reason": "Are cardiovascular-event definitions, components, counts and denominators verified? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "Are cardiovascular-event definitions, components, counts and denominators verified? Distinguish Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Cardiovascular benefits require direct results, power and follow-up material." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Can the three clinical events be calculated as one composite?", "needed": "If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.", "role": "Required", "role_reason": "Can the three clinical events be calculated as one composite? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "No new totals of overlapping people/events or composite HRs are created.", "criterion": "Can the three clinical events be calculated as one composite? Distinguish If an actual clinical composite exists, its prespecified definition, overlap, first events and component material in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Original plans/tables must distinguish individual outcomes from composites." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What are the prespecified design and power for clinical events?", "needed": "Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.", "role": "Required", "role_reason": "What are the prespecified design and power for clinical events? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Insufficient power is not changed to established absence of clinical effect or a new grade.", "criterion": "What are the prespecified design and power for clinical events? Distinguish Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Clinical benefits require comparisons designed to answer them directly with sufficient events/follow-up." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "What does absent clinical-event CI/precision information mean?", "needed": "Event-specific between-group effects, intervals, time models, missingness and analysis plans.", "role": "Required", "role_reason": "What does absent clinical-event CI/precision information mean? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Absent CIs, HRs or hypothetical numbers are not invented.", "criterion": "What does absent clinical-event CI/precision information mean? Distinguish Event-specific between-group effects, intervals, time models, missingness and analysis plans in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material giving direct event-specific estimates and intervals is needed." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "How are randomized, analysis-population and at-risk denominators distinguished?", "needed": "Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.", "role": "Required", "role_reason": "How are randomized, analysis-population and at-risk denominators distinguished? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Safety, completer and ITT denominators are not certified as identical.", "criterion": "How are randomized, analysis-population and at-risk denominators distinguished? Distinguish Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Overall flows and outcome-specific analysis tables are needed to supplement clinical-event attribution." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "What are actual clinical-event follow-up, censoring and missingness?", "needed": "Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.", "role": "Required", "role_reason": "What are actual clinical-event follow-up, censoring and missingness? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "What are actual clinical-event follow-up, censoring and missingness? Distinguish Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Long-term clinical outcomes need sufficient follow-up and original at-risk populations." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "How do observed clinical events differ from demonstrated reduction effects?", "needed": "Observation methods, purpose, analyses, power and between-group clinical outcomes.", "role": "Required", "role_reason": "How do observed clinical events differ from demonstrated reduction effects? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "How do observed clinical events differ from demonstrated reduction effects? Distinguish Observation methods, purpose, analyses, power and between-group clinical outcomes in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Beyond descriptive event reports, direct comparisons answering the reduction claim are needed." }, { "item_id": "N41", "question_type": "Evidence condition", "question": "Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes?", "needed": "Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.", "role": "Required", "role_reason": "Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Original composite HR, absolute difference -8.3%p and NNT 12 are not selected-clinical-event values.", "criterion": "Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes? Distinguish Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material directly measuring/testing each clinical outcome is needed." }, { "item_id": "N42", "question_type": "Evidence condition", "question": "Does the Hb ≥1 g/dL response HR answer the selected clinical events?", "needed": "Separate Hb-response and patient-event outcomes, definitions, periods and denominators.", "role": "Required", "role_reason": "Does the Hb ≥1 g/dL response HR answer the selected clinical events? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Improved surrogates in the hemoglobin-response sheet do not fill the clinical-event question evidence gaps.", "criterion": "Does the Hb ≥1 g/dL response HR answer the selected clinical events? Distinguish Separate Hb-response and patient-event outcomes, definitions, periods and denominators in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Direct outcome material answering clinical benefit is needed." }, { "item_id": "N43", "question_type": "Evidence condition", "question": "How do unverified efficacy, safety, harmlessness and equivalence differ?", "needed": "Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.", "role": "Required", "role_reason": "How do unverified efficacy, safety, harmlessness and equivalence differ? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.", "criterion": "How do unverified efficacy, safety, harmlessness and equivalence differ? Distinguish Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Material directly answering each question, including rare/long-term harms, is needed." }, { "item_id": "N44", "question_type": "Evidence condition", "question": "Can application extend to other populations, dialysis states, eras or management strategies?", "needed": "Direct comparisons showing population, management, exposure and era differences.", "role": "Supplementary; required for extending applicability", "role_reason": "Can application extend to other populations, dialysis states, eras or management strategies? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "No product, dose, target, dialysis or treatment-selection recommendations are created.", "criterion": "Can application extend to other populations, dialysis states, eras or management strategies? Distinguish Direct comparisons showing population, management, exposure and era differences in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Clinical benefits under other conditions require material for the relevant population, strategy and follow-up." }, { "item_id": "N45", "question_type": "Evidence condition", "question": "What limits are retained when new direct material, follow-up reports or corrections are added?", "needed": "New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.", "role": "Required (update/independence limits)", "role_reason": "What limits are retained when new direct material, follow-up reports or corrections are added? This is needed to distinguish the direct scope of this question from other outcomes.", "application_exception": "No new independent trials, participant aggregation, calculations, reassessment or treatment guidance are run in this production.", "criterion": "What limits are retained when new direct material, follow-up reports or corrections are added? Distinguish New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons in original material and retain unverified limits.", "basis": "Family condition definitions linked to the stored summary; no official clinical-method assessment is run.", "condition_origin": "Application conditions for the current question; review of the existing content is incomplete", "proposed_research": "Condition versions and observation-application events remain separate with user-review scope retained." } ] }