{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2924-s1", "verdict_number": "2924", "title": "High-ferritin-target intravenous iron × Reduced dialysis, death or cardiovascular events in nondialysis CKD", "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": "Only the stored summary was read for production; external material was not accessed. Partial verification in this presentation does not mean clinical confirmation or completed review. Absent subclaim scores, status and axes are not filled with parent values. Some clinical observations are retained without establishing direct reductions, harmlessness or equivalence.", "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": "Hemoglobin response in iron-deficiency anemia with nondialysis chronic kidney disease", "intervention": "High-ferritin-target intravenous ferric carboxymaltose", "dose": "The ferritin 400~600 µg/L target and oral iron 100 mg twice daily are retained only as historical research conditions. Actual intravenous doses, frequency and achieved values are unverified; no dose conversions or use guidance are created.", "comparator": "Oral ferrous sulfate active control. Details of the other group in the three-arm design are unverified in the current summary.", "endpoint": "Direct questions of reduced dialysis, death or cardiovascular events. Some dialysis/death observations are retained; power for clinical benefit and cardiovascular details are unverified.", "duration": "56-week design; the primary composite Hb criterion concerns weeks 8~52. Exact analysis origins, follow-up and censoring for each clinical event are unverified.", "excluded_extensions": [ "Extending surrogate outcomes to dialysis, survival or cardiovascular protection", "Generalizing to all iron formulations, ferritin targets, dialysis states or long-term safety", "Administration, treatment-target, dialysis or treatment-suitability recommendations", "Adding the same report, trial, population, two sheets or events as independent replication" ] }, "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The selected stored summary concerns reduced dialysis, death or cardiovascular events; the selected question and existing verdict record are distinguished. Parent hemoglobin-verdict and other-subclaim context is retained. No new question, split or verdict is created.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Material retaining the selected subclaim-parent relationship, original question and verdict record is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Material retaining the selected subclaim-parent relationship, original question and verdict record.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material retaining the selected subclaim-parent relationship, original question and verdict record." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The selected subclaim grade is ? and its note says the trial was not designed/powered to answer these events. Subclaim score, status and axes are absent from the stored summary, recorded as null and field absence. Parent C, 50 points and axes are not substituted for subclaim values.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Actual selected-subclaim fields and separately retained parent fields is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual selected-subclaim fields and separately retained parent fields.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual selected-subclaim fields and separately retained parent fields." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Parent C, 50 points and B/S/R1/I0/E+/B2 are preserved. Precision is unrecorded; coprimary splitting, large hard-endpoint RCT and no-human-study flags are false; grade-override reasons are empty in both languages. Parent safety is caution. These values are not inherited as selected-subclaim scores or newly satisfied conditions.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete parent verdict, axes, safety labels and actual change history is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Complete parent verdict, axes, safety labels and actual change history.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete parent verdict, axes, safety labels and actual change history." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Parent and subclaim explanations in Korean/English are linked as originally written. The original reference date is 2026-08-26; corrections are an empty array and deliberation an empty value. Detailed Korean rates and concise English wording do not overwrite each other.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete original text, language-specific explanations, reference dates and additional correction records is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Complete original text, language-specific explanations, reference dates and additional correction records.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original text, language-specific explanations, reference dates and additional correction records." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The actual production input is the complete stored summary. Abstracts, full texts, registration, protocols, SAPs and original result tables were not accessed. Research-assessment wording in the summary does not mean current external reading.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Acquisition/reading levels and relevant result locations in original source material is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Acquisition/reading levels and relevant result locations in original source material.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Acquisition/reading levels and relevant result locations in original source material." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The stored direct report is Macdougall IC et al., 2014 FIND-CKD, linked to PMID 24891437 and NCT00994318. DOI, PMCID and external registration content are unverified.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Paper bibliography, original full text, registration content and their actual links is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Paper bibliography, original full text, registration content and their actual links.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Paper bibliography, original full text, registration content and their actual links." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The hemoglobin-response and clinical-event sheets share the same FIND-CKD report/population. Hemoglobin, dialysis, death, infection or two sheets are not added as independent trials/participants. One stored bibliographic entry does not certify a unique trial count.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original material distinguishing trial, report, population, group, outcome links and overlap is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original material distinguishing trial, report, population, group, outcome links and overlap.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material distinguishing trial, report, population, group, outcome links and overlap." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The parent question concerns iron-deficiency anemia in nondialysis chronic kidney disease. Results are not automatically transferred to dialysis patients, other anemia causes or preoperative preparation.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Detailed age, kidney-disease stage, baseline Hb/iron status, comorbidities and group distributions of clinical-event risk are absent from the current summary. A population name does not establish identical responses in all nondialysis patients.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Group baseline tables, recruitment pathways, exclusions, severity and comorbidities is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group baseline tables, recruitment pathways, exclusions, severity and comorbidities." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The historical high-group ferritin target is 400~600 µg/L. It is a trial strategy condition, not an achieved value or a recommended target. It is not extended to other iron formulations/targets.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Intervention strategy, product identity, target-adjustment rules and group achieved values is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Intervention strategy, product identity, target-adjustment rules and group achieved values.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Intervention strategy, product identity, target-adjustment rules and group achieved values." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original oral control provided 100 mg iron as ferrous sulfate twice daily. This compares an active control with the intravenous-iron strategy; no dosing guidance or dose conversion is created.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Oral formulation, research exposure, actual use, discontinuation and adherence material is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Oral formulation, research exposure, actual use, discontinuation and adherence material.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Oral formulation, research exposure, actual use, discontinuation and adherence material." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "FIND-CKD is a 56-week multicentre randomized open-label three-arm active-control trial. The selected stored comparison is high-ferritin-target intravenous iron versus oral iron; specific targets, group values and exposure of the other intravenous-iron group are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Intravenous formulation and target strategy are described, but actual doses/frequency, group cumulative exposure, achieved ferritin, oral adherence and changes are unverified in the current summary.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Actual group administration, achieved values, adherence, changes and discontinuation records is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Actual group administration, achieved values, adherence, changes and discontinuation records.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual group administration, achieved values, adherence, changes and discontinuation records." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Clinician decisions to start ESA, transfusions or other iron entered the primary composite. Actual treatment frequency, criteria and group courses are absent from the summary, requiring concurrent-management and composite-component roles to be distinguished.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Additional-management initiation criteria, group use/timing and outcome-counting rules is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Additional-management initiation criteria, group use/timing and outcome-counting rules.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional-management initiation criteria, group use/timing and outcome-counting rules." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The overall design is 56 weeks; the primary composite Hb window is weeks 8~52. Overall follow-up and outcome-specific counting windows are not merged.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Stored counts of 626 randomized, 613 ITT and 519 completed are distinguished. The stored summary says 519/626 (82.9%) completed and 17.1% did not complete. These denominators are not applied uniformly to all outcomes and exclusions are not newly calculated.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Primary-composite denominators are high-target 153 and oral 308; original death/infection denominators are 154 and 312. These differ; exact analysis-population definitions and exclusion reasons remain externally unread.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The stored assessment retains historical limitations of 17.1% noncompletion and substantial attrition. Group reasons, outcome-specific missingness, imputation and sensitivity analyses cannot be verified from the summary alone. The historical ≥15% category is not run as a new automatic scoring rule.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group missingness reasons, follow-up retrieval, analysis handling and sensitivity 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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The stored account says central interactive voice-response randomization was used. Actual sequence generation, concealment, stratification and implementation details remain externally unread.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Detailed allocation methods, protocols and implementation material is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Detailed allocation methods, protocols and implementation material.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed allocation methods, protocols and implementation material." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original limitation of open-label design and clinician additional-treatment decisions in the primary composite is retained. Laboratory measurement, assessor masking and consistent decision criteria are unverified in detail. No new claim that all Hb tests are inherently subjective is made.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "NCT00994318 is retained as the existing registration identifier. Registration was not opened here; initial registration date, prespecified endpoints, amendments, posted results and paper comparisons remain unverified.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Original registration text, versions, endpoints, analyses and changes is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original registration text, versions, endpoints, analyses and changes.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration text, versions, endpoints, analyses and changes." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The parent explanation distinguishes the other-anemia-management/consecutive-low-Hb composite as the exact primary endpoint. Prespecified plans, multiplicity and analysis hierarchy for Hb rise and clinical/safety events remain unread in registration, protocols and SAPs.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Stored material specifies Vifor Pharma sponsorship and oral-iron supply. Parent manufacturer-single-trial assessment remains historical. Sponsorship alone does not trigger a new verdict invalidating results.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Beyond summarized sponsorship/product supply, detailed author conflicts, contracts, data-access/analysis independence and publication decisions are unverified. Unverified information is not changed to absence of conflicts.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. COI, sponsorship contracts, analysis, data-access and publication-role disclosures is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; COI, sponsorship contracts, analysis, data-access and publication-role disclosures.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "COI, sponsorship contracts, analysis, data-access and publication-role disclosures." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Infections were high-target 51/154 (33.1%) versus oral 95/312 (30.4%). Historical wording describing similar infection events is retained alongside inadequate safety power. No absence of increased risk is established.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Some infection, death and dialysis values exist, but detailed collection methods, recurrent-event handling, assessors, period-specific missingness, severity and original safety tables are unverified. No attempted access is not changed to nonreporting or inaccessibility.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Results in the selected 56-week population are not extended to long-term/rare harms or safety in other kidney-disease states. Detailed links among baseline disease, concurrent care, treatment selection and events are absent, so sole causation or harmlessness cannot be established.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events." }, { "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.", "current_reports": [], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Existing citation 2560 concerns preoperative intravenous ferric carboxymaltose and transfusion/death in a different setting, linked as historical D, 34 points. It is not added as direct nondialysis chronic-anemia evidence or a new independent trial entry. That page remains unread.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Direct material and application limits for different use settings, populations, timepoints and clinical outcomes is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material and application limits for different use settings, populations, timepoints and clinical outcomes." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The selected question concerns reduced dialysis, death or cardiovascular events. Subclaim ? and its note that the trial was not designed/powered to answer them are retained. These outcomes do not substitute for each other or form a newly created composite.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Original wording reports 16 people overall (2.6%) starting dialysis over 56 weeks. Group events/denominators and the population used for the overall proportion are unverified. No new calculation selects arbitrarily among 626, 613 or 519.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Both Korean and English say no group difference in dialysis initiation. Detailed between-group effects, CIs, P values and power are absent; no equivalence, noninferiority or zero difference is certified.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Deaths were high-target 7/154 (4.5%) versus oral 15/312 (4.8%). Only original denominators/proportions are retained; absent differences, RRs, HRs, P values and CIs are not calculated.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original mortality tables, group analysis populations, follow-up, effects and precision is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original mortality tables, group analysis populations, follow-up, effects and precision.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original mortality tables, group analysis populations, follow-up, effects and precision." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The summary provides death counts, but detailed all-cause/cause-specific definitions, ascertainment, adjudication and cause distributions are unverified. The same numbers are not changed to cardiovascular-death counts.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Death counting, cause ascertainment, adjudication, classification and relatedness material is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Death counting, cause ascertainment, adjudication, classification and relatedness material.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Death counting, cause ascertainment, adjudication, classification and relatedness material." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original explanation says reduced cardiovascular events cannot be concluded, but detailed definitions/components, group counts/denominators, periods, effects and CIs are absent from the summary. Zero occurrence or complete nonmeasurement is not newly established.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The three events are described clinical-outcome categories; a single planned dialysis/death/cardiovascular composite definition or original composite effect is absent. Outcomes are not newly combined or events/participants independently added.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. If an actual clinical composite exists, its prespecified definition, overlap, first events and component material is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "If an actual clinical composite exists, its prespecified definition, overlap, first events and component material." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The selected note says the trial was not designed/powered to answer these events. The parent also describes insufficient power for safety events. Specific hypotheses, sample-size calculations, expected events, allowed effects and hierarchy values are unverified.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Some dialysis/death observations exist, but CIs, P values and precision for reductions are unverified. Hb-composite or Hb-rise intervals are not transferred to clinical events.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Event-specific between-group effects, intervals, time models, missingness and analysis plans is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Event-specific between-group effects, intervals, time models, missingness and analysis plans.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event-specific between-group effects, intervals, time models, missingness and analysis plans." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "626 randomized, 613 ITT and 519 completed are distinguished from clinical-event denominators 154/312. The denominator for the overall 16 dialysis starters and event-specific analysis-population details are not arbitrarily selected.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The 56-week design and original Korean dialysis/death context over 56 weeks are retained. Event origins, at-risk periods, follow-up retrieval, censoring, missingness and post-treatment-change follow-up are unverified in detail.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Dialysis/death values are not deleted as though none were observed. Some descriptive observations and no-group-difference wording are retained, distinguished from results designed/powered to demonstrate reductions. Cardiovascular details remain unverified.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Observation methods, purpose, analyses, power and between-group clinical outcomes is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Observation methods, purpose, analyses, power and between-group clinical outcomes.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Observation methods, purpose, analyses, power and between-group clinical outcomes." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The primary composite is other anemia management or consecutive Hb <10 g/dL during weeks 8~52: 36/153 (23.5%) versus 98/308 (31.8%), HR 0.65 (95% CI 0.44~0.95). This laboratory/treatment-decision composite is not transferred to selected clinical-event effects.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Hb ≥1 g/dL rise HR 2.04 (95% CI 1.52~2.72) is a reported hemoglobin response. It is not changed to dialysis, mortality or cardiovascular HRs, survival time or patient-event response rates.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate Hb-response and patient-event outcomes, definitions, periods and denominators is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Separate Hb-response and patient-event outcomes, definitions, periods and denominators.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate Hb-response and patient-event outcomes, definitions, periods and denominators." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "The original limitation that clinical-event reductions were not established remains alongside inadequate safety power. Historical similar mortality/infection proportions alone do not establish harmlessness, equivalence or safety noninferiority.", "condition_status": "Partly verified", "status_reason": "Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Current evidence compares the original intravenous-iron target strategy with oral iron in nondialysis CKD iron-deficiency anemia. Clinical-event reductions across other dialysis states, formulations, ferritin targets, baseline risks or treatment eras are not automatically established.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. Direct comparisons showing population, management, exposure and era differences is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; Direct comparisons showing population, management, exposure and era differences.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons showing population, management, exposure and era differences." }, { "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.", "current_reports": [ "R01" ], "existence": "Distinguishing stored summary/linking information in current source material from unverified material entries", "acquired_read": "Summary read; external materials not read", "observation": "Current direct-report sharing across two subclaim questions is retained. Follow-up reports of the same trial are not counted as new independent trials; independent clinical-event trials and long-term material are unverified. New material/corrections record the complete pre-change stored summary and separate events.", "condition_status": "Unverified", "status_reason": "Direct details are unverified within the current stored summary and unread external material. New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons is needed and remains subject to user review.", "missingness": "External abstracts, full texts, registration, plans and original tables remain unread; New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.", "uncertainty": "Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons." } ], "reports": [ { "report_id": "R01", "title": "Macdougall IC, Bock AH, Carrera F, et al. FIND-CKD. Nephrol Dial Transplant. 2014;29(11):2075-2084. PMID: 24891437.", "url": "https://pubmed.ncbi.nlm.nih.gov/24891437/", "report_type": "56-week multicentre randomized open-label three-arm active-control trial", "existence": "A direct report links to the existing review summary evidence/citation lists", "acquired_read": "Summary read; external papers and registration unread", "study_family": "F01", "independent_replication": false, "observed_result": "23.5% versus 31.8%; HR 0.65 (0.44~0.95), absolute difference -8.3%p, NNT 12", "result_level": "Original research-assessment wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored summary", "access_status": "Stored summary read for production", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T19:06:10.282288+09:00", "qualification": "The complete parent stored summary was read for production; the original paper was not acquired/read." }, { "material_type": "Paper abstract", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the stored PMID link is connected. Actual abstract content and original numerical locations were not verified." }, { "material_type": "Full paper", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The URL is a bibliographic link; full-text acquisition/accessibility was not verified." }, { "material_type": "Clinical trial registration", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the registration identifier is retained. Registration URL/content, initial/amended versions and prespecified plans are unverified." }, { "material_type": "Study protocol", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for three-group strategies, clinical hypotheses, components, follow-up and additional-treatment rules have not been acquired." }, { "material_type": "Statistical analysis plan", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Detailed hierarchy, time models, analysis populations, missingness, clinical-event power and multiplicity plans have not been acquired." }, { "material_type": "Original results and safety tables", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original tables are needed to verify Hb composite/response and dialysis, death, cardiovascular and infection event definitions, denominators, models, follow-up and detailed intervals." }, { "material_type": "Sponsorship and interest disclosures", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Beyond summarized sponsorship/oral-iron supply, original author conflicts, data-access, analysis and publication roles have not been acquired." }, { "material_type": "Related verdict in a different setting", "public_status": "External material unread; needed", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Historical D, 34-point link for the same drug in another preoperative setting. It is not added as a direct clinical report or independent replication here; the page was not read." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/24891437/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The existing two-sheet structure separates Hb-centred and clinical-event outcomes from the same FIND-CKD PMID 24891437, registration identifier NCT00994318, report and population. It shares 626 randomized, 613 ITT, 519 completed and different outcomes/denominators. Existing citation 2560 concerns the same drug in another preoperative setting and is not added as a new trial/participant total for this direct report." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 45 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-10" }