# High-ferritin-target intravenous iron × Hemoglobin-centred response in nondialysis CKD anemia Verdict 2924 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-10 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: Hemoglobin response in iron-deficiency anemia with nondialysis chronic kidney disease - Ingredient, formulation and route: 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. - Measured outcome: Initiation of other anemia management or consecutive Hb <10 g/dL during weeks 8~52; separate Hb ≥1 g/dL response - 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. - Questions outside this scope: 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 ## Checklist items ### N01 · Which existing subclaim and question direction does this sheet preserve? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected stored summary concerns hemoglobin-centred response; 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material retaining the selected subclaim-parent relationship, original question and verdict record. - Required materials and conditions: Material retaining the selected subclaim-parent relationship, original question and verdict record. - Materials to obtain first: Material retaining the selected subclaim-parent relationship, original question and verdict record. - Further research: When additional material becomes available, the existing question scope is recorded separately from other questions. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N02 · How are subclaim grade/note and absent score, status and axes distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The selected subclaim grade is C and its note says the surrogate composite improved. 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual selected-subclaim fields and separately retained parent fields. - Required materials and conditions: Actual selected-subclaim fields and separately retained parent fields. - Materials to obtain first: Actual selected-subclaim fields and separately retained parent fields. - Further research: If the original subclaim is corrected, the complete pre-change text and change event are preserved. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N03 · What historical context do parent C, 50 points, axes, safety and empty values represent? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Complete parent verdict, axes, safety labels and actual change history. - Required materials and conditions: Complete parent verdict, axes, safety labels and actual change history. - Materials to obtain first: Complete parent verdict, axes, safety labels and actual change history. - Further research: Even if a new verdict is requested, original grades and production status remain separately preserved. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Parent scores/axes are historical context and do not fill absent selected-subclaim values. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N04 · How are original Korean/English, reference dates and correction histories retained? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Complete original text, language-specific explanations, reference dates and additional correction records. - Required materials and conditions: Complete original text, language-specific explanations, reference dates and additional correction records. - Materials to obtain first: Complete original text, language-specific explanations, reference dates and additional correction records. - Further research: Added language-specific text or corrections preserve the complete existing version and link as a new event. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Historical cross-check and research-assessment wording does not mean newly completed review. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N05 · Which materials were actually read for this production and which external materials remain unread? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Acquisition/reading levels and relevant result locations in original source material. - Required materials and conditions: Acquisition/reading levels and relevant result locations in original source material. - Materials to obtain first: Acquisition/reading levels and relevant result locations in original source material. - Further research: Separate additional reading must record its scope and time as a new event. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: URLs link sources without being upgraded to reading, link testing or content verification. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N06 · What are the FIND-CKD report bibliography and registration identity? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Paper bibliography, original full text, registration content and their actual links. - Required materials and conditions: Paper bibliography, original full text, registration content and their actual links. - Materials to obtain first: Paper bibliography, original full text, registration content and their actual links. - Further research: Added report identities must be distinguished as the same trial or separate trials using original material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: A registration identifier does not verify registration content or certify a unique trial. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N07 · How do two subclaim sheets share one trial, report and population? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original material distinguishing trial, report, population, group, outcome links and overlap. - Required materials and conditions: Original material distinguishing trial, report, population, group, outcome links and overlap. - Materials to obtain first: Original material distinguishing trial, report, population, group, outcome links and overlap. - Further research: New follow-up/related reports link to the existing family; independent replication requires separate material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: New-unit increment remains 0 and the final independent count remains null. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N08 · Which nondialysis chronic kidney disease anemia population was studied? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria. - Required materials and conditions: Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria. - Materials to obtain first: Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria. - Further research: Population differences require direct comparison material for the relevant populations. - Conditions for verification: 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. - Why this condition is needed: Which nondialysis chronic kidney disease anemia population was studied? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Eligibility thresholds or disease stages absent from the current summary are not invented. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N09 · How much is verified about baseline risk and representativeness? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group baseline tables, recruitment pathways, exclusions, severity and comorbidities. - Required materials and conditions: Group baseline tables, recruitment pathways, exclusions, severity and comorbidities. - Materials to obtain first: Group baseline tables, recruitment pathways, exclusions, severity and comorbidities. - Further research: Application to different risk populations must be distinguished using direct studies with follow-up. - Conditions for verification: 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. - Why this condition is needed: How much is verified about baseline risk and representativeness? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N10 · What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Intervention strategy, product identity, target-adjustment rules and group achieved values. - Required materials and conditions: Intervention strategy, product identity, target-adjustment rules and group achieved values. - Materials to obtain first: Intervention strategy, product identity, target-adjustment rules and group achieved values. - Further research: Differences by formulation or target require direct strategy-comparison material. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Historical targets are not written as treatment, dose or suitability guidance. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N11 · What is the original research exposure of the oral ferrous sulfate control? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Oral formulation, research exposure, actual use, discontinuation and adherence material. - Required materials and conditions: Oral formulation, research exposure, actual use, discontinuation and adherence material. - Materials to obtain first: Oral formulation, research exposure, actual use, discontinuation and adherence material. - Further research: Material with different control conditions is linked separately with those differences specified. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Only original exposure values are retained; no new totals, conversions or use recommendations are calculated. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N12 · How are the selected comparison and other-group information separated in the three-arm design? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans. - Required materials and conditions: Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans. - Materials to obtain first: Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans. - Further research: Added other-group results retain separate attribution from the current comparison. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Other-group targets, denominators or effects are not inferred or back-calculated from totals. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N13 · How much is known about actual intravenous administration, achieved ferritin, adherence and changes? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual group administration, achieved values, adherence, changes and discontinuation records. - Required materials and conditions: Actual group administration, achieved values, adherence, changes and discontinuation records. - Materials to obtain first: Actual group administration, achieved values, adherence, changes and discontinuation records. - Further research: Exposure differences require material linking actual strategy implementation with outcomes. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: No new administered doses, schedules or unit conversions are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N14 · Are starting ESA, transfusions or other iron concurrent care or outcome components? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Additional-management initiation criteria, group use/timing and outcome-counting rules. - Required materials and conditions: Additional-management initiation criteria, group use/timing and outcome-counting rules. - Materials to obtain first: Additional-management initiation criteria, group use/timing and outcome-counting rules. - Further research: Interpreting additional management requires plans alongside actual courses. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Treatment switches are not presented as the same outcome as patient events. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N15 · Are 56-week follow-up and the weeks 8~52 composite window the same period? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up. - Materials to obtain first: Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up. - Further research: Added timepoint-specific material links each outcome to its relevant period separately. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N16 · What are the randomized, ITT and completed denominators? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons. - Required materials and conditions: Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons. - Materials to obtain first: Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons. - Further research: Added actual analysis inclusion/missingness rules supplement outcome-specific links. - Conditions for verification: 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. - Why this condition is needed: What are the randomized, ITT and completed denominators? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: No new differences, proportions or participant totals are created from current numbers. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N17 · How are group-denominator differences for the primary composite, death and infection recorded? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables. - Required materials and conditions: Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables. - Materials to obtain first: Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables. - Further research: Original explanations of outcome-specific denominators link only to the corresponding rows. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: One denominator is not used to recalculate other outcomes or certify common ITT. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N18 · What effects remain uncertain from noncompletion and missingness? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material. - Required materials and conditions: Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material. - Materials to obtain first: Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material. - Further research: Changes under missingness assumptions must be distinguished using original analyses/additional material. - Conditions for verification: 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. - Why this condition is needed: What effects remain uncertain from noncompletion and missingness? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Attrition effects, new bias grades or lost-person counts are not calculated. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N19 · What is the verification scope of central randomization? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored account says central interactive voice-response randomization was used. Actual sequence generation, concealment, stratification and implementation details remain externally unread. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Detailed allocation methods, protocols and implementation material. - Required materials and conditions: Detailed allocation methods, protocols and implementation material. - Materials to obtain first: Detailed allocation methods, protocols and implementation material. - Further research: Added allocation procedures must retain known levels separately from unverified details. - Conditions for verification: What is the verification scope of central randomization? Distinguish Detailed allocation methods, protocols and implementation material in original material and retain unverified limits. - Why this condition is needed: What is the verification scope of central randomization? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Central-allocation wording alone does not certify all randomization procedures as appropriate. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N20 · What distinctions does open-label design require for treatment decisions and laboratory measurement? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations. - Required materials and conditions: Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations. - Materials to obtain first: Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations. - Further research: Material separating component measurement from decision procedures is needed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: The original three-defect, avoidability and common bias-category wording remains historical only. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N21 · Was NCT00994318 registration content actually verified? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original registration text, versions, endpoints, analyses and changes. - Required materials and conditions: Original registration text, versions, endpoints, analyses and changes. - Materials to obtain first: Original registration text, versions, endpoints, analyses and changes. - Further research: Separately acquired registration material must retain its version and relationship to reports. - Conditions for verification: Was NCT00994318 registration content actually verified? Distinguish Original registration text, versions, endpoints, analyses and changes in original material and retain unverified limits. - Why this condition is needed: Was NCT00994318 registration content actually verified? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: A registration number is not displayed as actual reading or trial certification. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N22 · At what level are primary/secondary endpoint and analysis hierarchies known? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables. - Required materials and conditions: Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables. - Materials to obtain first: Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables. - Further research: Added plans link prespecified and post hoc distinctions to each outcome. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Parent primary-endpoint wording is not upgraded to direct external-plan verification. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N23 · What original information describes Vifor Pharma sponsorship and oral-iron supply? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles. - Required materials and conditions: Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles. - Materials to obtain first: Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles. - Further research: Added sponsorship, data-access or analysis-involvement information is recorded separately from interpretation limits. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N24 · What are the detailed author conflicts, data-access and publication roles? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; COI, sponsorship contracts, analysis, data-access and publication-role disclosures. - Required materials and conditions: COI, sponsorship contracts, analysis, data-access and publication-role disclosures. - Materials to obtain first: COI, sponsorship contracts, analysis, data-access and publication-role disclosures. - Further research: Added independent reports first distinguish actual parties, data sharing and analysis relationships. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N25 · What safety scope do stored infection observations cover? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power. - Required materials and conditions: Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power. - Materials to obtain first: Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power. - Further research: Clinically important infection harms require appropriate event collection, follow-up and comparisons. - Conditions for verification: 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. - Why this condition is needed: What safety scope do stored infection observations cover? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: No differences, ratios, P values or CIs beyond original values are calculated. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N26 · Are detailed safety collection, sparse events and attrition verified? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up. - Materials to obtain first: Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up. - Further research: Safety signals require material with definitions, ascertainment, denominators and follow-up. - Conditions for verification: 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. - Why this condition is needed: Are detailed safety collection, sparse events and attrition verified? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N27 · What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events. - Materials to obtain first: Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events. - Further research: Long-term/rare clinical harms need separate material with sufficient follow-up and appropriate comparisons. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N28 · Is preoperative verdict 2560 for the same drug direct evidence here? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Direct material and application limits for different use settings, populations, timepoints and clinical outcomes. - Materials to obtain first: Direct material and application limits for different use settings, populations, timepoints and clinical outcomes. - Further research: Material from other settings is not merged by drug name alone; question/population differences remain recorded. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: Another verdict grade is not inherited by this subclaim. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: ### N29 · What is the exact primary composite for hemoglobin-centred response? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored primary endpoint is initiation of other anemia management or consecutive Hb <10 g/dL during weeks 8~52, rather than simply Hb-rise response. The subclaim title and actual composite definition remain side by side. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Exact composite plans, components, event-counting and first-event rules is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Exact composite plans, components, event-counting and first-event rules. - Required materials and conditions: Exact composite plans, components, event-counting and first-event rules. - Materials to obtain first: Exact composite plans, components, event-counting and first-event rules. - Further research: Original material separating composite definitions from component-specific effects is needed. - Conditions for verification: What is the exact primary composite for hemoglobin-centred response? Distinguish Exact composite plans, components, event-counting and first-event rules in original material and retain unverified limits. - Why this condition is needed: What is the exact primary composite for hemoglobin-centred response? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N30 · What are the primary-composite group events, denominators, HR and CI? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The primary composite is stored as high-target 36/153 (23.5%) versus oral 98/308 (31.8%), HR 0.65 (95% CI 0.44~0.95). These are between-group composite values, not dialysis, mortality or cardiovascular HRs. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original composite tables, analysis populations, time models, CIs and covariate handling is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original composite tables, analysis populations, time models, CIs and covariate handling. - Required materials and conditions: Original composite tables, analysis populations, time models, CIs and covariate handling. - Materials to obtain first: Original composite tables, analysis populations, time models, CIs and covariate handling. - Further research: Material with different estimands or analysis populations is shown separately. - Conditions for verification: What are the primary-composite group events, denominators, HR and CI? Distinguish Original composite tables, analysis populations, time models, CIs and covariate handling in original material and retain unverified limits. - Why this condition is needed: What are the primary-composite group events, denominators, HR and CI? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Current values are not copied to other clinical endpoints or groups. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N31 · How do the directions of composite HR 0.65 and Hb-rise HR 2.04 differ? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original composite concerns reduced additional-treatment/consecutive-low-Hb events, with HR 0.65. Hb ≥1 g/dL rise is a separate outcome with HR 2.04. HRs for different event definitions/directions are not changed into the same response rate or clinical efficacy. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Event definitions, origins, models, denominators and interpretation targets for each HR is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Event definitions, origins, models, denominators and interpretation targets for each HR. - Required materials and conditions: Event definitions, origins, models, denominators and interpretation targets for each HR. - Materials to obtain first: Event definitions, origins, models, denominators and interpretation targets for each HR. - Further research: Added analysis definitions link each outcome to its estimand separately. - Conditions for verification: How do the directions of composite HR 0.65 and Hb-rise HR 2.04 differ? Distinguish Event definitions, origins, models, denominators and interpretation targets for each HR in original material and retain unverified limits. - Why this condition is needed: How do the directions of composite HR 0.65 and Hb-rise HR 2.04 differ? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: HRs are not converted into RRs, response rates or new relative percentage changes. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N32 · What original scope do the absolute difference and NNT concern? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored composite absolute difference is -8.3%p and NNT is 12. These remain within the original composite/comparison/period context without new calculations; they are not displayed as survival/dialysis-benefit counts. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original estimation timepoints, populations, analyses and intervals for absolute effects/NNT is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original estimation timepoints, populations, analyses and intervals for absolute effects/NNT. - Required materials and conditions: Original estimation timepoints, populations, analyses and intervals for absolute effects/NNT. - Materials to obtain first: Original estimation timepoints, populations, analyses and intervals for absolute effects/NNT. - Further research: Added original explanations supplement the application scope of existing values. - Conditions for verification: What original scope do the absolute difference and NNT concern? Distinguish Original estimation timepoints, populations, analyses and intervals for absolute effects/NNT in original material and retain unverified limits. - Why this condition is needed: What original scope do the absolute difference and NNT concern? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: No new NNTs, CIs or illustrative patient counts are calculated. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N33 · What are the count, measurement window and test conditions for consecutive Hb <10 g/dL? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Korean consecutive Hb <10 g/dL wording and English two consecutive Hb values below 10 g/dL are preserved. The window is weeks 8~52 and < is not changed to another inequality. Actual test intervals, specimens, equipment and confirmation rules are unverified. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Consecutive-measurement plans, intervals, laboratory standardization and event handling under missingness is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Consecutive-measurement plans, intervals, laboratory standardization and event handling under missingness. - Required materials and conditions: Consecutive-measurement plans, intervals, laboratory standardization and event handling under missingness. - Materials to obtain first: Consecutive-measurement plans, intervals, laboratory standardization and event handling under missingness. - Further research: Added measurement plans link the actual rules for two consecutive values. - Conditions for verification: What are the count, measurement window and test conditions for consecutive Hb <10 g/dL? Distinguish Consecutive-measurement plans, intervals, laboratory standardization and event handling under missingness in original material and retain unverified limits. - Why this condition is needed: What are the count, measurement window and test conditions for consecutive Hb <10 g/dL? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Test schedules or consecutive values outside the original text are not invented. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N34 · How was the additional-treatment-initiation component measured and decided? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original limitation is that clinician decisions to start ESA, transfusions or other iron entered the open-label composite. Group initiation criteria, frequencies, first-event timing and component effects are unverified. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Component-specific initiation criteria, adjudication, group events, denominators and effects is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Component-specific initiation criteria, adjudication, group events, denominators and effects. - Required materials and conditions: Component-specific initiation criteria, adjudication, group events, denominators and effects. - Materials to obtain first: Component-specific initiation criteria, adjudication, group events, denominators and effects. - Further research: Composite contents require material presenting treatment decisions and repeated-Hb criteria separately. - Conditions for verification: How was the additional-treatment-initiation component measured and decided? Distinguish Component-specific initiation criteria, adjudication, group events, denominators and effects in original material and retain unverified limits. - Why this condition is needed: How was the additional-treatment-initiation component measured and decided? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N35 · What are the reported Hb ≥1 g/dL rise-response values? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Hb ≥1 g/dL response HR is 2.04 (95% CI 1.52~2.72). It is retained as the original laboratory-response outcome; this HR is not direct dialysis/survival benefit. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original tables of Hb-response event definitions, origins, denominators, analyses and CIs is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original tables of Hb-response event definitions, origins, denominators, analyses and CIs. - Required materials and conditions: Original tables of Hb-response event definitions, origins, denominators, analyses and CIs. - Materials to obtain first: Original tables of Hb-response event definitions, origins, denominators, analyses and CIs. - Further research: Hb-rise details must link separately from the composite. - Conditions for verification: What are the reported Hb ≥1 g/dL rise-response values? Distinguish Original tables of Hb-response event definitions, origins, denominators, analyses and CIs in original material and retain unverified limits. - Why this condition is needed: What are the reported Hb ≥1 g/dL rise-response values? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N36 · Are absolute Hb change, group responder counts and durability verified? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Beyond the Hb ≥1 g/dL response HR, group responder counts/rates/denominators, mean Hb changes, unit-specific estimates, durability and detailed timepoints are absent from the summary. These are not filled from composite event counts. - Why unverified: Direct details are unverified within the current stored summary and unread external material. Original Hb responders, mean changes, timepoints, denominators, missingness and durability material is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original Hb responders, mean changes, timepoints, denominators, missingness and durability material. - Required materials and conditions: Original Hb responders, mean changes, timepoints, denominators, missingness and durability material. - Materials to obtain first: Original Hb responders, mean changes, timepoints, denominators, missingness and durability material. - Further research: Response magnitude and durability require direct detailed laboratory-outcome material. - Conditions for verification: Are absolute Hb change, group responder counts and durability verified? Distinguish Original Hb responders, mean changes, timepoints, denominators, missingness and durability material in original material and retain unverified limits. - Why this condition is needed: Are absolute Hb change, group responder counts and durability verified? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N37 · Do baseline Hb/iron status and achieved ferritin link to outcomes? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The target ferritin range is described, but group baseline Hb/iron status, achieved values, distributions and changes are unverified in the summary. Targets are not changed into actual measurements. - Why unverified: Direct details are unverified within the current stored summary and unread external material. Original baseline/repeated Hb, ferritin and iron-status tables linked to exposure is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original baseline/repeated Hb, ferritin and iron-status tables linked to exposure. - Required materials and conditions: Original baseline/repeated Hb, ferritin and iron-status tables linked to exposure. - Materials to obtain first: Original baseline/repeated Hb, ferritin and iron-status tables linked to exposure. - Further research: Material presenting targets separately from achieved values is needed. - Conditions for verification: Do baseline Hb/iron status and achieved ferritin link to outcomes? Distinguish Original baseline/repeated Hb, ferritin and iron-status tables linked to exposure in original material and retain unverified limits. - Why this condition is needed: Do baseline Hb/iron status and achieved ferritin link to outcomes? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N38 · How much is known about composite components and group contributions? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Overall composite events are retained, but additional-treatment-type events, contributions of consecutive-low-Hb, overlap, first events and recurrent-event counting are unverified in detail. Composite reduction is not extended to improvement in every component. - Why unverified: Direct details are unverified within the current stored summary and unread external material. Component events, denominators, overlap, time, effects and planned comparisons is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Component events, denominators, overlap, time, effects and planned comparisons. - Required materials and conditions: Component events, denominators, overlap, time, effects and planned comparisons. - Materials to obtain first: Component events, denominators, overlap, time, effects and planned comparisons. - Further research: Material showing the composite alongside each component is needed. - Conditions for verification: How much is known about composite components and group contributions? Distinguish Component events, denominators, overlap, time, effects and planned comparisons in original material and retain unverified limits. - Why this condition is needed: How much is known about composite components and group contributions? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N39 · Do hemoglobin outcomes answer symptoms, quality of life or sustained patient benefit? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: Original material describes improved laboratory/treatment-decision surrogates. Direct symptom, quality-of-life or sustained post-follow-up benefits are absent from the summary and are not replaced by Hb response. - Why unverified: Direct details are unverified within the current stored summary and unread external material. Direct patient-reported outcomes, function, quality-of-life and long-term follow-up definitions/comparisons is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct patient-reported outcomes, function, quality-of-life and long-term follow-up definitions/comparisons. - Required materials and conditions: Direct patient-reported outcomes, function, quality-of-life and long-term follow-up definitions/comparisons. - Materials to obtain first: Direct patient-reported outcomes, function, quality-of-life and long-term follow-up definitions/comparisons. - Further research: Patient-important outcomes must link the question and evidence using separate direct material. - Conditions for verification: Do hemoglobin outcomes answer symptoms, quality of life or sustained patient benefit? Distinguish Direct patient-reported outcomes, function, quality-of-life and long-term follow-up definitions/comparisons in original material and retain unverified limits. - Why this condition is needed: Do hemoglobin outcomes answer symptoms, quality of life or sustained patient benefit? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N40 · Do current dialysis observations clinically validate Hb response? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Original wording reports 16 people overall (2.6%) starting dialysis over 56 weeks with no group difference. Group events, denominators, effects and CIs are unverified; insufficient power limits interpretation, so Hb response is not translated into reduced dialysis. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Group dialysis events, definitions, at-risk populations, denominators, follow-up, effects and power is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group dialysis events, definitions, at-risk populations, denominators, follow-up, effects and power. - Required materials and conditions: Group dialysis events, definitions, at-risk populations, denominators, follow-up, effects and power. - Materials to obtain first: Group dialysis events, definitions, at-risk populations, denominators, follow-up, effects and power. - Further research: Dialysis benefit requires direct comparisons designed to answer that clinical event adequately. - Conditions for verification: Do current dialysis observations clinically validate Hb response? Distinguish Group dialysis events, definitions, at-risk populations, denominators, follow-up, effects and power in original material and retain unverified limits. - Why this condition is needed: Do current dialysis observations clinically validate Hb response? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: The overall 16 people are not copied as events in each of two groups. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N41 · Do current mortality observations establish survival benefit? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Deaths are retained as high-target 7/154 (4.5%) versus oral 15/312 (4.8%). Detailed death definitions, between-group estimates, CIs and power are absent; Hb improvement does not establish increased survival. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Death counting, causes, analysis populations, follow-up, between-group estimation and precision material is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Death counting, causes, analysis populations, follow-up, between-group estimation and precision material. - Required materials and conditions: Death counting, causes, analysis populations, follow-up, between-group estimation and precision material. - Materials to obtain first: Death counting, causes, analysis populations, follow-up, between-group estimation and precision material. - Further research: Survival benefit needs sufficient follow-up and comparison material directly addressing death. - Conditions for verification: Do current mortality observations establish survival benefit? Distinguish Death counting, causes, analysis populations, follow-up, between-group estimation and precision material in original material and retain unverified limits. - Why this condition is needed: Do current mortality observations establish survival benefit? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: No new mortality differences, risk ratios, P values or CIs are calculated. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N42 · What direct cardiovascular-event reduction material is unverified? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The parent and clinical-event subclaim say reduced cardiovascular events cannot be concluded and the trial was not designed/powered to answer them. Current cardiovascular definitions, components, counts, denominators and CIs are absent. Absence of information is not changed to zero events or an established null effect. - Why unverified: Direct details are unverified within the current stored summary and unread external material. Cardiovascular outcome plans, definitions, group events, effects, CIs and follow-up is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Cardiovascular outcome plans, definitions, group events, effects, CIs and follow-up. - Required materials and conditions: Cardiovascular outcome plans, definitions, group events, effects, CIs and follow-up. - Materials to obtain first: Cardiovascular outcome plans, definitions, group events, effects, CIs and follow-up. - Further research: Cardiovascular benefits require material powered directly for those outcomes. - Conditions for verification: What direct cardiovascular-event reduction material is unverified? Distinguish Cardiovascular outcome plans, definitions, group events, effects, CIs and follow-up in original material and retain unverified limits. - Why this condition is needed: What direct cardiovascular-event reduction material is unverified? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N43 · What limits extension from hemoglobin-centred response to clinical events? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Subclaim C and the improved-surrogate-composite note are retained. Laboratory/additional-treatment improvement is not extended to separate dialysis, mortality or cardiovascular-protection claims. Positive Hb response remains alongside unverified patient-event benefit. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Direct surrogate-clinical-outcome relationships and separate outcome material is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct surrogate-clinical-outcome relationships and separate outcome material. - Required materials and conditions: Direct surrogate-clinical-outcome relationships and separate outcome material. - Materials to obtain first: Direct surrogate-clinical-outcome relationships and separate outcome material. - Further research: Extension questions require added material directly measuring/testing patient events. - Conditions for verification: What limits extension from hemoglobin-centred response to clinical events? Distinguish Direct surrogate-clinical-outcome relationships and separate outcome material in original material and retain unverified limits. - Why this condition is needed: What limits extension from hemoglobin-centred response to clinical events? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N44 · Was the same strategy/outcome replicated in other independent research? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The current direct evidence entry is one FIND-CKD report. Independent replication, new material or separate clinical-event trials of the same strategy are unverified within the current original material. Parent R1/I0 history is not changed into new independent-count certification. - Why unverified: Direct details are unverified within the current stored summary and unread external material. Bibliographic, registration and population independence with direct same-strategy/outcome comparisons is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Bibliographic, registration and population independence with direct same-strategy/outcome comparisons. - Required materials and conditions: Bibliographic, registration and population independence with direct same-strategy/outcome comparisons. - Materials to obtain first: Bibliographic, registration and population independence with direct same-strategy/outcome comparisons. - Further research: Added independent results first distinguish trial, report and population sharing. - Conditions for verification: Was the same strategy/outcome replicated in other independent research? Distinguish Bibliographic, registration and population independence with direct same-strategy/outcome comparisons in original material and retain unverified limits. - Why this condition is needed: Was the same strategy/outcome replicated in other independent research? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ### N45 · What is preserved when formulation, population or duration changes, or material is corrected? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Current scope is original high-ferritin-target intravenous iron versus oral iron over 56 weeks in nondialysis CKD anemia. Effects across other formulations, targets, populations or timepoints are not merged automatically; new stored summaries/corrections must be recorded as separate events. - Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete pre-change original text, new material versions and reasons for question/condition/observation changes is needed and remains subject to user review. - Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Complete pre-change original text, new material versions and reasons for question/condition/observation changes. - Required materials and conditions: Complete pre-change original text, new material versions and reasons for question/condition/observation changes. - Materials to obtain first: Complete pre-change original text, new material versions and reasons for question/condition/observation changes. - Further research: Added material separates condition-version changes from observation application and retains user-review requirements. - Conditions for verification: What is preserved when formulation, population or duration changes, or material is corrected? Distinguish Complete pre-change original text, new material versions and reasons for question/condition/observation changes in original material and retain unverified limits. - Why this condition is needed: What is preserved when formulation, population or duration changes, or material is corrected? This is needed to distinguish the direct scope of this question from other outcomes. - Application exceptions: No new searches, calculations, grades or treatment recommendations are run in this production. - Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade. - Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run. - Related sources: R01 ## Evidence and sources ### R01 Macdougall IC, Bock AH, Carrera F, et al. FIND-CKD. Nephrol Dial Transplant. 2014;29(11):2075-2084. PMID: 24891437. [PubMed](https://pubmed.ncbi.nlm.nih.gov/24891437/) Materials actually read: Summary read; external papers and registration unread Findings recorded in the summary: 23.5% versus 31.8%; HR 0.65 (0.44~0.95), absolute difference -8.3%p, NNT 12 Record level: Original research-assessment wording in the stored summary Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored summary | Stored summary read for production | Summary read | The complete parent stored summary was read for production; the original paper was not acquired/read. | | Paper abstract | External material unread; needed | Access not attempted; not obtained | Not read | Only the stored PMID link is connected. Actual abstract content and original numerical locations were not verified. | | Full paper | External material unread; needed | Access not attempted; not obtained | Not read | The URL is a bibliographic link; full-text acquisition/accessibility was not verified. | | Clinical trial registration | External material unread; needed | Access not attempted; not obtained | Not read | Only the registration identifier is retained. Registration URL/content, initial/amended versions and prespecified plans are unverified. | | Study protocol | External material unread; needed | Access not attempted; not obtained | Not read | Original plans for three-group strategies, clinical hypotheses, components, follow-up and additional-treatment rules have not been acquired. | | Statistical analysis plan | External material unread; needed | Access not attempted; not obtained | Not read | Detailed hierarchy, time models, analysis populations, missingness, clinical-event power and multiplicity plans have not been acquired. | | Original results and safety tables | External material unread; needed | Access not attempted; not obtained | Not read | Original tables are needed to verify Hb composite/response and dialysis, death, cardiovascular and infection event definitions, denominators, models, follow-up and detailed intervals. | | Sponsorship and interest disclosures | External material unread; needed | Access not attempted; not obtained | Not read | Beyond summarized sponsorship/oral-iron supply, original author conflicts, data-access, analysis and publication roles have not been acquired. | | Related verdict in a different setting | External material unread; needed | Access not attempted; not obtained | Not read | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work. ## What the statuses mean - Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation. - Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete. - Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access. - Review incomplete: 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. ## Change history 2026-10-10 · Public page/materials 1.0. Public reader pages and material were prepared from the existing 45 items. No new clinical searches, verification-state changes or scoring were performed.