| 1 |
Partly verified |
Full text not readStored summary read |
N01 · Evidence conditionWhich existing subclaim and question direction does this sheet preserve?Required |
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. |
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. |
Material retaining the selected subclaim-parent relationship, original question and verdict record. |
When additional material becomes available, the existing question scope is recorded separately from other questions. |
| 2 |
Partly verified |
Full text not readStored summary read |
N02 · Evidence conditionHow are subclaim grade/note and absent score, status and axes distinguished?Required |
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. |
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. |
Actual selected-subclaim fields and separately retained parent fields. |
If the original subclaim is corrected, the complete pre-change text and change event are preserved. |
| 3 |
Partly verified |
Full text not readStored summary read |
N03 · Evidence conditionWhat historical context do parent C, 50 points, axes, safety and empty values represent?Required |
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. |
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. |
Complete parent verdict, axes, safety labels and actual change history. |
Even if a new verdict is requested, original grades and production status remain separately preserved. |
| 4 |
Partly verified |
Full text not readStored summary read |
N04 · Evidence conditionHow are original Korean/English, reference dates and correction histories retained?Required |
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. |
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. |
Complete original text, language-specific explanations, reference dates and additional correction records. |
Added language-specific text or corrections preserve the complete existing version and link as a new event. |
| 5 |
Partly verified |
Full text not readStored summary read |
N05 · Evidence conditionWhich materials were actually read for this production and which external materials remain unread?Required |
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. |
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. |
Acquisition/reading levels and relevant result locations in original source material. |
Separate additional reading must record its scope and time as a new event. |
| 6 |
Partly verified |
Full text not readStored summary read |
N06 · Evidence conditionWhat are the FIND-CKD report bibliography and registration identity?Required |
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. |
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. |
Paper bibliography, original full text, registration content and their actual links. |
Added report identities must be distinguished as the same trial or separate trials using original material. |
| 7 |
Partly verified |
Full text not readStored summary read |
N07 · Evidence conditionHow do two subclaim sheets share one trial, report and population?Required |
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. |
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. |
Original material distinguishing trial, report, population, group, outcome links and overlap. |
New follow-up/related reports link to the existing family; independent replication requires separate material. |
| 8 |
Partly verified |
Full text not readStored summary read |
N08 · Evidence conditionWhich nondialysis chronic kidney disease anemia population was studied?Required |
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. |
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. |
Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria. |
Population differences require direct comparison material for the relevant populations. |
| 9 |
Unverified |
Full text not readStored summary read |
N09 · Evidence conditionHow much is verified about baseline risk and representativeness?Supplementary; required for general application |
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. |
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. |
Group baseline tables, recruitment pathways, exclusions, severity and comorbidities. |
Application to different risk populations must be distinguished using direct studies with follow-up. |
| 10 |
Partly verified |
Full text not readStored summary read |
N10 · Evidence conditionWhat are the research conditions for high-ferritin-target intravenous ferric carboxymaltose?Required |
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. |
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. |
Intervention strategy, product identity, target-adjustment rules and group achieved values. |
Differences by formulation or target require direct strategy-comparison material. |
| 11 |
Partly verified |
Full text not readStored summary read |
N11 · Evidence conditionWhat is the original research exposure of the oral ferrous sulfate control?Required |
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. |
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. |
Oral formulation, research exposure, actual use, discontinuation and adherence material. |
Material with different control conditions is linked separately with those differences specified. |
| 12 |
Partly verified |
Full text not readStored summary read |
N12 · Evidence conditionHow are the selected comparison and other-group information separated in the three-arm design?Required |
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. |
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. |
Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans. |
Added other-group results retain separate attribution from the current comparison. |
| 13 |
Unverified |
Full text not readStored summary read |
N13 · Evidence conditionHow much is known about actual intravenous administration, achieved ferritin, adherence and changes?Required |
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. |
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. |
Actual group administration, achieved values, adherence, changes and discontinuation records. |
Exposure differences require material linking actual strategy implementation with outcomes. |
| 14 |
Partly verified |
Full text not readStored summary read |
N14 · Evidence conditionAre starting ESA, transfusions or other iron concurrent care or outcome components?Required |
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. |
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. |
Additional-management initiation criteria, group use/timing and outcome-counting rules. |
Interpreting additional management requires plans alongside actual courses. |
| 15 |
Partly verified |
Full text not readStored summary read |
N15 · Evidence conditionAre 56-week follow-up and the weeks 8~52 composite window the same period?Required |
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. |
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. |
Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up. |
Added timepoint-specific material links each outcome to its relevant period separately. |
| 16 |
Partly verified |
Full text not readStored summary read |
N16 · Evidence conditionWhat are the randomized, ITT and completed denominators?Required |
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. |
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. |
Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons. |
Added actual analysis inclusion/missingness rules supplement outcome-specific links. |
| 17 |
Partly verified |
Full text not readStored summary read |
N17 · Evidence conditionHow are group-denominator differences for the primary composite, death and infection recorded?Required |
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. |
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. |
Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables. |
Original explanations of outcome-specific denominators link only to the corresponding rows. |
| 18 |
Partly verified |
Full text not readStored summary read |
N18 · Evidence conditionWhat effects remain uncertain from noncompletion and missingness?Required |
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. |
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. |
Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material. |
Changes under missingness assumptions must be distinguished using original analyses/additional material. |
| 19 |
Partly verified |
Full text not readStored summary read |
N19 · Evidence conditionWhat is the verification scope of central randomization?Required |
The stored account says central interactive voice-response randomization was used. Actual sequence generation, concealment, stratification and implementation details remain externally unread. |
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. |
Detailed allocation methods, protocols and implementation material. |
Added allocation procedures must retain known levels separately from unverified details. |
| 20 |
Partly verified |
Full text not readStored summary read |
N20 · Evidence conditionWhat distinctions does open-label design require for treatment decisions and laboratory measurement?Required |
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. |
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. |
Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations. |
Material separating component measurement from decision procedures is needed. |
| 21 |
Unverified |
Full text not readStored summary read |
N21 · Evidence conditionWas NCT00994318 registration content actually verified?Required |
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. |
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. |
Original registration text, versions, endpoints, analyses and changes. |
Separately acquired registration material must retain its version and relationship to reports. |
| 22 |
Partly verified |
Full text not readStored summary read |
N22 · Evidence conditionAt what level are primary/secondary endpoint and analysis hierarchies known?Required |
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. |
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. |
Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables. |
Added plans link prespecified and post hoc distinctions to each outcome. |
| 23 |
Partly verified |
Full text not readStored summary read |
N23 · Evidence conditionWhat original information describes Vifor Pharma sponsorship and oral-iron supply?Required |
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. |
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. |
Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles. |
Added sponsorship, data-access or analysis-involvement information is recorded separately from interpretation limits. |
| 24 |
Unverified |
Full text not readStored summary read |
N24 · Evidence conditionWhat are the detailed author conflicts, data-access and publication roles?Supplementary; required for independence claims |
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. |
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. |
COI, sponsorship contracts, analysis, data-access and publication-role disclosures. |
Added independent reports first distinguish actual parties, data sharing and analysis relationships. |
| 25 |
Partly verified |
Full text not readStored summary read |
N25 · Evidence conditionWhat safety scope do stored infection observations cover?Required |
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. |
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. |
Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power. |
Clinically important infection harms require appropriate event collection, follow-up and comparisons. |
| 26 |
Unverified |
Full text not readStored summary read |
N26 · Evidence conditionAre detailed safety collection, sparse events and attrition verified?Required |
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. |
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. |
Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up. |
Safety signals require material with definitions, ascertainment, denominators and follow-up. |
| 27 |
Unverified |
Full text not readStored summary read |
N27 · Evidence conditionWhat harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors?Supplementary; required for long-term/safety extension |
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. |
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. |
Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events. |
Long-term/rare clinical harms need separate material with sufficient follow-up and appropriate comparisons. |
| 28 |
Partly verified |
Full text not readStored summary read |
N28 · Evidence conditionIs preoperative verdict 2560 for the same drug direct evidence here?Supplementary; required for limits of extension to other settings |
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. |
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. |
Direct material and application limits for different use settings, populations, timepoints and clinical outcomes. |
Material from other settings is not merged by drug name alone; question/population differences remain recorded. |
| 29 |
Partly verified |
Full text not readStored summary read |
N29 · Evidence conditionWhat is the exact primary composite for hemoglobin-centred response?Required |
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. |
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. |
Exact composite plans, components, event-counting and first-event rules. |
Original material separating composite definitions from component-specific effects is needed. |
| 30 |
Partly verified |
Full text not readStored summary read |
N30 · Evidence conditionWhat are the primary-composite group events, denominators, HR and CI?Required |
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. |
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. |
Original composite tables, analysis populations, time models, CIs and covariate handling. |
Material with different estimands or analysis populations is shown separately. |
| 31 |
Partly verified |
Full text not readStored summary read |
N31 · Evidence conditionHow do the directions of composite HR 0.65 and Hb-rise HR 2.04 differ?Required |
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. |
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. |
Event definitions, origins, models, denominators and interpretation targets for each HR. |
Added analysis definitions link each outcome to its estimand separately. |
| 32 |
Partly verified |
Full text not readStored summary read |
N32 · Evidence conditionWhat original scope do the absolute difference and NNT concern?Required |
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. |
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. |
Original estimation timepoints, populations, analyses and intervals for absolute effects/NNT. |
Added original explanations supplement the application scope of existing values. |
| 33 |
Partly verified |
Full text not readStored summary read |
N33 · Evidence conditionWhat are the count, measurement window and test conditions for consecutive Hb <10 g/dL?Required |
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. |
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. |
Consecutive-measurement plans, intervals, laboratory standardization and event handling under missingness. |
Added measurement plans link the actual rules for two consecutive values. |
| 34 |
Partly verified |
Full text not readStored summary read |
N34 · Evidence conditionHow was the additional-treatment-initiation component measured and decided?Required |
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. |
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. |
Component-specific initiation criteria, adjudication, group events, denominators and effects. |
Composite contents require material presenting treatment decisions and repeated-Hb criteria separately. |
| 35 |
Partly verified |
Full text not readStored summary read |
N35 · Evidence conditionWhat are the reported Hb ≥1 g/dL rise-response values?Required |
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. |
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. |
Original tables of Hb-response event definitions, origins, denominators, analyses and CIs. |
Hb-rise details must link separately from the composite. |
| 36 |
Unverified |
Full text not readStored summary read |
N36 · Evidence conditionAre absolute Hb change, group responder counts and durability verified?Required |
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. |
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. |
Original Hb responders, mean changes, timepoints, denominators, missingness and durability material. |
Response magnitude and durability require direct detailed laboratory-outcome material. |
| 37 |
Unverified |
Full text not readStored summary read |
N37 · Evidence conditionDo baseline Hb/iron status and achieved ferritin link to outcomes?Required |
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. |
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. |
Original baseline/repeated Hb, ferritin and iron-status tables linked to exposure. |
Material presenting targets separately from achieved values is needed. |
| 38 |
Unverified |
Full text not readStored summary read |
N38 · Evidence conditionHow much is known about composite components and group contributions?Required |
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. |
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. |
Component events, denominators, overlap, time, effects and planned comparisons. |
Material showing the composite alongside each component is needed. |
| 39 |
Unverified |
Full text not readStored summary read |
N39 · Evidence conditionDo hemoglobin outcomes answer symptoms, quality of life or sustained patient benefit?Supplementary; required for extension to patient benefit |
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. |
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. |
Direct patient-reported outcomes, function, quality-of-life and long-term follow-up definitions/comparisons. |
Patient-important outcomes must link the question and evidence using separate direct material. |
| 40 |
Partly verified |
Full text not readStored summary read |
N40 · Evidence conditionDo current dialysis observations clinically validate Hb response?Required |
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. |
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. |
Group dialysis events, definitions, at-risk populations, denominators, follow-up, effects and power. |
Dialysis benefit requires direct comparisons designed to answer that clinical event adequately. |
| 41 |
Partly verified |
Full text not readStored summary read |
N41 · Evidence conditionDo current mortality observations establish survival benefit?Required |
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. |
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. |
Death counting, causes, analysis populations, follow-up, between-group estimation and precision material. |
Survival benefit needs sufficient follow-up and comparison material directly addressing death. |
| 42 |
Unverified |
Full text not readStored summary read |
N42 · Evidence conditionWhat direct cardiovascular-event reduction material is unverified?Required |
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. |
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. |
Cardiovascular outcome plans, definitions, group events, effects, CIs and follow-up. |
Cardiovascular benefits require material powered directly for those outcomes. |
| 43 |
Partly verified |
Full text not readStored summary read |
N43 · Evidence conditionWhat limits extension from hemoglobin-centred response to clinical events?Required |
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. |
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. |
Direct surrogate-clinical-outcome relationships and separate outcome material. |
Extension questions require added material directly measuring/testing patient events. |
| 44 |
Unverified |
Full text not readStored summary read |
N44 · Evidence conditionWas the same strategy/outcome replicated in other independent research?Supplementary; required to claim independent replication |
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. |
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. |
Bibliographic, registration and population independence with direct same-strategy/outcome comparisons. |
Added independent results first distinguish trial, report and population sharing. |
| 45 |
Partly verified |
Full text not readStored summary read |
N45 · Evidence conditionWhat is preserved when formulation, population or duration changes, or material is corrected?Required (update boundaries) |
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. |
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. |
Complete pre-change original text, new material versions and reasons for question/condition/observation changes. |
Added material separates condition-version changes from observation application and retains user-review requirements. |