CHAMGAP
MethodologyVerdictsExplanations (KO)Evidence CheckCitation KitMonitoring

Darbepoetin alfa × Neurodevelopment in preterm infants — Evidence sheet with separate follow-up unverified

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Comparative efficacyWere the selected claim and its subclaim grade distinguished from the parent verdict?Required
The selected claim is 'Improved neurodevelopment', with the subclaim grade retained as '?' from the stored summary. The note says this is a separate follow-up outcome rather than the primary endpoint of the main outcome paper. These are preserved separately from the parent B72 and Caution status.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made.
Separate preservation of the existing claim, grade, note and parent values
Link additional material separately to each existing question and its parent context.
2 Partly verified Full text not readStored summary read N02 · Comparative efficacyWhat were the actual birth weight, enrollment timing and preterm population?Required
The existing review summary states that preterm infants with birth weight 500~1250 g were included within 48 hours of birth.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread.
Original eligibility, baseline, birth weight, enrollment age and denominators
Obtain the original eligibility, baseline, weight, gestational age and enrollment/treatment timing material.
3 Partly verified Full text not readStored summary read N03 · Comparative efficacyWere darbepoetin and sham study identity distinguished from common care?Required
The existing review summary records darbepoetin, sham and standardized transfusion criteria.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread.
Original drug, placebo/sham, concurrent treatment, baseline care and actual exposure
Obtain the original drug, sham, common care, concurrent treatment and actual exposure material.
4 Partly verified Full text not readStored summary read N04 · Comparative efficacyAre 10µg/kg once weekly and the stopping time historical exposure conditions?Required
The existing Korean text retains 10µg/kg once weekly through 35 weeks of corrected gestational age, while the English text states through 35 weeks gestation as the research condition.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment.
Original study plan, dose, frequency, stopping time and actual exposure
Obtain the original exposure plan, age definitions and tables of actual completion, missed doses, dose reduction or discontinuation.
5 Partly verified Full text not readStored summary read N05 · Comparative efficacyWere 102 infants, 34 per arm and the three-arm design distinguished?Required
The existing review summary and evidence list describe a multicenter masked placebo-controlled three-arm trial with 102 infants and 34 per arm.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread.
Allocation, arm identity, arm-specific analyses, missing data and denominators
Obtain the original three-arm identities, allocation, analysis populations, missing data and participant flow.
6 Partly verified Full text not readStored summary read N06 · Comparative efficacyWere other study arms, other ESAs and verdict 2798 combined as the same result?Required
The existing review summary contains the three-arm trial and a cross-citation to high-dose epoetin alfa in verdict 2798 for a different encephalopathy indication.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants.
Original arm identities, ESAs, comparisons, indications and outcome relationships
Obtain original material separately for each drug, arm, indication and direct comparison.
7 Partly verified Full text not readStored summary read N07 · Comparative efficacyWhat were the roles of standardized restrictive transfusion criteria and clinicians' decisions?Required
The existing review summary records a standardized restrictive protocol based on Hb/Hct, respiratory support and symptoms, and actual blood administration records as the basis for treating transfusion as a hard endpoint.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread.
Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations
Obtain the original protocol, implementation/deviations, records, arm-specific criteria and denominators.
8 Partly verified Full text not readStored summary read N08 · Comparative efficacyWere mean transfusions per infant and the ± notation preserved as recorded?Required
Transfusions were 1.2±2.4 with darbepoetin versus 2.4±2.9 with placebo. The existing reader answer records a mean of 1.2 versus 2.4 transfusions per infant.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI.
Original counts, statistic, dispersion, arm order, duration and denominators
Obtain the original dispersion type, denominators, duration, count distribution, model and test.
9 Partly verified Full text not readStored summary read N09 · Comparative efficacyWas the original absolute reduction of 1.2 transfusions distinguished from preventing an infant from receiving a transfusion?Required
The existing reader answer describes an absolute reduction of 1.2 transfusions per infant.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples.
Original mean difference, effect, observation duration, denominators and uncertainty
Obtain the original mean difference, model, interval, test, duration and denominators.
10 Partly verified Full text not readStored summary read N10 · Comparative efficacyWere the hospitalization transfusion-free proportions of 59% and 38% distinguished from the original 21%p difference?Required
The original text records transfusion-free proportions of 59% versus 38%, an original absolute increase of 21%p.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread.
Transfusion-free definition, people, duration, denominators and original difference
Obtain the original transfusion-free criteria, arm denominators, infant counts, duration, CI and test.
11 Partly verified Full text not readStored summary read N11 · Comparative efficacyAre transfusion counts, transfusion-free status and donor exposure the same measure?Required
The existing summary and citations describe reduced transfusion counts and donor exposure, and record the transfusion-free proportion separately.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials.
Counts, people, donors, blood volume and each denominator
Obtain the original definitions for each measure, people/events, denominators and donor/blood-volume material.
12 Partly verified Full text not readStored summary read N12 · Comparative efficacyWere the hospitalization/35-week stopping window and two-year developmental follow-up distinguished?Required
The parent record preserves the historical judgment that the period through 35 weeks matched the natural course of transfusion during hospitalization, and records separate two-year developmental follow-up.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread.
Intervention window, transfusion observation window, follow-up age, original duration and denominators
Obtain each original duration, age definition, exposure, discharge, follow-up and denominator.
13 Partly verified Full text not readStored summary read N13 · Comparative efficacyWhat were the original computer block allocation, caregiver/investigator masking and sham procedures?Required
The existing review summary records computer block randomization, caregiver/investigator masking, sham and standardized transfusion criteria as the historical basis for counting no additional defects.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread.
Original allocation, concealment, masking, transfusion records and analysts
Obtain the original allocation, masking, recording, analysis and missing-data procedures.
14 Partly verified Full text not readStored summary read N14 · Comparative efficacyWhat is the actual access status for primary transfusion, secondary developmental follow-up and registration plans?Required
The existing review summary states that transfusion count was prespecified primary, while neurodevelopment was a planned separate two-year secondary follow-up rather than primary in the main paper. The registration identifier is NCT00334737.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans.
Original endpoint hierarchy, registration, protocol, SAP, changes and multiplicity
Obtain original registration, plans, hierarchy, changes, multiplicity and analysis-population material.
15 Partly verified Full text not readStored summary read N15 · Comparative efficacyWere the main paper, separate follow-up and relationships among the same participants distinguished?Required
The existing citation is the Ohls 2013 main paper, and the existing review summary describes planned/published separate two-year follow-up. It does not provide the specific bibliography, URL or result tables of that follow-up paper.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null.
Original reports, follow-up bibliography, registration, assessment age and population mapping
Obtain the original follow-up bibliography, registration, arm-specific assessments and population/follow-up mapping.
16 Unverified Full text not readStored summary read N16 · Comparative efficacyWhat are the gaps in direct neurodevelopmental effects, instruments and denominators?Required
The existing review summary describes separate two-year secondary follow-up but does not provide the developmental scores, between-arm effects, CIs, P values, original instruments or assessment denominators. The subclaim grade '?' remains unchanged.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations.
Original follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals
Obtain the original follow-up paper, instruments, denominators, models, effects, intervals and tests.
17 Unverified Full text not readStored summary read N17 · Comparative efficacyWere two-year assessment age, survivors, dropout, missing data and repeated assessments distinguished?Required
The stored summary records a two-year follow-up plan and separate outcomes.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator.
Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data handling
Obtain the original assessment age, survival/follow-up flow, arm denominators, instruments and missing-data handling.
18 Unverified Full text not readStored summary read N18 · Comparative efficacyWere primary/secondary hierarchy, multiple developmental scales and clinical function established?Required
The existing review summary states that development was separate secondary follow-up rather than primary in the main paper.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes.
Original secondary-outcome plan, scales, multiplicity, models, function and plan changes
Obtain the original follow-up plan, scales, hierarchy, changes, multiplicity and clinical-function material.
19 Unverified Full text not readStored summary read N19 · Comparative efficacyWas a separate follow-up report certified as an independent trial or individual neuroprotection?Required
There is only a reference to separate follow-up of the same trial; the specified existing review summary contains no corresponding bibliography or effects.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications.
Original trial, same population, follow-up bibliography, drugs and direct long-term outcomes
Obtain the original registration, follow-up bibliography, same-population mapping and direct long-term outcomes.
20 Partly verified Full text not readStored summary read N20 · Comparative efficacyWhat are the small-study, original sample-size design and precision gaps?Required
The existing review summary records 102 infants, 34 per arm, a sample-size plan adding dropout allowance to 27 per arm, and the historical judgment of one small-study item.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation.
Original size, assumptions, plan, dropout, intervals and clinical importance
Obtain the original size assumptions, power, dropout handling, intervals and clinical boundaries.
21 Partly verified Full text not readStored summary read N21 · Comparative efficacyWere public/nonprofit research funding and Amgen antibody assays distinguished?Required
Support from Thrasher Research Fund, Colorado CTSI and NIH/NCRR/NCATS and Amgen's antibody assay work are retained. The existing review summary records that study-drug supply and trial funding were not disclosed.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread.
Cash, products/in-kind support, assay provision, affiliations, analysis and roles
Obtain original disclosures of cash, drugs/in-kind support, assays, affiliations, design, analysis and writing.
22 Partly verified Full text not readStored summary read N22 · Supplementary harm evidenceWere similar prematurity morbidity/ROP and the original safety denominators distinguished?Required
The original safety text describes similar prematurity morbidity and retinopathy of prematurity across arms; the parent safety status is Caution.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread.
Harm definitions, grades, events/people, exposure, denominators and relatedness
Obtain original harm definitions, arm-specific events/people, denominators, exposure, relatedness and tests.
23 Unverified Full text not readStored summary read N23 · Supplementary harm evidenceWas a trial with 102 infants used to exclude rare/long-term harms or discontinuations?Required
The existing review summary records that 102 infants are too few to exclude rare harms, and that long-term neurodevelopment and safety are separate questions.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims.
Rare harms, actual exposure, duration, discontinuations and safety population
Obtain the original safety population, actual exposure, discontinuations, collection and rare/long-term harm material.
24 Unverified Full text not readStored summary read N24 · Supplementary harm evidenceWere development and other ESAs/indications combined as the same harm or clinical effect?Required
The original verdict 2798 cross-citation concerns high-dose epoetin alfa for hypoxic-ischemic encephalopathy treatment: the same ESA class but a different indication.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability.
Developmental outcomes, other drugs, populations, indications and direct comparisons
Obtain direct effects/harms and report relationships for each population, drug and indication.
25 Partly verified Full text not readStored summary read N25 · Comparative efficacyWere original bibliography, cross-citations, registration identifiers and access to follow-up material distinguished?Required
Ohls 2013 PubMed PMID23776118, NCT00334737 and the original link to related verdict 2798 are retained. The existing review summary contains no separate follow-up bibliography.
R01 R02
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles.
Reports/related verdicts, original URLs, registration and material-specific access status
Link user-provided original material by report type, assessment age and access status.
26 Partly verified Full text not readStored summary read N26 · Comparative efficacyWere the Korean/English texts, axes, reference date, corrections, empty values, candidate history and production status retained?Supplementary
The original 2026-08-26 date, empty correction/deliberation values, parent B72, Caution, axes, Korean/English texts, selected subclaim B/'?' and notes are preserved.
R01
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history.
Distinguishing the selected verdict record, complete parent, languages and history from current production
Link only user material/decisions as separate events after preserving the complete original text.
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26 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
Preterm infants with birth weight 500~1250 g, enrolled within 48 hours of birth; detailed baseline and eligibility information unread
Ingredient, formulation and route
Historical research exposure to darbepoetin alfa; no recommendation on transfusion or developmental treatment selection
Dose
The original 10µg/kg once weekly and 35-week stopping condition are retained as history only; no individual administration, dose or suitability guidance
Comparator
Placebo/sham and a standardized transfusion protocol; details of the other arm in the three-arm trial and concurrent exposures unread
Measured outcome
Original claim of improved neurodevelopment; subclaim '?', separate two-year secondary follow-up and direct instruments/values/denominators unverified
Duration
The hospitalization/35-week research exposure and transfusion window are distinguished from separate two-year developmental follow-up; details of age definitions and actual duration unread
Questions outside this scope
Combining mean transfusions, transfusion-free status, donors and developmental assessment as the same effect; Replacing '?' uniformly with D/B or inventing follow-up values, instruments or bibliography; Counting follow-up, two questions or the same infants as new independent evidence; Transferring effects from other ESAs or encephalopathy/cancer indications; Recommendations on transfusion, dose, administration, suitability, product selection or treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Ohls RK, Christensen RD, Kamath-Rayne BD, et al. A Randomized, Masked, Placebo-Controlled Study of Darbepoetin Alfa in Preterm Infants. Pediatrics. 2013;132(1):e119-e127. PMID: 23776118.

PubMed

Material type
Original trial paper report
Materials actually read
Summary read; external or linked material unread
Findings recorded in the stored summary
Darbepoetin 1.2±2.4 versus placebo 2.4±2.9 transfusions; transfusion-free 59% versus 38%
Record level
Existing review summary; no comparison with the external original report
Study overlap and independent replication
The main transfusion paper of the same three-arm trial, a reference to separate two-year follow-up and two subclaim questions; follow-up bibliography/denominators not acquired. Verdict 2798 is a cross-citation to an existing verdict for another ESA and encephalopathy treatment; linked material unread and not independent replication of darbepoetin in preterm infants. Family IDs link relationships, not certified independent counts; events, composite components, institutions, cross-citations and the same participants are not newly counted as independent evidence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal URL preservedSummary readSummary readPreserved parent verdict summary; report-specific links to the same stored summary copy
abstractOriginal URL preservedNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
fulltextNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
registrationNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
protocol_sapNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete

R02 · High-dose epoetin alfa with no benefit × Neonatal hypoxic-ischemic encephalopathy: verdict 2798 has grade D and 34 points.

Official source

Material type
Cross-citation to an existing verdict; original trial report/bibliography not acquired
Materials actually read
Summary read; external or linked material unread
Findings recorded in the stored summary
The same ESA class, but a different indication: encephalopathy treatment.
Record level
Only the original cross-citation summary is preserved; no newly read clinical evidence for the other ESA/indication
Study overlap and independent replication
The main transfusion paper of the same three-arm trial, a reference to separate two-year follow-up and two subclaim questions; follow-up bibliography/denominators not acquired. Verdict 2798 is a cross-citation to an existing verdict for another ESA and encephalopathy treatment; linked material unread and not independent replication of darbepoetin in preterm infants. Family IDs link relationships, not certified independent counts; events, composite components, institutions, cross-citations and the same participants are not newly counted as independent evidence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
local_summaryOriginal URL preservedSummary readSummary readPreserved parent verdict summary; report-specific links to the same stored summary copy
source_linkOriginal URL preservedNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
fulltextNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
registrationNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete
protocol_sapNo separate URL in the original materialNot readNot readExternal or linked verdict material unread; a URL does not mean reading or review is complete

Report counts versus independent study counts

The main transfusion paper of the same three-arm trial, a reference to separate two-year follow-up and two subclaim questions; follow-up bibliography/denominators not acquired. Verdict 2798 is a cross-citation to an existing verdict for another ESA and encephalopathy treatment; linked material unread and not independent replication of darbepoetin in preterm infants. Family IDs link relationships, not certified independent counts; events, composite components, institutions, cross-citations and the same participants are not newly counted as independent evidence.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Were the selected claim and its subclaim grade distinguished from the parent verdict?
Required materials and conditions
Separate preservation of the existing claim, grade, note and parent values
Conditions for verification
Separate preservation of the existing claim, grade, note and parent values
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N02 · What were the actual birth weight, enrollment timing and preterm population?
Required materials and conditions
Original eligibility, baseline, birth weight, enrollment age and denominators
Conditions for verification
Original eligibility, baseline, birth weight, enrollment age and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N03 · Were darbepoetin and sham study identity distinguished from common care?
Required materials and conditions
Original drug, placebo/sham, concurrent treatment, baseline care and actual exposure
Conditions for verification
Original drug, placebo/sham, concurrent treatment, baseline care and actual exposure
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N04 · Are 10µg/kg once weekly and the stopping time historical exposure conditions?
Required materials and conditions
Original study plan, dose, frequency, stopping time and actual exposure
Conditions for verification
Original study plan, dose, frequency, stopping time and actual exposure
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N05 · Were 102 infants, 34 per arm and the three-arm design distinguished?
Required materials and conditions
Allocation, arm identity, arm-specific analyses, missing data and denominators
Conditions for verification
Allocation, arm identity, arm-specific analyses, missing data and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N06 · Were other study arms, other ESAs and verdict 2798 combined as the same result?
Required materials and conditions
Original arm identities, ESAs, comparisons, indications and outcome relationships
Conditions for verification
Original arm identities, ESAs, comparisons, indications and outcome relationships
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N07 · What were the roles of standardized restrictive transfusion criteria and clinicians' decisions?
Required materials and conditions
Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations
Conditions for verification
Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N08 · Were mean transfusions per infant and the ± notation preserved as recorded?
Required materials and conditions
Original counts, statistic, dispersion, arm order, duration and denominators
Conditions for verification
Original counts, statistic, dispersion, arm order, duration and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N09 · Was the original absolute reduction of 1.2 transfusions distinguished from preventing an infant from receiving a transfusion?
Required materials and conditions
Original mean difference, effect, observation duration, denominators and uncertainty
Conditions for verification
Original mean difference, effect, observation duration, denominators and uncertainty
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N10 · Were the hospitalization transfusion-free proportions of 59% and 38% distinguished from the original 21%p difference?
Required materials and conditions
Transfusion-free definition, people, duration, denominators and original difference
Conditions for verification
Transfusion-free definition, people, duration, denominators and original difference
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N11 · Are transfusion counts, transfusion-free status and donor exposure the same measure?
Required materials and conditions
Counts, people, donors, blood volume and each denominator
Conditions for verification
Counts, people, donors, blood volume and each denominator
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N12 · Were the hospitalization/35-week stopping window and two-year developmental follow-up distinguished?
Required materials and conditions
Intervention window, transfusion observation window, follow-up age, original duration and denominators
Conditions for verification
Intervention window, transfusion observation window, follow-up age, original duration and denominators
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N13 · What were the original computer block allocation, caregiver/investigator masking and sham procedures?
Required materials and conditions
Original allocation, concealment, masking, transfusion records and analysts
Conditions for verification
Original allocation, concealment, masking, transfusion records and analysts
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N14 · What is the actual access status for primary transfusion, secondary developmental follow-up and registration plans?
Required materials and conditions
Original endpoint hierarchy, registration, protocol, SAP, changes and multiplicity
Conditions for verification
Original endpoint hierarchy, registration, protocol, SAP, changes and multiplicity
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N15 · Were the main paper, separate follow-up and relationships among the same participants distinguished?
Required materials and conditions
Original reports, follow-up bibliography, registration, assessment age and population mapping
Conditions for verification
Original reports, follow-up bibliography, registration, assessment age and population mapping
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N16 · What are the gaps in direct neurodevelopmental effects, instruments and denominators?
Required materials and conditions
Original follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals
Conditions for verification
Original follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N17 · Were two-year assessment age, survivors, dropout, missing data and repeated assessments distinguished?
Required materials and conditions
Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data handling
Conditions for verification
Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data handling
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N18 · Were primary/secondary hierarchy, multiple developmental scales and clinical function established?
Required materials and conditions
Original secondary-outcome plan, scales, multiplicity, models, function and plan changes
Conditions for verification
Original secondary-outcome plan, scales, multiplicity, models, function and plan changes
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N19 · Was a separate follow-up report certified as an independent trial or individual neuroprotection?
Required materials and conditions
Original trial, same population, follow-up bibliography, drugs and direct long-term outcomes
Conditions for verification
Original trial, same population, follow-up bibliography, drugs and direct long-term outcomes
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N20 · What are the small-study, original sample-size design and precision gaps?
Required materials and conditions
Original size, assumptions, plan, dropout, intervals and clinical importance
Conditions for verification
Original size, assumptions, plan, dropout, intervals and clinical importance
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N21 · Were public/nonprofit research funding and Amgen antibody assays distinguished?
Required materials and conditions
Cash, products/in-kind support, assay provision, affiliations, analysis and roles
Conditions for verification
Cash, products/in-kind support, assay provision, affiliations, analysis and roles
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N22 · Were similar prematurity morbidity/ROP and the original safety denominators distinguished?
Required materials and conditions
Harm definitions, grades, events/people, exposure, denominators and relatedness
Conditions for verification
Harm definitions, grades, events/people, exposure, denominators and relatedness
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N23 · Was a trial with 102 infants used to exclude rare/long-term harms or discontinuations?
Required materials and conditions
Rare harms, actual exposure, duration, discontinuations and safety population
Conditions for verification
Rare harms, actual exposure, duration, discontinuations and safety population
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N24 · Were development and other ESAs/indications combined as the same harm or clinical effect?
Required materials and conditions
Developmental outcomes, other drugs, populations, indications and direct comparisons
Conditions for verification
Developmental outcomes, other drugs, populations, indications and direct comparisons
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N25 · Were original bibliography, cross-citations, registration identifiers and access to follow-up material distinguished?
Required materials and conditions
Reports/related verdicts, original URLs, registration and material-specific access status
Conditions for verification
Reports/related verdicts, original URLs, registration and material-specific access status
Requirement and applicability
Required
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
N26 · Were the Korean/English texts, axes, reference date, corrections, empty values, candidate history and production status retained?
Required materials and conditions
Distinguishing the selected verdict record, complete parent, languages and history from current production
Conditions for verification
Distinguishing the selected verdict record, complete parent, languages and history from current production
Requirement and applicability
Supplementary
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Referenced methods
Improved neurodevelopment
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing
What the statuses mean
Partly verified
Some information is in the stored summary; detailed original material remains unverified. This does not certify passed review or clinical efficacy
Unverified
Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete
Awaiting user review
Met
Use only within the relevant condition's scope after user review; no automatic display in this preparation
Not reported
Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible
Not applied during this preparation because actual access was not tested
Not applicable
Use with a reason for non-applicability based on an explicit question boundary
Conflicting data
Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions
Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-10 · Public page/material version 1.0

The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Were the selected claim and its subclaim grade distinguished from the parent verdict?

Current findings
The selected claim is 'Improved neurodevelopment', with the subclaim grade retained as '?' from the stored summary. The note says this is a separate follow-up outcome rather than the primary endpoint of the main outcome paper. These are preserved separately from the parent B72 and Caution status.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made.
Reason for missing information
Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made.
Required materials and conditions
Separate preservation of the existing claim, grade, note and parent values
Materials to obtain first
Missing subclaim scores, status and axes are not filled with parent values. '?' is not uniformly replaced with D or confirmed B, and no new verdict is made.
Further research
Link additional material separately to each existing question and its parent context.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Separate preservation of the existing claim, grade, note and parent values
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N02 · What were the actual birth weight, enrollment timing and preterm population?

Current findings
The existing review summary states that preterm infants with birth weight 500~1250 g were included within 48 hours of birth.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread.
Reason for missing information
Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread.
Required materials and conditions
Original eligibility, baseline, birth weight, enrollment age and denominators
Materials to obtain first
Do not extend this to all newborns, other weights/gestational ages or other anemia/encephalopathy indications. Detailed gestational age, eligibility exclusions and baseline risk are unread.
Further research
Obtain the original eligibility, baseline, weight, gestational age and enrollment/treatment timing material.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original eligibility, baseline, birth weight, enrollment age and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N03 · Were darbepoetin and sham study identity distinguished from common care?

Current findings
The existing review summary records darbepoetin, sham and standardized transfusion criteria.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread.
Reason for missing information
Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread.
Required materials and conditions
Original drug, placebo/sham, concurrent treatment, baseline care and actual exposure
Materials to obtain first
Do not extend this to specific products, administration routes or other drugs, or fill in such details. Original details of concurrent exposures such as iron/nutrition are unread.
Further research
Obtain the original drug, sham, common care, concurrent treatment and actual exposure material.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original drug, placebo/sham, concurrent treatment, baseline care and actual exposure
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N04 · Are 10µg/kg once weekly and the stopping time historical exposure conditions?

Current findings
The existing Korean text retains 10µg/kg once weekly through 35 weeks of corrected gestational age, while the English text states through 35 weeks gestation as the research condition.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment.
Reason for missing information
Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment.
Required materials and conditions
Original study plan, dose, frequency, stopping time and actual exposure
Materials to obtain first
Do not turn this condition into individual instructions for administration, scheduling, stopping or suitability. Do not arbitrarily redefine the original gestational-age wording or certify that everyone actually completed treatment.
Further research
Obtain the original exposure plan, age definitions and tables of actual completion, missed doses, dose reduction or discontinuation.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original study plan, dose, frequency, stopping time and actual exposure
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N05 · Were 102 infants, 34 per arm and the three-arm design distinguished?

Current findings
The existing review summary and evidence list describe a multicenter masked placebo-controlled three-arm trial with 102 infants and 34 per arm.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread.
Reason for missing information
Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread.
Required materials and conditions
Allocation, arm identity, arm-specific analyses, missing data and denominators
Materials to obtain first
Do not invent the remaining arm's drug, dose or effect from the numbers in the two displayed arms. Outcome-specific analysis, dropout and follow-up denominators are separately unread.
Further research
Obtain the original three-arm identities, allocation, analysis populations, missing data and participant flow.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Allocation, arm identity, arm-specific analyses, missing data and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N06 · Were other study arms, other ESAs and verdict 2798 combined as the same result?

Current findings
The existing review summary contains the three-arm trial and a cross-citation to high-dose epoetin alfa in verdict 2798 for a different encephalopathy indication.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants.
Reason for missing information
Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants.
Required materials and conditions
Original arm identities, ESAs, comparisons, indications and outcome relationships
Materials to obtain first
Do not fill missing details of other arms with verdict 2798 values, or use that verdict to establish direct superiority/equivalence among ESAs or no effect on transfusion/development in preterm infants.
Further research
Obtain original material separately for each drug, arm, indication and direct comparison.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original arm identities, ESAs, comparisons, indications and outcome relationships
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01 R02

N07 · What were the roles of standardized restrictive transfusion criteria and clinicians' decisions?

Current findings
The existing review summary records a standardized restrictive protocol based on Hb/Hct, respiratory support and symptoms, and actual blood administration records as the basis for treating transfusion as a hard endpoint.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread.
Reason for missing information
Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread.
Required materials and conditions
Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations
Materials to obtain first
Do not invent individual transfusion thresholds or procedures. Details of standardized implementation/deviations and other institutions' transfusion policies are unread.
Further research
Obtain the original protocol, implementation/deviations, records, arm-specific criteria and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Transfusion thresholds, Hb/Hct, respiratory support, symptoms, records and deviations
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N08 · Were mean transfusions per infant and the ± notation preserved as recorded?

Current findings
Transfusions were 1.2±2.4 with darbepoetin versus 2.4±2.9 with placebo. The existing reader answer records a mean of 1.2 versus 2.4 transfusions per infant.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI.
Reason for missing information
Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI.
Required materials and conditions
Original counts, statistic, dispersion, arm order, duration and denominators
Materials to obtain first
Do not newly identify ± as SD, SE or CI. Do not calculate event counts, transfused infant counts, total blood volume, donor counts, RR, P or CI.
Further research
Obtain the original dispersion type, denominators, duration, count distribution, model and test.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original counts, statistic, dispersion, arm order, duration and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N09 · Was the original absolute reduction of 1.2 transfusions distinguished from preventing an infant from receiving a transfusion?

Current findings
The existing reader answer describes an absolute reduction of 1.2 transfusions per infant.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples.
Reason for missing information
Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples.
Required materials and conditions
Original mean difference, effect, observation duration, denominators and uncertainty
Materials to obtain first
Do not turn the mean difference into the same 1.2 reduction for every individual or a risk difference for receiving transfusion. There are no new mean differences, CIs, P values, total savings or event examples.
Further research
Obtain the original mean difference, model, interval, test, duration and denominators.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original mean difference, effect, observation duration, denominators and uncertainty
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N10 · Were the hospitalization transfusion-free proportions of 59% and 38% distinguished from the original 21%p difference?

Current findings
The original text records transfusion-free proportions of 59% versus 38%, an original absolute increase of 21%p.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread.
Reason for missing information
Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread.
Required materials and conditions
Transfusion-free definition, people, duration, denominators and original difference
Materials to obtain first
Do not convert proportions into infant counts, RR, NNT or transfusion-free status for all periods. Details of original event counts, outcome denominators, CI and P are unread.
Further research
Obtain the original transfusion-free criteria, arm denominators, infant counts, duration, CI and test.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Transfusion-free definition, people, duration, denominators and original difference
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N11 · Are transfusion counts, transfusion-free status and donor exposure the same measure?

Current findings
The existing summary and citations describe reduced transfusion counts and donor exposure, and record the transfusion-free proportion separately.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials.
Reason for missing information
Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials.
Required materials and conditions
Counts, people, donors, blood volume and each denominator
Materials to obtain first
Do not fill missing donor values or totals with transfusion values. Do not count multiple measures or repeated transfusions as new participants or independent trials.
Further research
Obtain the original definitions for each measure, people/events, denominators and donor/blood-volume material.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Counts, people, donors, blood volume and each denominator
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N12 · Were the hospitalization/35-week stopping window and two-year developmental follow-up distinguished?

Current findings
The parent record preserves the historical judgment that the period through 35 weeks matched the natural course of transfusion during hospitalization, and records separate two-year developmental follow-up.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread.
Reason for missing information
Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread.
Required materials and conditions
Intervention window, transfusion observation window, follow-up age, original duration and denominators
Materials to obtain first
Do not substitute long-term developmental assessment for the short intervention window or assume the same follow-up duration for all participants. Details of the exact end of transfusion observation, actual exposure and postnatal age are unread.
Further research
Obtain each original duration, age definition, exposure, discharge, follow-up and denominator.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Intervention window, transfusion observation window, follow-up age, original duration and denominators
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N13 · What were the original computer block allocation, caregiver/investigator masking and sham procedures?

Current findings
The existing review summary records computer block randomization, caregiver/investigator masking, sham and standardized transfusion criteria as the historical basis for counting no additional defects.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread.
Reason for missing information
Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread.
Required materials and conditions
Original allocation, concealment, masking, transfusion records and analysts
Materials to obtain first
Do not certify independent review of the original paper's procedures in this work or newly certify absence of bias. Detailed allocation concealment, analyst, missing-data and assessor procedures are unread.
Further research
Obtain the original allocation, masking, recording, analysis and missing-data procedures.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original allocation, concealment, masking, transfusion records and analysts
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N14 · What is the actual access status for primary transfusion, secondary developmental follow-up and registration plans?

Current findings
The existing review summary states that transfusion count was prespecified primary, while neurodevelopment was a planned separate two-year secondary follow-up rather than primary in the main paper. The registration identifier is NCT00334737.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans.
Reason for missing information
Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans.
Required materials and conditions
Original endpoint hierarchy, registration, protocol, SAP, changes and multiplicity
Materials to obtain first
Registrations, full texts, plans and follow-up reports are not newly read. Do not invent test P values, α, ordering, multiplicity or changes to follow-up plans.
Further research
Obtain original registration, plans, hierarchy, changes, multiplicity and analysis-population material.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original endpoint hierarchy, registration, protocol, SAP, changes and multiplicity
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N15 · Were the main paper, separate follow-up and relationships among the same participants distinguished?

Current findings
The existing citation is the Ohls 2013 main paper, and the existing review summary describes planned/published separate two-year follow-up. It does not provide the specific bibliography, URL or result tables of that follow-up paper.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null.
Reason for missing information
Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null.
Required materials and conditions
Original reports, follow-up bibliography, registration, assessment age and population mapping
Materials to obtain first
Do not count follow-up assessments of the same trial, two questions or other ESAs as independent trials or new participants. Final independent counts and total participants remain null.
Further research
Obtain the original follow-up bibliography, registration, arm-specific assessments and population/follow-up mapping.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original reports, follow-up bibliography, registration, assessment age and population mapping
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N16 · What are the gaps in direct neurodevelopmental effects, instruments and denominators?

Current findings
The existing review summary describes separate two-year secondary follow-up but does not provide the developmental scores, between-arm effects, CIs, P values, original instruments or assessment denominators. The subclaim grade '?' remains unchanged.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations.
Reason for missing information
Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations.
Required materials and conditions
Original follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals
Materials to obtain first
Do not fill developmental effects with transfusion values or encephalopathy values for other ESAs. There are no new scale names, effects, scores, grades or clinical confirmations.
Further research
Obtain the original follow-up paper, instruments, denominators, models, effects, intervals and tests.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original follow-up paper, assessment instruments, original scales, arm denominators, effects and intervals
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N17 · Were two-year assessment age, survivors, dropout, missing data and repeated assessments distinguished?

Current findings
The stored summary records a two-year follow-up plan and separate outcomes.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator.
Reason for missing information
Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator.
Required materials and conditions
Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data handling
Materials to obtain first
Do not invent corrected-age definitions, survivor denominators, assessment completion, dropout, repeated assessments or institution-specific values. Do not use the initial 102 infants as the follow-up completer denominator.
Further research
Obtain the original assessment age, survival/follow-up flow, arm denominators, instruments and missing-data handling.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Corrected/chronological age, assessment population, survival, dropout, instruments and missing-data handling
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N18 · Were primary/secondary hierarchy, multiple developmental scales and clinical function established?

Current findings
The existing review summary states that development was separate secondary follow-up rather than primary in the main paper.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes.
Reason for missing information
Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes.
Required materials and conditions
Original secondary-outcome plan, scales, multiplicity, models, function and plan changes
Materials to obtain first
Do not newly decide which developmental scales, subscales, clinical disabilities or functions were prespecified key outcomes. Do not transfer transfusion success to success across multiple developmental outcomes.
Further research
Obtain the original follow-up plan, scales, hierarchy, changes, multiplicity and clinical-function material.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original secondary-outcome plan, scales, multiplicity, models, function and plan changes
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N19 · Was a separate follow-up report certified as an independent trial or individual neuroprotection?

Current findings
There is only a reference to separate follow-up of the same trial; the specified existing review summary contains no corresponding bibliography or effects.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications.
Reason for missing information
A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications.
Required materials and conditions
Original trial, same population, follow-up bibliography, drugs and direct long-term outcomes
Materials to obtain first
A reference to follow-up publication alone does not establish independent replication, neuroprotection, individual effects or confirmation for other ESAs/indications.
Further research
Obtain the original registration, follow-up bibliography, same-population mapping and direct long-term outcomes.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original trial, same population, follow-up bibliography, drugs and direct long-term outcomes
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01 R02

N20 · What are the small-study, original sample-size design and precision gaps?

Current findings
The existing review summary records 102 infants, 34 per arm, a sample-size plan adding dropout allowance to 27 per arm, and the historical judgment of one small-study item.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation.
Reason for missing information
Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation.
Required materials and conditions
Original size, assumptions, plan, dropout, intervals and clinical importance
Materials to obtain first
Do not convert this into new power, success probabilities, parent scores or subclaim scores. Original assumption, MCID and CI details are unread, and there is no new sample-size calculation.
Further research
Obtain the original size assumptions, power, dropout handling, intervals and clinical boundaries.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Original size, assumptions, plan, dropout, intervals and clinical importance
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N21 · Were public/nonprofit research funding and Amgen antibody assays distinguished?

Current findings
Support from Thrasher Research Fund, Colorado CTSI and NIH/NCRR/NCATS and Amgen's antibody assay work are retained. The existing review summary records that study-drug supply and trial funding were not disclosed.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread.
Reason for missing information
Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread.
Required materials and conditions
Cash, products/in-kind support, assay provision, affiliations, analysis and roles
Materials to obtain first
Do not turn antibody assays into external efficacy analysis of the entire trial or certification of no study-drug/funding provision. Employee authors and other roles are separately unread.
Further research
Obtain original disclosures of cash, drugs/in-kind support, assays, affiliations, design, analysis and writing.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Cash, products/in-kind support, assay provision, affiliations, analysis and roles
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N22 · Were similar prematurity morbidity/ROP and the original safety denominators distinguished?

Current findings
The original safety text describes similar prematurity morbidity and retinopathy of prematurity across arms; the parent safety status is Caution.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread.
Reason for missing information
Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread.
Required materials and conditions
Harm definitions, grades, events/people, exposure, denominators and relatedness
Materials to obtain first
Do not turn this into absence of all harms, equivalence or zero events for a specific harm. Details of each original event, denominator, CI, P, relatedness and collection are unread.
Further research
Obtain original harm definitions, arm-specific events/people, denominators, exposure, relatedness and tests.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Harm definitions, grades, events/people, exposure, denominators and relatedness
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N23 · Was a trial with 102 infants used to exclude rare/long-term harms or discontinuations?

Current findings
The existing review summary records that 102 infants are too few to exclude rare harms, and that long-term neurodevelopment and safety are separate questions.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims.
Reason for missing information
Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims.
Required materials and conditions
Rare harms, actual exposure, duration, discontinuations and safety population
Materials to obtain first
Retain the original blood pressure, thrombosis and blood-count monitoring text as history only; do not create implementation instructions, new risk rates, P values, CIs or long-term safety claims.
Further research
Obtain the original safety population, actual exposure, discontinuations, collection and rare/long-term harm material.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Rare harms, actual exposure, duration, discontinuations and safety population
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01

N24 · Were development and other ESAs/indications combined as the same harm or clinical effect?

Current findings
The original verdict 2798 cross-citation concerns high-dose epoetin alfa for hypoxic-ischemic encephalopathy treatment: the same ESA class but a different indication.
Verification status
Unverified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability.
Reason for missing information
Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability.
Required materials and conditions
Developmental outcomes, other drugs, populations, indications and direct comparisons
Materials to obtain first
Do not transfer cancer/encephalopathy judgments for other indications to transfusion or development in preterm infants. Do not create instructions on product/transfusion/drug/treatment selection, use or suitability.
Further research
Obtain direct effects/harms and report relationships for each population, drug and indication.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Developmental outcomes, other drugs, populations, indications and direct comparisons
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01 R02

N25 · Were original bibliography, cross-citations, registration identifiers and access to follow-up material distinguished?

Current findings
Ohls 2013 PubMed PMID23776118, NCT00334737 and the original link to related verdict 2798 are retained. The existing review summary contains no separate follow-up bibliography.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles.
Reason for missing information
External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles.
Required materials and conditions
Reports/related verdicts, original URLs, registration and material-specific access status
Materials to obtain first
External abstracts, full texts, registrations, plans, follow-up reports and linked verdicts are unread, with no separate link testing. Do not invent DOIs, URLs or paper titles.
Further research
Link user-provided original material by report type, assessment age and access status.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Reports/related verdicts, original URLs, registration and material-specific access status
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01 R02

N26 · Were the Korean/English texts, axes, reference date, corrections, empty values, candidate history and production status retained?

Current findings
The original 2026-08-26 date, empty correction/deliberation values, parent B72, Caution, axes, Korean/English texts, selected subclaim B/'?' and notes are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external or linked material unread
Why unverified
Only the relevant information in the stored summary is recorded; detailed original material and user review remain outstanding. Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history.
Reason for missing information
Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history.
Required materials and conditions
Distinguishing the selected verdict record, complete parent, languages and history from current production
Materials to obtain first
Original judgments of hard endpoints, independence and design defects are historical, not certification of review in this work. Missing subclaim values are not filled, and the original review-pending/production-eligibility labels are history.
Further research
Link only user material/decisions as separate events after preserving the complete original text.
Remaining uncertainty
Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification
Distinguishing the selected verdict record, complete parent, languages and history from current production
Why this condition is needed
Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries
Application exceptions
Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.
Referenced methods
Improved neurodevelopment

Related sources R01