Preoperative red-cell transfusion × Reduced clinically important surgical complications in sickle cell disease

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat are the selected question and existing complete verdict record?Required	The selected stored summary concerns reduced clinically important complications in low- and medium-risk surgery in sickle cell disease. The selected question and complete existing verdict record are distinguished. Candidate history is preserved without creating nonexistent subclaims. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The relationship between the original complete verdict and selected question remains subject to user review.	The relationship between the original complete verdict and selected question.	If the original question is corrected, the complete pre-change text, current verdict linkage and historical candidate records are preserved separately.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat are the verdict’s actual grade, score, status and axes?Required	Original grade B, score 76, axes B/H/R1/I2/E+/B0 and safety caution are used. An existing verification-status field is absent from the stored summary; that absence is recorded. A statement of absent subclaim scores is not applied to a verdict with its own score and axes. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Existing verdict values, original wording and history remains subject to user review.	Existing verdict values, original wording and history.	If a correction occurs, actual before/after values and reasons are preserved as a separate event.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat is the scope of null, false, empty values and the historical B0 decision?Required	Original precision null, coprimary_split/big_hard_rct/no_human_study false and empty override_reason/override_reason_en strings are preserved. The original B0/B76 decision not to count safety stopping or the 70-person sample as defects is historical. No new criteria or review are run. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Versions of original axes, study assessment and correction history remains subject to user review.	Versions of original axes, study assessment and correction history.	A separate reassessment request must distinguish original history from current production status.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow are Korean/English, the reference date, corrections and empty arrays preserved?Required	Complete Korean/English articles, reference date 2026-08-26 and existing empty correction/subclaim/deliberation values are preserved. Stored cross-check/Primary-source cross-check wording is historical, not completed current review. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original wording, dates, corrections, structure and additional versions in each language remains subject to user review.	Original wording, dates, corrections, structure and additional versions in each language.	When original text or corrections are added, the complete pre-change text and a separate event are retained.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat was actually read, and which external materials remain unread?Required	The complete designated stored JSON was read for production. Abstracts, full texts, NCT/ISRCTN registration, protocols, SAPs, DSMC records and original tables were not accessed. Links, stored citations and historical review do not certify current external reading. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Acquisition/reading level for each material and locations of original results/plans remains subject to user review.	Acquisition/reading level for each material and locations of original results/plans.	Any later direct reading must record its scope, time and version.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionHow are the TAPS bibliography and two registration identifiers linked?Required	The direct report is TAPS, Howard J et al., Lancet 2013, PMID 23352054. Stored registration text is NCT00512577 · ISRCTN00862331; both identifiers link to one stored report. DOI, PMCID and registration content are unverified. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Bibliography, paper/registration versions and material linking them to the same trial remains subject to user review.	Bibliography, paper/registration versions and material linking them to the same trial.	New reports/registration must distinguish identity, populations and relationships using source material.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionHow is sharing across the trial, reports, populations and multiple outcomes maintained?Required	One direct TAPS report contains clinically important complications, acute chest syndrome, SAEs, transfusion-related complications and alloantibodies. Shared people, groups, events or timepoints are not added as new independent trials/participants. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Relationships/overlap between each outcome, trial, population, analysis set and follow-up remains subject to user review.	Relationships/overlap between each outcome, trial, population, analysis set and follow-up.	Added follow-up/related reports must distinguish population sharing within the existing TAPS family.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat are the population and surgical risk scope?Required	The verdict question concerns low-/medium-risk surgery in sickle cell disease. The stored summary lacks detailed ages, genotypes, surgical types, risk classification and eligibility/exclusions, so it is not automatically extended to all sickle cell disease or high-risk surgery. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk remains subject to user review.	Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.	Other surgery/risk populations require direct comparison material for their own question.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionHow much is verified about baseline disease risk, representativeness and clinical setting?Supplementary; required for general application	The current summary lacks disease severity, baseline haemoglobin, previous transfusions, antibodies, comorbidities, recruitment setting and group distributions. The population name and original effect do not guide transfusion suitability for an individual patient. R01	Required direct details are unverified within the current summary and unread external material. Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material remains subject to user review.	Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.	General application requires direct material showing actual population differences.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat was the original study exposure to preoperative red-cell transfusion?Required	The intervention is preoperative red-cell transfusion. The current summary lacks actual methods, units, targets, timing, antigen matching, changes and adherence. No transfusion procedure, dose, target or suitability recommendations are created. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Trial transfusion strategy, actual implementation, products, exposure and change records remains subject to user review.	Trial transfusion strategy, actual implementation, products, exposure and change records.	Effects of other transfusion strategies must be distinguished using direct comparison material.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat are the no-transfusion control and concurrent surgical/care conditions?Required	The stored comparison is transfusion versus no transfusion, while the reported OR is no transfusion versus transfusion. Actual surgery, anaesthesia, concurrent care, transfusion changes and rescue treatment details are unverified. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original control, concurrent care, surgery, actual transfusion changes and timing material remains subject to user review.	Original control, concurrent care, surgery, actual transfusion changes and timing material.	Actual strategy implementation material is required to address exposure differences and concurrent-care effects.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionWhat were the actual procedures of the multicentre randomized sequential superiority trial?Required	The original design is a multicentre randomized sequential superiority trial. The current summary lacks sequence generation, concealment, stratification, centre implementation and assessment blinding details. Original B0 is not inherited as direct procedural verification. R01	Required direct details are unverified within the current summary and unread external material. Original allocation, concealment, assessor, centre and sequential-design plans/procedures remains subject to user review.	Original allocation, concealment, assessor, centre and sequential-design plans/procedures.	Added design details must distinguish original reports/historical assessments from actual verification.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionHow do planned 405, enrolled 70 and ITT 67 differ?Required	Of a planned 405 participants, 70 were enrolled and 67 analyzed by ITT. Original planned, enrolled and analyzed counts are distinguished. Enrolled 70 is not changed to a completed-randomization count beyond the stored summary, and no differences or proportions are calculated. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions remains subject to user review.	Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.	An original flow diagram showing actual analysis-population pathways is needed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat are the events, groups and denominators in 13/33 and 5/34?Required	Clinically important complications were no transfusion 13/33 (39%) versus transfusion 5/34 (15%). These are original group values for the same verdict, not mixed with separate acute chest syndrome or SAE measures. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions remains subject to user review.	Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.	Added direct outcome material must link each event to its group denominator.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat are the direction and interval of the no-transfusion versus transfusion OR?Required	Reported no-transfusion versus transfusion OR: 3.8 (95% CI 1.2–12.2). Its direction is retained, without conversion to a transfusion versus no-transfusion OR, RR, HR or survival outcome. No P value or other effect absent from the stored summary is calculated. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Details of the original OR model, analysis population, adjustment and interval remains subject to user review.	Details of the original OR model, analysis population, adjustment and interval.	The original explanation of the estimand, direction and scale is needed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat is the original comparison behind the absolute difference of -24 percentage points?Required	The original absolute difference of -24 percentage points is preserved in the context of important surgical complications: no transfusion 39% versus transfusion 15%. No new absolute difference, NNT, treated-person example or interval is calculated. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original absolute-effect population, time, analysis and interval remains subject to user review.	Original absolute-effect population, time, analysis and interval.	Added original explanations should link the absolute effect to its relevant scope.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat is the observation window for clinically important complications?Required	The endpoint runs from randomization through 30 days after surgery. Thirty days after surgery is distinguished from the transfusion group’s three-month alloantibody observation; the complication window is not changed to simply 30 days after enrollment. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring remains subject to user review.	Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.	Outcomes at each timepoint must be linked to their relevant analysis windows.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionHow much is known about important complication definitions, components and adjudication?Required	The original important-complication definition and some acute chest syndrome/SAE values are available, but full components, overlap, first events, severity, assessors, blinding and ascertainment details are unverified. Equal reductions in all components are not newly established. R01	Required direct details are unverified within the current summary and unread external material. Complication components, severity, adjudication, overlap, original outcomes and plans remains subject to user review.	Complication components, severity, adjudication, overlap, original outcomes and plans.	Direct material presenting the composite and individual components side by side is needed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat separate outcome is acute chest syndrome in 9 versus 1 participants?Required	Original acute chest syndrome counts are 9 versus 1 participants. The no-transfusion versus transfusion context is retained; absent denominators, proportions, effects, CIs or P values for that outcome are not calculated from other outcome numbers. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The event definition, original tables, denominators, periods and between-group analyses remains subject to user review.	The event definition, original tables, denominators, periods and between-group analyses.	Direct material for each component must be linked separately from the composite outcome.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat are the original serious adverse event counts, denominators and proportions?Required	SAEs were no transfusion 10/33 (30%) versus transfusion 1/34 (3%). These outcomes come from the same trial as complications and acute chest syndrome; detailed overlap is unverified. No new effect, CI or P value is created. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. SAE definitions, periods, calculation, overlap, group tables and plans remains subject to user review.	SAE definitions, periods, calculation, overlap, group tables and plans.	Direct material on the reason for safety stopping and original SAE analysis is needed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionHow did the first planned interim analysis differ from the later unplanned safety analysis?Required	At the first planned interim analysis, no stopping boundaries had been crossed and the trial continued. The original sequence is retained: an unexpected SAE imbalance later led the DSMC to request an unscheduled interim analysis and recommend stopping for safety. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records remains subject to user review.	Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.	Added original decision material must separately record plans, actual events and interpretation.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionHow are safety stopping and the original B0/sample-size defect treatment related?Required	The historical assessment says stopping was not at a prespecified primary-endpoint boundary and the safety stop was unavoidable, so early stopping and fewer than 200 participants were not counted as defects. This history is preserved alongside the facts: enrolled 70, ITT 67 and planned 405. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Stopping circumstances, original verdict rationale and actual plans/analyses remains subject to user review.	Stopping circumstances, original verdict rationale and actual plans/analyses.	A separate correction to the original decision must preserve before/after wording and reasons.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat effect-size uncertainty arises from the small sample and early termination?Required	The original counterpoint says the small sample and early termination may have overestimated the effect size. The original OR 95% CI width, 1.2–12.2, is preserved without new precision-axis or reliability scores. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material remains subject to user review.	Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.	Direct comparison material with independent replication and sufficient events/follow-up is needed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWhat are the details of ITT, missingness, changes and follow-up?Required	ITT 67 and group counts 33/34 are preserved. Enrollment, analysis inclusion, surgery not performed, treatment changes, missingness, follow-up and analysis handling details are unverified. Group results are not assigned a denominator of all enrollees. R01	Required direct details are unverified within the current summary and unread external material. Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses remains subject to user review.	Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.	Material linking the planned estimand to the actual analysis population is needed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionWhat is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons?Required	Historical explanations of the randomized sequential superiority trial and interim analyses are preserved. Actual registration/protocol/SAP details of primary-outcome hierarchy, stopping rules, multiple comparisons, adjustment and analysis versions remain unread. R01	Required direct details are unverified within the current summary and unread external material. Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy remains subject to user review.	Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.	Any later comparison of prespecified plans with reports must retain its actual scope.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhat is the scope of 0 versus 0 clinically important transfusion-related complications?Required	The original description of zero clinically important transfusion-related complications in both TAPS groups is preserved. The stored summary did not test this comparison, so no between-group significance wording is used and not all transfusion harms are established as absent or harmless. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Event definitions, collection, periods, denominators, testing plans and follow-up material remains subject to user review.	Event definitions, collection, periods, denominators, testing plans and follow-up material.	Rare transfusion harms require material with sufficient exposure, collection and follow-up.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhat separate harm is the three-month anti-S alloantibody observation?Required	One participant in the transfusion group developed an anti-S red-cell alloantibody at three months. This is separate from the primary complication window through 30 days after surgery. Incidence, between-group effects, P values or CIs absent from the summary are not calculated. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence remains subject to user review.	Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.	Long-term alloimmunization effects require direct ascertainment, comparison and follow-up material.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat remains unverified about acute/delayed haemolytic reactions and alloimmunization?Required	The original counterview explains alloimmunization and acute/delayed haemolytic transfusion reaction risks. Beyond TAPS important complications 0 versus 0 and one anti-S participant, detailed frequencies, ascertainment and long-term results for each harm are unverified. R01	Required direct details are unverified within the current summary and unread external material. Definitions, collection, denominators, ascertainment and long-term follow-up for each harm remains subject to user review.	Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.	Material documenting actual harm collection/ascertainment and direct clinical impact is needed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionHow much is known about harm collection, ascertainment, recurrence and causality adjudication?Required	Some original transfusion-harm/SAE values are available, but collection, assessors, severity, recurrence, event relatedness, risk periods and safety-denominator details are unverified. Observed events are distinguished from established causality. R01	Required direct details are unverified within the current summary and unread external material. Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up remains subject to user review.	Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.	Harm signals must be supplemented by actual exposure, timing, ascertainment and alternative-factor material.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre a safety imbalance and long-term harmlessness the same conclusion?Required	The historical recommendation to stop for safety following an SAE imbalance in the no-transfusion group is retained alongside harms of transfusion itself. A signal of comparative advantage does not establish harmlessness for every patient/long-term transfusion or suitability for every surgery. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event remains subject to user review.	Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.	Long-term/rare transfusion harms and clinical benefits each require direct material.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat were NHSBT public sponsorship, author employment and research roles?Required	NHS Blood and Transplant sponsored the trial; five authors were employed by NHSBT. Original information that NHSBT and the MRC Clinical Studies Unit performed design, data collection, analysis and interpretation is retained. Public funding and actual involvement are shown together. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original sponsorship, employment, research-role, data-access and COI disclosures remains subject to user review.	Original sponsorship, employment, research-role, data-access and COI disclosures.	Added role disclosures must record actual involvement and analysis/data relationships.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionWhat are the details of contracts, data access, publication and other COI?Required	The summary describes sponsorship, author employment, design, collection, analysis and interpretation, but contract, data-access, publication-decision and other conflict details are unverified. Original I2 is not inherited as new analysis-independence certification. R01	Required direct details are unverified within the current summary and unread external material. Original COI, contract, data-access, analysis and publication-role disclosures remains subject to user review.	Original COI, contract, data-access, analysis and publication-role disclosures.	Claims of broader independence require actual data-sharing, involvement and analysis-relationship material.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionHow is a single confirmatory report distinguished from additional independent replication?Required	The evidence weight describes a single small confirmatory trial, and the original overall summary says independent replication is needed. One direct report, two registrations and multiple outcomes are not added as new independent replications. Additional direct trials are unverified in the current input. R01	Required direct details are unverified within the current summary and unread external material. Linkage material for new bibliography, registration, populations, designs, exposures and outcomes remains subject to user review.	Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.	Added independent results must first distinguish population/report sharing with existing TAPS.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionIs the related case 1485 hydroxyurea verdict the same question?Supplementary; required for the boundary of the related question	Case 1485 concerns routine prevention of vaso-occlusive complications in adults with sickle cell anaemia, linked with historical B77. Its population and purpose differ from preparation for low-/medium-risk surgery here. That page was not read and is not counted as a direct TAPS report or new trial.	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Disease, population, purpose, timepoint and intervention differences, with direct material remains subject to user review.	Disease, population, purpose, timepoint and intervention differences, with direct material.	Related questions are not combined solely because they name the same disease; differences in conditions and purpose are retained.
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionCan the findings be extended to other surgical risks, genotypes, ages or transfusion strategies?Supplementary; required for extending applicability	The current verdict preserves the original preoperative transfusion comparison in low-/medium-risk surgery. Benefits/harms for other surgical risks, disease types, ages, baseline antibodies or transfusion strategies are not automatically established as identical. Relevant direct material is unverified. R01	Required direct details are unverified within the current summary and unread external material. Direct comparison material showing population, surgery and exposure-strategy differences remains subject to user review.	Direct comparison material showing population, surgery and exposure-strategy differences.	Clinical outcomes under other conditions must be distinguished using their relevant populations, strategies and follow-up.
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionDoes a reduction in complications answer survival, quality of life and every long-term outcome?Supplementary; required to extend to other outcomes	Original results for actual clinically important surgical complications are preserved. Direct long-term survival, quality-of-life, all-complication and routine disease-control values are absent, so they do not substitute for those separate questions. R01	Required direct details are unverified within the current summary and unread external material. Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes remains subject to user review.	Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.	Broader clinical-outcome scope requires direct outcome material for each question.
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionWhat remains unverified about prespecified subgroup, component and multiple-outcome effects?Required	Total important complications and some event counts are preserved, but group-specific subgroup/component plans, precision, interactions and multiple-comparison details are unverified. The overall OR is not copied to every component/population. R01	Required direct details are unverified within the current summary and unread external material. Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables remains subject to user review.	Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.	Direct material answering each outcome/subgroup and prespecified plans are needed.
38	Unverified	Full text not readStored summary read	N38 · Evidence conditionHow much is verified about transfusion/event timing and alternative factors?Required	Detailed timing between underlying disease, previous transfusions, concurrent care, surgery type, changes and events is unverified. Randomized strategy comparisons are distinguished from attributing every individual event to a single cause. R01	Required direct details are unverified within the current summary and unread external material. Baseline risk, actual exposure, care, changes, event timing and adjudication material remains subject to user review.	Baseline risk, actual exposure, care, changes, event timing and adjudication material.	Interpreting harms and clinical course requires direct records, ascertainment and comparisons.
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionHow are direct clinical outcomes, a large original effect and uncertainty preserved together?Required	Original B76 and wording of a large important-complication reduction, actual events 13/33 versus 5/34 and the OR direction/interval are preserved. Small sample, safety stopping, transfusion harms and the need for independent replication remain limitations. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Relevant original outcome, design, follow-up, uncertainty and independent-material scope remains subject to user review.	Relevant original outcome, design, follow-up, uncertainty and independent-material scope.	Additional material directly addressing clinical benefits and harms is separately needed.
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionWhat is preserved when material, corrections or record-location displays are updated?Required (update boundaries)	The existing complete verdict, selected question, candidate history, Korean/English articles, dates and empty correction-history values are retained. New material must separate the complete pre-change stored summary, version/reason, condition changes and separate application of observations. R01	Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Version relationships between new material, corrections, changed text, questions, conditions and observations remains subject to user review.	Version relationships between new material, corrections, changed text, questions, conditions and observations.	Separately added follow-up material must retain report/population sharing and the user-review scope.

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40 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: Reduced clinically important complications in low- and medium-risk surgery in sickle cell disease
Ingredient, formulation and route: Preoperative red-cell transfusion
Dose: The current article lacks details of the actual transfusion method, dose, targets and schedule; no new procedural guidance is created
Comparator: No transfusion. The reported OR is in the no-transfusion versus transfusion direction
Measured outcome: Clinically important complications from randomization through 30 days after surgery
Duration: Important complications from randomization through 30 days after surgery; the three-month anti-S observation is a separate timepoint
Questions outside this scope: Generalizing effects/safety to other populations, diseases, surgical risks, formulations or timepoints; Adding the same report, population, groups, timepoints or outcomes as new independent trials/participants; Recommending individual treatments, procedures, doses, suitability or usage choices

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 · Howard J, et al. Lancet. 2013. PMID: 23352054.

PubMed

Material type: Multicentre randomized sequential superiority trial
Materials actually read: Summary read; external papers and registration unread
Findings recorded in the stored summary: 13/33 (39%) versus 5/34 (15%); absolute difference -24 percentage points; no-transfusion versus transfusion OR 3.8 (95% CI 1.2–12.2)
Record level: Reported values from the existing review summary. The original paper was not directly verified in this work.
Study overlap and independent replication: Original functional/clinical outcomes, analyses, harms and related timepoints share one TAPS report/population; they are not added as new independent replications.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Stored summary	Locally stored existing review summary read for preparation	Summary read	The existing complete review summary was read for production; the original paper was not acquired or read.
Paper abstract	External material unread; needed	Access not attempted; not obtained	Not read	Only the bibliographic PMID link was connected. The actual abstract and result locations were not directly verified.
Full paper	External material unread; needed	Access not attempted; not obtained	Not read	The URL is a bibliographic link; full-text acquisition and accessibility were not verified.
Clinical trial registration	External material unread; needed	Access not attempted; not obtained	Not read	Only original registration-identifier text is preserved. Registration content, versions, first date, changes and comparison with reports are unverified.
Study protocol	External material unread; needed	Access not attempted; not obtained	Not read	Original sequential-design, hypothesis, transfusion-strategy, outcome-component, interim-analysis and DSMC stopping-plan documents have not been acquired.
Statistical analysis plan	External material unread; needed	Access not attempted; not obtained	Not read	Direct plans for analysis populations, estimands, adjustment, missingness, sensitivity, hierarchy and precision have not been acquired.
Original results and safety tables	External material unread; needed	Access not attempted; not obtained	Not read	Original definitions, group outcomes, timing and denominators are needed for important complications, acute chest syndrome, SAEs, transfusion harms, alloantibodies and stopping.
Sponsorship and interest disclosures	External material unread; needed	Access not attempted; not obtained	Not read	Beyond stored funding/role information, original contract, data-access, publication-decision and author-specific COI documents have not been acquired.
Verdict on a different related question	External material unread; needed	Access not attempted; not obtained	Not read	A historical link distinguishing routine prevention in the same disease from original preoperative preparation. It is not a direct TAPS report or independent replication; that page was not read.

Report counts versus independent study counts

Original functional/clinical outcomes, analyses, harms and related timepoints share one TAPS report/population; they are not added as new independent replications.

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 · What are the selected question and existing complete verdict record?

Required materials and conditions: The relationship between the original complete verdict and selected question.
Conditions for verification: What are the selected question and existing complete verdict record? Distinguish The relationship between the original complete verdict and selected question in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The existing complete verdict is not converted to a subquestion, and nonexistent subclaims are not created.
Why this condition is needed: What are the selected question and existing complete verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N02 · What are the verdict’s actual grade, score, status and axes?

Required materials and conditions: Existing verdict values, original wording and history.
Conditions for verification: What are the verdict’s actual grade, score, status and axes? Distinguish Existing verdict values, original wording and history in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The verdict’s original values are preserved; this is not a new grade or score judgment.
Why this condition is needed: What are the verdict’s actual grade, score, status and axes? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N03 · What is the scope of null, false, empty values and the historical B0 decision?

Required materials and conditions: Versions of original axes, study assessment and correction history.
Conditions for verification: What is the scope of null, false, empty values and the historical B0 decision? Distinguish Versions of original axes, study assessment and correction history in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Historical rules on fewer than 200 participants and stopping classification are not run as current automated checks.
Why this condition is needed: What is the scope of null, false, empty values and the historical B0 decision? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N04 · How are Korean/English, the reference date, corrections and empty arrays preserved?

Required materials and conditions: Original wording, dates, corrections, structure and additional versions in each language.
Conditions for verification: How are Korean/English, the reference date, corrections and empty arrays preserved? Distinguish Original wording, dates, corrections, structure and additional versions in each language in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How are Korean/English, the reference date, corrections and empty arrays preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N05 · What was actually read, and which external materials remain unread?

Required materials and conditions: Acquisition/reading level for each material and locations of original results/plans.
Conditions for verification: What was actually read, and which external materials remain unread? Distinguish Acquisition/reading level for each material and locations of original results/plans in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Only URLs were written in the original preparation; no separate link/content checks were performed.
Why this condition is needed: What was actually read, and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N06 · How are the TAPS bibliography and two registration identifiers linked?

Required materials and conditions: Bibliography, paper/registration versions and material linking them to the same trial.
Conditions for verification: How are the TAPS bibliography and two registration identifiers linked? Distinguish Bibliography, paper/registration versions and material linking them to the same trial in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The two registration identifiers are not counted as two independent trials.
Why this condition is needed: How are the TAPS bibliography and two registration identifiers linked? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N07 · How is sharing across the trial, reports, populations and multiple outcomes maintained?

Required materials and conditions: Relationships/overlap between each outcome, trial, population, analysis set and follow-up.
Conditions for verification: How is sharing across the trial, reports, populations and multiple outcomes maintained? Distinguish Relationships/overlap between each outcome, trial, population, analysis set and follow-up in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: A direct report entry does not certify independent unique trial or participant totals.
Why this condition is needed: How is sharing across the trial, reports, populations and multiple outcomes maintained? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N08 · What are the population and surgical risk scope?

Required materials and conditions: Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.
Conditions for verification: What are the population and surgical risk scope? Distinguish Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Ages, genotypes and risk criteria absent from the original are not filled in.
Why this condition is needed: What are the population and surgical risk scope? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N09 · How much is verified about baseline disease risk, representativeness and clinical setting?

Required materials and conditions: Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.
Conditions for verification: How much is verified about baseline disease risk, representativeness and clinical setting? Distinguish Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required for general application
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is verified about baseline disease risk, representativeness and clinical setting? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N10 · What was the original study exposure to preoperative red-cell transfusion?

Required materials and conditions: Trial transfusion strategy, actual implementation, products, exposure and change records.
Conditions for verification: What was the original study exposure to preoperative red-cell transfusion? Distinguish Trial transfusion strategy, actual implementation, products, exposure and change records in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No new Hb targets, exchange/simple transfusion methods, administration schedules or doses are written.
Why this condition is needed: What was the original study exposure to preoperative red-cell transfusion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N11 · What are the no-transfusion control and concurrent surgical/care conditions?

Required materials and conditions: Original control, concurrent care, surgery, actual transfusion changes and timing material.
Conditions for verification: What are the no-transfusion control and concurrent surgical/care conditions? Distinguish Original control, concurrent care, surgery, actual transfusion changes and timing material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No transfusion is not extended to no lifetime transfusion history or to waiting/treatment recommendations.
Why this condition is needed: What are the no-transfusion control and concurrent surgical/care conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N12 · What were the actual procedures of the multicentre randomized sequential superiority trial?

Required materials and conditions: Original allocation, concealment, assessor, centre and sequential-design plans/procedures.
Conditions for verification: What were the actual procedures of the multicentre randomized sequential superiority trial? Distinguish Original allocation, concealment, assessor, centre and sequential-design plans/procedures in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What were the actual procedures of the multicentre randomized sequential superiority trial? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N13 · How do planned 405, enrolled 70 and ITT 67 differ?

Required materials and conditions: Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.
Conditions for verification: How do planned 405, enrolled 70 and ITT 67 differ? Distinguish Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No new lost/excluded participant counts or recruitment completion rates are calculated from current numbers.
Why this condition is needed: How do planned 405, enrolled 70 and ITT 67 differ? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N14 · What are the events, groups and denominators in 13/33 and 5/34?

Required materials and conditions: Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.
Conditions for verification: What are the events, groups and denominators in 13/33 and 5/34? Distinguish Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What are the events, groups and denominators in 13/33 and 5/34? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N15 · What are the direction and interval of the no-transfusion versus transfusion OR?

Required materials and conditions: Details of the original OR model, analysis population, adjustment and interval.
Conditions for verification: What are the direction and interval of the no-transfusion versus transfusion OR? Distinguish Details of the original OR model, analysis population, adjustment and interval in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The OR is not converted to its reciprocal, a risk ratio or a new relative reduction.
Why this condition is needed: What are the direction and interval of the no-transfusion versus transfusion OR? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N16 · What is the original comparison behind the absolute difference of -24 percentage points?

Required materials and conditions: Original absolute-effect population, time, analysis and interval.
Conditions for verification: What is the original comparison behind the absolute difference of -24 percentage points? Distinguish Original absolute-effect population, time, analysis and interval in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original absolute values are not copied to long-term survival or effects in other surgery.
Why this condition is needed: What is the original comparison behind the absolute difference of -24 percentage points? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N17 · What is the observation window for clinically important complications?

Required materials and conditions: Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.
Conditions for verification: What is the observation window for clinically important complications? Distinguish Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What is the observation window for clinically important complications? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N18 · How much is known about important complication definitions, components and adjudication?

Required materials and conditions: Complication components, severity, adjudication, overlap, original outcomes and plans.
Conditions for verification: How much is known about important complication definitions, components and adjudication? Distinguish Complication components, severity, adjudication, overlap, original outcomes and plans in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is known about important complication definitions, components and adjudication? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N19 · What separate outcome is acute chest syndrome in 9 versus 1 participants?

Required materials and conditions: The event definition, original tables, denominators, periods and between-group analyses.
Conditions for verification: What separate outcome is acute chest syndrome in 9 versus 1 participants? Distinguish The event definition, original tables, denominators, periods and between-group analyses in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The 9 and 1 participants are not added independently to SAEs or total complications as separate events/people.
Why this condition is needed: What separate outcome is acute chest syndrome in 9 versus 1 participants? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N20 · What are the original serious adverse event counts, denominators and proportions?

Required materials and conditions: SAE definitions, periods, calculation, overlap, group tables and plans.
Conditions for verification: What are the original serious adverse event counts, denominators and proportions? Distinguish SAE definitions, periods, calculation, overlap, group tables and plans in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: SAEs and important complication events are not independently added together.
Why this condition is needed: What are the original serious adverse event counts, denominators and proportions? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N21 · How did the first planned interim analysis differ from the later unplanned safety analysis?

Required materials and conditions: Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.
Conditions for verification: How did the first planned interim analysis differ from the later unplanned safety analysis? Distinguish Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: The trial is not re-described as stopping for efficacy after crossing the first planned boundary.
Why this condition is needed: How did the first planned interim analysis differ from the later unplanned safety analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N22 · How are safety stopping and the original B0/sample-size defect treatment related?

Required materials and conditions: Stopping circumstances, original verdict rationale and actual plans/analyses.
Conditions for verification: How are safety stopping and the original B0/sample-size defect treatment related? Distinguish Stopping circumstances, original verdict rationale and actual plans/analyses in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: No new sample-size criteria, bias grades or defect scores are calculated.
Why this condition is needed: How are safety stopping and the original B0/sample-size defect treatment related? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N23 · What effect-size uncertainty arises from the small sample and early termination?

Required materials and conditions: Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.
Conditions for verification: What effect-size uncertainty arises from the small sample and early termination? Distinguish Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Uncertainty is not converted into deletion of the original positive result or a new null verdict.
Why this condition is needed: What effect-size uncertainty arises from the small sample and early termination? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N24 · What are the details of ITT, missingness, changes and follow-up?

Required materials and conditions: Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.
Conditions for verification: What are the details of ITT, missingness, changes and follow-up? Distinguish Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What are the details of ITT, missingness, changes and follow-up? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N25 · What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons?

Required materials and conditions: Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.
Conditions for verification: What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons? Distinguish Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N26 · What is the scope of 0 versus 0 clinically important transfusion-related complications?

Required materials and conditions: Event definitions, collection, periods, denominators, testing plans and follow-up material.
Conditions for verification: What is the scope of 0 versus 0 clinically important transfusion-related complications? Distinguish Event definitions, collection, periods, denominators, testing plans and follow-up material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Zero observed events are not changed into zero risk or safety noninferiority.
Why this condition is needed: What is the scope of 0 versus 0 clinically important transfusion-related complications? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N27 · What separate harm is the three-month anti-S alloantibody observation?

Required materials and conditions: Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.
Conditions for verification: What separate harm is the three-month anti-S alloantibody observation? Distinguish Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: One participant is not converted into a new 1/34 proportion or long-term disease value.
Why this condition is needed: What separate harm is the three-month anti-S alloantibody observation? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N28 · What remains unverified about acute/delayed haemolytic reactions and alloimmunization?

Required materials and conditions: Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.
Conditions for verification: What remains unverified about acute/delayed haemolytic reactions and alloimmunization? Distinguish Definitions, collection, denominators, ascertainment and long-term follow-up for each harm in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What remains unverified about acute/delayed haemolytic reactions and alloimmunization? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N29 · How much is known about harm collection, ascertainment, recurrence and causality adjudication?

Required materials and conditions: Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.
Conditions for verification: How much is known about harm collection, ascertainment, recurrence and causality adjudication? Distinguish Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is known about harm collection, ascertainment, recurrence and causality adjudication? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N30 · Are a safety imbalance and long-term harmlessness the same conclusion?

Required materials and conditions: Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.
Conditions for verification: Are a safety imbalance and long-term harmlessness the same conclusion? Distinguish Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Are a safety imbalance and long-term harmlessness the same conclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N31 · What were NHSBT public sponsorship, author employment and research roles?

Required materials and conditions: Original sponsorship, employment, research-role, data-access and COI disclosures.
Conditions for verification: What were NHSBT public sponsorship, author employment and research roles? Distinguish Original sponsorship, employment, research-role, data-access and COI disclosures in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Public funding is not changed into absence of research involvement.
Why this condition is needed: What were NHSBT public sponsorship, author employment and research roles? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N32 · What are the details of contracts, data access, publication and other COI?

Required materials and conditions: Original COI, contract, data-access, analysis and publication-role disclosures.
Conditions for verification: What are the details of contracts, data access, publication and other COI? Distinguish Original COI, contract, data-access, analysis and publication-role disclosures in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What are the details of contracts, data access, publication and other COI? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N33 · How is a single confirmatory report distinguished from additional independent replication?

Required materials and conditions: Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.
Conditions for verification: How is a single confirmatory report distinguished from additional independent replication? Distinguish Linkage material for new bibliography, registration, populations, designs, exposures and outcomes in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How is a single confirmatory report distinguished from additional independent replication? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N34 · Is the related case 1485 hydroxyurea verdict the same question?

Required materials and conditions: Disease, population, purpose, timepoint and intervention differences, with direct material.
Conditions for verification: Is the related case 1485 hydroxyurea verdict the same question? Distinguish Disease, population, purpose, timepoint and intervention differences, with direct material in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required for the boundary of the related question
Application exceptions: The citation’s JSON-path verification label is historical; it does not mean the link was checked or read here.
Why this condition is needed: Is the related case 1485 hydroxyurea verdict the same question? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N35 · Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies?

Required materials and conditions: Direct comparison material showing population, surgery and exposure-strategy differences.
Conditions for verification: Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies? Distinguish Direct comparison material showing population, surgery and exposure-strategy differences in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required for extending applicability
Application exceptions: No recommendations on transfusion suitability, methods, products, doses or surgical choice are made.
Why this condition is needed: Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N36 · Does a reduction in complications answer survival, quality of life and every long-term outcome?

Required materials and conditions: Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.
Conditions for verification: Does a reduction in complications answer survival, quality of life and every long-term outcome? Distinguish Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes in the original material and retain the limits of direct verification.
Requirement and applicability: Supplementary; required to extend to other outcomes
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: Does a reduction in complications answer survival, quality of life and every long-term outcome? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N37 · What remains unverified about prespecified subgroup, component and multiple-outcome effects?

Required materials and conditions: Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.
Conditions for verification: What remains unverified about prespecified subgroup, component and multiple-outcome effects? Distinguish Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: What remains unverified about prespecified subgroup, component and multiple-outcome effects? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N38 · How much is verified about transfusion/event timing and alternative factors?

Required materials and conditions: Baseline risk, actual exposure, care, changes, event timing and adjudication material.
Conditions for verification: How much is verified about transfusion/event timing and alternative factors? Distinguish Baseline risk, actual exposure, care, changes, event timing and adjudication material in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How much is verified about transfusion/event timing and alternative factors? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N39 · How are direct clinical outcomes, a large original effect and uncertainty preserved together?

Required materials and conditions: Relevant original outcome, design, follow-up, uncertainty and independent-material scope.
Conditions for verification: How are direct clinical outcomes, a large original effect and uncertainty preserved together? Distinguish Relevant original outcome, design, follow-up, uncertainty and independent-material scope in the original material and retain the limits of direct verification.
Requirement and applicability: Required
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Why this condition is needed: How are direct clinical outcomes, a large original effect and uncertainty preserved together? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

N40 · What is preserved when material, corrections or record-location displays are updated?

Required materials and conditions: Version relationships between new material, corrections, changed text, questions, conditions and observations.
Conditions for verification: What is preserved when material, corrections or record-location displays are updated? Distinguish Version relationships between new material, corrections, changed text, questions, conditions and observations in the original material and retain the limits of direct verification.
Requirement and applicability: Required (update boundaries)
Application exceptions: No new searches, calculations, grades or treatment/procedural guidance are created in this production.
Why this condition is needed: What is preserved when material, corrections or record-location displays are updated? This is needed to distinguish the relevant outcome, population and design from other scopes.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Awaiting user review, or actual review remains incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

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

The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was 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.

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N01 · What are the selected question and existing complete verdict record?

Current findings: The selected stored summary concerns reduced clinically important complications in low- and medium-risk surgery in sickle cell disease. The selected question and complete existing verdict record are distinguished. Candidate history is preserved without creating nonexistent subclaims.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The relationship between the original complete verdict and selected question remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; The relationship between the original complete verdict and selected question.
Required materials and conditions: The relationship between the original complete verdict and selected question.
Materials to obtain first: The relationship between the original complete verdict and selected question.
Further research: If the original question is corrected, the complete pre-change text, current verdict linkage and historical candidate records are preserved separately.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the selected question and existing complete verdict record? Distinguish The relationship between the original complete verdict and selected question in the original material and retain the limits of direct verification.
Why this condition is needed: What are the selected question and existing complete verdict record? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The existing complete verdict is not converted to a subquestion, and nonexistent subclaims are not created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N02 · What are the verdict’s actual grade, score, status and axes?

Current findings: Original grade B, score 76, axes B/H/R1/I2/E+/B0 and safety caution are used. An existing verification-status field is absent from the stored summary; that absence is recorded. A statement of absent subclaim scores is not applied to a verdict with its own score and axes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Existing verdict values, original wording and history remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Existing verdict values, original wording and history.
Required materials and conditions: Existing verdict values, original wording and history.
Materials to obtain first: Existing verdict values, original wording and history.
Further research: If a correction occurs, actual before/after values and reasons are preserved as a separate event.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the verdict’s actual grade, score, status and axes? Distinguish Existing verdict values, original wording and history in the original material and retain the limits of direct verification.
Why this condition is needed: What are the verdict’s actual grade, score, status and axes? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The verdict’s original values are preserved; this is not a new grade or score judgment.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N03 · What is the scope of null, false, empty values and the historical B0 decision?

Current findings: Original precision null, coprimary_split/big_hard_rct/no_human_study false and empty override_reason/override_reason_en strings are preserved. The original B0/B76 decision not to count safety stopping or the 70-person sample as defects is historical. No new criteria or review are run.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Versions of original axes, study assessment and correction history remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Versions of original axes, study assessment and correction history.
Required materials and conditions: Versions of original axes, study assessment and correction history.
Materials to obtain first: Versions of original axes, study assessment and correction history.
Further research: A separate reassessment request must distinguish original history from current production status.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the scope of null, false, empty values and the historical B0 decision? Distinguish Versions of original axes, study assessment and correction history in the original material and retain the limits of direct verification.
Why this condition is needed: What is the scope of null, false, empty values and the historical B0 decision? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Historical rules on fewer than 200 participants and stopping classification are not run as current automated checks.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N04 · How are Korean/English, the reference date, corrections and empty arrays preserved?

Current findings: Complete Korean/English articles, reference date 2026-08-26 and existing empty correction/subclaim/deliberation values are preserved. Stored cross-check/Primary-source cross-check wording is historical, not completed current review.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original wording, dates, corrections, structure and additional versions in each language remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original wording, dates, corrections, structure and additional versions in each language.
Required materials and conditions: Original wording, dates, corrections, structure and additional versions in each language.
Materials to obtain first: Original wording, dates, corrections, structure and additional versions in each language.
Further research: When original text or corrections are added, the complete pre-change text and a separate event are retained.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are Korean/English, the reference date, corrections and empty arrays preserved? Distinguish Original wording, dates, corrections, structure and additional versions in each language in the original material and retain the limits of direct verification.
Why this condition is needed: How are Korean/English, the reference date, corrections and empty arrays preserved? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N05 · What was actually read, and which external materials remain unread?

Current findings: The complete designated stored JSON was read for production. Abstracts, full texts, NCT/ISRCTN registration, protocols, SAPs, DSMC records and original tables were not accessed. Links, stored citations and historical review do not certify current external reading.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Acquisition/reading level for each material and locations of original results/plans remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Acquisition/reading level for each material and locations of original results/plans.
Required materials and conditions: Acquisition/reading level for each material and locations of original results/plans.
Materials to obtain first: Acquisition/reading level for each material and locations of original results/plans.
Further research: Any later direct reading must record its scope, time and version.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What was actually read, and which external materials remain unread? Distinguish Acquisition/reading level for each material and locations of original results/plans in the original material and retain the limits of direct verification.
Why this condition is needed: What was actually read, and which external materials remain unread? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Only URLs were written in the original preparation; no separate link/content checks were performed.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N06 · How are the TAPS bibliography and two registration identifiers linked?

Current findings: The direct report is TAPS, Howard J et al., Lancet 2013, PMID 23352054. Stored registration text is NCT00512577 · ISRCTN00862331; both identifiers link to one stored report. DOI, PMCID and registration content are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Bibliography, paper/registration versions and material linking them to the same trial remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Bibliography, paper/registration versions and material linking them to the same trial.
Required materials and conditions: Bibliography, paper/registration versions and material linking them to the same trial.
Materials to obtain first: Bibliography, paper/registration versions and material linking them to the same trial.
Further research: New reports/registration must distinguish identity, populations and relationships using source material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are the TAPS bibliography and two registration identifiers linked? Distinguish Bibliography, paper/registration versions and material linking them to the same trial in the original material and retain the limits of direct verification.
Why this condition is needed: How are the TAPS bibliography and two registration identifiers linked? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The two registration identifiers are not counted as two independent trials.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N07 · How is sharing across the trial, reports, populations and multiple outcomes maintained?

Current findings: One direct TAPS report contains clinically important complications, acute chest syndrome, SAEs, transfusion-related complications and alloantibodies. Shared people, groups, events or timepoints are not added as new independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Relationships/overlap between each outcome, trial, population, analysis set and follow-up remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Relationships/overlap between each outcome, trial, population, analysis set and follow-up.
Required materials and conditions: Relationships/overlap between each outcome, trial, population, analysis set and follow-up.
Materials to obtain first: Relationships/overlap between each outcome, trial, population, analysis set and follow-up.
Further research: Added follow-up/related reports must distinguish population sharing within the existing TAPS family.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How is sharing across the trial, reports, populations and multiple outcomes maintained? Distinguish Relationships/overlap between each outcome, trial, population, analysis set and follow-up in the original material and retain the limits of direct verification.
Why this condition is needed: How is sharing across the trial, reports, populations and multiple outcomes maintained? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: A direct report entry does not certify independent unique trial or participant totals.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N08 · What are the population and surgical risk scope?

Current findings: The verdict question concerns low-/medium-risk surgery in sickle cell disease. The stored summary lacks detailed ages, genotypes, surgical types, risk classification and eligibility/exclusions, so it is not automatically extended to all sickle cell disease or high-risk surgery.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.
Required materials and conditions: Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.
Materials to obtain first: Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk.
Further research: Other surgery/risk populations require direct comparison material for their own question.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the population and surgical risk scope? Distinguish Original tables of eligibility, exclusions, genotype, surgical risk/type and baseline risk in the original material and retain the limits of direct verification.
Why this condition is needed: What are the population and surgical risk scope? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Ages, genotypes and risk criteria absent from the original are not filled in.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N09 · How much is verified about baseline disease risk, representativeness and clinical setting?

Current findings: The current summary lacks disease severity, baseline haemoglobin, previous transfusions, antibodies, comorbidities, recruitment setting and group distributions. The population name and original effect do not guide transfusion suitability for an individual patient.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.
Required materials and conditions: Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.
Materials to obtain first: Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material.
Further research: General application requires direct material showing actual population differences.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is verified about baseline disease risk, representativeness and clinical setting? Distinguish Baseline characteristics, recruitment, distribution, surgery, concurrent care and risk material in the original material and retain the limits of direct verification.
Why this condition is needed: How much is verified about baseline disease risk, representativeness and clinical setting? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N10 · What was the original study exposure to preoperative red-cell transfusion?

Current findings: The intervention is preoperative red-cell transfusion. The current summary lacks actual methods, units, targets, timing, antigen matching, changes and adherence. No transfusion procedure, dose, target or suitability recommendations are created.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Trial transfusion strategy, actual implementation, products, exposure and change records remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Trial transfusion strategy, actual implementation, products, exposure and change records.
Required materials and conditions: Trial transfusion strategy, actual implementation, products, exposure and change records.
Materials to obtain first: Trial transfusion strategy, actual implementation, products, exposure and change records.
Further research: Effects of other transfusion strategies must be distinguished using direct comparison material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What was the original study exposure to preoperative red-cell transfusion? Distinguish Trial transfusion strategy, actual implementation, products, exposure and change records in the original material and retain the limits of direct verification.
Why this condition is needed: What was the original study exposure to preoperative red-cell transfusion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new Hb targets, exchange/simple transfusion methods, administration schedules or doses are written.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N11 · What are the no-transfusion control and concurrent surgical/care conditions?

Current findings: The stored comparison is transfusion versus no transfusion, while the reported OR is no transfusion versus transfusion. Actual surgery, anaesthesia, concurrent care, transfusion changes and rescue treatment details are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original control, concurrent care, surgery, actual transfusion changes and timing material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original control, concurrent care, surgery, actual transfusion changes and timing material.
Required materials and conditions: Original control, concurrent care, surgery, actual transfusion changes and timing material.
Materials to obtain first: Original control, concurrent care, surgery, actual transfusion changes and timing material.
Further research: Actual strategy implementation material is required to address exposure differences and concurrent-care effects.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the no-transfusion control and concurrent surgical/care conditions? Distinguish Original control, concurrent care, surgery, actual transfusion changes and timing material in the original material and retain the limits of direct verification.
Why this condition is needed: What are the no-transfusion control and concurrent surgical/care conditions? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No transfusion is not extended to no lifetime transfusion history or to waiting/treatment recommendations.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N12 · What were the actual procedures of the multicentre randomized sequential superiority trial?

Current findings: The original design is a multicentre randomized sequential superiority trial. The current summary lacks sequence generation, concealment, stratification, centre implementation and assessment blinding details. Original B0 is not inherited as direct procedural verification.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original allocation, concealment, assessor, centre and sequential-design plans/procedures remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original allocation, concealment, assessor, centre and sequential-design plans/procedures.
Required materials and conditions: Original allocation, concealment, assessor, centre and sequential-design plans/procedures.
Materials to obtain first: Original allocation, concealment, assessor, centre and sequential-design plans/procedures.
Further research: Added design details must distinguish original reports/historical assessments from actual verification.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What were the actual procedures of the multicentre randomized sequential superiority trial? Distinguish Original allocation, concealment, assessor, centre and sequential-design plans/procedures in the original material and retain the limits of direct verification.
Why this condition is needed: What were the actual procedures of the multicentre randomized sequential superiority trial? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N13 · How do planned 405, enrolled 70 and ITT 67 differ?

Current findings: Of a planned 405 participants, 70 were enrolled and 67 analyzed by ITT. Original planned, enrolled and analyzed counts are distinguished. Enrolled 70 is not changed to a completed-randomization count beyond the stored summary, and no differences or proportions are calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.
Required materials and conditions: Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.
Materials to obtain first: Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions.
Further research: An original flow diagram showing actual analysis-population pathways is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How do planned 405, enrolled 70 and ITT 67 differ? Distinguish Recruitment, allocation, surgery, follow-up and ITT flow; exclusions, missingness and group definitions in the original material and retain the limits of direct verification.
Why this condition is needed: How do planned 405, enrolled 70 and ITT 67 differ? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new lost/excluded participant counts or recruitment completion rates are calculated from current numbers.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N14 · What are the events, groups and denominators in 13/33 and 5/34?

Current findings: Clinically important complications were no transfusion 13/33 (39%) versus transfusion 5/34 (15%). These are original group values for the same verdict, not mixed with separate acute chest syndrome or SAE measures.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.
Required materials and conditions: Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.
Materials to obtain first: Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions.
Further research: Added direct outcome material must link each event to its group denominator.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the events, groups and denominators in 13/33 and 5/34? Distinguish Original outcome tables, analysis populations, event adjudication, overlap and follow-up definitions in the original material and retain the limits of direct verification.
Why this condition is needed: What are the events, groups and denominators in 13/33 and 5/34? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N15 · What are the direction and interval of the no-transfusion versus transfusion OR?

Current findings: Reported no-transfusion versus transfusion OR: 3.8 (95% CI 1.2–12.2). Its direction is retained, without conversion to a transfusion versus no-transfusion OR, RR, HR or survival outcome. No P value or other effect absent from the stored summary is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Details of the original OR model, analysis population, adjustment and interval remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Details of the original OR model, analysis population, adjustment and interval.
Required materials and conditions: Details of the original OR model, analysis population, adjustment and interval.
Materials to obtain first: Details of the original OR model, analysis population, adjustment and interval.
Further research: The original explanation of the estimand, direction and scale is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the direction and interval of the no-transfusion versus transfusion OR? Distinguish Details of the original OR model, analysis population, adjustment and interval in the original material and retain the limits of direct verification.
Why this condition is needed: What are the direction and interval of the no-transfusion versus transfusion OR? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The OR is not converted to its reciprocal, a risk ratio or a new relative reduction.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N16 · What is the original comparison behind the absolute difference of -24 percentage points?

Current findings: The original absolute difference of -24 percentage points is preserved in the context of important surgical complications: no transfusion 39% versus transfusion 15%. No new absolute difference, NNT, treated-person example or interval is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original absolute-effect population, time, analysis and interval remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original absolute-effect population, time, analysis and interval.
Required materials and conditions: Original absolute-effect population, time, analysis and interval.
Materials to obtain first: Original absolute-effect population, time, analysis and interval.
Further research: Added original explanations should link the absolute effect to its relevant scope.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the original comparison behind the absolute difference of -24 percentage points? Distinguish Original absolute-effect population, time, analysis and interval in the original material and retain the limits of direct verification.
Why this condition is needed: What is the original comparison behind the absolute difference of -24 percentage points? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original absolute values are not copied to long-term survival or effects in other surgery.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N17 · What is the observation window for clinically important complications?

Current findings: The endpoint runs from randomization through 30 days after surgery. Thirty days after surgery is distinguished from the transfusion group’s three-month alloantibody observation; the complication window is not changed to simply 30 days after enrollment.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.
Required materials and conditions: Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.
Materials to obtain first: Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring.
Further research: Outcomes at each timepoint must be linked to their relevant analysis windows.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the observation window for clinically important complications? Distinguish Original outcome-specific starting points, surgery dates, risk periods, follow-up and censoring in the original material and retain the limits of direct verification.
Why this condition is needed: What is the observation window for clinically important complications? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N18 · How much is known about important complication definitions, components and adjudication?

Current findings: The original important-complication definition and some acute chest syndrome/SAE values are available, but full components, overlap, first events, severity, assessors, blinding and ascertainment details are unverified. Equal reductions in all components are not newly established.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Complication components, severity, adjudication, overlap, original outcomes and plans remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Complication components, severity, adjudication, overlap, original outcomes and plans.
Required materials and conditions: Complication components, severity, adjudication, overlap, original outcomes and plans.
Materials to obtain first: Complication components, severity, adjudication, overlap, original outcomes and plans.
Further research: Direct material presenting the composite and individual components side by side is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is known about important complication definitions, components and adjudication? Distinguish Complication components, severity, adjudication, overlap, original outcomes and plans in the original material and retain the limits of direct verification.
Why this condition is needed: How much is known about important complication definitions, components and adjudication? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N19 · What separate outcome is acute chest syndrome in 9 versus 1 participants?

Current findings: Original acute chest syndrome counts are 9 versus 1 participants. The no-transfusion versus transfusion context is retained; absent denominators, proportions, effects, CIs or P values for that outcome are not calculated from other outcome numbers.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. The event definition, original tables, denominators, periods and between-group analyses remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; The event definition, original tables, denominators, periods and between-group analyses.
Required materials and conditions: The event definition, original tables, denominators, periods and between-group analyses.
Materials to obtain first: The event definition, original tables, denominators, periods and between-group analyses.
Further research: Direct material for each component must be linked separately from the composite outcome.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What separate outcome is acute chest syndrome in 9 versus 1 participants? Distinguish The event definition, original tables, denominators, periods and between-group analyses in the original material and retain the limits of direct verification.
Why this condition is needed: What separate outcome is acute chest syndrome in 9 versus 1 participants? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The 9 and 1 participants are not added independently to SAEs or total complications as separate events/people.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N20 · What are the original serious adverse event counts, denominators and proportions?

Current findings: SAEs were no transfusion 10/33 (30%) versus transfusion 1/34 (3%). These outcomes come from the same trial as complications and acute chest syndrome; detailed overlap is unverified. No new effect, CI or P value is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. SAE definitions, periods, calculation, overlap, group tables and plans remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; SAE definitions, periods, calculation, overlap, group tables and plans.
Required materials and conditions: SAE definitions, periods, calculation, overlap, group tables and plans.
Materials to obtain first: SAE definitions, periods, calculation, overlap, group tables and plans.
Further research: Direct material on the reason for safety stopping and original SAE analysis is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the original serious adverse event counts, denominators and proportions? Distinguish SAE definitions, periods, calculation, overlap, group tables and plans in the original material and retain the limits of direct verification.
Why this condition is needed: What are the original serious adverse event counts, denominators and proportions? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: SAEs and important complication events are not independently added together.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N21 · How did the first planned interim analysis differ from the later unplanned safety analysis?

Current findings: At the first planned interim analysis, no stopping boundaries had been crossed and the trial continued. The original sequence is retained: an unexpected SAE imbalance later led the DSMC to request an unscheduled interim analysis and recommend stopping for safety.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.
Required materials and conditions: Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.
Materials to obtain first: Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records.
Further research: Added original decision material must separately record plans, actual events and interpretation.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How did the first planned interim analysis differ from the later unplanned safety analysis? Distinguish Prespecified sequential plans, interim results, DSMC decisions, dates and stopping records in the original material and retain the limits of direct verification.
Why this condition is needed: How did the first planned interim analysis differ from the later unplanned safety analysis? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The trial is not re-described as stopping for efficacy after crossing the first planned boundary.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N22 · How are safety stopping and the original B0/sample-size defect treatment related?

Current findings: The historical assessment says stopping was not at a prespecified primary-endpoint boundary and the safety stop was unavoidable, so early stopping and fewer than 200 participants were not counted as defects. This history is preserved alongside the facts: enrolled 70, ITT 67 and planned 405.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Stopping circumstances, original verdict rationale and actual plans/analyses remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Stopping circumstances, original verdict rationale and actual plans/analyses.
Required materials and conditions: Stopping circumstances, original verdict rationale and actual plans/analyses.
Materials to obtain first: Stopping circumstances, original verdict rationale and actual plans/analyses.
Further research: A separate correction to the original decision must preserve before/after wording and reasons.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are safety stopping and the original B0/sample-size defect treatment related? Distinguish Stopping circumstances, original verdict rationale and actual plans/analyses in the original material and retain the limits of direct verification.
Why this condition is needed: How are safety stopping and the original B0/sample-size defect treatment related? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new sample-size criteria, bias grades or defect scores are calculated.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N23 · What effect-size uncertainty arises from the small sample and early termination?

Current findings: The original counterpoint says the small sample and early termination may have overestimated the effect size. The original OR 95% CI width, 1.2–12.2, is preserved without new precision-axis or reliability scores.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.
Required materials and conditions: Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.
Materials to obtain first: Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material.
Further research: Direct comparison material with independent replication and sufficient events/follow-up is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What effect-size uncertainty arises from the small sample and early termination? Distinguish Original effect estimation, sequential analysis, stopping, sensitivity and independent outcome material in the original material and retain the limits of direct verification.
Why this condition is needed: What effect-size uncertainty arises from the small sample and early termination? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Uncertainty is not converted into deletion of the original positive result or a new null verdict.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N24 · What are the details of ITT, missingness, changes and follow-up?

Current findings: ITT 67 and group counts 33/34 are preserved. Enrollment, analysis inclusion, surgery not performed, treatment changes, missingness, follow-up and analysis handling details are unverified. Group results are not assigned a denominator of all enrollees.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.
Required materials and conditions: Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.
Materials to obtain first: Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses.
Further research: Material linking the planned estimand to the actual analysis population is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the details of ITT, missingness, changes and follow-up? Distinguish Original flow diagrams, ITT definitions, changes, missingness, follow-up and sensitivity analyses in the original material and retain the limits of direct verification.
Why this condition is needed: What are the details of ITT, missingness, changes and follow-up? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N25 · What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons?

Current findings: Historical explanations of the randomized sequential superiority trial and interim analyses are preserved. Actual registration/protocol/SAP details of primary-outcome hierarchy, stopping rules, multiple comparisons, adjustment and analysis versions remain unread.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.
Required materials and conditions: Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.
Materials to obtain first: Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy.
Further research: Any later comparison of prespecified plans with reports must retain its actual scope.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons? Distinguish Registration, protocol, SAP and DSMC document versions, changes, hypotheses and hierarchy in the original material and retain the limits of direct verification.
Why this condition is needed: What is verified about the prespecified primary endpoint, sequential boundaries and multiple comparisons? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N26 · What is the scope of 0 versus 0 clinically important transfusion-related complications?

Current findings: The original description of zero clinically important transfusion-related complications in both TAPS groups is preserved. The stored summary did not test this comparison, so no between-group significance wording is used and not all transfusion harms are established as absent or harmless.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Event definitions, collection, periods, denominators, testing plans and follow-up material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Event definitions, collection, periods, denominators, testing plans and follow-up material.
Required materials and conditions: Event definitions, collection, periods, denominators, testing plans and follow-up material.
Materials to obtain first: Event definitions, collection, periods, denominators, testing plans and follow-up material.
Further research: Rare transfusion harms require material with sufficient exposure, collection and follow-up.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is the scope of 0 versus 0 clinically important transfusion-related complications? Distinguish Event definitions, collection, periods, denominators, testing plans and follow-up material in the original material and retain the limits of direct verification.
Why this condition is needed: What is the scope of 0 versus 0 clinically important transfusion-related complications? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Zero observed events are not changed into zero risk or safety noninferiority.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N27 · What separate harm is the three-month anti-S alloantibody observation?

Current findings: One participant in the transfusion group developed an anti-S red-cell alloantibody at three months. This is separate from the primary complication window through 30 days after surgery. Incidence, between-group effects, P values or CIs absent from the summary are not calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.
Required materials and conditions: Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.
Materials to obtain first: Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence.
Further research: Long-term alloimmunization effects require direct ascertainment, comparison and follow-up material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What separate harm is the three-month anti-S alloantibody observation? Distinguish Original antibody tests, follow-up, group collection, denominators, clinical impact and persistence in the original material and retain the limits of direct verification.
Why this condition is needed: What separate harm is the three-month anti-S alloantibody observation? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: One participant is not converted into a new 1/34 proportion or long-term disease value.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N28 · What remains unverified about acute/delayed haemolytic reactions and alloimmunization?

Current findings: The original counterview explains alloimmunization and acute/delayed haemolytic transfusion reaction risks. Beyond TAPS important complications 0 versus 0 and one anti-S participant, detailed frequencies, ascertainment and long-term results for each harm are unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Definitions, collection, denominators, ascertainment and long-term follow-up for each harm remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.
Required materials and conditions: Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.
Materials to obtain first: Definitions, collection, denominators, ascertainment and long-term follow-up for each harm.
Further research: Material documenting actual harm collection/ascertainment and direct clinical impact is needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What remains unverified about acute/delayed haemolytic reactions and alloimmunization? Distinguish Definitions, collection, denominators, ascertainment and long-term follow-up for each harm in the original material and retain the limits of direct verification.
Why this condition is needed: What remains unverified about acute/delayed haemolytic reactions and alloimmunization? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N29 · How much is known about harm collection, ascertainment, recurrence and causality adjudication?

Current findings: Some original transfusion-harm/SAE values are available, but collection, assessors, severity, recurrence, event relatedness, risk periods and safety-denominator details are unverified. Observed events are distinguished from established causality.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.
Required materials and conditions: Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.
Materials to obtain first: Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up.
Further research: Harm signals must be supplemented by actual exposure, timing, ascertainment and alternative-factor material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is known about harm collection, ascertainment, recurrence and causality adjudication? Distinguish Original safety tables, collection, relatedness adjudication, recurrence, denominators and follow-up in the original material and retain the limits of direct verification.
Why this condition is needed: How much is known about harm collection, ascertainment, recurrence and causality adjudication? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N30 · Are a safety imbalance and long-term harmlessness the same conclusion?

Current findings: The historical recommendation to stop for safety following an SAE imbalance in the no-transfusion group is retained alongside harms of transfusion itself. A signal of comparative advantage does not establish harmlessness for every patient/long-term transfusion or suitability for every surgery.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.
Required materials and conditions: Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.
Materials to obtain first: Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event.
Further research: Long-term/rare transfusion harms and clinical benefits each require direct material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Are a safety imbalance and long-term harmlessness the same conclusion? Distinguish Safety hypotheses, decisions, long-term follow-up and comparisons for each exposure, group and event in the original material and retain the limits of direct verification.
Why this condition is needed: Are a safety imbalance and long-term harmlessness the same conclusion? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N31 · What were NHSBT public sponsorship, author employment and research roles?

Current findings: NHS Blood and Transplant sponsored the trial; five authors were employed by NHSBT. Original information that NHSBT and the MRC Clinical Studies Unit performed design, data collection, analysis and interpretation is retained. Public funding and actual involvement are shown together.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Original sponsorship, employment, research-role, data-access and COI disclosures remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original sponsorship, employment, research-role, data-access and COI disclosures.
Required materials and conditions: Original sponsorship, employment, research-role, data-access and COI disclosures.
Materials to obtain first: Original sponsorship, employment, research-role, data-access and COI disclosures.
Further research: Added role disclosures must record actual involvement and analysis/data relationships.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What were NHSBT public sponsorship, author employment and research roles? Distinguish Original sponsorship, employment, research-role, data-access and COI disclosures in the original material and retain the limits of direct verification.
Why this condition is needed: What were NHSBT public sponsorship, author employment and research roles? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Public funding is not changed into absence of research involvement.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N32 · What are the details of contracts, data access, publication and other COI?

Current findings: The summary describes sponsorship, author employment, design, collection, analysis and interpretation, but contract, data-access, publication-decision and other conflict details are unverified. Original I2 is not inherited as new analysis-independence certification.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Original COI, contract, data-access, analysis and publication-role disclosures remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original COI, contract, data-access, analysis and publication-role disclosures.
Required materials and conditions: Original COI, contract, data-access, analysis and publication-role disclosures.
Materials to obtain first: Original COI, contract, data-access, analysis and publication-role disclosures.
Further research: Claims of broader independence require actual data-sharing, involvement and analysis-relationship material.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What are the details of contracts, data access, publication and other COI? Distinguish Original COI, contract, data-access, analysis and publication-role disclosures in the original material and retain the limits of direct verification.
Why this condition is needed: What are the details of contracts, data access, publication and other COI? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N33 · How is a single confirmatory report distinguished from additional independent replication?

Current findings: The evidence weight describes a single small confirmatory trial, and the original overall summary says independent replication is needed. One direct report, two registrations and multiple outcomes are not added as new independent replications. Additional direct trials are unverified in the current input.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Linkage material for new bibliography, registration, populations, designs, exposures and outcomes remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.
Required materials and conditions: Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.
Materials to obtain first: Linkage material for new bibliography, registration, populations, designs, exposures and outcomes.
Further research: Added independent results must first distinguish population/report sharing with existing TAPS.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How is a single confirmatory report distinguished from additional independent replication? Distinguish Linkage material for new bibliography, registration, populations, designs, exposures and outcomes in the original material and retain the limits of direct verification.
Why this condition is needed: How is a single confirmatory report distinguished from additional independent replication? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N34 · Is the related case 1485 hydroxyurea verdict the same question?

Current findings: Case 1485 concerns routine prevention of vaso-occlusive complications in adults with sickle cell anaemia, linked with historical B77. Its population and purpose differ from preparation for low-/medium-risk surgery here. That page was not read and is not counted as a direct TAPS report or new trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Disease, population, purpose, timepoint and intervention differences, with direct material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Disease, population, purpose, timepoint and intervention differences, with direct material.
Required materials and conditions: Disease, population, purpose, timepoint and intervention differences, with direct material.
Materials to obtain first: Disease, population, purpose, timepoint and intervention differences, with direct material.
Further research: Related questions are not combined solely because they name the same disease; differences in conditions and purpose are retained.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Is the related case 1485 hydroxyurea verdict the same question? Distinguish Disease, population, purpose, timepoint and intervention differences, with direct material in the original material and retain the limits of direct verification.
Why this condition is needed: Is the related case 1485 hydroxyurea verdict the same question? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: The citation’s JSON-path verification label is historical; it does not mean the link was checked or read here.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources

N35 · Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies?

Current findings: The current verdict preserves the original preoperative transfusion comparison in low-/medium-risk surgery. Benefits/harms for other surgical risks, disease types, ages, baseline antibodies or transfusion strategies are not automatically established as identical. Relevant direct material is unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Direct comparison material showing population, surgery and exposure-strategy differences remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct comparison material showing population, surgery and exposure-strategy differences.
Required materials and conditions: Direct comparison material showing population, surgery and exposure-strategy differences.
Materials to obtain first: Direct comparison material showing population, surgery and exposure-strategy differences.
Further research: Clinical outcomes under other conditions must be distinguished using their relevant populations, strategies and follow-up.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies? Distinguish Direct comparison material showing population, surgery and exposure-strategy differences in the original material and retain the limits of direct verification.
Why this condition is needed: Can the findings be extended to other surgical risks, genotypes, ages or transfusion strategies? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No recommendations on transfusion suitability, methods, products, doses or surgical choice are made.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N36 · Does a reduction in complications answer survival, quality of life and every long-term outcome?

Current findings: Original results for actual clinically important surgical complications are preserved. Direct long-term survival, quality-of-life, all-complication and routine disease-control values are absent, so they do not substitute for those separate questions.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.
Required materials and conditions: Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.
Materials to obtain first: Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes.
Further research: Broader clinical-outcome scope requires direct outcome material for each question.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: Does a reduction in complications answer survival, quality of life and every long-term outcome? Distinguish Direct definitions, comparisons, denominators and follow-up for long-term, patient-reported and other clinical outcomes in the original material and retain the limits of direct verification.
Why this condition is needed: Does a reduction in complications answer survival, quality of life and every long-term outcome? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N37 · What remains unverified about prespecified subgroup, component and multiple-outcome effects?

Current findings: Total important complications and some event counts are preserved, but group-specific subgroup/component plans, precision, interactions and multiple-comparison details are unverified. The overall OR is not copied to every component/population.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.
Required materials and conditions: Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.
Materials to obtain first: Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables.
Further research: Direct material answering each outcome/subgroup and prespecified plans are needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What remains unverified about prespecified subgroup, component and multiple-outcome effects? Distinguish Prespecified subgroups, components, hierarchy, multiple comparisons and original analysis tables in the original material and retain the limits of direct verification.
Why this condition is needed: What remains unverified about prespecified subgroup, component and multiple-outcome effects? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

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N38 · How much is verified about transfusion/event timing and alternative factors?

Current findings: Detailed timing between underlying disease, previous transfusions, concurrent care, surgery type, changes and events is unverified. Randomized strategy comparisons are distinguished from attributing every individual event to a single cause.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Required direct details are unverified within the current summary and unread external material. Baseline risk, actual exposure, care, changes, event timing and adjudication material remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Baseline risk, actual exposure, care, changes, event timing and adjudication material.
Required materials and conditions: Baseline risk, actual exposure, care, changes, event timing and adjudication material.
Materials to obtain first: Baseline risk, actual exposure, care, changes, event timing and adjudication material.
Further research: Interpreting harms and clinical course requires direct records, ascertainment and comparisons.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How much is verified about transfusion/event timing and alternative factors? Distinguish Baseline risk, actual exposure, care, changes, event timing and adjudication material in the original material and retain the limits of direct verification.
Why this condition is needed: How much is verified about transfusion/event timing and alternative factors? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N39 · How are direct clinical outcomes, a large original effect and uncertainty preserved together?

Current findings: Original B76 and wording of a large important-complication reduction, actual events 13/33 versus 5/34 and the OR direction/interval are preserved. Small sample, safety stopping, transfusion harms and the need for independent replication remain limitations.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Relevant original outcome, design, follow-up, uncertainty and independent-material scope remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Relevant original outcome, design, follow-up, uncertainty and independent-material scope.
Required materials and conditions: Relevant original outcome, design, follow-up, uncertainty and independent-material scope.
Materials to obtain first: Relevant original outcome, design, follow-up, uncertainty and independent-material scope.
Further research: Additional material directly addressing clinical benefits and harms is separately needed.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: How are direct clinical outcomes, a large original effect and uncertainty preserved together? Distinguish Relevant original outcome, design, follow-up, uncertainty and independent-material scope in the original material and retain the limits of direct verification.
Why this condition is needed: How are direct clinical outcomes, a large original effect and uncertainty preserved together? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: Original stored information is distinguished from unread external material. No numbers, calculations or new verdicts beyond the source are created.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01

N40 · What is preserved when material, corrections or record-location displays are updated?

Current findings: The existing complete verdict, selected question, candidate history, Korean/English articles, dates and empty correction-history values are retained. New material must separate the complete pre-change stored summary, version/reason, condition changes and separate application of observations.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; clinical confirmation/content review is not complete. Version relationships between new material, corrections, changed text, questions, conditions and observations remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Version relationships between new material, corrections, changed text, questions, conditions and observations.
Required materials and conditions: Version relationships between new material, corrections, changed text, questions, conditions and observations.
Materials to obtain first: Version relationships between new material, corrections, changed text, questions, conditions and observations.
Further research: Separately added follow-up material must retain report/population sharing and the user-review scope.
Remaining uncertainty: Absence or unread external material does not mean zero effect, zero events, no paper, failed access or a new verdict.
Conditions for verification: What is preserved when material, corrections or record-location displays are updated? Distinguish Version relationships between new material, corrections, changed text, questions, conditions and observations in the original material and retain the limits of direct verification.
Why this condition is needed: What is preserved when material, corrections or record-location displays are updated? This is needed to distinguish the relevant outcome, population and design from other scopes.
Application exceptions: No new searches, calculations, grades or treatment/procedural guidance are created in this production.
Referenced methods: Study-family condition definitions linked to the stored original; no official clinical method assessment was run.

Related sources R01