Evidence map›Paper›PMID 25230735›Full record

Trial reportTrials2014

The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial.

Carmel Moore, Jennifer Sambrook, Matthew Walker, Zoe Tolkien, Stephen Kaptoge, David Allen, Susan Mehenny, Jonathan Mant, Emanuele Di Angelantonio, Simon G Thompson and 3 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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21 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Carmel Moore
Jennifer Sambrook
Matthew Walker
Zoe Tolkien
Stephen Kaptoge
David Allen
Susan Mehenny
Jonathan Mant
Emanuele Di Angelantonio
Simon G Thompson
Willem Ouwehand
David J Roberts
John DaneshDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge CB1 8RN, UK. interval@medschl.cam.ac.uk.

Funding

British Heart Foundation RG/08/014/24067British Heart Foundation RG/09/012/28096Department of Health RP-PG-0310-1002Department of Health RP-PG-0310-1004Medical Research Council MC_QA137933Medical Research Council MR/L003120/1
6 · The paper itself

Abstract

backgroundAgeing populations may demand more blood transfusions, but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors. One approach to increase blood supply is to collect blood more frequently from existing donors. If more donations could be safely collected in this manner at marginal cost, then it would be of considerable benefit to blood services. National Health Service (NHS) Blood and Transplant in England currently allows men to donate up to every 12 weeks and women to donate up to every 16 weeks. In contrast, some other European countries allow donations as frequently as every 8 weeks for men and every 10 weeks for women. The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors. METHODS/

designINTERVAL is a randomised trial of whole blood donors enrolled from all 25 static centres of NHS Blood and Transplant. Recruitment of about 50,000 male and female donors started in June 2012 and was completed in June 2014. Men have been randomly assigned to standard 12-week versus 10-week versus 8-week inter-donation intervals, while women have been assigned to standard 16-week versus 14-week versus 12-week inter-donation intervals. Sex-specific comparisons will be made by intention-to-treat analysis of outcomes assessed after two years of intervention. The primary outcome is the number of blood donations made. A key secondary outcome is donor quality of life, assessed using the Short Form Health Survey. Additional secondary endpoints include the number of 'deferrals' due to low haemoglobin (and other factors), iron status, cognitive function, physical activity, and donor attitudes. A comprehensive health economic analysis will be undertaken. DISCUSSION: The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply, acceptability, and donors' physical and mental well-being. The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere.

trial registrationCurrent Controlled Trials ISRCTN24760606, 25 January 2012.

Indexed as

Blood TransfusionResearch DesignBlood DonorsClinical ProtocolsDonor SelectionEnglandFemaleHealth StatusHumansIntention to Treat AnalysisMaleMiddle AgedPatient SafetyQuality of LifeRisk AssessmentRisk Factors

Identifiers

PMID25230735
PMCPMC4177700

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.