Evidence map›Paper›PMID 27645285›Full record

Trial reportTrials2016

Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals.

Carmel Moore, Thomas Bolton, Matthew Walker, Stephen Kaptoge, David Allen, Michael Daynes, Susan Mehenny, Jennifer Sambrook, Nicholas A Watkins, Gail Miflin and 5 more

Abstract readComparative StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Carmel MooreDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN, UK.
Thomas BoltonDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN, UK.
Matthew WalkerDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN, UK.
Stephen KaptogeDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN, UK.
David AllenNHS Blood and Transplant - Oxford Centre, Level 2, John Radcliffe Hospital, Headley Way, Oxford, OX3 9BQ, UK.
Michael DaynesNHS Blood and Transplant, Northway, Filton, Bristol, BS34 7QH, UK.
Susan MehennyNHS Blood and Transplant, Longley Lane, Sheffield, S5 7JN, UK.
Jennifer SambrookDepartment of Haematology, University of Cambridge, Cambridge Biomedical Campus, Long Road, Cambridge, CB2 OPT, UK.
Nicholas A WatkinsNHS Blood and Transplant, Cambridge Biomedical Campus, Long Road, Cambridge, CB2 OPT, UK.
Gail MiflinNHS Blood and Transplant, Reeds Crescent, Watford, Herts, WD24 4QN, UK.
Emanuele Di AngelantonioDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN, UK.
Willem H OuwehandDepartment of Haematology, University of Cambridge, Cambridge Biomedical Campus, Long Road, Cambridge, CB2 OPT, UK.
David J RobertsNHS Blood and Transplant - Oxford Centre, Level 2, John Radcliffe Hospital, Headley Way, Oxford, OX3 9BQ, UK.
John DaneshDepartment of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN, UK.
Simon G ThompsonDepartment 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/09/012/28096British Heart Foundation RG/13/13/30194Department 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

backgroundThe interpretation of trial results can be helped by understanding how generalisable they are to the target population for which inferences are intended. INTERVAL, a large pragmatic randomised trial of blood donors in England, is assessing the effectiveness and safety of reducing inter-donation intervals. The trial recruited mainly from the blood service's static centres, which collect only about 10 % of whole-blood donations. Hence, the extent to which the trial's participants are representative of the general blood donor population is uncertain. We compare these groups in detail.

methodsWe present the CONSORT flowchart from participant invitation to randomisation in INTERVAL. We compare the characteristics of those eligible and consenting to participate in INTERVAL with the general donor population, using the national blood supply 'PULSE' database for the period of recruitment. We compare the characteristics of specific groups of trial participants recruited from different sources, as well as those who were randomised versus those not randomised.

resultsFrom a total of 540,459 invitations, 48,725 donors were eligible and consented to participate in INTERVAL. The proportion of such donors varied from 1-22 % depending on the source of recruitment. The characteristics of those consenting were similar to those of the general population of 1.3 million donors in terms of ethnicity, blood group distribution and recent deferral rates from blood donation due to low haemoglobin. However, INTERVAL participants included more men (50 % versus 44 %), were slightly older (mean age 43.1 versus 42.3 years), included fewer new donors (3 % versus 22 %) and had given more donations over the previous 2 years (mean 3.3 versus 2.2) than the general donor population. Of the consenting participants, 45,263 (93 %) donors were randomised. Compared to those not randomised, the randomised donors showed qualitatively similar differences to those described above.

conclusionsThere was broad similarity of participants in INTERVAL with the general blood donor population of England, notwithstanding some differences in age, sex and donation history. Any heterogeneity of the trial's results according to these characteristics will need to be studied to ensure its generalisability to the general donor population.

trial registrationCurrent Controlled Trials ISRCTN24760606 . Registered on 25 January 2012.

Indexed as

Patient SelectionAdolescentAdultAgedBlood BanksBlood DonorsDonor SelectionEnglandFemaleHealth StatusHumansMaleMiddle AgedTime FactorsYoung AdultBlood donationBlood donorsGeneralisabilityRandomised trialRecruitmentRepresentativeness

Identifiers

PMID27645285
PMCPMC5029021

What OpenQuestion holds

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LicenceCC BY
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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.