dedup_wf_001--7ce94e12540f704a601fcc6fb68c07cd

Background Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. Methods A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. Results Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77–1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71–1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65–1.31, p = 0.65)). Conclusions This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. Trial registration International Standard Randomised Controlled Trials Number registry, ISRCTN68240461. Registered on 01 July 2011. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1797-7) contains supplementary material, which is available to authorized users.

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PID https://www.doi.org/10.1186/s13063-017-1797-7
PID pmid:28351376
PID urn:uri:4d2e7233-5568-41e1-aaef-8f398d01af4d
PID pmc:PMC5370466
PID https://www.doi.org/10.17863/cam.9433
URL https://core.ac.uk/display/80840952
URL https://eprints.ncl.ac.uk/245306
URL http://link.springer.com/article/10.1186/s13063-017-1797-7
URL https://doi.org/10.1186/s13063-017-1797-7
URL https://figshare.com/collections/An_optimised_patient_information_sheet_did_not_significantly_increase_recruitment_or_retention_in_a_falls_prevention_study_an_embedded_randomised_recruitment_trial/3728689/1
URL https://www.ndorms.ox.ac.uk/publications/688728
URL http://europepmc.org/articles/PMC5370466
URL https://rehabresearch.ndorms.ox.ac.uk/publications/688728
URL http://eprints.whiterose.ac.uk/115012/1/art_10.1186_s13063-017-1797-7.pdf
URL http://eprints.whiterose.ac.uk/114683/1/art_3A10.1186_2Fs13063_017_1797_7.pdf
URL http://ora.ox.ac.uk/objects/uuid:
URL http://eprints.whiterose.ac.uk/114683/
URL https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-017-1797-7
URL https://www.octru.ox.ac.uk/publications/688728
URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1797-7
URL http://www.scopus.com/inward/record.url?scp=85016482306&partnerID=8YFLogxK
URL https://www.clahrc-oxford.nihr.ac.uk/publications/688728
URL http://dx.doi.org/10.17863/cam.9433
URL https://www.research.manchester.ac.uk/portal/en/publications/an-optimised-patient-information-sheet-did-not-significantly-increase-recruitment-or-retention-in-a-falls-prevention-study(ca763c9c-e51d-4d24-a36e-99093b52323a).html
URL http://link.springer.com/content/pdf/10.1186/s13063-017-1797-7.pdf
URL https://dx.doi.org/10.1186/s13063-017-1797-7
URL https://springernature.figshare.com/collections/An_optimised_patient_information_sheet_did_not_significantly_increase_recruitment_or_retention_in_a_falls_prevention_study_an_embedded_randomised_recruitment_trial/3728689/1
URL https://link.springer.com/article/10.1186/s13063-017-1797-7
URL https://eprint.ncl.ac.uk/245306
URL http://qmro.qmul.ac.uk/xmlui/handle/123456789/22361
URL https://www.ncbi.nlm.nih.gov/pubmed/28351376
URL https://www.botnar.ox.ac.uk/publications/688728
URL http://dx.doi.org/10.17863/CAM.9433
URL https://www.csm.ox.ac.uk/publications/688728
URL https://doaj.org/toc/1745-6215
URL https://academic.microsoft.com/#/detail/2599279520
URL http://dx.doi.org/10.1186/s13063-017-1797-7
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Access Right Open Access
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Author Cockayne, Sarah, 0000-0002-1288-5497
Author Fairhurst, Caroline, 0000-0003-0547-462X
Author Adamson, Joy, 0000-0002-9860-0850
Author Hewitt, Catherine, 0000-0002-0415-3536
Author Hull, Robin
Author Hicks, Kate, 0000-0002-6424-0164
Author Keenan, Anne-Maree
Author Lamb, Sarah E, 0000-0003-4349-7195
Author Green, Lorraine
Author McIntosh, Caroline
Author Menz, Hylton B, 0000-0002-2045-3846
Author Redmond, Anthony C
Author Rodgers, Sara, 0000-0003-1757-541X
Author Torgerson, David J, 0000-0002-1667-4275
Author Vernon, Wesley
Author Watson, Judith, 0000-0003-0694-3854
Author Knapp, Peter, 0000-0001-5904-8699
Author Rick, Jo, 0000-0002-4659-8111
Author Bower, Peter
Author Eldridge, Sandra, 0000-0001-5638-2317
Author Madurasinghe, Vichithranie W, 0000-0002-3853-3422
Author Graffy, Jonathan
Contributor Apollo-University Of Cambridge Repository
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Collected From OpenAPC Initiative; ORCID; Datacite; The University of Manchester - Institutional Repository; Microsoft Academic Graph; Oxford University Research Archive; CORE (RIOXX-UK Aggregator); Europe PubMed Central; PubMed Central; UnpayWall; DOAJ-Articles; OpenAIRE; Crossref
Hosted By OpenAPC Initiative; Europe PubMed Central; SpringerOpen; Trials; The University of Manchester - Institutional Repository; White Rose Research Online; Oxford University Research Archive
Journal Trials, ,
Publication Date 2017-03-28
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Country United Kingdom
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Language UNKNOWN
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Source https://science-innovation-policy.openaire.eu/search/publication?articleId=dedup_wf_001::7ce94e12540f704a601fcc6fb68c07cd
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Last Updated 24 December 2020, 11:08 (CET)
Created 24 December 2020, 11:08 (CET)