Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

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Abstract

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.

One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical ‘top tips’ that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one.

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A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

Ben G O Sully, Steven A Julious, Jon Nicholl … (2013)

Background Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded trials fail to reach their target sample size. This study seeks to assess the current state of recruitment success and grant extensions in trials funded by the Health Technology Assessment (HTA) program and the UK Medical Research Council (MRC). Methods Data were gathered from two sources: the National Institute for Health Research (NIHR) HTA Journal Archive and the MRC subset of the International Standard Randomised Controlled Trial Number (ISRCTN) register. A total of 440 trials recruiting between 2002 and 2008 were assessed for eligibility, of which 73 met the inclusion criteria. Where data were unavailable from the reports, members of the trial team were contacted to ensure completeness. Results Over half (55%) of trials recruited their originally specified target sample size, with over three-quarters (78%) recruiting 80% of their target. There was no evidence of this improving over the time of the assessment. Nearly half (45%) of trials received an extension of some kind. Those that did were no more likely to successfully recruit. Trials with 80% power were less likely to successfully recruit compared to studies with 90% power. Conclusions While recruitment appears to have improved since 1994 to 2002, publicly-funded trials in the UK still struggle to recruit to their target sample size, and both time and financial extensions are often requested. Strategies to cope with such problems should be more widely applied. It is recommended that where possible studies are planned with 90% power.

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Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials

Mei-See Man, , Jo Rick … (2015)

Background Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions. Methods The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD). Results In Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61). Conclusions Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population. Trial registration Current Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012 Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0820-0) contains supplementary material, which is available to authorized users.

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An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

Sarah Cockayne, Caroline Fairhurst, Joy Adamson … (2017)

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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Contributors

Shaun Treweek:

ORCID: http://orcid.org/0000-0002-7239-7241

streweek@mac.com

Simon Bevan: simon.bevan@nihr.ac.uk

Peter Bower: peter.bower@manchester.ac.uk

Marion Campbell: m.k.campbell@abdn.ac.uk

Jacquie Christie: Jacquie.A.Christie@gsk.com

Mike Clarke: m.clarke@qub.ac.uk

Clive Collett: clive.collett@nhs.net

Seonaidh Cotton: s.c.cotton@abdn.ac.uk

Declan Devane: declan.devane@nuigalway.ie

Adel El Feky: a.elfeky@abdn.ac.uk

Ella Flemyng: Ella.flemyng@biomedcentral.com

Sandra Galvin: sandra.galvin@nuigalway.ie

Heidi Gardner: heidi.gardner.10@aberdeen.ac.uk

Katie Gillies: k.gillies@abdn.ac.uk

Jan Jansen: jjansen@uabmc.edu

Roberta Littleford: R.Littleford@dundee.ac.uk

Adwoa Parker: adwoa.parker@york.ac.uk

Craig Ramsay: c.r.ramsay@abdn.ac.uk

Lynne Restrup: lrestrup@btinternet.com

Frank Sullivan: fms20@st-andrews.ac.uk

David Torgerson: david.torgerson@york.ac.uk

Liz Tremain: liz.tremain@nihr.ac.uk

Matthew Westmore: M.J.Westmore@soton.ac.uk

Paula R. Williamson: prw@liv.ac.uk

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 23 February 2018

Publication date PMC-release: 23 February 2018

Publication date Collection: 2018

Volume: 19

Electronic Location Identifier: 139

Affiliations

[1 ]ISNI 0000 0004 1936 7291, GRID grid.7107.1, Health Services Research Unit, , University of Aberdeen, ; Aberdeen, UK

[2 ]ISNI 0000 0004 1936 9297, GRID grid.5491.9, National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, , University of Southampton, ; Southampton, UK

[3 ]ISNI 0000000121662407, GRID grid.5379.8, Centre for Primary Care, , University of Manchester, ; Manchester, UK

[4 ]ISNI 0000 0001 2162 0389, GRID grid.418236.a, GSK Medicines Research Centre, ; Stevenage, UK

[5 ]ISNI 0000 0004 0374 7521, GRID grid.4777.3, Northern Ireland Network for Trials Methodology Research, , Queen’s University Belfast, ; Belfast, UK

[6 ]Health Research Authority, London, UK

[7 ]ISNI 0000 0004 0488 0789, GRID grid.6142.1, HRB-Trials Methodology Research Network, , National University of Ireland Galway, ; Galway, Ireland

[8 ]ISNI 0000 0004 0544 054X, GRID grid.431362.1, BioMed Central, ; London, UK

[9 ]ISNI 0000000106344187, GRID grid.265892.2, Division of Acute Care Surgery, , University of Alabama at Birmingham, ; Birmingham, AL USA

[10 ]ISNI 0000 0004 0397 2876, GRID grid.8241.f, Tayside Clinical Trials Unit, , University of Dundee, ; Dundee, UK

[11 ]ISNI 0000 0004 1936 9668, GRID grid.5685.e, York Trials Unit, , University of York, ; York, UK

[12 ]Aberdeen, UK

[13 ]ISNI 0000 0001 0721 1626, GRID grid.11914.3c, School of Medicine, , St Andrews University, ; St Andrews, UK

[14 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, , University of Liverpool, ; Liverpool, UK

Author information

Shaun Treweek http://orcid.org/0000-0002-7239-7241

Article

Publisher ID: 2535

DOI: 10.1186/s13063-018-2535-5

PMC ID: 5824570

PubMed ID: 29475444

SO-VID: 84e586a3-a2ec-4f89-b5da-b44ff7843f7c

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Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 3 October 2017

Date accepted : 7 February 2018

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Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?

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Most cited references 6

A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

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Cited by 110

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