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

Treweek, Shaun; Bevan, Simon; Bower, Peter; Campbell, Marion K; Christie, Jacquie; Clarke, Mike; Collett, Clive; Cotton, Seonaidh; Devane, Declan; Feky, Adel El; Flemyng, Ella; Galvin, Sandra; Gardner, Heidi; Gillies, Katie; Jansen, Jan O.; Littleford, Roberta; Parker, Adwoa; Ramsay, Craig R; Restrup, Lynne; Sullivan, Frank; Torgerson, David; Tremain, Liz; Westmore, Matthew; Williamson, Paula

doi:10.1186/s13063-018-2535-5

Cited by 210 publications

(232 citation statements)

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“…Despite these problems and their effects on trial validity and costs, there is little rigorous quantitative research to support recruitment efforts. Embedding trials of different recruitment methods in trials (so called 'studies within a trial' or SWATs) is an effective way of testing methods [3] and is increasingly supported by funders [4], but a recent Cochrane review identified only 68 studies of this type [5].…”

Section: Resultsmentioning

confidence: 99%

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled study-within-a-trial (SWAT) of a multimedia information resource

Jolly

Sidhu

Madurasinghe

et al. 2019

Preprint

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Background: Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates by conducting a pragmatic 'study within a trial' (SWAT) embedding a trial of a multimedia resource within an existing trial. Methods: The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by patient and public involvement (PPI) contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised.Results: Nine point six percent of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (odds ratio (OR) = 0.844, 95% confidence interval (CI) 0.58 to 1.22). We also found no effects on the proportion of people responding to the invitation (OR = 1.02, 95% CI 0.79 to 1.33) or retention in the trial at 6 (ORs 0.84, 95% CI 0.57 to 1.22) and 12 months after randomisation (ORs 0.80, 95% CI 0.54 to 1.18), respectively.(Continued on next page)

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Section: Resultsmentioning

confidence: 99%

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled study-within-a-trial (SWAT) of a multimedia information resource

Jolly

Sidhu

Madurasinghe

et al. 2019

Preprint

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“…The results of this review could help improve the design and conduct of RCTs by helping researchers to identify and implements strategies to reduce research burden. Such strategies might be implemented and evaluated in a Study Within A Trial (SWAT) [42] and thereby add to the evidence base on recruitment and retention in trials [5,6]. Further, we need to explore other study designs that could reduce burden and improve external validity such as trials embedded in registries, cohorts, or routinely collected data [43] but also observational studies and use of routinely collected data.…”

Section: Toward Minimally Disruptive and Compassionate Clinical Researchmentioning

confidence: 99%

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence

Naidoo

Nguyen

Ravaud

et al. 2020

BMC Med

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Background: Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT. Methods: We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool. Results: We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention. Conclusions: Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention. Review registration: PROSPERO CRD42018098994

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“…The primary outcome will be physical symptoms (PHQ-15) [20] at 52 weeks after randomisation. PHQ-15 comprises 15 physical symptoms, with each accorded 2,1 or 0 points based on how much they have bothered the patient over the last 4 weeks (bothered a lot, bothered a little, not at all).…”

Section: Assessments and Procedures 71 Primary Outcome Measurementioning

confidence: 99%

Multiple Symptoms Study 3

Mooney¹

2018

http://isrctn.com/

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

Cited by 210 publications

References 10 publications

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled study-within-a-trial (SWAT) of a multimedia information resource

Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled study-within-a-trial (SWAT) of a multimedia information resource

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence

Multiple Symptoms Study 3

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