Producing better evidence on how to improve randomised controlled trials

Adamson, Joy; Hewitt, Catherine; Torgerson, David

doi:10.1136/bmj.h4923

Cited by 32 publications

(41 citation statements)

References 16 publications

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“…Failure to recruit to target can negatively affect the reliability of the trial results, costs and timely dissemination of the findings for clinical practice [1]. Because recruitment into trials is often challenging, identifying effective recruitment strategies is a common primary focus for trial methodology research because there is a lack of evidence about which strategies are most successful [2]. …”

Section: Introductionmentioning

confidence: 99%

Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial

Powell

Wilson

Redmond

et al. 2016

Trials

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BackgroundRecruiting to target in randomised controlled trials of investigational medicinal products (CTIMPs) in primary care and paediatric populations is notoriously difficult. More evidence is needed for effective recruitment strategies in these settings. We report on the impact of different recruitment strategies used in the Choice of Moisturiser in Eczema Treatment (COMET) study – a feasibility trial comparing the effectiveness of four emollients for the treatment of childhood eczema – recruiting via general practitioner (GP) surgeries.MethodsInitially, 16 GP practices invited potentially eligible children to take part in the trial by sending an invitation letter (self-referral pathway) or by consenting and randomising them into the study during a visit to the practice (in-consultation referral). Measures implemented during the study to maximise accrual included signing up six additional GP practices, increasing the upper age limit eligibility criterion from 3 to 5 years, and permitting healthcare professionals other than doctors to confirm participant eligibility. We used descriptive statistics and univariate linear regression models to explore associations with practice recruitment rates.ResultsA total of 197 participants were recruited, exceeding the target of 160. Of these, 107 children entered via self-referral and 90 by in-consultation pathways. Of the recruited population, 12.6 % were aged between 3 and 5 years (the raised upper age limit). The six additional practices contributed 37.4 % (40 of 107) of participants recruited by self-referral. Only almost one-third (18 of 56 [32.1 %]) of potential recruiting clinicians recruited one or more participants in-consultation, which was a more problematic pathway because of data verification issues. Three research nurses and a pharmacist from four practices recruited 48.9 % (44 of 90) of participants via this pathway. Univariate linear regression models showed no evidence of association between the number of children recruited via the self-referral pathway by practice and practice list size (p = 0.092) or practice deprivation decile (p = 0.270), but practice deprivation was associated with a higher number of children recruited in-consultation (p = 0.020) by practice.ConclusionsSelf-referral and in-consultation recruitment yielded similar numbers, but the in-consultation pathway was more problematic. Future trials of this type should consider the condition, normal care pathway and number of potentially eligible children and be prepared to use multiple recruitment strategies to achieve recruitment targets.Trial registration ISRCTN21828118. Registered on 1 May 2014.EudraCT2013-003001-26. Registered on 23 Dec 2013.

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Section: Introductionmentioning

confidence: 99%

Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial

Powell

Wilson

Redmond

et al. 2016

Trials

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“…Recruitment trials embedded within host trials are often plagued by the problem of small sample sizes as embedded trials are reliant upon the numbers of patients approached by the host trial. These numbers are not usually sufficient to show small but important differences in recruitment [11, 15]. …”

Section: Discussionmentioning

confidence: 99%

“…As is usual with a trial embedded within a host trial, we did not undertake a formal power calculation to determine the sample size [15], since the sample size was constrained by the number of mental health teams and patients being approached in the EQUIP host trial. Our sample size was the total number of service users invited to participate in EQUIP from the 34 available clusters at the time of implementing the embedded trial, which was 8182 potential participants.…”

Section: Methodsmentioning

confidence: 99%

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

Hughes-Morley

Hann

Fraser

et al. 2016

Trials

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BackgroundPatient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants.MethodsThis is a cluster trial, embedded within a host trial (‘EQUIP’) recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation.ResultsThirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes.ConclusionTo our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research.Trial registration numbersISRCTN, ISRCTN16488358. Registered on 14 May 2014.Study Within A Trial, SWAT-26. Registered on 21 January 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1718-1) contains supplementary material, which is available to authorized users.

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“…Following the challenge of recruiting the required number of participants, there is the problem of ensuring that all participants remain in the trial and adhere to the trial intervention as required 6,11 . Nonadherence to the trial intervention has serious implications, resulting in decreasing the statistical power of the study, impacting negatively on the trial outcomes and increasing the risk of attrition bias due to incomplete data 14,15,18 . In addition to the loss of valuable knowledge, low adherence rates can result in research resource wasting and increasing the cost of randomized trials 15,19 …”

Section: Design For the Swatmentioning

confidence: 99%

“…Poor adherence is particularly challenging in cardiovascular trials, which mostly aim to manage risk factors and improve cardiovascular disease prevention 11,13 . While accepting that routine clinical cardiovascular secondary prevention practice also suffers from low adherence rates, yet reduced adherence in cardiovascular clinical trials can have a negative effect on the trial sample size and estimation of the treatment effects 14,15 …”

Section: Introductionmentioning

confidence: 99%

A telephone reminder to enhance adherence to interventions in cardiovascular randomized trials: A protocol for a study within a trial (SWAT)

Bensaaud

Gibson

Jones

et al. 2020

J Evidence Based Medicine

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The impact of reduced adherence in randomized clinical trials is well documented in the literature. Nonadherence can negatively affect the trial sample size and estimation of the treatment effect. This protocol aims to evaluate the effects of a telephone call reminder on the adherence rates of participants to interventions in a cardiovascular randomized trial. This is a study within a trial (SWAT). The host trial is evaluating the effectiveness of a multidisciplinary 16‐wk cardiovascular disease prevention program on risk factor profile among patients with carotid artery stenosis. Simultaneously, this SWAT will evaluate the effectiveness of telephone call reminders on the participants’ adherence to the host trial intervention. The primary outcome is adherence to the protocol of the host trial. Secondary outcomes are level of adherence, number of dropouts, and time to drop out from the host trial.

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Producing better evidence on how to improve randomised controlled trials

Abstract: Effective recruitment and retention are essential to successful clinical research but we have little good evidence about how to achieve this. Joy Adamson and colleagues call for more use of methodological trials embedded within clinical trials to improve our knowledge

Cited by 32 publications

References 16 publications

Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial

Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

A telephone reminder to enhance adherence to interventions in cardiovascular randomized trials: A protocol for a study within a trial (SWAT)

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