Strategies to improve retention in randomised trials

Gillies, Katie; Kearney, Anna; Keenan, Ciara; Treweek, Shaun; Hudson, Jemma; Brueton, Valerie; Conway, Thomas; Hunter, Andrew; Murphy, Louise; Carr, Peter; Rait, Greta; Manson, Paul; Aceves‐Martins, Magaly

doi:10.1002/14651858.mr000032.pub3

Cited by 76 publications

(167 citation statements)

References 172 publications

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“…However, this promising single result has to be interpreted in the context of three similar studies. The totality of evidence regarding the effect on retention of the addition of a monetary incentive (unconditional) versus the addition of a monetary reward (conditional) remains highly uncertain though, especially in the presence of significant heterogeneity [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

Juszczak

Hewer

Partlett

et al. 2021

Trials

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Background Loss to follow-up resulting in missing outcomes compromises the validity of trial results by reducing statistical power, negatively affecting generalisability and undermining assumptions made at analysis, leading to potentially biased and misleading results. Evidence that incentives are effective at improving response rates exists, but there is little evidence regarding the best approach, especially in the field of perinatal medicine. The NIHR-funded SIFT trial follow-up of infants at 2 years of age provided an ideal opportunity to address this remaining uncertainty. Methods Participants: parents of infants from participating neonatal units in the UK and Ireland followed up for SIFT (multicentre RCT investigating two speeds of feeding in babies with gestational age at birth < 32 weeks and/or birthweight < 1500 g). Interventions: parents were randomly allocated to receive incentives (£15 gift voucher) before or after questionnaire return. The objective was to establish whether offering an unconditional incentive in advance or promising an incentive on completion of a questionnaire (conditional) improved the response rate in parents of premature babies. The primary outcome was questionnaire response rate. Permuted block randomisation was performed (variable size blocks), stratified by SIFT allocation (slower/faster feeds) and single/multiple birth. Multiple births were given the same incentives allocation. Parents were unaware that they were in an incentives SWAT; SIFT office staff were not blinded to allocation. Results Parents of 923 infants were randomised: 459 infants allocated to receive incentive before, 464 infants allocated to receive incentive after; analysis was by intention to treat. Allocation to the incentive before completion led to a significantly higher response rate, 83.0% (381/459) compared to the after-completion group, 76.1% (353/464); adjusted absolute difference of 6.8% (95% confidence interval 1.6% to 12.0%). Giving an incentive in advance is the more costly approach, but the mean difference of ~£3 per infant is small given the higher return. Conclusions An unconditional incentive in advance led to a significantly higher response rate compared to the promise of an incentive on completion. Against a backdrop of falling response rates to questionnaires, incentives can be an effective way to increase returns. Trial registration SIFT (ISRCTN76463425). Registered on March 5, 2013.; SWAT registration (SWAT 69 available from http://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,864297,en.pdf). Registered on June 27, 2016.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

Juszczak

Hewer

Partlett

et al. 2021

Trials

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“…Retention was also challenging, and in a DT more intensive efforts would be required to assist participants to complete follow up (30). The 'organisation' of a DT would also require changes to incorporate both the community facilitators' and researcher speci c training in working with women who have low literacy.…”

Section: Discussionmentioning

confidence: 99%

An Application of PRECIS-2 to Evaluate Trial Design in a Pilot Cluster Randomised Controlled Trial of a Community-based Smoking Cessation Intervention for Women Living in Disadvantaged Areas of Ireland

Darker

Loudon²,

O’Connell

et al. 2021

Preprint

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Background “We Can Quit2” (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of ‘We Can Quit’ (WCQ), a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised ‘enhanced usual care’ offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under ‘real world’ conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT).Methods The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: Eligibility, Recruitment, Setting, Organisation, Flexibility-Delivery, Flexibility-Adherence, Follow-up, Primary Outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. Results Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Recruitment to trial was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. Conclusions PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. Trial registration: This trial is registered with the ISRCTN registry (No. 74721694), available at https://doi.org/10.1186/ISRCTN74721694

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“…The Cochrane reviews on interventions to improve recruitment to and retention in clinical trials have found very little evidence of effect [ 16 , 33 ]. The reviews largely include interventions that were not designed as behaviour change interventions (BCIs) with only a minority (< 5%) conceptualised as BCIs, yet the implicit aim of the majority is to change participants’ recruitment or retention behaviour.…”

Section: The Potential Value Of Behavioural Science To Inform Trial Design Delivery and Reportingmentioning

confidence: 99%

“…A small number of studies have developed behaviour change interventions for trial retention by incorporating BCTs into covering letters of questionnaires, newsletters, and also use of trial stickers on envelopes (to act as prompts) [ 36 ]. Preliminary evaluations of these behaviourally focussed trial process interventions are showing promise, but replication and further research to include patient input and assessment are required to maximise their potential [ 33 , 36 ]. Creating a shift in the conceptualisation of recruitment and retention interventions to be considered (during design and delivery) as behaviour change interventions may provide more potential for more focused assessment of effectiveness and may enhance replicability.…”

Section: The Potential Value Of Behavioural Science To Inform Trial Design Delivery and Reportingmentioning

confidence: 99%

How can behavioural science help us design better trials?

Gillies

Brehaut

Coffey

et al. 2021

Trials

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Strategies to improve retention in randomised trials

Abstract: Editorial group: Cochrane Methodology Review Group. Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 3, 2021.

Cited by 76 publications

References 172 publications

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

An Application of PRECIS-2 to Evaluate Trial Design in a Pilot Cluster Randomised Controlled Trial of a Community-based Smoking Cessation Intervention for Women Living in Disadvantaged Areas of Ireland

How can behavioural science help us design better trials?

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