Bah humbug! Association between sending Christmas cards to trial participants and trial retention: randomised study within a trial conducted simultaneously across eight host trials

Abstract

Objectives To determine the effectiveness of sending Christmas cards to participants in randomised controlled trials to increase retention rate at follow-ups, and to explore the feasibility of doing a study within a trial (SWAT) across multiple host trials simultaneously. Design Randomised SWAT conducted simultaneously across eight host trials. Setting Eight randomised controlled trials researching various areas including surgery and smoking cessation. Participants 3223 trial participants who were still due at least one follow-up from their host randomised controlled trial. Intervention Participants were randomised (1:1, separately by each host trial) to either received a Christmas card in mid-December 2019 or to not receive a card. Main outcome measure Proportion of participants completing their next follow-up (retention rate) within their host randomised controlled trial. Results 1469 participants (age 16-94 years; 70% (n=1033) female; 96% (813/847) white ethnicity) across the eight host randomised controlled trials were involved in the analysis (cut short owing to covid-19). No evidence was found of a difference in retention rate between the two arms for any of the host trials when analysed separately or when the results were combined (85.3% (639/749) for cards versus 85.4% (615/720) for no card; odds ratio 0.96, 95% confidence interval 0.71 to 1.29; P=0.77). No difference was observed when comparing just participants who were due a follow-up in the 30 days after receiving the card (odds ratio 0.96, 0.42 to 2.21). No evidence of a difference in time to complete the questionnaire was found (hazard ratio 1.01, 95% confidence interval 0.91 to 1.13; P=0.80). These results were robust to post hoc sensitivity analyses. The cost of this intervention was £0.76 (€0.91; $1.02) per participant, and it will have a carbon footprint of approximately 140 g CO 2 equivalent per card. One benefit of this approach was the need to only submit one ethics application. Conclusions Sending Christmas cards to participants in randomised controlled trials does not increase retention. Undertaking a SWAT within multiple randomised controlled trials at the same time is, however, possible. This approach should be used more often to build an evidence base to support selection of recruitment and retention strategies. Although no evidence of a boost to retention was found, embedding a SWAT in multiple host trials simultaneously has been shown to be possible. Study registration SWAT repository https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,846275,en.pdf#search=SWAT%2082 .

Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial

“…n=5) has been informed by previous co-ordinated programmes that have simultaneously embedded a SWAT in multiple host trials (e.g. [ 32 , 42 – 44 ]).…”

The PROMoting the USE of SWATs (PROMETHEUS) programme: Lessons learnt and future developments for SWATs

“…8 This is where one SWAT intervention is tested within multiple host trials in a centrally coordinated way within a limited time window. One assessed the effectiveness of sending a Christmas card on participant retention across eight host trials, run by two trials units (SWAT 82 in the SWAT repository 18 ), 6 and the other one recruiter training on recruitment rates across four host, surgical, trials. 7 This design is efficient as it results in a rapid increase in the evidence base and has the possibility to answer SWAT questions definitively in one concurrent evaluation.…”

“…PROMETHEUS also funded and completed two simultaneous SWATs evaluations. 6,7 Many of the PROMETHEUS funded SWATs are still ongoing, due to the COVID-19 pandemic pausing host trials. Further details of the PROMETHEUS programme are available here.…”

Study within a review (SWAR)

“…We are not yet aware of examples of embedding a SWAR addressing the same question within multiple host reviews simultaneously. However, a simultaneous SWAT evaluation design proved successful for trial retention, being demonstrated as both feasible and efficient 21 . Such an approach appears suitable for SWARs.…”

“…However, a simultaneous SWAT evaluation design proved successful for trial retention, being demonstrated as both feasible and efficient. 21 Such an approach appears suitable for SWARs. For example, a SWAR trial looking at single versus dual screening of citations for inclusion in a review could be embedded as a trial in multiple host reviews simultaneously, the SWAR results collated, synthesized, and reported allowing a more rapid increase of the evidence base.…”