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BMJ ; 375: e067742, 2021 12 14.
Article in English | MEDLINE | ID: covidwho-1574061


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 CO2 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,846275,en.pdf#search=SWAT%2082.

Holidays , Patient Dropouts , Randomized Controlled Trials as Topic , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , United Kingdom , Young Adult
Trials ; 22(1): 381, 2021 Jun 05.
Article in English | MEDLINE | ID: covidwho-1259215


After the SARS-CoV-2 pandemic took hold in the UK, the ActWELL trial team's plans to present the trial results to participants and other stakeholders had to change. Instead of face-face events, three online events were planned and hosted successfully. In this article, we describe the choices made in planning and organisation of the online events including things we would do differently if we were to do it again. We think that online events are a useful platform when informing participants and other stakeholders of the results of your trial, even beyond the SARS-CoV-2 pandemic, and we hope this article can help other trial teams to plan their own online events.

COVID-19 , Pandemics , Humans , SARS-CoV-2 , United Kingdom/epidemiology