Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial.

Jennifer Mccaffery,David J Torgerson,Sarah Cockayne,Clare Relton,Caroline Fairhurst,Alex S Mitchell,Sara Rodgers

doi:10.12688/f1000research.18939.1

Jennifer Mccaffery, David J Torgerson + Show 5 more

Open Access

https://doi.org/10.12688/f1000research.18939.1

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Journal: F1000Research	Publication Date: May 14, 2019
Citations: 8	License type: CC BY 4.0

Affiliation: University of York, University of Sheffield

Abstract

Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial. Secondary outcomes related to trial eligibility and retention. Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.

Highlights

Randomised controlled trials (RCTs) are regarded as the gold standard design to evaluate the effectiveness of interventions in health research[1,2,3]
Participants for OTIS were recruited by mail out of recruitment packs to: i) participants in the Yorkshire Health Study (YHS)[12]; ii) cohorts of previous trials held by the YTU13–15; iii) potentially eligible patients identified in GP practice databases; and iv) via opportunistic screening
Of the 317 embedded trial participants, 12 (3.8%) were randomised into the OTIS trial

Summary

Introduction

Randomised controlled trials (RCTs) are regarded as the gold standard design to evaluate the effectiveness of interventions in health research[1,2,3]. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial.

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