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

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.

SUBMITTER: McCaffery J

PROVIDER: S-EPMC6733374 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

McCaffery Jennifer J Mitchell Alex A Fairhurst Caroline C Cockayne Sarah S Rodgers Sara S Relton Clare C Torgerson David J DJ

F1000Research 20190514

<b>Background:</b> 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. <b>Methods:</b> A ...[more]

PMID: 31543954

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Project description:BACKGROUND:Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants' response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it. METHODS:Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630). RESULTS:The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94-1.17) and 1.10 (95% CI 0.94-1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33). CONCLUSIONS:Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.

Project description:BACKGROUND:The number of web-based E-epidemiologic studies using online recruitment methods is increasing. However, the optimal online recruitment method in terms of maximizing recruitment rates is still unknown. Our aim was to compare the recruitment rates of three online recruitment methods and to describe how these rates differ according to individual's socioeconomic and demographic factors. METHODS:A total of 2394 members of the 1993 Pelotas birth cohort that provided an e-mail address, a Facebook name, and a WhatsApp number during a face-to-face follow-up were randomly allocated to be recruited by e-mail, Facebook or WhatsApp (798 individuals per method). This was a parallel randomised trial applying a block randomisation (block size?=?3). Between January and February 2018, we sent messages inviting them to register into the web-based coortesnaweb platform. Recruitment rates were calculated for each method, and stratified according to the individual's socioeconomic and demographic characteristics. We also analysed absolute and relative inequalities on recruitment according to schooling and socioeconomic position. RESULTS:Out of the 2394 individuals analysed, 642 registered into the platform. The overall recruitment rate was 26.8%. Recruitment rates for women were almost 10 percentage points higher compared to men. Facebook was the most effective recruitment method, as 30.6% of those invited through the social network were recruited. Recruitment rates of e-mail and WhatsApp were similar (recruitment rate?=?24.9%). E-mail and Facebook were the most effective recruitment methods to invite highly educated and wealthier individuals. However, sending e-mails to recruit individuals also reflected in the highest inequalities according to schooling and socioeconomic position. In contrast, the lowest inequalities according to socioeconomic position were observed using Facebook. CONCLUSIONS:Facebook was the most effective online recruitment method, also achieving the most equitable sample in terms of schooling and socioeconomic position. The effectiveness of online recruitment methods depends on the characteristics of the sample. It is important to know the profile of the target sample in order to decide which online recruitment method to use. TRIAL REGISTRATION:Brazilian Registry of Clinical Trials, identifier: RBR-3dv7gc , retrospectively registered in 10 April 2018.

Project description:BACKGROUND:The NHS Health Check (NHS HC) is a cardiovascular risk assessment to prevent cardiovascular disease. Public Health England (PHE) wants to increase uptake. METHODS:We explored the impact of behaviourally informed invitation letters and pre-notification and reminder SMS on uptake of NHS HCs. Patients at 28 General Practices in the London Borough of Southwark who were eligible to receive an NHS HC between 1st November 2013 and 31st December 2014 were included. A double-blind randomised controlled trial with a mixed 2 (pre-notification SMS - yes or no) × 4 (letter - national template control, open-ended, time-limited, social norm) × 2 (reminder SMS - yes or no) factorial design was used. The open-ended letter used simplification, behavioural instruction and a personalised planning prompt for patients to record the date and time of their NHS HC. The time-limited letter was similar but stated the NHS HC was due in a named forthcoming month. The social norms letter was similar to the open-ended letter but included a descriptive social norms message and testimonials from local residents and no planning prompt. The outcome measure was attendance at an NHS HC. RESULTS:Data for 12, 244 invites were analysed. Uptake increased in almost all letter and SMS combinations compared to the control letter without SMS (Uptake 18%), with increases of up to 12 percentage points for the time-limited letter with pre-notification and reminder (Uptake 30%; Adjusted Odds Ratio AOR 1.86; 95% CI 1.45-2.83; p < 0.00); 10 percentage points for the open-ended letter with reminder (Uptake 27%; AOR 1.68; 95% CI 1.31-2.17; p < 0.00) and a 9 percentage point increase using the time-limited letter with reminder (Uptake 27%; AOR 1.61; 95% CI 1.25-2.10; p < 0.00). The reminder SMS increased uptake for all intervention letters. The pre-notification did not add to this effect. CONCLUSIONS:This large randomised controlled trial adds support to the evidence that small, low cost behaviourally informed changes to letter-based invitations can increase uptake of NHS HCs. It also provides novel evidence on the effect of SMS reminders and pre-notification on NHS HC attendance. TRIAL REGISTRATION:Retrospectively Registered (24/01/2014) ISRCTN36027094 .

Project description:Background: Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store ( SWAT-100). ReStOre II: ClinicalTrials.gov ( NCT03958019).

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

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

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