The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial

Adwoa Parker, Peter Knapp, Shaun Treweek, Vichithranie Madhurasinghe, Roberta Littleford, Stephanie Gallant, Frank Sullivan, Stuart Schembri, Jo Rick, Jonathan Graffy, David J Collier, Sandra Eldridge, Anne Kennedy, Peter Bower, Adwoa Parker, Peter Knapp, Shaun Treweek, Vichithranie Madhurasinghe, Roberta Littleford, Stephanie Gallant, Frank Sullivan, Stuart Schembri, Jo Rick, Jonathan Graffy, David J Collier, Sandra Eldridge, Anne Kennedy, Peter Bower

Abstract

Background: Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates.

Methods: We conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS.

Results: In total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR = 1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR = 1.103, 95% CI, 0.778 to 1.565).

Conclusions: Optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial.

Trial registration: ClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016.

Keywords: Patient information; Randomised controlled trial; Recruitment; Research methodology; Study within a trial (SWAT).

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval to undertake ECLS was obtained from the UK National Research Ethics Service on 16 April 2013, using the recruitment method outlined above (East of Scotland Research Ethics Service REC 1, REC reference 13/ES/0024).

Consent for publication

This manuscript does not report individual patient data, thus it was not necessary to obtain consent to publish from individual participants.

Competing interests

One of the MRC START investigators (ST) proofread the content of the control PIB in his former role as the assistant director of TCTU and a co-investigator in ECLS. All of the other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of participant response and recruitment. Based on the guidelines for reporting embedded recruitment trials, which adapt Consolidated Standards of Reporting Trials (CONSORT) for embedded recruitment trials [17]. MRC START Medical Research Council Systematic Techniques for Assisting Recruitment to Trials study

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