Patient recruitment to a diabetic retinopathy screening trial through optimised patient information materials: an embedded study within a trial (SWAT)

Rebecca Sheridan; Peter Knapp; Peter Bower; Vichithranie Madurasinghe; Deborah M Broadbent; Lola Awoyale; Amu Wang; Tracy Moitt; on behalf of the ISDR Trial Group

doi:10.12688/f1000research.24938.1

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Research Article

Patient recruitment to a diabetic retinopathy screening trial through optimised patient information materials: an embedded study within a trial (SWAT)

[version 1; peer review: 1 approved, 1 approved with reservations]

Rebecca Sheridan¹, Peter Knapp ^1,2, Peter Bower³, [...] Vichithranie Madurasinghe^4,5, Deborah M Broadbent^6,7, Lola Awoyale⁸, Amu Wang⁶, Tracy Moitt⁸, on behalf of the ISDR Trial Group

Rebecca Sheridan¹, Peter Knapp ^1,2, [...] Peter Bower³, Vichithranie Madurasinghe^4,5, Deborah M Broadbent^6,7, Lola Awoyale⁸, Amu Wang⁶, Tracy Moitt⁸, on behalf of the ISDR Trial Group

PUBLISHED 28 Jul 2020

Author details Author details

¹ Department of Health Sciences, University of York, UK, York, UK
² Hull York Medical School, York, UK
³ Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK
⁴ Nuffield Department of Population Health, University of Oxford, Oxford, UK
⁵ Institute for Population Health Sciences, Queen Mary University of London, London, UK
⁶ Department of Eye and Vision Science, University of Liverpool, Liverpool, UK
⁷ St. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, UK
⁸ Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK

Rebecca Sheridan
Roles: Writing – Original Draft Preparation, Writing – Review & Editing

Peter Knapp
Roles: Conceptualization, Data Curation, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Peter Bower
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Writing – Review & Editing

Vichithranie Madurasinghe
Roles: Formal Analysis, Methodology, Writing – Review & Editing

Deborah M Broadbent
Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing

Lola Awoyale
Roles: Data Curation, Project Administration, Writing – Review & Editing

Amu Wang
Roles: Data Curation, Project Administration, Writing – Review & Editing

Tracy Moitt
Roles: Data Curation, Methodology, Project Administration, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Studies Within A Trial (SWAT) collection.

Abstract

Background: Printed participant information about trials is often technical, long and difficult to navigate. Optimisation and user testing can improve information materials, and may improve participant understanding and rates of recruitment.
Methods: A study within a trial (SWAT) was undertaken within the ISDR trial. Potential participants in the ISDR trial were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing.
Results: A total of 3,169 patients were randomised in the SWAT. Recruitment rates to the ISDR trial were 25.3% in the optimised information group and 26.1% in the standard information group (odds ratio 0.951; 95% CI 0.752 to 1.201; p=0.672). Clinic attendance rates were 71.6% in the optimised information group and 69.3% in the standard information group (OR 1.145; 95% CI 0.885 to 1.480; p=0.304).
Conclusions: Optimisation of participant information through information design and user testing did not affect rate of recruitment to the host ISDR trial.
Registration: ISRCTN ID ISRCTN87561257; registered on 08 May 2014.

Keywords

SWAT, trial, recruitment, patient information, user testing, diabetic retinopathy, screening

Corresponding author: Peter Knapp

Competing interests: No competing interests were disclosed.

Grant information: This work was supported by the UK National Institute for Health Research (NIHR) Programme Grants for Applied Research programme [RG-PG-1210–12016].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2020 Sheridan R et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Sheridan R, Knapp P, Bower P et al. Patient recruitment to a diabetic retinopathy screening trial through optimised patient information materials: an embedded study within a trial (SWAT) [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2020, 9:779 (https://doi.org/10.12688/f1000research.24938.1) First published: 28 Jul 2020, 9:779 (https://doi.org/10.12688/f1000research.24938.1) Latest published: 28 Jul 2020, 9:779 (https://doi.org/10.12688/f1000research.24938.1)

Introduction

Information materials for potential randomised controlled trial participants are often long and complex^1–3. This can result in a lack of understanding of key study details^1,4,5, limiting the ability to provide informed consent.

One approach to improve materials is through optimisation and user testing, involving revisions to the text and design based on people’s ability to find and understand informational content⁶. Whilst people tend to prefer the materials revised after user testing^7,8, a recent review concluded there was no evidence that optimised information materials improve recruitment⁹. However, the relevant evidence base is small^10–14 and a recent ‘review of reviews’ found that information quality can facilitate research participation¹⁵.

Study aims

This study within a trial (SWAT) aimed to assess whether optimisation through user testing of patient information materials could increase recruitment to the Individualised Screening for Diabetic Retinopathy (ISDR) trial¹⁶.

Methods

Ethical statement

ISDR was approved by the Health Research Authority (REC reference: 14/NW/0034). The SWAT was approved by Yorkshire and the Humber REC – South Yorkshire (11/YH/0271). The REC waived the requirement to obtain participant consent for the SWAT.

Design

SWAT conducted within ISDR, which investigated the safety and acceptability of changing from annual screening to personalised (individualised) risk-based screening for diabetic patients¹⁶. This study is one of the SWATs run by the MRC-funded Systematic Techniques to Assist Recruitment to Trials (START) programme¹⁷.

Participants

SWAT participants were eligible for ISDR¹⁸ and aged 16 years or older.

Intervention

All participants were posted a study invitation letter and participant information sheet (PIS) alongside their annual screening clinic appointment. The control group received the standard ISDR materials (see Extended data¹⁹) whilst the intervention group were sent optimised patient information materials (see Extended data²⁰) developed through two rounds of user testing.

If the patient attended their scheduled screening appointment, they were approached by a researcher to determine whether they had received, read and understood the information and whether they wanted to participate in ISDR. Clinic attendance and trial participation were recorded. If a researcher was not available on the clinic date, patients were not invited to participate.

User testing

User testing was undertaken face-to-face by Luto Research Limited at their premises in Leeds, UK, and involved 20 people, to reflect the age and gender distribution of the ISDR target population. In the first testing round 10 participants were given printed copies of materials and read the standard invitation letter and PIS (see Extended data)¹⁹. They were then asked to locate and demonstrate their understanding of 16 key items of trial information within the materials⁶. Materials were then revised based on participants’ responses. A second testing round was then completed using the same method, testing revised versions of the PIS and invitation letter.

Through testing, wording edits were made to the invitation letter to simplify content. Changes to the PIS included adding a title page, a summary of key points and a contents page, highlighting headings using coloured text and enlarged font, and simplifying wording. The final optimised PIS was presented as an A5 booklet (see Extended data)²⁰.

Outcomes

The primary outcome measure was the proportion of patients in each group who were randomised within ISDR. The secondary outcome was the proportion of patients attending their screening appointment.

Sample size

A power estimate was generated using an estimated baseline recruitment rate of 20%, whereby running the trial for 16 weeks (clusters) would provide 84% power to detect a planned 10% difference (alpha 0.05).

Randomisation

Cluster randomised allocation to receive the standard or optimised PIS by week of mail-out (1:1), by random number generator, determined by date of clinic appointment; the SWAT ran for sixteen weeks (January-May 2016). Patients attended clinic at one of seven sites across Liverpool, UK. Concealment of allocation was achieved because the appointment schedule was set before SWAT allocations were randomised. Recruiting researchers were not masked as they saw the ISDR booklet the patients brought with them; patients were not masked but were nevertheless unaware that a SWAT was ongoing.

Statistical analysis

Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were calculated to compare the proportion of patients from each randomised group (standard or optimised information) and the proportion of patients attending their appointment. Intention-to-treat analysis was used, with patients randomised to the SWAT irrelevant of whether a researcher was available for recruitment. Analyses were adjusted for cluster design and conducted in Stata version 14.2²¹.

Results

3,169 participants were invited, 1,503 (47.4%) were randomised to the control group and 1,666 (52.6%) to the intervention group (Figure 1)²².

A total of 2,235 (70.5%) patients attended a screening appointment and 815 (25.7%) patients were randomised to host trial (Table 1). There was no difference between the control group and the intervention group in randomisation (26.1% vs 25.3%; OR=0.951, 95% CI 0.752 to 1.201, p=0.672) or attendance (69.3% vs 71.6%; OR=1.145, 95% CI 0.885 to 1.480, p=0.304).

An additional 620 patients attended an appointment when no researcher was present and therefore were not asked to participate in ISDR. Sensitivity analysis including those patients did not substantially alter results.

Figure 1. Flow diagram of recruitment to the host trial.

Table 1. Attendance at screening appointment and randomisation to the host trial by intervention group.

Outcome	Intervention				Odds ratio (95% confidence interval)	p - value
	ISDR participant information sheet		Optimised participant information sheet
	number of patients	%	number of patients	%
¹Attended screening appointment	1,042/1,503	69.3%	1,193/1,666	71.6%	1.145 [0.885 to 1.480]	0.304
²Randomised to host trial	393/1,503	26.1%	422/1,666	25.3%	0.951 [0.752 to 1.201]	0.672

¹ Intra-cluster correlation coefficient is 0.008.

² Intra-cluster correlation coefficient is 0.004.

Discussion

There was no statistically significant difference in randomisation to ISDR or attendance rates between those receiving standard or optimised materials. This is consistent with previous research⁹, including other embedded trials within MRC START which have observed only small effects on recruitment^11–13.

There was no prior reason to expect recruitment rates to be affected by date of posting because choice of mail-out date was determined by clinic appointment and there were no systematic trends in appointments by time.

Whilst there was no impact on recruitment, the optimised materials may have improved understanding of the trial thus enabling patients to make a more informed decision. Improved comprehension could also increase retention, due to greater understanding of the trial prior to recruitment. These outcomes were not assessed and further research examining this is warranted.

The study sample size was large, and results are likely to be generalisable to adult diabetic patients.

Conclusion

Optimised patient information materials did not affect appointment attendance rates or randomisation to the host trial.

Data availability

Underlying data

Figshare: ISDR trial SWAT dataset. https://doi.org/10.6084/m9.figshare.12388136²².

Extended data

Figshare: ISDR trial SWAT original participation materials. https://doi.org/10.6084/m9.figshare.12388190.v1¹⁹.

This project contains the following extended data:

- Appendix 1 – Original ISDR trial invitation letter.docx
- Appendix 2 – Original ISDR trial PIS.docx

Figshare: ISDR trial SWAT optimised participant materials. https://doi.org/10.6084/m9.figshare.12388220.v1²⁰.

This project contains the following extended data:

- Appendix 3 – Optimised ISDR trial invitation letter.docx
- Appendix 4 – Optimised ISDR PIS.pdf

Reporting guidelines

Figshare: CONSORT checklist for ‘Patient recruitment to a diabetic retinopathy screening trial through optimised patient information materials: an embedded study within a trial (SWAT)’. https://doi.org/10.6084/m9.figshare.12388175.v1²³.

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

We thank Luto Research Limited (luto.co.uk) for undertaking the user testing, and Making Sense (makingsense.co.uk) for graphic design input. The authors would also like to thank the participants in the embedded trial, the screening clinics involved in the SWAT, Jo Rick for her contributions to the early stages of this research, and the administrative support of Christopher Grierson, David Szmyt and Alannah Nightingale.

The ISDR Trial Group is: Simon P Harding (Chair), Deborah M Broadbent (ISDR Trial Principal Investigator), Paula Byrne, Anthony C Fisher, Mark Gabbay, Marta García-Fiñana, Marilyn James, Tracy Moitt, John R Roberts, Daniel Seddon, Irene M Stratton, Paula Williamson, Duncan Appelbe, Lola Howard, Ayesh Alshukri, Abigail Bennett, Christopher P Cheyne, Paula Byrne, Antonio Eleuteri, Christopher Grierson, Bryar Kadir, Mehrdad Mobayen-Rahni, Andrew Ovens, Christopher J Sampson, David Szmyt, Clare Thetford, Amu Wang, Helen Cooper, John Collins, Sue Howlin, John Kelly, Nathalie Massat, Gideon Smith, Vineeth Kumar, Chris Rogers, Julia West, Naveed Younis.

Faculty Opinions recommended

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