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Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study

Terheyden, J. H., Behning, C., Lüning, A., Wintergerst, L., Basile, P., Tavares, D., Melício, B., Leal, S., Weissgerber, G., Luhmann, U. F. O., Crabb, D. P. ORCID: 0000-0001-8754-3902, Tufail, A., Hoyng, C., Berger, M., Schmid, M., Silva, R., Martinho, C., Cunha-Vaz, J., Holz, F. G., Finger, R. P. and MACUSTAR consortium, (2021). Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study. BMC Medical Research Methodology, 21(1), 54.. doi: 10.1186/s12874-021-01243-8

Abstract

BACKGROUND: Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).

METHODS: Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered.

RESULTS: A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018-2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367-0.591]) and reaching 80% of the site's recruitment target (relative risk decrease 0.699, 95% CI [0.367-0.591]) were associated with the number of screenings at an individual site level.

CONCLUSIONS: Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03349801 . Registered on 22 November 2017.

Publication Type: Article
Additional Information: © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/
Publisher Keywords: Early disease stages, Age-related macular degeneration, Cohort study, Screening, Recruitment
Subjects: R Medicine > RC Internal medicine
R Medicine > RE Ophthalmology
Departments: School of Health Sciences > Optometry & Visual Science
Date available in CRO: 26 Apr 2021 10:20
Date deposited: 26 April 2021
Date of acceptance: 28 February 2021
Date of first online publication: 17 March 2021
URI: https://openaccess.city.ac.uk/id/eprint/25986
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