Please use this identifier to cite or link to this item: https://hdl.handle.net/10316/103787
Title: Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
Authors: Terheyden, Jan Henrik
Behning, Charlotte
Lüning, Anna
Wintergerst, Ludmila
Basile, Pier G.
Tavares, Diana 
Melício, Beatriz A. 
Leal, Sergio
Weissgerber, George
Luhmann, Ulrich F. O.
Crabb, David P.
Tufail, Adnan
Hoyng, Carel
Berger, Moritz
Schmid, Matthias
Silva, Rufino 
Martinho, Cecília V. 
Cunha-Vaz, José 
Holz, Frank G.
Finger, Robert P.
Keywords: Early disease stages; Age-related macular degeneration; Cohort study; Screening; Recruitment
Issue Date: 17-Mar-2021
Publisher: Springer Nature
Project: Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116076 
European Union’s Horizon 2020 research and innovation programme and EFPIA 
Open Access funding enabled and organized by Projekt DEAL 
metadata.degois.publication.title: BMC Medical Research Methodology
metadata.degois.publication.volume: 21
metadata.degois.publication.issue: 1
Abstract: 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 multicentre 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.
URI: https://hdl.handle.net/10316/103787
ISSN: 1471-2288
DOI: 10.1186/s12874-021-01243-8
Rights: openAccess
Appears in Collections:I&D CIBIT - Artigos em Revistas Internacionais

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