Jan Henrik Terheyden1, Charlotte Behning2, Anna Lüning3, Ludmila Wintergerst3, Pier G Basile4, Diana Tavares4, Beatriz A Melício4, Sergio Leal5, George Weissgerber6, Ulrich F O Luhmann7, David P Crabb8, Adnan Tufail9, Carel Hoyng10, Moritz Berger2, Matthias Schmid2, Rufino Silva4,11,12, Cecília V Martinho4, José Cunha-Vaz4, Frank G Holz3, Robert P Finger13. 1. Department of Ophthalmology, University Hospital Bonn, Bonn, Germany. Jan.Terheyden@ukbonn.de. 2. Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany. 3. Department of Ophthalmology, University Hospital Bonn, Bonn, Germany. 4. Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal. 5. Bayer AG, Berlin, Germany. 6. Novartis Pharma AG, Basel, Switzerland. 7. Roche Pharmaceutical Research and Early Development, Translational Medicine Ophthalmology, Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland. 8. Division of Optometry and Visual Sciences, School of Health Sciences, City, University of London, London, UK. 9. Moorfields Eye Hospital, London, UK. 10. Radboud University Medical Center, Nijmegen, Netherlands. 11. University of Coimbra, Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, Coimbra, Portugal. 12. Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal. 13. Department of Ophthalmology, University Hospital Bonn, Bonn, Germany. Robert.Finger@ukbonn.de.
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.
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.
Authors: Robert P Finger; Steffen Schmitz-Valckenberg; Matthias Schmid; Gary S Rubin; Hannah Dunbar; Adnan Tufail; David P Crabb; Alison Binns; Clara I Sánchez; Philippe Margaron; Guillaume Normand; Mary K Durbin; Ulrich F O Luhmann; Parisa Zamiri; José Cunha-Vaz; Friedrich Asmus; Frank G Holz Journal: Ophthalmologica Date: 2018-08-28 Impact factor: 3.250
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Authors: Jan H Terheyden; Frank G Holz; Steffen Schmitz-Valckenberg; Anna Lüning; Matthias Schmid; Gary S Rubin; Hannah Dunbar; Adnan Tufail; David P Crabb; Alison Binns; Clara I Sánchez; Carel Hoyng; Philippe Margaron; Nadia Zakaria; Mary Durbin; Ulrich Luhmann; Parisa Zamiri; José Cunha-Vaz; Cecília Martinho; Sergio Leal; Robert P Finger Journal: Trials Date: 2020-07-18 Impact factor: 2.279