. 2021 Mar 17;21(1):54.

doi: 10.1186/s12874-021-01243-8.

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

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 Silva^{4

11

12}, Cecília V Martinho⁴, José Cunha-Vaz⁴, Frank G Holz³, Robert P Finger¹³; MACUSTAR consortium

Collaborators, Affiliations

Collaborators

MACUSTAR consortium:
H Agostini, F Bandello, P Basile, C Behning, M Berger, A Binns, M Böttger, C Bouchet, J E Brazier, T Butt, C Carapezzi, J Carlton, A Carneiro, A Charil, R Coimbra, D P Crabb, J Cunha-Vaz, C Dahlke, H Dunbar, M Durbin, R P Finger, E Fletcher, H Floyd, R Hogg, F G Holz, C Hoyng, J Krätzschmar, L Kühlewein, M Larsen, S Leal, U Luhmann, A Lüning, C Martinho, B Melício, S Mohand-Said, S Nunes, M Parravano, D Pauleikhoff, M Pfau, S Pondorfer, S Poor, S Priglinger, D Rowen, G S Rubin, J Sahel, D Sanches Fernandes, C Sánchez, M Saßmannshausen, M Schmid, S Schmitz-Valckenberg, H Schrinner-Fenske, R Silva, A Skelly, E Souied, G Staurenghi, L Stöhr, D Tavares, D J Taylor, J H Terheyden, S Thiele, A Tufail, J Werner, G Weissgerber, L Wintergerst, C Wojek, N Zakaria

Affiliations

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.

PMID: 33731014
PMCID: PMC7967977
DOI: 10.1186/s12874-021-01243-8

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

Jan Henrik Terheyden et al. BMC Med Res Methodol. 2021.

. 2021 Mar 17;21(1):54.

doi: 10.1186/s12874-021-01243-8.

Authors

Collaborators

MACUSTAR consortium:
H Agostini, F Bandello, P Basile, C Behning, M Berger, A Binns, M Böttger, C Bouchet, J E Brazier, T Butt, C Carapezzi, J Carlton, A Carneiro, A Charil, R Coimbra, D P Crabb, J Cunha-Vaz, C Dahlke, H Dunbar, M Durbin, R P Finger, E Fletcher, H Floyd, R Hogg, F G Holz, C Hoyng, J Krätzschmar, L Kühlewein, M Larsen, S Leal, U Luhmann, A Lüning, C Martinho, B Melício, S Mohand-Said, S Nunes, M Parravano, D Pauleikhoff, M Pfau, S Pondorfer, S Poor, S Priglinger, D Rowen, G S Rubin, J Sahel, D Sanches Fernandes, C Sánchez, M Saßmannshausen, M Schmid, S Schmitz-Valckenberg, H Schrinner-Fenske, R Silva, A Skelly, E Souied, G Staurenghi, L Stöhr, D Tavares, D J Taylor, J H Terheyden, S Thiele, A Tufail, J Werner, G Weissgerber, L Wintergerst, C Wojek, N Zakaria

Affiliations

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.

PMID: 33731014
PMCID: PMC7967977
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.

Keywords: Age-related macular degeneration; Cohort study; Early disease stages; Recruitment; Screening.

PubMed Disclaimer

Conflict of interest statement

J. H. Terheyden: Heidelberg Engineering, Optos, Carl Zeiss MedicTec, CenterVue.

C. Behning: None.

A. Lüning: Heidelberg Engineering, Optos, Carl Zeiss MedicTec, CenterVue.

L. Wintergerst: Heidelberg Engineering, Optos, Carl Zeiss MedicTec, CenterVue.

P. G. Basile: None.

D. Tavares: None.

B. A. Melício: None.

S. Leal: Employee of Bayer AG.

G. Weissgerber: Employee of Novartis Pharma AG.

U. F. O. Luhmann: Employee of F. Hoffmann-La Roche Ltd.

D. P. Crabb: Allergan, Roche, Santen, Centervue.

A. Tufail: None.

C. Hoyng: Optos, Bayer.

M. Berger: None.

M. Schmid: Pixum Vision.

R. Silva: Allergan, Allimera Sciences, Alcon, Bayer, Novartis, Thea.

C. V. Martinho: EVICR.net

J. Cunha-Vaz: Alimera Sciences, Allergan, Bayer, Gene Signal, Novartis, Pfizer, Precision Ocular Ltd., Roche, Sanofi-Aventis, Vifor Pharma and Carl Zeiss Meditec, EVICR.net

F. G. Holz: Acucela, Allergan, Apellis, Bayer, Boehringer-Ingelheim, Bioeq/Formycon, CenterVue, Ellex, Roche/Genentech, Geuder, Grayburg Vision, Heidelberg Engineering, Kanghong, LinBioscience, NightStarX, Novartis, Optos, Pixium, Vision, Oxurion, Stealth BioTherapeutics, Zeiss.

R. P. Finger: Novartis, Bayer, Allergan, Alimera, Roche/Genentech, Santhera, Opthea, Inositec, Ellex, CentreVue, Zeiss, Heidelberg Engineering.

Figures

**Fig. 1**
Participants screened and participants eligible for the MACUSTAR study with intermediate age-related macular degeneration as well as number of active sites and factors impacting screenings, displayed per week since start of recruitment at the first study site (80% target reached refers to individual clinical sites; all other factors are global). The blue curves represent cumulative numbers; the grey curve represents numbers per week

See this image and copyright information in PMC

References

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical