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

Detalhes bibliográficos
Autor(a) principal: Terheyden, Jan Henrik
Data de Publicação: 2021
Outros Autores: 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.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
Texto Completo: https://hdl.handle.net/10316/103787
https://doi.org/10.1186/s12874-021-01243-8
Resumo: 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.
id RCAP_36e0ceae68a67e6f366f71f5ebcc046b
oai_identifier_str oai:estudogeral.uc.pt:10316/103787
network_acronym_str RCAP
network_name_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
repository_id_str https://opendoar.ac.uk/repository/7160
spelling Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR studyEarly disease stagesAge-related macular degenerationCohort studyScreeningRecruitmentCohort StudiesHumansResearch PersonnelMacular DegenerationRecruiting 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.Springer Nature2021-03-17info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://hdl.handle.net/10316/103787https://hdl.handle.net/10316/103787https://doi.org/10.1186/s12874-021-01243-8eng1471-2288Terheyden, Jan HenrikBehning, CharlotteLüning, AnnaWintergerst, LudmilaBasile, Pier G.Tavares, DianaMelício, Beatriz A.Leal, SergioWeissgerber, GeorgeLuhmann, Ulrich F. O.Crabb, David P.Tufail, AdnanHoyng, CarelBerger, MoritzSchmid, MatthiasSilva, RufinoMartinho, Cecília V.Cunha-Vaz, JoséHolz, Frank G.Finger, Robert P.info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2022-11-28T21:38:55Zoai:estudogeral.uc.pt:10316/103787Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-29T05:53:40.849612Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse
dc.title.none.fl_str_mv Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
title Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
spellingShingle Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
Terheyden, Jan Henrik
Early disease stages
Age-related macular degeneration
Cohort study
Screening
Recruitment
Cohort Studies
Humans
Research Personnel
Macular Degeneration
title_short Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
title_full Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
title_fullStr Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
title_full_unstemmed Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
title_sort Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study
author Terheyden, Jan Henrik
author_facet 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.
author_role author
author2 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.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv 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.
dc.subject.por.fl_str_mv Early disease stages
Age-related macular degeneration
Cohort study
Screening
Recruitment
Cohort Studies
Humans
Research Personnel
Macular Degeneration
topic Early disease stages
Age-related macular degeneration
Cohort study
Screening
Recruitment
Cohort Studies
Humans
Research Personnel
Macular Degeneration
description 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.
publishDate 2021
dc.date.none.fl_str_mv 2021-03-17
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://hdl.handle.net/10316/103787
https://hdl.handle.net/10316/103787
https://doi.org/10.1186/s12874-021-01243-8
url https://hdl.handle.net/10316/103787
https://doi.org/10.1186/s12874-021-01243-8
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1471-2288
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Springer Nature
publisher.none.fl_str_mv Springer Nature
dc.source.none.fl_str_mv reponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron:RCAAP
instname_str FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron_str RCAAP
institution RCAAP
reponame_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
collection Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
repository.name.fl_str_mv Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
repository.mail.fl_str_mv info@rcaap.pt
_version_ 1833602509310001152