Evidence map›Paper›PMID 33731014›Full record

ArticleBMC medical research methodology2021

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

Jan Henrik Terheyden, Charlotte Behning, Anna Lüning, Ludmila Wintergerst, Pier G Basile, Diana Tavares, Beatriz A Melício, Sergio Leal, George Weissgerber, Ulrich F O Luhmann and 11 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC medical research methodology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03349801 (Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03349801 active not recruitingnot on this map

Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration (AMD)

TypeobservationalSponsorFrank G. HolzRan2018 to 2026Enrolled718ConditionsAge Related Macular Degeneration (AMD)ArmsNo intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Uncovering key clinical trial features influencing recruitment.Journal of clinical and translational science · 2023
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 9 institutions in 5 countries.

Jan Henrik TerheydenDepartment of Ophthalmology, University Hospital Bonn, Bonn, Germany. Jan.Terheyden@ukbonn.de.ORCID 0000-0002-0174-4066
Charlotte BehningInstitute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.
Anna LüningDepartment of Ophthalmology, University Hospital Bonn, Bonn, Germany.
Ludmila WintergerstDepartment of Ophthalmology, University Hospital Bonn, Bonn, Germany.
Pier G BasileAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Diana TavaresAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Beatriz A MelícioAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Sergio LealBayer AG, Berlin, Germany.
George WeissgerberNovartis Pharma AG, Basel, Switzerland.
Ulrich F O LuhmannRoche Pharmaceutical Research and Early Development, Translational Medicine Ophthalmology, Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland.
David P CrabbDivision of Optometry and Visual Sciences, School of Health Sciences, City, University of London, London, UK.
Adnan TufailMoorfields Eye Hospital, London, UK.
Carel HoyngRadboud University Medical Center, Nijmegen, Netherlands.
Moritz BergerInstitute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.
Matthias SchmidInstitute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.
Rufino SilvaAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Cecília V MartinhoAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
José Cunha-VazAssociation for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Frank G HolzDepartment of Ophthalmology, University Hospital Bonn, Bonn, Germany.
Robert P FingerDepartment of Ophthalmology, University Hospital Bonn, Bonn, Germany. Robert.Finger@ukbonn.de.
MACUSTAR consortium
University Hospital Bonn · DEAssociation for Innovation and Biomedical Research on Light and Image · PTBayer (Germany) · DECity, University of London · GBHospitais da Universidade de Coimbra · PTMoorfields Eye Hospital · GBNovartis (Switzerland) · CHRadboud University Nijmegen · NLRoche (Switzerland) · CH

Funding

Horizon 2020 116076
6 · The paper itself

Abstract

backgroundRecruiting 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).

methodsScreening 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.

resultsA 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.

conclusionsCareful 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 registrationClinicalTrials.gov NCT03349801 . Registered on 22 November 2017.

Indexed as

Macular DegenerationCohort StudiesHumansResearch PersonnelAge-related macular degenerationCohort studyEarly disease stagesRecruitmentScreening

Identifiers

PMID33731014
PMCPMC7967977
OpenAlexW3139307362

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.