Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel

Isaksson, Eva; Wester, Per; Laska, Ann Charlotte; Näsman, Per; Lundström, Erik

doi:10.1186/s13063-019-3737-1

Cited by 43Ethics in Clinical ResearchStatistical Methods in Clinical TrialsHealth Policy Implementation Science

Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel

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Isaksson, Eva, Wester, Per, Laska, Ann Charlotte, Näsman, Per, Lundström, Erik·2019·Trials

DOI 10.1186/s13063-019-3737-1PMC PMC6822437

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Abstract

BACKGROUND: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT. METHODS: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively. RESULTS: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%). CONCLUSIONS: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine. TRIAL REGISTRATION: The protocol for this study was registered at the Northern Ireland Hub for trials methodology research (SWAT ID 64 ). The EFFECTS study has EudraCT number 2011-006130-16 and was registered 17 February 2016 at ClinicalTrials.gov number NCT02683213 .

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Lack of time and resources devoted to research are common barriers to patient recruitment into RCTs and our study was not an exception.
“Lack of time and resources devoted to research are common barriers to patient recruitment into RCTs and our study was not an exception (55).”
From Total Sleep Deprivation Followed by Bright Light Therapy as Rapid Relief for Depression: A Pragmatic Randomized Controlled Trial (2021) · cites this paper as [55]

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Authors: Isaksson, E., Wester, P., Laska, A. C., Näsman, P., & Lundström, E.
Affiliations: Karolinska Institutet (SE)
Danderyds sjukhus (SE)
KTH Royal Institute of Technology (SE)
Uppsala University (SE)
Corresponding author: Isaksson, Eva
ORCID: Isaksson, Eva
Wester, Per
Laska, Ann Charlotte
Näsman, Per
Lundström, Erik
Venue: Trials
Publisher: Springer Science and Business Media LLC
Published: 2019-10-30
Volume: 20
Issue: 1
Pages: 618-618
ISSN: 1745-6215 (ISSN-L)
DOI: 10.1186/s13063-019-3737-1
PMC: PMC6822437
OpenAlex: W2982638365
Cited by: 43
References: 31
Citations by year: 2026: 4 · 2025: 3 · 2024: 4 · 2023: 6 · 2022: 5 · 2021: 19 · 2020: 2
FWCI: 5.99
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Trials (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
Uppsala University Publications (Uppsala University) (submittedVersion, other-oa)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders: University of Edinburgh
Hjärt-Lungfonden
Vetenskapsrådet
Svenska Läkaresällskapet
STROKE-Riksförbundet
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords: patient recruitment, randomized controlled trials, recruitment barriers, recruitment strategies, informed consent, language barriers, fear of side effects
MeSH terms: Adult, Female, Humans, Male, Middle Aged, Pilot Projects, Surveys and Questionnaires, Randomized Controlled Trials as Topic, Patient Selection

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Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel

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