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Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel
Karolinska Inst, Dept Clin Neurosci, Neurol, Nobels Vag 6, SE-17176 Stockholm, Sweden.
Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden;Umea Univ, Dept Publ Hlth & Clin Med, S-90187 Umea, Sweden.
Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden.
KTH Royal Inst Technol, Ctr Safety Res, SE-10044 Stockholm, Sweden.
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2019 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 618Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2019. Vol. 20, no 1, article id 618
Keywords [en]
Recruitment, Survey, Questionnaire, Randomised controlled trials, RCT
National Category
Neurology
Identifiers
URN: urn:nbn:se:uu:diva-400767DOI: 10.1186/s13063-019-3737-1ISI: 000502747500001PubMedID: 31666093OAI: oai:DiVA.org:uu-400767DiVA, id: diva2:1382470
Funder
Swedish Research CouncilSwedish Heart Lung FoundationAvailable from: 2020-01-03 Created: 2020-01-03 Last updated: 2020-01-03Bibliographically approved

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