A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable
| Autor: | Benjamin Kasenda, Arnav Agarwal, Erik von Elm, Matthias Briel, Reem Alturki, Kelechi K Olu, Stefan Schandelmaier, Neera Bhatnagar |
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| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Epidemiology Psychological intervention MEDLINE law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Informed consent medicine Humans 030212 general & internal medicine Lost to follow-up Randomized Controlled Trials as Topic business.industry Patient Selection Checklist 3. Good health Discontinuation Family medicine Epidemiologic Research Design Cohort Physical therapy Lost to Follow-Up business 030217 neurology & neurosurgery |
| Zdroj: | Europe PubMed Central Journal of Clinical Epidemiology |
| ISSN: | 1878-5921 |
| Popis: | OBJECTIVE To collect and classify reported reasons for recruitment failure in discontinued randomized controlled trials (RCTs) and to assess reporting quality. METHODS We systematically searched MEDLINE and EMBASE (2010-2014) and a previous cohort of RCTs for published RCTs reporting trial discontinuation due to poor recruitment. Teams of two investigators selected eligible RCTs working independently and extracted information using standardized forms. We used an iterative approach to classify reasons for poor recruitment. RESULTS We included 172 RCTs discontinued due to poor recruitment (including 26 conference abstracts and 63 industry-funded RCTs). Of those, 131 (76%) reported one or more reasons for discontinuation due to poor recruitment. We identified 28 different reasons for recruitment failure; most frequently mentioned were overestimation of prevalence of eligible participants and prejudiced views of recruiters and participants on trial interventions. Few RCTs reported relevant details about the recruitment process such as how eligible participants were identified, the number of patients assessed for eligibility, and who actually recruited participants. CONCLUSION Our classification could serve as a checklist to assist investigators in the planning of RCTs. Most reasons for recruitment failure seem preventable with a pilot study that applies the planned informed consent procedure. |
| Databáze: | OpenAIRE |
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