Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness
| Autor: | Graham Thornicroft, Louise M. Howard, Jenny L Donovan, Isabel O C de Salis, Zelda Tomlin |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Research design medicine.medical_specialty Adolescent Mental disorders Article law.invention Paternalism Young Adult Clinical trials as topic 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Qualitative research Humans Medicine Pharmacology (medical) 030212 general & internal medicine Patient participation Young adult Psychiatry Aged Randomized Controlled Trials as Topic Supported employment Medicine(all) business.industry Data Collection Patient Selection General Medicine Middle Aged Mental illness medicine.disease Research Design Randomized controlled trials Female business 030217 neurology & neurosurgery |
| Zdroj: | Contemporary Clinical Trials |
| ISSN: | 1551-7144 |
| DOI: | 10.1016/j.cct.2008.07.007 |
| Popis: | Background Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. Aim To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness Methods Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. Results Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. Conclusion Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials. |
| Databáze: | OpenAIRE |
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