Series: Pragmatic trials and real world evidence: Paper 3. Patient selection challenges and consequences
| Autor: | Diederick E. Grobbee, Antonio Ciaglia, Alison Lightbourne, Elaine A. Irving, Rolf H.H. Groenwold, Katrien Oude Rengerink, Laurent Eckert, Susan Collier, Sally Worsley, Shona Kalkman |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Epidemiology Alternative medicine Sample (statistics) Target population Real world evidence Pragmatic trial 03 medical and health sciences 0302 clinical medicine Enrollment Pragmatic Clinical Trials as Topic Journal Article Humans Medicine Generalizability theory 030212 general & internal medicine Intensive care medicine Selection (genetic algorithm) Representativeness Real-world evidence business.industry Patient Selection Participant Recruitment business Research setting 030217 neurology & neurosurgery |
| Zdroj: | Journal of Clinical Epidemiology, 89, 173. Elsevier USA |
| ISSN: | 0895-4356 |
| DOI: | 10.1016/j.jclinepi.2016.12.021 |
| Popis: | This paper addresses challenges of identifying, enrolling and retaining participants in a in a trial conducted within a routine care setting. All patients that are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice this can be best achieved by including - within the selected sites - all patients without further selection. If relevant heterogeneity between subgroups is expected, increasing the relative proportion of the subgroup of patients in the heterogeneous trial could be considered (oversampling), or a separate trial in this subgroup can be planned. Selection will nevertheless occur. Low enrolment and loss to follow-up can introduce selection and can jeopardize validity as well as generalizability. Pragmatic trials are conducted in clinical practice rather than in a dedicated research setting, which could reduce recruitment rates. However, if a trial poses a minimal burden to the physician and the patient, and routine clinical practice is maximally adhered to, the participation rate may be high and loss to follow-up will not be a specific problem for pragmatic trials. |
| Databáze: | OpenAIRE |
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