Why do GPs exclude patients from participating in research? An exploration of adherence to and divergence from trial criteria
| Autor: | David Kessler, Holly Victoria Rose Sugg, Nicola J Wiles, Nicola Ridgway, Martin Roberts, Caroline E Jenkinson, Willem Kuyken, John Campbell, Rachel Winder |
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| Rok vydání: | 2014 |
| Předmět: |
Research design
Adult Male medicine.medical_specialty Adolescent medicine.medical_treatment Comorbidity law.invention External validity Young Adult Randomized controlled trial law General Practitioners medicine Humans Generalizability theory Practice Patterns Physicians' Psychiatry Aged Randomized Controlled Trials as Topic Depressive Disorder Cognitive Behavioral Therapy business.industry Patient Selection Secondary data Middle Aged Mental health Cognitive behavioral therapy Research Design Family medicine Cognitive therapy Female Guideline Adherence Family Practice business |
| Zdroj: | Family practice. 31(3) |
| ISSN: | 1460-2229 |
| Popis: | Background. The role of GPs in recruiting or excluding par ticipants critically underpins the feasibility, external validity and generalizability of primary care research. A better understanding of this role is needed. Aim. T o investigate why GPs excluded potentially eligible participants from a large scale randomized controlled trial (RCT), to determine the proportion of patients excluded on account of trial eligibility compared with other reasons, and to explore the impact of such exclusions on the management and generalizability of RCTs. Design and setting. S econdary analysis of data from the CoBalT study, a multi-centre generalpractice-based RCT investigating cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression. Method. GPs were ask ed to screen patient lists generated from computerized record searches for trial eligibility and to provide narrative reasons for excluding patients. These reasons were coded independently by two researchers, with a third researcher resolving discrepancies. Results. Thir ty-one percent (4750/15 379) of patients were excluded at the GP screening stage, including 663 on patient lists that remained unscreened. Of the 4087 acti vely excluded patients, 67% were excluded on account of trial exclusion criteria, 20% for other criteria (half of which were comorbid conditions) and 13% without reason. Conclusion. Clear , comprehensive criteria, particularly with regards to comorbidities, are required for GPs to confidently screen patients for potential participation in research. Future studies should promote inclusivity and encourage GPs to adopt a liberal approach when screening patient lists. This would enhance the validity and generalizability of primary care research and encourage greater patient autonomy. |
| Databáze: | OpenAIRE |
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