Why do GPs exclude patients from participating in research? An exploration of adherence to and divergence from trial criteria

Jenkinson, C. E., Winder, R. E., Sugg, H. V. R., Roberts, M. J., Ridgway, N., Kuyken, W., Wiles, N., Kessler, D. and Campbell, J. (2014) Why do GPs exclude patients from participating in research? An exploration of adherence to and divergence from trial criteria. Family Practice, 31(3), pp. 364-370. (doi:10.1093/fampra/cmu005)

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Abstract

Background. The role of GPs in recruiting or excluding participants critically underpins the feasibility, external validity and generalizability of primary care research. A better understanding of this role is needed.

Aim. To 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. Secondary analysis of data from the CoBalT study, a multi-centre general-practice-based RCT investigating cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression.

Method. GPs were asked 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. Thirty-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 actively 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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Ridgway, Dr Nicola
Authors: Jenkinson, C. E., Winder, R. E., Sugg, H. V. R., Roberts, M. J., Ridgway, N., Kuyken, W., Wiles, N., Kessler, D., and Campbell, J.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Mental Health and Wellbeing
Journal Name:Family Practice
Publisher:Oxford University Press
ISSN:0263-2136
ISSN (Online):1460-2229

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
459001Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care - a randomised controlled trial (COBALT)Christopher WilliamsHealth Technology Assessment (HTA)06/404/02IHW - MENTAL HEALTH & WELLBEING