Research project
Title: An evidence base to optimise methods for involving patient and public representatives in clinical trials: a systematic investigation of a cohort of Health Technology Assessment (HTA) funded clinical trials
Project timescale: From 03 October, 2011 to 12 February, 2013
(Added to website on: 15 January, 2013 - Date last updated: 23 January, 2013)
Source of funding:
Health Services Research Programme (National Institute for Health Research)
Aims: To increase knowledge of patient and public involvement (PPI) within clinical trials by systematically describing and critically evaluating the process and impact of PPI from the perspectives of the PPI representative, chief investigator and clinical trials unit (CTU) staff. To provide an evidence base that will inform the optimisation of PPI.
Research designs used:
Evaluation
Study of views/experiences
Systematic review
Other:
Methods used to collect data:
Interviews
Questionnaire survey
Other (please specify):
Research project description: This project will consist of 4 phases. Phase 1 is a systematic investigation of levels of PPI planned in HTA funded trials. Phase 2 is a survey of PPI representatives and chief investigators (CIs) of each trial to assess how the PPI plans have evolved. Phase 3 is a qualitative exploration of a purposive sample of respondents to phase 2 to investigate their views of the impact of PPI within the trial. Phase 4 is examining the existing role and identifying the future role of CTUs in identifying and supporting PPI needs.
Stages at which the public were involved:
Managing the research
Writing or co-writing final report
Designing the research instruments
(eg questionnaires, patient information sheets)
Undertaking the research
Disseminating research
Final Research Report
Planning the research
Contributing / commenting on final report
Other:
Description of public involvement in research stages:
Training and support provided for either members of the public or researchers involved in the project: The PPI coordinator provides support to the PPI Advisory Group.
Examples of ways the public have made a difference to the research project: 1. During the design of our project, our PPI co-applicant suggested that our study should investigate the potential drawbacks of PPI as well as its benefits. The project was revised in light of this suggestion, to critically assess involvement. 2. The PPI advisory group made recommendations for changes to our database extraction tool. 3. Various amendments to our surveys as a result of PPI including rewording of questions and adding extra questions.
Evaluating the impact of public involvement in the research: We are gathering feedback from our PPI representatives after each meeting to gain their views on the PPI processes. We are providing a summary of the feedback to our PPI representatives for their comments.
Details of publications or reports resulting from the research:
Links to Reports:
Was/is your project user controlled: No
For further information on the project, please contact:
Louise Dudley
The University of Liverpool
ldudley@liv.ac.uk
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