title: Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies.
abstract: Patient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice.
  
  
  
  We used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned.
  
  
  
  We conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research.
  
  
  
  A range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. A.south@ucl.ac.uk.
authors.forename: Annabelle
authors.identifier: 0000-0001-8912-2001
authors.initials: A
authors.lastname: South
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Bec
authors.initials: B
authors.lastname: Hanley
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Mitzy
authors.initials: M
authors.lastname: Gafos
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.|North Yorkshire AIDS Action, 20 St Saviourgate, York, YO1 8NN, UK.
authors.forename: Ben
authors.initials: B
authors.lastname: Cromarty
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.|National Cancer Research Institute Consumer Forum, Angel Building, 407 St John Street, London, EC1V 4AD, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Stephens
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Sturgeon
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Karen
authors.initials: K
authors.lastname: Scott
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: William J
authors.initials: WJ
authors.lastname: Cragg
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Conor D
authors.initials: CD
authors.lastname: Tweed
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Teera
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Vale
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D006801:Humans; D010358:Patient Participation; D012107:Research Design; D014495:Universities
keywords: Clinical trials; Consumer involvement; Patient and public involvement; RCTs; Systematic reviews