title: The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial.
abstract: Patient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants.
  
  
  
  This is a cluster trial, embedded within a host trial ('EQUIP') recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation.
  
  
  
  Thirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes.
  
  
  
  To our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research.
  
  
  
  ISRCTN, ISRCTN16488358 . Registered on 14 May 2014. Study Within A Trial, SWAT-26 . Registered on 21 January 2016.
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK. adwoa.hughes-morley@york.ac.uk.|Division of Population Health, Health Services Research and Primary Care, University of Manchester, Williamson Building, Manchester, M13 9PL, UK. adwoa.hughes-morley@york.ac.uk.
authors.forename: Adwoa
authors.identifier: 0000-0002-2880-3935
authors.initials: A
authors.lastname: Hughes-Morley
authors.affiliation: Division of Population Health, Health Services Research and Primary Care, University of Manchester, Williamson Building, Manchester, M13 9PL, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Hann
authors.affiliation: Division of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Manchester, M13 9PL, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Fraser
authors.affiliation: School of Health Sciences, Queen's Medical Centre, The University of Nottingham, Nottingham, NG7 2HA, UK.
authors.forename: Oonagh
authors.initials: O
authors.lastname: Meade
authors.affiliation: Division of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Manchester, M13 9PL, UK.
authors.forename: Karina
authors.initials: K
authors.lastname: Lovell
authors.affiliation: MRC North West Hub for Trials Methodology Research, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
authors.affiliation: Division of Population Health, Health Services Research and Primary Care, University of Manchester, Williamson Building, Manchester, M13 9PL, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Roberts
authors.affiliation: Division of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Manchester, M13 9PL, UK.
authors.forename: Lindsey
authors.initials: L
authors.lastname: Cree
authors.affiliation: Division of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Manchester, M13 9PL, UK.
authors.forename: Donna
authors.initials: D
authors.lastname: More
authors.affiliation: HRB Clinical Research Facility, National University of Ireland Galway, Galway, Republic of Ireland.
authors.forename: Neil
authors.initials: N
authors.lastname: O'Leary
authors.affiliation: School of Health Sciences and Institute of Mental Health, The University of Nottingham, Jubilee Campus, Nottingham, NG7 2TU, UK.
authors.forename: Patrick
authors.initials: P
authors.lastname: Callaghan
authors.affiliation: Division of Population Health, Health Services Research and Primary Care, University of Manchester, Williamson Building, Manchester, M13 9PL, UK.
authors.forename: Waquas
authors.initials: W
authors.lastname: Waheed
authors.affiliation: MRC North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, University of Manchester, Williamson Building, Manchester, M13 9PT, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
mesh_terms: D000328:Adult; D003142:Communication; D003156:Community Mental Health Services / Q000379:methods*; D000067088:Direct-to-Consumer Advertising / Q000379:methods*; D004739:England; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008389:Marketing of Health Services / Q000379:methods*; D001523:Mental Disorders / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy; D008875:Middle Aged; D016017:Odds Ratio; D010174:Pamphlets; D010347:Patient Care Planning; D010358:Patient Participation; D017060:Patient Satisfaction; D018579:Patient Selection; D011639:Public Opinion; D035842:Research Subjects / Q000523:psychology*; D012720:Severity of Illness Index
keywords: Mesh: embedded trial; Patient and public involvement; Randomised controlled trial; Recruitment; Research methodology; Service user involvement; Study within a trial