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The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation

  • Bugge, Carol1
  • Kearney, Rohna2, 3
  • Dembinsky, Melanie1
  • Khunda, Aethele4
  • Graham, Margaret1
  • Agur, Wael5
  • Breeman, Suzanne6
  • Dwyer, Lucy2
  • Elders, Andrew7
  • Forrest, Mark6
  • Goodman, Kirsteen7
  • Guerrero, Karen8
  • Hemming, Christine9
  • Mason, Helen7
  • McClurg, Doreen7
  • Melone, Lynn7
  • Norrie, John10
  • Thakar, Ranee11
  • Hagen, Suzanne7
  • 1 University of Stirling, Stirling, UK , Stirling (United Kingdom)
  • 2 Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK , Manchester (United Kingdom)
  • 3 University of Manchester, Manchester, UK , Manchester (United Kingdom)
  • 4 South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK , Middlesbrough (United Kingdom)
  • 5 University of Glasgow, Kilmarnock, UK , Kilmarnock (United Kingdom)
  • 6 University of Aberdeen, Aberdeen, UK , Aberdeen (United Kingdom)
  • 7 Glasgow Caledonian University, Glasgow, UK , Glasgow (United Kingdom)
  • 8 NHS Greater Glasgow & Clyde, Glasgow, UK , Glasgow (United Kingdom)
  • 9 Grampian University Hospitals NHS Trust, Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Aberdeen, UK , Aberdeen (United Kingdom)
  • 10 The University of Edinburgh, Edinburgh, UK , Edinburgh (United Kingdom)
  • 11 Croydon University Hospital, Croydon, UK , Croydon (United Kingdom)
Published Article
Springer (Biomed Central Ltd.)
Publication Date
Oct 08, 2020
DOI: 10.1186/s13063-020-04729-w
Springer Nature


BackgroundProcess evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences.MethodsThe trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan.DiscussionThe wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs.Trial registrationISRCTN62510577. Registered on 6 October 2017.

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