The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
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STUDY PROTOCOL
Open Access
The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation Carol Bugge1* , Rohna Kearney2,3, Melanie Dembinsky1, Aethele Khunda4, Margaret Graham1, Wael Agur5, Suzanne Breeman6, Lucy Dwyer2, Andrew Elders7, Mark Forrest6, Kirsteen Goodman7, Karen Guerrero8, Christine Hemming9, Helen Mason10, Doreen McClurg7, Lynn Melone7, John Norrie11, Ranee Thakar12 and Suzanne Hagen7
Abstract Background: Process 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. Methods: The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixedmethods 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. (Continued on next page)
* Correspondence: [email protected] 1 Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credi
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