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

Trials

Ranee Thakar¹  Karen Guerrero²  Melanie Dembinsky³  Carol Bugge³  Margaret Graham³  Christine Hemming⁴  Mark Forrest⁵  Suzanne Breeman⁵  Wael Agur⁶  Kirsteen Goodman⁷  Lynn Melone⁷  Andrew Elders⁷  Doreen McClurg⁷  Suzanne Hagen⁷  Aethele Khunda⁸  Lucy Dwyer⁹  Rohna Kearney^1,10  John Norrie^1,11  Helen Mason^1,12 

[1] Croydon Health Services NHS Trust, Croydon University Hospital, Croydon, UK;Department of Urogynaecology, NHS Greater Glasgow & Clyde, Glasgow, UK;Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK;Grampian University Hospitals NHS Trust, Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Aberdeen, UK;Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK;NHS Ayrshire & Arran, Crosshouse Hospital, School of Medicine, Dentistry & Nursing, University of Glasgow, Kilmarnock, UK;Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK;South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK;The Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK;The Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK;Faculty of Biology Medicine and Health, School of Medical Sciences, University of Manchester, Manchester, UK;Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK;Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK;

关键词: Process evaluation;    Prolapse;    Pessary;    Self-management;    Randomised controlled trial;   

DOI  :  10.1186/s13063-020-04729-w

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY