Award Title: Understanding factors which affect willingness to self-manage a pessary for pelvic organ prolapse: A mixed methods study aiming to improve access to pessary self-management.
Funder: Health Education England

Abstract: Pelvic organ prolapse is descent of the uterus, vaginal compartments and/or neighbouring organs which causes bothersome symptoms for 10% of UK women. While surgical management is an option, mechanical support from a vaginal pessary provides alternative, effective management. Pessary follow-up tends to be biannual which requires significant healthcare resources and is burdensome for women. Self-management is the woman's ability to remove and reinsert her pessary. In addition to reducing hospital appointments, self-management offers women autonomy regarding how to use their pessary. Pessary self-management was identified by patients and healthcare professionals as a James Lind Alliance priority for research in 2017. There is currently an NIHR funded study exploring whether pessary self-management improves quality of life. Recruitment has highlighted many women are unwilling to self-manage their pessary. At present there is a dearth of evidence regarding factors which affect willingness to self-manage. Barriers previously reported include; physical inability; preference for clinician-led care; difficulty; the intimate nature of pessary self-management; pain; emotional barriers; age; insufficient cognitive ability; inability to attend self-management teaching, personal circumstances and lacking willingness. Further exploration is required to understand causes of the lack of willingness and whether this can be overcome. Research aims	To determine whether women can remove and insert their shelf or gell-horn pessary 	To gain a deeper understanding of factors affecting willingness to self-manage a pessary for prolapse 	To investigate the presence of these factors in a larger population of pessary users and prioritise the influence of factorsClinical aims	To develop a questionnaire for clinical practice to help women identify and communicate concerns about pessary self-management 	To develop resources to help women overcome factors that influence their willingness to self-manageExploratory sequential mixed methods underpinned by a pragmatic paradigm will be used. The methods will incorporate quantitative findings which inform sampling, qualitative interview and quantitative questionnaire data collected using The Delphi technique.	Work package 1- Study of 45 shelf and gell-horn users at Manchester University NHS Foundation Trust (MFT) to determine whether women are able to insert and remove these pessaries. 	Work package 2- Grounded theory exploration of factors which affect willingness to self-manage a pessary. Data will be collected through semi-structured interviews with 20-30 women with the initial sample recruited at MFT. 	Work package 3- Delphi survey questionnaires completed by 30 women who don't self-manage their pessary from 5 UK hospitals. Respondents will quantify and prioritise factors which affect willingness to self-manage. 	Work package 4- Creation of a clinical questionnaire and resources to support women to overcome factors which affect willingnessIf factors negatively affecting willingness to self-manage a pessary can be overcome through support or education, this may increase the number of women empowered to self-manage. Findings will be submitted for presentation at conferences and publication. The applicant will utilise her position on the National Pessary Best Practice Group to ensure findings are disseminated to clinical leaders. Findings will also be shared via Facebook support groups for women with prolapse, on Twitter, in an e-newsletter and a webinair.

Lay Abstract: Pelvic organ prolapse caused by weakness in pelvic floor muscles causes bothersome symptoms for 1 in 10 UK women who have given birth. Symptoms include a bulge protruding into or outside the vagina, dragging discomfort and difficulty emptying the bladder or bowels. Prolapse can be managed with a mechanical device called a pessary (Appendix 1-image of pessaries) or by surgery. Comparisons of surgery versus pessary show both options improve quality of life. A pessary is inserted while the woman is awake in clinic and needs to be removed on a regular basis. At each appointment, the doctor or nurse removes the pessary, checks the skin inside the vagina and inserts a new pessary. In the UK, pessary follow-up is usually performed every 3-6 months. In other countries, women are taught to remove and reinsert their pessary independently; however a survey of practice in the UK showed only 17% of women are offered this. A project in Cambridge suggested some women prefer self-management. There is no published research on reasons women may or may not be willing to self-manage pessaries. It is important to understand this so we can develop ways of enabling women. Therefore this study plans to research factors affecting willingness to self-manage a pessary for prolapse. There are 4 work packages: 1-Investigating whether women are able to remove and reinsert shelf and gell-horn pessaries 2-Qualitative in-depth exploration of factors affecting willingness to self-manage a pessary will be undertaken by conducting semi-structured interviews with pessary users. 3-Using data from interviews, a list of factors that affect willingness to self-manage a pessary for prolapse will be generated. Using consensus technique, a questionnaire will be developed and sent to pessary users across the UK to evaluate whether these concerns and fears are issues for them and score the factors in terms of influence. Agreement on factors will be achieved by repeated rounds of questionnaires. 4-A further clinical questionnaire will be developed based on information collected in work packages 2 and 3. The questionnaire will be completed in clinic by women who have concerns but wish to self-manage. Women will complete the questionnaire to identify and communicate their specific areas of concern. Resources will be developed to support women to overcome their specific barriers to self-management. This research aims to support and facilitate woman-centred care; therefore collaboration with pessary users is essential. Two pessary users will be invited to be members of the project steering committee to offer guidance and support throughout the study. They will also contribute to questionnaire design, revision and data analysis to ensure themes and concepts important to pessary users are prioritised and analysed from the perspective of a service user. In addition, patients attending a service user group meeting at Saint Mary's Hospital and members of a national patient group will be asked to advise upon study literature, the research proposal and development of the clinical questionnaire and resources to support self-management. Findings of the study will be submitted for presentation at national and international conferences and for publication within relevant journals. Findings will also be posted out to all study participants and shared using social media targeted at women with an interest in prolapse and pessary care. Results will also be disseminated to appropriate clinical forums including The Pessary Best Practice Guideline Group, which the applicant is a member of, to ensure findings are translated into practice and benefit future women.

Research Activity Codes: 7.1 INDIVIDUAL CARE NEEDS
Health Categories: REPRODUCTIVE HEALTH AND CHILDBIRTH