Feasibility, Acceptability, and Appropriateness of the Menstrual Cup for Short Term Non-Surgical Management of Vesicovaginal Fistula (VVF) among Potential Users and Stakeholders NESSA RYAN, MPH, MSCI; GABRIEL Y.K. GANYAGLO, MD; ROSE MANTEY, MPH; JOONHEE PARK, MD
Financial Disclosure No financial relationships to disclose.
Background Obstetric fistula (OF): ◦ Permanent childbirth injury ◦ Due to obstructed or prolonged labor ◦ VVF: hole between bladder and vagina= continuous urine leakage Results in: ◦ Pain, discomfort, infection, malodor ◦ Vulnerability to stigma ◦ Economic burden ◦ Reduced quality of life WHO (2014) http://www.who.int/features/factfiles/obstetric_fistula/facts/en/index3.html ; UNFPA Campaign to End Fistula. (2015) http://www.endfistula.org/campaign-end-fistula-countries-0#overlay-context=publication
Problem: Management of Fistula Treatment Barriers ◦ Surgery accessed by 1 in 50 ◦ Barriers: individual, social, cultural, system Treatment Effectiveness ◦ Global: Success rate 85% (41-100%) ◦ Ghana: Success rate 73% Surgery is necessary but not sufficient Image source: personal photo Source: United Nations, 2014; GHS, 2015
The Innovation Strategy
Rationale Local assessment of the need necessary Feasibility, acceptability , appropriateness unknown Pre-implementation context unknown Involve affected community (girls and women) in implementation Image source: UNFPA brochure personal photo
Significance Inform a future effectiveness trial Informs innovation + implementation strategies Develop implementation partnerships Image source: personal photo
Research Questions 1. How do women with OF in Ghana develop strategies for coping in the absence of access to successful surgical repair? 2. What is the feasibility, acceptability, and appropriateness of an innovation to support coping among women with OF seeking care in a health facility in Ghana? 3. What are the perceived facilitators and barriers to implementation among additional OF stakeholders regarding the innovation?
Conceptual Framework Consolidated Framework for Implementation Research(CFIR) (Damschroder et al., 2009) Transactional Model of Coping and Stress (Lazarus & Folkman, 1984) Implementation outcomes (Proctor et al., 2011)
Design Sequential Exploratory Mixed Methods Design (1) quant --> (2) QUAL Semi-structured In-depth Interviews Interviews with Clinical Trial with Women Living Stakeholders with OF (Aug-Dec 2016) (July-Nov 2017) (Jun 2017) N=11 N=29 N=6 Analysis Analysis informs informs To evaluate innovation: To assess innovation: To assess innovation: data data - feasibility -local need collection -appropriateness collection -efficacy -appropriateness To identify pre-implementation: -acceptability - barriers -facilitators
Methods Domain Construct Level of analysis Measures Data source RQ (Quant/Qual) • Relative advantage Stakeholders Qual Key informant 3 Intervention interviews characteristics • Complexity (CFIR) • Cost • Culture • Available Stakeholders Qual Key informant 3 Organizational resources interviews characteristics (CFIR) • Implementation • User needs and climate Document review • inner setting resources • Tension for Observation • outer setting • Compatibility change individual Knowledge and beliefs about the Stakeholders/women with Qual Key informant 1, 2 intervention fistula interviews characteristics (CFIR) Self-efficacy Women with fistula In-depth interviews Quant Other personal attributes Women with fistula Questionnaire Acceptability Women with fistula Quant Questionnaire 2 Implementation Outcomes Stakeholders Qual Appropriateness Women with fistula Qual In-depth interview 2 (Proctor et al., 2011) Feasibility Women with fistula Quant (2-hr pad test) Clinical observation 2 Stakeholders Qual In-depth interview
Results: Feasibility and Efficacy of Innovation 61% mean reduction in leakage with the cup 78% reduction if multiple surgical attempts No adverse events
Results: Acceptability Women with VVF could easily: • Insert (72.7%) • Remove (72.7%) • Comfortably wear (100.0%) Additional Stakeholders (clinicians, policy-makers, programmers, and researchers): • Content and complexity are acceptable
Results: Appropriateness Good perceived fit of the cup to address incontinence for this setting and user Women ◦ Already use various practices/resources to cope ◦ Expressed usefulness Additional Stakeholders ◦ Low-cost, low-tech solution ◦ Water access a concern Organizational Setting ◦ Cultural norms and existing activities align with approach
Results: Local Needs Assessment Coping with leaking ◦ Initially, I was using pampers but now because of financial difficulties I have to use rags. ◦ Anytime I realized the cloth in my pant is getting soaked, I leave my things in the care of someone, run home, change, and come back to continue selling my items. Coping with other impairment ◦ Sometimes I feel weak, so my husband and my daughter help me with the washing. The way my family treats me gives me the strength to fight on, we eat together, they support me in everything. ◦ God always gives me the strength to cope. Coping with stigma ◦ People relate to me normal, but I just do not want to mingle with them… because I don’t want my condition to spread. If one person gets to know about it, it will spread. ◦ There was a day I sat close to one woman in church. She told me I have a bad scent so I should not come to church again, and I reported her to my mother. My mother confronted her.
Results: Pre-implementation Context Facilitators ◦ Clear relative advantage to self-management ◦ Simple and low-cost device ◦ Tension for change to address surgical gaps ◦ Compatible with ongoing programming ◦ Build upon existing partnerships Barriers ◦ User Acceptability ◦ User Appropriateness (available resources)
Discussion The innovation is efficacious, acceptable, adds to current coping strategies, and fits within existing fistula programs. Stakeholders pre-implementation perceptions highlight the importance of partnerships and the need for an evidence base related to effectiveness, acceptability, and cost. Challenges to address include access to resources within these contexts (water, soap, and safe space) and development appropriate counseling message. Image source: personal photo
Conclusion IMPLEMENTATION STRATEGY (ERIC) INTERVENTION STRATEGY Build a coalition Cup design modification Conduct local consensus discussions Need for a counseling component Develop a formal implementation blueprint Develop academic partnerships Develop educational materials Identify and prepare champions Involve patients/consumers and family members Use advisory boards and workgroups Use an implementation advisor Source: Powell et al., 2015; Image source: personal photo UNFPA Ghana
Next steps Joonhee Park, MD joonheepark@restore-health.org Larger clinical trial with Restore Cup (Hybrid Type I) ◦ Evaluating effectiveness ◦ Exploring implementation context Joanna Pozen, JD/MPH joannapozen@restore-health.org In-depth interviews with women living with fistula ◦ Expanding on acceptability Nessa Ryan, MPH, MSCI ◦ Expanding on stigma process nessaryan@restore-health.org https://restore-health.org
Acknowledgements The participants Dr. Gabriel Ganyaglo Rose Mantey, MPH Dr. Joonhee Park Joanna Pozen, JD/MPH Dr. Bernadette Boden-Albala Dr. Alison El Ayadi Dr. Lawrence Yang NYU Clinical and Translational Science Institute TL1 Program NYU Stern Social Entrepreneurship Challenge Image source: personal photo
References 1. Damshroeder et al., Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation Science (2009) 4:50 doi:10.1186/1748-5908-4-50 2. Ghana Health Service, Report on Fistula Report Burden in Ghana. 2015. 3. Kirk et al., A systematic review of the use of the Consolidated Framework for Implementation Research. Implementation Science (2016) 11:72 doi 10.1186/s13012-016-0437-z 4. Powell et al., A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implementation Science (2015) 10:21 doi 10.1186/s13012-015-0209- 1 5. Proctor et al., Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda. Adm Policy Ment Health (2011) 38:65 – 76. doi 10.1007/s10488-010-0319-7 6. United Nations. (2014). Report of the Secretary General, “Supporting Efforts to End Obstetric Fistula. UN doc. A/69/25 (5 Aug. 2014) 7. Wall, Lewis. Obstetric vesicovaginal fistula as an international public-health problem. Lancet. 2006;3., 2006. 368 (9542): p. 1201-1209.
Questions? Image source: personal drawing
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