Feasibility, Acceptability, and Appropriateness of the Menstrual Cup - - PowerPoint PPT Presentation

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 N=11 N=29 N=6 Clinical Trial (Aug-Dec 2016) In-depth Interviews with Women Living with OF (Jun 2017) Semi-structured Interviews with Stakeholders (July-Nov 2017)

Analysis informs data collection Analysis informs data collection

To evaluate innovation:

• feasibility
• efficacy
• acceptability

To assess innovation:

• local need
• appropriateness

To assess innovation:

• appropriateness

To identify pre-implementation:

• barriers
• facilitators

Methods

Domain Construct Level of analysis Measures (Quant/Qual) Data source RQ Intervention characteristics (CFIR)

• Relative advantage
• Complexity
• Cost

Stakeholders Qual Key informant interviews 3

Organizational characteristics (CFIR)

• inner setting
• outer setting
• Culture
• Implementation

climate

• Tension for

change

• Available

resources

• User needs and

resources

• Compatibility

Stakeholders Qual Key informant interviews Document review Observation 3

individual characteristics (CFIR)

Knowledge and beliefs about the intervention Self-efficacy Other personal attributes Stakeholders/women with fistula Women with fistula Women with fistula Qual Quant Key informant interviews In-depth interviews Questionnaire 1, 2

Implementation Outcomes (Proctor et al., 2011)

Acceptability Women with fistula Stakeholders Quant Qual Questionnaire 2 Appropriateness Women with fistula Qual In-depth interview 2 Feasibility Women with fistula Stakeholders Quant (2-hr pad test) Qual Clinical observation In-depth interview 2

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)

Build a coalition Conduct local consensus discussions 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

INTERVENTION STRATEGY

Cup design modification Need for a counseling component

Source: Powell et al., 2015; Image source: personal photo UNFPA Ghana

Next steps

Larger clinical trial with Restore Cup (Hybrid Type I)

• Evaluating effectiveness
• Exploring implementation context

In-depth interviews with women living with fistula

• Expanding on acceptability
• Expanding on stigma process

https://restore-health.org Joonhee Park, MD joonheepark@restore-health.org joannapozen@restore-health.org nessaryan@restore-health.org Joanna Pozen, JD/MPH Nessa Ryan, MPH, MSCI

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