Tools for self-management of obstetric fistula in low- and middle-income countries: a qualitative study exploring pre-implementation barriers and facilitators among global stakeholders

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Ganyaglo, Bernadette Boden-Albala, Lawrence H. Yang, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2051782/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Obstetric fistula, a debilitating maternal morbidity, occurs in contexts with poor access to and quality of emergency obstetric care, predominantly in sub-Saharan Africa. As many as two million women and girls suffer from fistula, which results in urinary incontinence, vulnerability to stigma for women and families, and economic consequences for the household and the healthcare system. Surgical repair, the gold standard for treatment, remains inaccessible to many and success is not guaranteed. Non-surgical, user-controlled fistula management options are not readily accessible, although some technologies, like insertable devices, have been found to have some level of feasibility and acceptability and provide short-term control over incontinence. As evidence for the effectiveness of tools to support self-management grows, the determinants of their implementation within various contexts remain unknown. The purpose of this qualitative study was to explore with key stakeholders, prior to implementation, those factors that could influence successful implementation of an innovation for self-management of obstetric fistula in a LMIC. Methods: Stakeholders were purposefully identified from sectors that address the needs of women with obstetric fistula in sub-Saharan Africa: clinical care, academia, international health organizations, civil society, and government. Twenty-one key stakeholders were interviewed about their perceptions of innovations for fistula self-management and their implementation. The Consolidated Framework for Implementation Research (CFIR) guided data collection and analysis of transcripts from recorded interviews. Analyses were carried out within Nvivo v.12. Deductive coding focused on constructs within the CFIR, then inductive coding identified additional constructs relevant for implementation. Results: Potential facilitators to implementation included a clear tension for change for low-cost, accessible innovations for self-management and a relative advantage over existing tools. The development of partnerships and identification of champions could also support implementation. Barriers included the lack of evidence identifying the optimal beneficiary and the need for educational strategies that encourage acceptability among clinical providers. Inductive coding revealed an additional relevant construct of sustainability. Conclusions : Effectiveness and implementation of non-surgical tools for fistula self-management should be further examined in LMICs. Future research could inform comprehensive fistula care to reduce vulnerability to stigma and improve quality of life. Obstetric fistula female genital fistula device incontinence management self-management non-surgical management pre-implementation consolidated framework for implementation research theory of change Background Obstetric fistula, a maternal morbidity eliminated in high-income countries with the scale-up of accessible, quality maternal healthcare, persists in low- and middle-income countries (LMICs) where 99% of global maternal deaths occur ( 1 ). This injury results most commonly from prolonged or obstructed labor and involves the formation of an abnormal connection between the genital and urinary tract or rectum, resulting in urinary and/or fecal incontinence, discomfort, malodor, and skin irritation ( 2 ). Other obstructed labor related health consequences include injury to the urinary or genital tract, neurological damage to the extremities, musculoskeletal injury, gastrointestinal injury, and stillbirth. Up to two million women and girls, predominantly in sub-Saharan Africa, live with fistula and are subsequently vulnerable to psychosocial and economic consequences, including stigma and reduced opportunities for community participation and income generation that ultimately reduces their wellbeing ( 3 – 5 ). Subsequent mental health morbidities include depression, anxiety, post-traumatic stress disorder, and suicidal ideation and attempts ( 6 , 7 ). Globally, genital fistula is responsible for 1.15 million years lived with disability (YLDs), accounting for 65% of the total YLDs attributable to all maternal complications ( 8 ). Obstetric fistula remains an understudied, underfunded issue of global health inequity: this largely preventable injury is caused by delay in receiving emergency comprehensive obstetric care (i.e. caesarean section and instrumental delivery), which is less accessible in rural settings where geographic, economic, and social barriers increase the risk for women and girls. Although the most immediate cause of obstetric fistula is inadequate and/or delayed obstetric care, there are various root causes that increase likelihood and/or severity of the prolonged, obstructed labor that leads to the injury, including low education, limited opportunities for income generation, gender inequity, low personal or household income, lack of access to family planning and skilled birth attendance, and limited community resources like transportation ( 9 ). Just as access to preventative surgical intervention like emergency caesarean section to alleviate prolonged, obstructed labor is a challenge, multiple barriers to fistula treatment exist ( 10 , 11 ). The approach to fistula management has evolved over the last few decades, with an increasing commitment to holistic care ( 12 , 13 ). This is in part a reflection of a growing appreciation of the social determinants of this condition, as well as the priorities of funding agencies. Although initially common to be dependent on visiting surgeons, many settings are transitioning away from the less sustainable, potentially harmful medical tourism model ( 14 ) and instead are focusing on increasing training of local surgeons and surgical capacity at facilities. Substantial global mobilization and capacity building efforts have been guided by the United Nations Population Fund (UNFPA) and partners through the Campaign to End Fistula, and global fistula care has grown more comprehensive and multi-sectoral in its approach—with varying degrees of successful implementation. The clinical focus of fistula management in some settings has expanded from solely providing surgical services such as outreach, screening, preoperative care, treatment, and post-operative care, to include tertiary preventative services that focus on improving quality of life and addressing co-morbidities, including physiotherapy for rehabilitation ( 15 , 16 ) and mental health services to address depression and anxiety related to the condition ( 6 ). Fistula care across various contexts is provided via different models, including dedicated fistula clinics integrated into existing hospital facilities, stand-alone specialist fistula hospitals, and intermittent outreach camps in remote areas ( 12 ). Various stakeholders support fistula programming and policy development, implementation, and evaluation at the local, regional, national, and/or global level, including those working in clinical, governmental, international health, civil society, and academic sectors. (Table 1 ) Some support from private partners also exists. Various nations have enhanced coordination through global partnerships among various stakeholders via national alliances, such as national obstetric fistula task forces and/or technical working groups. The partnerships plan and monitor development of national strategies to eliminate fistula and help to ensure a comprehensive response, to avoid duplication and to place fistula in the context of broader development plans ( 12 ). Many countries have developed national plans for eliminating obstetric fistula, including a preventive component to strengthen emergency obstetric care, and training and equipment of health facilities for fistula treatment ( 17 , 18 ). Table 1. Explanation of role in fistula management for each stakeholder category Stakeholder category Role in fistula management Clinician • Clinicians are usually involved in training of fistula surgeons and other physicians, nurses, and midwives to identify, refer, and/or treat fistula, as appropriate, and in implementing programs for surgical repair. • These partners may be associated with regional referral hospitals, medical training institutions, departments of Obstetrics and Gynecology, and local and international clinical professional societies such as the International Society of Obstetric Fistula Surgeon (ISOFS) (https://www.isofs-global.org/) and the International Federation of Gynecology and Obstetrics (FIGO) (https://www.figo.org/). Governmental representatives • Governmental partners include the governments of donor HICs and the health and gender-related ministries in-country. • The Ministry of Health (MOH) plays a critical role in ensuring equitable access to health care and stewardship for health resources. • As part of a country’s maternal health strategy, the MOH plans for service delivery and applies standards, policies, and guidelines within the healthcare system. International health organizations • International health organizations include partners that are multilateral agencies like UNFPA (the country-level offices as well as headquarters in NYC) and the World Health Organization (WHO), as well as bilateral agencies like United States Agency for International Development (USAID). • UNFPA, together with partners, launched the global Campaign to End Fistula in 2003 and has since established three pillars of focus: prevention, treatment, and social reintegration. Civil society representatives • Civil society partners may include faith-based organizations, local opinion leaders, local or international non-governmental organizations (NGOs) working in women’s health, empowerment, and wellbeing. • These partners provide services in line with their respective mandates, which could include addressing the barriers to accessing care (i.e., supporting transportation to the facility) as well as providing social support services (i.e. training in income generating activities to improve women’s financial independence). • As these organizations may have closer ties to the community, they are best served to identify the needs of women with fistula. Likely the most important stakeholder, affected women and girls, can be considered a type of civil society partner. Academic researchers • Academics are another partner and the focus of research on obstetric fistula has grown exponentially in the last decade. The number of published articles for ‘obstetric fistula’ in Pubmed from 2003 to present is 776, almost twice that published in the 100 years prior. • Academics have supported research, often in collaboration with other stakeholders, to quantify the magnitude of fistula, to identify the determinants of fistula and to assess surgical outcomes, to identify the needs of women with current or previous fistula, to support the development and evaluation of interventions for prevention, and to examine obstetric fistula policy. • This has required contributions from researchers in public health, nursing and midwifery, medicine, anthropology, sociology, biomedical engineering, and various other disciplines. [place Table 1 here] The fistula literature lacks a focus on implementation research, as it is unknown what impact provider characteristics (e.g., training), patient characteristics (e.g., complexity of anatomical damage), or intervention delivery (e.g., whether surgery was provided as part of an outreach program or at a centralized center of excellence) have on implementation or effectiveness outcomes ( 19 – 22 ). Fistula care is delivered through different means which could impact effectiveness and cost. Estimates suggest that surgical repair and social integration costs range from $ 300 to $ 1700 per patient ( 23 ). One study calculated for surgery the cost per DALY averted of $ 54 in Uganda when estimating the cost of repair at $ 378 ( 24 ). There is particularly little evidence on management of cases who have previously failed surgical repair and who remain incontinent even with closure of the fistula. Evidence for fistula self-management is expanding, but there is a need to Inform implementation planning. Fistula programs predominantly focus on the three programming pillars identified by the UNFPA’s Campaign to End Fistula: prevention, surgical repair, and reintegration; however, there remains an opportunity to integrate non-surgical, therapeutic self-management. Traditional management requires surgical repair ( 25 ); however, various individual, social, or structural barriers delay or prevent women’s access to surgery ( 11 ). When surgery is accessed, repair outcomes are variable: reported rates of fistula closure vary from 65–90% ( 17 , 26 ). Fistula closure is the most used metric for surgical success; however, persistent leaking after successful surgical repair is not uncommon and represents an important functional outcome ( 27 , 28 ). Although women may be managing various types of fistula-related urinary incontinence ( 22 ), including incontinence among those who are unrepaired and residual or stress incontinence among those who are repaired, little focus has been applied to understanding self-management. As the mean duration a woman lives with fistula before seeking repair is 4–10 years ( 29 – 31 ) and successful surgical repair is not guaranteed, user-controlled tools for self-management have the potential to improve the quality of life of many women living with this chronic condition. Although some fistula care settings provide support for self-management of residual incontinence ( 15 ), less attention has been paid to self-management for fistula-related incontinence. This has ethical implications for women who are undergoing multiple surgical attempts that are likely to be unsuccessful. A body of evidence on self-management of fistula is growing ( 32 – 34 ), including on the feasibility and acceptability of an insertable device to manage incontinence and support coping ( 35 ). However, the potential determinants of successful implementation for these novel tools have not been examined. Therefore, we sought to explore the perceived pre-implementation facilitators and barriers among diverse fistula stakeholders regarding self-management tools to support coping among women with obstetric fistula in LMICs. Methods Qualitative approach and paradigm We conducted in-depth interviews to understand key stakeholder perspectives on pre-implementation facilitators and barriers around fistula self-management tools. The approach was framed by the Consolidated Framework for Implementation Research (CFIR) ( 36 ) to understand the interrelated factors that affect implementation. The framework is composed of five main domains: characteristics of the intervention, inner setting, outer setting, the individuals involved, and the process through which implementation occurs. CFIR has been comparatively less utilized during the pre-implementation phase than during or after implementation ( 37 ). Twenty-one individuals were purposively sampled to ensure a broad examination of global fistula stakeholders working in fistula endemic settings in sub-Saharan Africa and likely to inform implementation of an innovation for fistula self-management in LMICs. Five categories of participants were enrolled: researchers ( 11 ), clinicians ( 4 ), representatives of civil society ( 2 ) or international health organizations ( 2 ) working on fistula, and government representatives ( 2 ). Although these categories are not mutually exclusive, participants were asked to select the role with which they most identify. Researchers were often also clinicians (8/11) or also involved with fistula-related civil society organizations (5/11). Researcher characteristics and reflexivity Interviews and coding were carried out by NR in part for completion of her dissertation research. She was trained in qualitative methods and was apprenticing under experienced qualitative researchers. Prior to initiation of the interview, the interviewer spent time discussing with participant the study’s goal and rationale. The interviewer was a member of a collaborative team working to study the effectiveness of an insertable device to manage fistula-related incontinence. She engaged in reflexivity throughout the research process by examining any potential researcher bias due to this endeavor. Sampling strategy Stakeholders were recruited via purposive sampling through introduction to members of various national Obstetric Fistula Task Forces, an UNFPA-supported multi-sectoral group working to address fistula in their respective nations. Subsequent interviews were carried out via snowball sampling from those who agreed to participate. Participants were involved in addressing obstetric fistula in sub-Saharan Africa through advocacy, prevention, treatment, and/or reintegration in settings throughout Ghana, Nigeria, Ethiopia, Tanzania, Malawi, and the Democratic Republic of Congo. All invited participants consented to participate, except one who did not agree she was a stakeholder and instead directed the researcher to another contact. Participants were approached in-person and via email. Setting Interviews were carried out in-person in a fistula-endemic setting (n = 7), in-person in the US (n = 8), or over the phone (n = 6). When possible, interviews were carried out face-to-face, but due to the global focus of this work, in-person interview was not always feasible. All interviews were one-on-one, except for one interview between the researcher and two clinicians. Additionally, the researcher observed at a fistula ward in an endemic setting and observed during community outreach to improve understanding of fistula care. Data collection methods Data collection occurred from November 2017 to March 2019. Primary data collection occurred at clinical or community sites for fistula care, in professional settings where fistula-related policy decisions are planned, and at relevant conferences. Most participants were interviewed only once, although a few (n = 2) were contacted for a follow-up discussion when clarification was needed during the analysis stage. Participants reviewed a summary of research on an insertable device for self-management and a brief video of the device’s functionality and potential implementation. Interviews were carried out in English, recorded, and transcribed verbatim. Field notes were generated throughout recruitment and interview processes to purposively guide participant selection, as well as adapt the interview guide. On average, interviews lasted 50 minutes. Recruitment continued until data saturation was met, or the point at which no new codes were generated and the developed themes had sufficient coverage and could be supported with strong illustrative quotes (p.196) ( 38 ). Data collection instruments Development of the in-depth interview content was informed by the CFIR ( 36 ), which included the domains of the intervention characteristics, the process, the organizational characteristics (inner and outer setting), and the individual characteristics. The interview guide was pilot-tested and refined and the order of questions was subsequently modified to improve the flow of discussion. Data analysis Analysis of interviews was conducted by the primary author (NR). Each interview was first read in full, and a narrative summary was generated as a memo. Interviews were then coded deductively based on the CFIR domains and constructs. This was followed by inductive coding to capture additional content represented by the perspectives of the participants but not identified by the framework. To address the research question, constructs were categorized further as facilitator or barrier. Data management and analysis was carried out in NVivo v.12. Preliminary findings were formatively evaluated via member check: as the findings were generated from diverse stakeholders, emerging themes were shared with a selection of participants who were members of each stakeholder category to note whether interpretations were appropriate. Additionally, an audit trail was generated to capture the progression of the analysis and decisions that were being made regarding coding and the development of themes. Results Interviews with stakeholders identified a variety of potential facilitators and barriers to implementation of interventions for self-management of obstetric fistula across the five key CFIR domains: ( 1 ) intervention characteristics, ( 2 ) characteristics of individuals, ( 3 ) inner setting, ( 4 ) outer setting, and ( 5 ) process. Key facilitators and barriers to implementation are described below and presented in Table 2 . Table 2. Barriers and facilitators to implementation of an innovation for self-management of obstetric fistula using the Consolidated Framework for Implementation Research (CFIR) CFIR Domain Construct Barriers Facilitators INTERVENTION CHARACTERISTICS Relative advantage • Stakeholders needed to be reminded that the relative comparison was not to surgery, but to self-management tools. • Individuals had questions about current non-surgical management options, which include fabrics, sanitary pads, diapers, and urethral plugs. • Innovations for self-management seen as an improvement upon options that are less sustainable, effective, or accessible. Cost • Women have limited finances and may not be able to purchase products for self-management. • Women are already using significant resources on concealing leaking and related odor. • More effective innovations could be donated or subsidized by government or international health organizations, who could procure products at scale to reduce cost, and distributed by local civil society organizations already working in fistula programming. INDIVIDUAL CHARACTERISTICS Knowledge & beliefs about the intervention • Optimal user and comparative effectiveness between tools are unknown. • There is uncertainty regarding unintended consequences of innovations. • Acceptability among providers would need to be addressed, and education of providers may be a greater challenge than education of users. • Stakeholders perceive the potential health and social impact of tools for self-management are probable. • Distribution of tools could be integrated into programming for surgical management, as well as integrated into outreach services. INNER SETTING Culture • There is a lack of political will to address this issue in many contexts where fistula persists. • Common values emerged throughout. • The values of global funding organizations aligned with (and potentially influenced) the values at lower-tier organizations regarding evidence-based decision making, multi-sectoral collaboration, a human-rights approach, a person-centered approach, and a focus on sustainability. Implementation climate • Obstetric fistula is just a small part of maternal health programming and therapeutic self-management of fistula will have lesser priority than interventions for fistula prevention or access to surgery. • All stakeholders report some degree of hypothetical receptivity to implementation of tools for self-management of fistula -- from agreement to continue in general discussion, to specific advice on next steps for implementation and requests for establishing partnerships. Tension for change • A strong tension for change is qualified by the desire to confirm that women will not be harmed by an innovation. • A clear tension for change for expansion of options for self-management was present amongst most stakeholders. Compatibility • Some organizations were more focused on prioritizing prevention and treatment, rather than therapeutic self-management. • Stakeholders could identify workflows, including integration into management options and task sharing for distribution. OUTER SETTING Patient needs and resources • Unknown which user could benefit most from innovation. • Tools for self-management could provide a patient-centered approach that targets affected women’s needs. External policy and incentives • No examples. • Some stakeholders are prepared to partner on this once effectiveness of self-management tools has been established. • Globally, obstetric fistula programming is somewhat top-down, so getting buy-in at the top will facilitate implementation in multiple contexts. PROCESS Collaboration • No examples. • Discussions with stakeholders served as a springboard for the development of partnerships for research and implementation of an innovation for self-management. [place Table 2 here] Domain: Intervention characteristics Relative advantage and cost emerged as important intervention characteristics that could potentially affect the implementation of an innovation for self-management of obstetric fistula. Relative advantage Overall, there was low awareness of the various strategies women were already using to self-manage their fistula symptoms, of the comparative effectiveness of various strategies to conceal leaking and manage related odor, and of innovations either on the market or in the pipeline to support affected women. However, all participants perceived that novel tools for self-management had the potential to improve upon various harmful and less sustainable existing options, such as cloths that lead to skin irritation and cost-prohibitive disposable diapers or sanitary napkins. Some researchers (n = 5/11) and clinicians (n = 2/4) had heard that homemade or easily available tools, like fabrics and other found absorptive materials, were used by women to manage leaking urine by between the leg placement; albeit, holding urine against the upper thighs and genitalia could lead to skin irritation and infection. They were also aware of women using sanitary pads for the same purpose, but these were comparatively more expensive and harder to access. Some stakeholders (n = 3) discussed a more technocratic solution available for post-repair incontinence, the urethral plug. Inserted in the urethra to manage residual or stress incontinence, this tool was briefly mentioned but was generally perceived as inaccessible to most women in need and otherwise limited due to the need to replace it every few months. Although formative research on sanitary pad innovations (either disposable pads developed from local materials or highly absorbent, reusable pads) was cited by some researchers and representatives of civil service organizations, the comparative effectiveness and implementation of these innovations was unknown. It was unclear which women were the best candidates for the respective innovations. Clinicians seemed to have comparatively less understanding of women’s experience with and capacity for self-management, while researchers who had examined the lived experience of affected women shared why they believed appropriate technologies should be used for chronic management of fistula. I know women …who were able to conceal their conditions for decades from everyone they knew, sometimes including their husband and it was exhausting. I mean you had women getting up in the middle of the night, going out in the middle of the bush to wash their pads, to dry them, to iron them, to put perfume on them. Hiding little bags of soiled pads in the middle of the night in spots in fields. Women went to extreme lengths… Women currently have pretty good techniques for managing fistula. It’s just very time consuming and expensive, so expensive to be constantly buying fabric because the fabric gets deteriorated by the urine really quickly. (Researcher) Most participants, including all clinicians, needed clarification that non-surgical options for fistula management were not fistula treatment alternatives. These tools do not cure the injury but are rather intended to support coping with this chronic condition; therefore, the advantage of innovations for self-management like an insertable cup are relative to existing strategies for self-management, such as sanitary pads and rags. Cost Cost was an anticipated barrier repeatedly mentioned throughout these discussions, particularly costs to the intended beneficiary of an innovation and for those implementing the innovation within difficult-to-reach populations. Stakeholders were concerned that many affected women already have limited disposable income prior to developing the injury, and the expense of concealing their fistula and seeking repair added an additional individual and household financial burden. Stakeholders discussed how an innovation would need to be donated or subsidized by government agencies in endemic settings and/or by civil service organizations active in fistula programming and policy globally. For the example of an insertable cup for self-management, stakeholders discussed the potential reduction in cost for implementers if the cup could be procured at scale for distribution across several settings. Sustainability was also mentioned when stakeholders discussed the need for products that are reusable and that have a long shelf-life. Domain: Characteristics of individuals The knowledge and beliefs participants shared regarding implementation emerged as the sole relevant construct within this domain. While stakeholders based their knowledge and beliefs regarding the intervention on a summary of existing research and an explanatory video shared by NR prior to the interview, their knowledge and beliefs regarding implementation were based on lessons learned implementing other intervention strategies in fistula-endemic settings. Knowledge and beliefs about implementation Stakeholders expressed various beliefs about the effectiveness of tools for self-management of incontinence, including beliefs about which user is most likely to benefit from different products targeting different types of urinary incontinence attributable to prolonged, obstructed labor. Perspectives on optimal beneficiaries included biological, social, and economic characteristics of women living with fistula-related incontinence or post-repair residual incontinence. Participants considered the appropriateness of these innovations based on how these tools could fit with women’s anatomical and physiological characteristics, their personal intentions, social expectations, livelihood priorities, as well as with surgical capacity and other health system factors. Stakeholders discussed their perspectives on the potential utility of an insertable cup as a temporary solution for incontinence management among women with certain fistula criteria, and how they might determine who the eligible population for such an intervention would be: I think we could categorize women in different ways. Maybe they've already been identified and are waiting for treatment, but the treatment isn't scheduled until a few months down the road. Since they’re already identified by a health worker, that could be a kind of short-term intervention for that time before they get the surgical treatment. I think another potential category could be for women after having had treatment. If they still have a degree of incontinence, but it's not warranting having another surgery or it's decided either by the surgical team or by the woman herself that she doesn't need or want to have another surgery, that this could be a potential intervention. (International health organization representative) Most (n = 18/21) expressed beliefs regarding a theory of change that, if a tool for self-management can be used to increase control or maintain continence even temporarily among those who cannot access surgery, who failed repair, or who are inoperable, then positive health and social impact should follow. A reduction in stigma was one of the main indicators of potential social impact attributed to tools for self-management mentioned by stakeholders. Participants discussed the burden of stigma related to the condition itself (e.g., the deterioration or loss of relationships with loved ones), but also the potential for stigma related to seeking fistula treatment in these contexts (e.g., having to wear clothing that identifies them as fistula patients). Both should be considered when designing interventions to address the needs of women living with fistula. Stakeholders who had previously implemented novel insertable technologies for fistula symptom management like the urethral plug or had implemented innovations for family planning, maternal health, or menstrual hygiene in similar settings relayed their experiences that informed both positive and negative perceptions about implementation of tools for self-management. Stakeholders felt women needed more options for self-management but reiterated the need to monitor unintended consequences. They stressed that technocratic solutions cannot be implemented without understanding and addressing the accompanying user education and water, sanitation, and hygiene facilities needed to produce and maintain any positive impact. One clinician researcher with experience implementing family planning commodities in a fistula endemic setting discussed the need to prioritize educating all the various actors involved for successful implementation: Well, you [referring to someone delivering an implementation strategy to support adoption of these tools] have to do a lot more education on the provider side. The only education we really had to do on the provider side [for family planning implementation] was myth busting that patients would not want [commodities for family planning]... In the case of an unknown technology [referring to tools for self-management of fistula], you’re educating the patients, you’re also educating the staff, the providers, the administrators, and the whole. (Clinician researcher) Others discussed the feasibility of community-based implementation of tools for self-management through use of task sharing with community health workers, midwives, fistula surgeons, and other clinicians. Distribution of tools could be integrated into non-surgical management, as well as into outreach programming. Domain: Inner setting Regarding the inner setting domain, organizational culture, implementation climate, tension for change , and compatibility were the most relevant constructs. Organizational culture Stakeholders were asked to identify the cultural characteristics of the organization they worked with that provided care to women with fistula (i.e., academic institution, clinical facility, government agency, international health organization, or civil society organization) including the norms, values, and basic assumptions that guide the decisions and actions of individuals in that organization. Discussions revealed that the top grant-funding organization’s values shaped the values and priorities at the lower-tier or funding-receiving organizations, in part. Overwhelmingly, representatives of organizations identified their organizational goals of ‘putting women first.’ Other values mentioned included a human-rights approach, a person-centered approach, evidence-based decision-making regarding priority areas (prevention, repair, and rehabilitation), and a focus on sustainability. Evidence-based decision-making and sustainability, in particular, were cited as guiding the extent to which new ideas are embraced and used to make improvements within the respective organizations. However, the implementation of evidence-based interventions was still faced with barriers like lack of political will, either internal to or external to the organization. Implementation climate The level of receptivity to implementing tools for self-management seemed higher amongst those interested in evaluating the implementation (i.e., academic researchers), and somewhat tempered among the international health or civil society organizations who might be expected to in part fund implementation. One stakeholder reported receptivity to the innovation but anticipated competing needs in maternal health programming that might require horizontal rather than vertical integration (e.g., being implemented as one component of a comprehensive maternal health intervention strategy rather than being funded through fistula-specific programming). Tension for change Various stakeholders stated that the current situation was untenable and that an innovation for self-management was needed. For example, one researcher expressed the need for a paradigm shift that would frame obstetric fistula as a chronic injury in need of self-management options to improve quality of life. She called for a transfer of power back to affected women by providing material support with tools that integrate into what women are already doing to self-manage, conceal, or cope. Almost all stakeholders (n = 18/21) were eager to receive the results of future effectiveness and implementation trials and some expressed interest in developing partnerships to support this ongoing research. Compatibility Some stakeholders expressed in detail how the intervention could be integrated into current organizational processes. First of all, there should be a procurement plan. And to have a procurement plan, it means somebody has to foot it (pay for it). Is it [an international health organization]? Is it government? If it is government, then it means we have to carry the evidence and information to government and let them know. So, these are areas that agencies can help to advocate for so that we can procure them and ensure that the procurement is sustained…Secondly, we need to have a distribution plan. It means that the [women] who have fistula need to be identified and be registered. And we must have a criteria for giving it to them. Because I’m sure that you don’t just go about giving it to every woman… (International health organization representative) Some stakeholders also expressed how the intervention will complement existing fistula programming. One area could be…women who have been identified for a fistula camp that's been set up for a certain part of the year, …and because of scheduling, [local civil society organizations] have to say, ‘okay, [surgeries] can take place in six months’ time, but let's start recruiting the women now so that we have them ready to go when this [surgical] campaign is happening.’ That could potentially be a situation where the women are recruited six or three months ahead of time, but that “In the meantime, here's something else that we encourage you to use…maybe this will help alleviate some of the symptoms you're experiencing.” (International health organization representative) Overall, various stakeholders reported that self-management tools fit with their organization’s values and norms. I think it does fit because I see it as being an intervention for the individual person based on her own perception of the use of it and if it's basically “Does this help me as an individual and help make my life better?” which I think speaks to the rights-based approach of [civil society organization]. (Civil society organization representative) A potential barrier is that therapeutic management seemed to be less of a priority than access to successful repair or primary prevention. Domain: Outer setting Patient needs and resources and external policy and incentives emerged as important characteristics of the outer setting that could potentially shape implementation. Patient needs and resources Various stakeholders agreed that tools for self-management could further strengthen a patient-centered approach to fistula management. Stakeholders postulated on the different types of fistula patients that could potentially benefit. There is a need to develop categories for potential users based on clinical needs and access to surgical resources; however, categorizing potential users is somewhat complicated by the lack of epidemiological evidence on the prevalence of this issue and lack of standardized categorization of types of fistula ( 22 ). External policy and incentives Over the years, there has been a growing policy focus on prevention of obstetric fistula through training midwives to refer for emergency obstetric care (EmOC). Stakeholders discussed the potential to integrate distribution of tools for self-management into existing guidelines and policies for midwives. As fistula programming is somewhat top-down, securing buy-in from particular international health organizations is crucial. Globally, a few large international health organizations set priorities, recommendations, and guidelines, while governments implement programs and share responsibility for funding. Domain: Process Collaboration emerged as an important characteristic of the perceived implementation process. The interviews, in addition to providing findings as a deliverable or product, could also be conceptualized as a process. Throughout various interviews, the participants, many of whom had only recently discovered the possibility of self-management of this chronic condition, began to identify themselves as potential champions of this innovation, even suggesting possible design modifications to allow for greater storage capacity. And so when you talk about these design modifications and the kinds of freedom that will be provided to women through the use of this, the way that they can control the smell and go to mosque and go to market or church or just be in their communities and sleep in the bed with someone else… that's a quality of life thing for which… I feel like I’m trying to sell this concept to you. (Civil society organization) Discussion Through interviews with diverse fistula stakeholders experienced in addressing the needs of women affected by fistula in multiple LMIC contexts, various facilitators and barriers to implementation of tools for self-management emerged. Stakeholder perceptions reveal that low-cost, accessible innovations for self-management would improve upon the few therapeutic options available and accessible. Such a tool could potentially fit within existing programs for fistula management, although the distribution channels are not yet clear. For example, an insertable device for incontinence management could be distributed by clinical providers in a facility, or, to markedly increase access, could potentially be distributed by a well-trained lower cadre of worker in the community. There is a clear tension for change for tools to improve the quality of life of women who have not yet accessed successful surgical repair, and this sentiment is in line with the commonly reported organizational goal of putting ‘the needs of women first.’ Stakeholders’ responses highlight the importance of building partnerships and the need for an evidence base related to comparative effectiveness, cost, and acceptability. The main barriers to implementation include implementer and user acceptability, a lack of political will, and ambiguity regarding who is the intended user of such an innovation. Stakeholders needed to know who the optimal user(s) of these tools would be, in part to inform implementation, as well as to ensure there would be no risk of safety concerns or unintended consequences. This knowledge will be particularly helpful to include during provider education. Acceptability among providers may be a particular challenge; therefore, implementer education will need to frame self-management of fistula as a means to support coping among affected women that can be offered as a complimentary option to accessing successful surgical repair. Strategies for educating providers should reiterate that implementation of therapeutic tools for self-management, similar to surgical intervention, aims to put ‘the needs of women first.’ Strategies for educating users and implementers alike should allow for demonstration and the opportunity to ask questions. A lack of political will to implement non-surgical, therapeutic management of fistula in LMICs could be addressed by building the evidence base on effectiveness, cost, and sustainability, as well as by developing partnerships with or seeking funding from the private sector working on global health innovation or from others outside the traditional obstetric fistula programming funding sources. Additionally, government partnerships will be crucial to developing sustainability by establishing buy-in and ownership from ministries of health in LMICs where fistula is endemic. Additional challenges to address include access to resources that support the use of these tools, including water, soap, and private latrine facilities, as appropriate. Similarly, these factors have previously proven important for implementation of novel insertable devices for contraception, STI prevention, and menstrual hygiene management in LMICs ( 39 , 40 ). In this study, the CFIR was used as intended by developers to guide both data collection and analysis, during the comparatively less studied pre-implementation period ( 37 ). This work suggests which constructs are seemingly most applicable for this stage (i.e., tension for change, compatibility) and which are less so (i.e., process constructs). As with previous applications ( 41 ), sustainability emerged through inductive coding as a construct not identified in the framework. Sustainability might be particularly relevant for implementation of global health innovations in low-resource settings where cost is a particularly important issue that guides decision making. This is supported by the work of Means et al. (2020) who call for the optimization of the CFIR for low-resource settings like LMICs ( 43 ). The application of this framework at this stage supports preparation for the implementation process itself through supporting stakeholder partnership development and further elaborating on a theory of change. Similar to the critiques of Ilott et al., the framework lacks a consideration of scale-up, which should be integrated into the development of a theory of change even when used for intervention development. This allowed the authors to think broadly and draw on lessons learned from implementation strategies for other interventions. Drawing on the Expert Recommendations for Implementing Change (ERIC), which lists potential implementation strategies ( 42 ), these findings seem to suggest that building a multi-sectoral coalition, developing academic partnerships, developing educational materials, and identifying and preparing champions could all be potentially effective implementation strategies for a novel tool to support women’s self-management of obstetric fistula in LMICs. However, this should be further examined in future research. This study has various strengths and limitations. It gathered perspectives from a diverse set of stakeholders to generate a broad understanding of facilitators and barriers for an innovation for self-management of obstetric fistula. The work employed various strategies for rigor with qualitative research, including developing an audit trail and carrying out member checking among stakeholders. Limitations include the fact that stakeholder categories are not equally represented (for example, almost half of the sample are researchers) and the fact that two important voices are not included among this sample of fistula stakeholders: affected women and community opinion leaders in fistula-endemic settings. This could provide an additional research opportunity to further examine implementation determinants, particularly at the community level. Lastly, one researcher (NR) conducted the coding, as is common for dissertation research; however, as the researcher reported out to her expert committee, the strategies for rigor employed likely addressed any potential faults in trustworthiness. Conclusion This paper makes an important contribution to our understanding of key perceived factors for successful implementation of an innovation for self-management of obstetric fistula. Early and continued engagement with stakeholders on identifying determinants of successful implementation will inform design and adaptation of implementation strategies for non-surgical management in various clinical and community settings wherein fistula care is provided. With a growing demand for provision of therapeutic options but with no accessible supply, stakeholder insights around implementation of an innovation for self-management will inform clinical practice and future research among those interested in integrating these user-controlled options into the provision of fistula care. Abbreviations CFIR Consolidated Framework for Implementation Research LMICs Low- and middle-income countries Declarations Ethics approval and consent to participate Human subjects approval was obtained from the New York University NYU IRB/University Committee on Activities Involving Human Subjects (protocol number IRB-FY2017-1144). All participants underwent an informed consent process and participated voluntarily in the study. All methods were carried out in accordance with relevant guidelines and regulations. Consent for publication Not applicable Availability of data and materials The datasets (i.e., transcripts, memos, field notes) generated and/or analyzed during the current study are not publicly available due to the fact that they cannot be readily deidentified, but are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding This work was supported in part by the NYU CTSA grants UL1 TR0001445 and TL1 TR001447 from the National Center for Advancing Translational Sciences, National Institutes of Health. Authors' contributions NR AME GG LY JP BBA contributed to the conceptualization of this work. NR collected and analyzed the data and drafted the manuscript. NR AME GG LY JP BBA NVD EP contributed to interpretation. All authors have reviewed and approved the submitted version. Acknowledgements We wish to thank our interview participants for their time and effort. References WHO. The World health report 2005: Make every mother and child count. 2005. Wall L. Obstetric vesicovaginal fistula as an international public-health problem. Lancet (London, England). 2006;368 (9542):1201–9. Gharoro EP AK. Aspects of psychosocial problems of patients with vesico-vaginal fistula. Journal of Obstetrics & Gynaecology 2009;29(7)::644-7. Chong E. Healing Wounds, Instilling Hope; the Tanzanian Partnership against Obstetric Fistula.. New York, USA: Population Council; 2004. Ahmed S, Holtz SA. Social and economic consequences of obstetric fistula: life changed forever? Int J Gynaecol Obstet. 2007;99 Suppl 1:S10-5. Watt MH, Mosha MV, Platt AC, Sikkema KJ, Wilson SM, Turner EL, et al. A nurse-delivered mental health intervention for obstetric fistula patients in Tanzania: results of a pilot randomized controlled trial. Pilot Feasibility Stud. 2017;3:35. Wilson SM, Sikkema KJ, Watt MH, Masenga GG. Psychological Symptoms Among Obstetric Fistula Patients Compared to Gynecology Outpatients in Tanzania. Int J Behav Med. 2015;22(5):605–13. Higashi H, Barendregt JJ, Kassebaum NJ, Weiser TG, Bickler SW, Vos T. Surgically avertable burden of obstetric conditions in low- and middle-income regions: a modelled analysis. Bjog. 2015;122(2):228–36. Wall LL. A framework for analyzing the determinants of obstetric fistula formation. 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Frajzyngier V, Ruminjo J, Barone MA. Factors influencing urinary fistula repair outcomes in developing countries: a systematic review. American Journal of Obstetrics & Gynecology. 2012;207(4):248–58. Pope R. Research in Obstetric Fistula: Addressing Gaps and Unmet Needs. Obstetrics & Gynecology. 2018;131(5):863–70. Heller A. The Hidden Harm of Surgery. Anthropology News. 2018. Epiu I, Alia G, Mukisa J, Tavrow P, Lamorde M, Kuznik A. Estimating the cost and cost-effectiveness for obstetric fistula repair in hospitals in Uganda: a low income country. Health Policy And Planning. 2018. Polan ML, Sleemi A, Bedane MM, Lozo S, Morgan MA. Obstetric Fistula. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, editors. Essential Surgery: Disease Control Priorities, Third Edition (Volume 1). Washington (DC): The International Bank for Reconstruction and Development / The World Bank.; 2015. Kayondo M WS, Kabakyenga J, Mukiibi N, Jude Senkungu, Stenson A, et al.. Predictors and outcome of surgical repair of obstetric fistula at a regional referral hospital,Mbarara, western Uganda. BMC Urology. 2011;11(23). Jarvis K RS, Vallianatos H. Exploring the needs and challenges of women reintegrating after obstetric fistula repair in northern Ghana. Midwifery. 2017;50:55–61. El Ayadi AM, Barageine J, Korn A, Kakaire O, Turan J, Obore S, et al. Trajectories of women's physical and psychosocial health following obstetric fistula repair in Uganda: a longitudinal study. Tropical Medicine & International Health. 2019;24(1):53–64. Maulet N, Keita M, Macq J. Medico-social pathways of obstetric fistula patients in Mali and Niger: an 18-month cohort follow-up. Trop Med Int Health. 2013;18(5):524–33. Sori DA, Azale AW, Gemeda DH. Characteristics and repair outcome of patients with Vesicovaginal fistula managed in Jimma University teaching Hospital, Ethiopia. BMC Urology. 2016;16(1):41. Delamou A, Delvaux T, Utz B, Camara BS, Beavogui AH, Cole B, et al. Factors associated with loss to follow-up in women undergoing repair for obstetric fistula in Guinea. Trop Med Int Health. 2015;20(11):1454–61. Russell KW, Robinson RE, Mone MC, Scaife CL. Enterovaginal or Vesicovaginal Fistula Control Using a Silicone Cup. Obstet Gynecol. 2016;128(6):1365–8. New Vision Reporter. Menstrual cup: Temporary relief for fistula patients. New Vision. 2012. Goldberg L, Elsamra S, Hutchinson-Colas J, Segal S. Delayed Diagnosis of Vesicouterine Fistula After Treatment for Mixed Urinary Incontinence: Menstrual Cup Management and Diagnosis. Female Pelvic Med Reconstr Surg. 2016;22(5):e29-31. Ganyaglo GYK, Ryan N, Park J, Lassey AT. Feasibility and acceptability of the menstrual cup for non-surgical management of vesicovaginal fistula among women at a health facility in Ghana.. PLoS ONE. 2018;13(11). Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation science: IS. 2009;4:50. Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implementation science: IS. 2016;11:72. Padgett D. Qualitative and Mixed Methods in Public Health: Sage 2012. N. R, press) KAi. Therapeutic management of obstetric fistula: learning from implementation of insertable devices to improve the health and well-being of women and girls in low- and middle-income countries In: LB Drew BR, DA Schwartz, editor. A Multidisciplinary Approach to Obstetric Fistula in Africa - Public Health, Anthropological, and Medical Perspectives: Springer; 2021. Tellier S, Hyttel M. Menstrual Health Management in East and Southern Africa: a Review Paper. United Nations Population Fund and WoMena; 2018. Ilott I, Gerrish K, Booth A, Field B. Testing the Consolidated Framework for Implementation Research on health care innovations from South Yorkshire. J Eval Clin Pract. 2013;19(5):915–24. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implementation Science. 2015;10(1):21. Means, A.R., Kemp, C.G., Gwayi-Chore, MC. et al. Evaluating and optimizing the consolidated framework for implementation research (CFIR) for use in low- and middle-income countries: a systematic review. Implementation Sci 15, 17 (2020). https://doi.org/10.1186/s13012-020-0977-0 Additional Declarations No competing interests reported. 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Ganyaglo","email":"","orcid":"","institution":"Korle Bu Teaching Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Gabriel","middleName":"Y.K.","lastName":"Ganyaglo","suffix":""},{"id":136724283,"identity":"8ba1f8b8-73b2-46d0-8b25-9018f5bb23e7","order_by":2,"name":"Bernadette Boden-Albala","email":"","orcid":"","institution":"Program in Public Health, University of California, Irvine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Bernadette","middleName":"","lastName":"Boden-Albala","suffix":""},{"id":136724284,"identity":"61a925b7-5e68-480f-aab4-1971e22f578d","order_by":3,"name":"Lawrence H. Yang","email":"","orcid":"","institution":"New York University School of Global Public Health","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Lawrence","middleName":"H.","lastName":"Yang","suffix":""},{"id":136724287,"identity":"d8429af6-8fbf-47d8-9904-779d40887336","order_by":4,"name":"Joonhee Park","email":"","orcid":"","institution":"Restore Health, Inc","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Joonhee","middleName":"","lastName":"Park","suffix":""},{"id":136724289,"identity":"a4871857-0588-4e80-a8af-638ae74eeac3","order_by":5,"name":"Nancy Van Devanter","email":"","orcid":"","institution":"New York University School of Global Public Health","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Nancy","middleName":"Van","lastName":"Devanter","suffix":""},{"id":136724291,"identity":"d3cc36e4-96fe-4f1e-b8ab-97a68a2ddaa4","order_by":6,"name":"Emmanuel Peprah","email":"","orcid":"","institution":"New York University School of Global Public Health","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Emmanuel","middleName":"","lastName":"Peprah","suffix":""},{"id":136724292,"identity":"614dafba-290d-4e58-aad8-35609f2bd21b","order_by":7,"name":"Alison M. El Ayadi","email":"","orcid":"","institution":"University of California, San Francisco School of Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Alison","middleName":"M. El","lastName":"Ayadi","suffix":""}],"badges":[],"createdAt":"2022-09-10 14:14:20","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2051782/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2051782/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":37074756,"identity":"d3188f21-b181-4890-aa4a-68cb92ed675c","added_by":"auto","created_at":"2023-05-16 08:44:46","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":597720,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2051782/v1/a0b4eda8-2dca-422e-82cf-e0c02a580d70.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Tools for self-management of obstetric fistula in low- and middle-income countries: a qualitative study exploring pre-implementation barriers and facilitators among global stakeholders","fulltext":[{"header":"Background","content":"\u003cp\u003eObstetric fistula, a maternal morbidity eliminated in high-income countries with the scale-up of accessible, quality maternal healthcare, persists in low- and middle-income countries (LMICs) where 99% of global maternal deaths occur (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e). This injury results most commonly from prolonged or obstructed labor and involves the formation of an abnormal connection between the genital and urinary tract or rectum, resulting in urinary and/or fecal incontinence, discomfort, malodor, and skin irritation (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e). Other obstructed labor related health consequences include injury to the urinary or genital tract, neurological damage to the extremities, musculoskeletal injury, gastrointestinal injury, and stillbirth. Up to two million women and girls, predominantly in sub-Saharan Africa, live with fistula and are subsequently vulnerable to psychosocial and economic consequences, including stigma and reduced opportunities for community participation and income generation that ultimately reduces their wellbeing (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). Subsequent mental health morbidities include depression, anxiety, post-traumatic stress disorder, and suicidal ideation and attempts (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e). Globally, genital fistula is responsible for 1.15\u0026nbsp;million years lived with disability (YLDs), accounting for 65% of the total YLDs attributable to all maternal complications (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e). Obstetric fistula remains an understudied, underfunded issue of global health inequity: this largely preventable injury is caused by delay in receiving emergency comprehensive obstetric care (i.e. caesarean section and instrumental delivery), which is less accessible in rural settings where geographic, economic, and social barriers increase the risk for women and girls. Although the most immediate cause of obstetric fistula is inadequate and/or delayed obstetric care, there are various root causes that increase likelihood and/or severity of the prolonged, obstructed labor that leads to the injury, including low education, limited opportunities for income generation, gender inequity, low personal or household income, lack of access to family planning and skilled birth attendance, and limited community resources like transportation (\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e). Just as access to preventative surgical intervention like emergency caesarean section to alleviate prolonged, obstructed labor is a challenge, multiple barriers to fistula treatment exist (\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe approach to fistula management has evolved over the last few decades, with an increasing commitment to holistic care (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e). This is in part a reflection of a growing appreciation of the social determinants of this condition, as well as the priorities of funding agencies. Although initially common to be dependent on visiting surgeons, many settings are transitioning away from the less sustainable, potentially harmful medical tourism model (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e) and instead are focusing on increasing training of local surgeons and surgical capacity at facilities. Substantial global mobilization and capacity building efforts have been guided by the United Nations Population Fund (UNFPA) and partners through the Campaign to End Fistula, and global fistula care has grown more comprehensive and multi-sectoral in its approach\u0026mdash;with varying degrees of successful implementation. The clinical focus of fistula management in some settings has expanded from solely providing surgical services such as outreach, screening, preoperative care, treatment, and post-operative care, to include tertiary preventative services that focus on improving quality of life and addressing co-morbidities, including physiotherapy for rehabilitation (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e) and mental health services to address depression and anxiety related to the condition (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e). Fistula care across various contexts is provided via different models, including dedicated fistula clinics integrated into existing hospital facilities, stand-alone specialist fistula hospitals, and intermittent outreach camps in remote areas (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eVarious stakeholders support fistula programming and policy development, implementation, and evaluation at the local, regional, national, and/or global level, including those working in clinical, governmental, international health, civil society, and academic sectors. (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e) Some support from private partners also exists. Various nations have enhanced coordination through global partnerships among various stakeholders via national alliances, such as national obstetric fistula task forces and/or technical working groups. The partnerships plan and monitor development of national strategies to eliminate fistula and help to ensure a comprehensive response, to avoid duplication and to place fistula in the context of broader development plans (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e). Many countries have developed national plans for eliminating obstetric fistula, including a preventive component to strengthen emergency obstetric care, and training and equipment of health facilities for fistula treatment (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1. Explanation of role in fistula management for each stakeholder category\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"20.650636492220652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eStakeholder category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"79.34936350777934%\"\u003e\n \u003cp\u003e\u003cstrong\u003eRole in fistula management\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"20.650636492220652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eClinician\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"79.34936350777934%\"\u003e\n \u003cp\u003e\u0026bull; Clinicians are usually involved in training of fistula surgeons and other physicians, nurses, and midwives to identify, refer, and/or treat fistula, as appropriate, and in implementing programs for surgical repair.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; These partners may be associated with regional referral hospitals, medical training institutions, departments of Obstetrics and Gynecology, and local and international clinical professional societies such as the International Society of Obstetric Fistula Surgeon (ISOFS) (https://www.isofs-global.org/) and the International Federation of Gynecology and Obstetrics (FIGO) (https://www.figo.org/). \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"20.650636492220652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eGovernmental representatives\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"79.34936350777934%\"\u003e\n \u003cp\u003e\u0026bull; Governmental partners include the governments of donor HICs and the health and gender-related ministries in-country. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; The Ministry of Health (MOH) plays a critical role in ensuring equitable access to health care and stewardship for health resources.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;As part of a country\u0026rsquo;s maternal health strategy, the MOH plans for service delivery and applies standards, policies, and guidelines within the healthcare system.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"20.650636492220652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eInternational health organizations\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"79.34936350777934%\"\u003e\n \u003cp\u003e\u0026bull; International health organizations include partners that are multilateral agencies like UNFPA (the country-level offices as well as headquarters in NYC) and the World Health Organization (WHO), as well as bilateral agencies like United States Agency for International Development (USAID). \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;UNFPA, together with partners, launched the global Campaign to End Fistula in 2003 and has since established three pillars of focus: prevention, treatment, and social reintegration.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"20.650636492220652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCivil society representatives\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"79.34936350777934%\"\u003e\n \u003cp\u003e\u0026bull; Civil society partners may include faith-based organizations, local opinion leaders, local or international non-governmental organizations (NGOs) working in women\u0026rsquo;s health, empowerment, and wellbeing.\u003c/p\u003e\n \u003cp\u003e\u0026bull; These partners provide services in line with their respective mandates, which could include addressing the barriers to accessing care (i.e., supporting transportation to the facility) as well as providing social support services (i.e. training in income generating activities to improve women\u0026rsquo;s financial independence).\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;As these organizations may have closer ties to the community, they are best served to identify the needs of women with fistula. \u0026nbsp;Likely the most important stakeholder, affected women and girls, can be considered a type of civil society partner.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"20.650636492220652%\"\u003e\n \u003cp\u003e\u003cstrong\u003eAcademic researchers\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"79.34936350777934%\"\u003e\n \u003cp\u003e\u0026bull; Academics are another partner and the focus of research on obstetric fistula has grown exponentially in the last decade. \u0026nbsp;The number of published articles for \u0026lsquo;obstetric fistula\u0026rsquo; in Pubmed from 2003 to present is 776, almost twice that published in the 100 years prior. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; Academics have supported research, often in collaboration with other stakeholders, to quantify the magnitude of fistula, to identify the determinants of fistula and to assess surgical outcomes, to identify the needs of women with current or previous fistula, to support the development and evaluation of interventions for prevention, and to examine obstetric fistula policy.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;This has required contributions from researchers in public health, nursing and midwifery, medicine, anthropology, sociology, biomedical engineering, and various other disciplines.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cdiv class=\"gridtable\"\u003e[place Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e here]\u003c/div\u003e\n\u003cp\u003eThe fistula literature lacks a focus on implementation research, as it is unknown what impact provider characteristics (e.g., training), patient characteristics (e.g., complexity of anatomical damage), or intervention delivery (e.g., whether surgery was provided as part of an outreach program or at a centralized center of excellence) have on implementation or effectiveness outcomes (\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e). Fistula care is delivered through different means which could impact effectiveness and cost. Estimates suggest that surgical repair and social integration costs range from \u003cspan\u003e$\u003c/span\u003e300 to \u003cspan\u003e$\u003c/span\u003e1700 per patient (\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e). One study calculated for surgery the cost per DALY averted of \u003cspan\u003e$\u003c/span\u003e54 in Uganda when estimating the cost of repair at \u003cspan\u003e$\u003c/span\u003e378 (\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e). There is particularly little evidence on management of cases who have previously failed surgical repair and who remain incontinent even with closure of the fistula.\u003c/p\u003e\n\u003cp\u003eEvidence for fistula self-management is expanding, but there is a need to Inform implementation planning. Fistula programs predominantly focus on the three programming pillars identified by the UNFPA\u0026rsquo;s Campaign to End Fistula: prevention, surgical repair, and reintegration; however, there remains an opportunity to integrate non-surgical, therapeutic self-management. Traditional management requires surgical repair (\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e); however, various individual, social, or structural barriers delay or prevent women\u0026rsquo;s access to surgery (\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e). When surgery is accessed, repair outcomes are variable: reported rates of fistula closure vary from 65\u0026ndash;90% (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e). Fistula closure is the most used metric for surgical success; however, persistent leaking after successful surgical repair is not uncommon and represents an important functional outcome (\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). Although women may be managing various types of fistula-related urinary incontinence (\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e), including incontinence among those who are unrepaired and residual or stress incontinence among those who are repaired, little focus has been applied to understanding self-management. As the mean duration a woman lives with fistula before seeking repair is 4\u0026ndash;10 years (\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e) and successful surgical repair is not guaranteed, user-controlled tools for self-management have the potential to improve the quality of life of many women living with this chronic condition. Although some fistula care settings provide support for self-management of residual incontinence (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e), less attention has been paid to self-management for fistula-related incontinence. This has ethical implications for women who are undergoing multiple surgical attempts that are likely to be unsuccessful. A body of evidence on self-management of fistula is growing (\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e), including on the feasibility and acceptability of an insertable device to manage incontinence and support coping (\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e). However, the potential determinants of successful implementation for these novel tools have not been examined. Therefore, we sought to explore the perceived pre-implementation facilitators and barriers among diverse fistula stakeholders regarding self-management tools to support coping among women with obstetric fistula in LMICs.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eQualitative approach and paradigm\u003c/h2\u003e \u003cp\u003eWe conducted in-depth interviews to understand key stakeholder perspectives on pre-implementation facilitators and barriers around fistula self-management tools. The approach was framed by the Consolidated Framework for Implementation Research (CFIR) (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e) to understand the interrelated factors that affect implementation. The framework is composed of five main domains: characteristics of the intervention, inner setting, outer setting, the individuals involved, and the process through which implementation occurs. CFIR has been comparatively less utilized during the pre-implementation phase than during or after implementation (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTwenty-one individuals were purposively sampled to ensure a broad examination of global fistula stakeholders working in fistula endemic settings in sub-Saharan Africa and likely to inform implementation of an innovation for fistula self-management in LMICs. Five categories of participants were enrolled: researchers (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), clinicians (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), representatives of civil society (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) or international health organizations (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) working on fistula, and government representatives (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). Although these categories are not mutually exclusive, participants were asked to select the role with which they most identify. Researchers were often also clinicians (8/11) or also involved with fistula-related civil society organizations (5/11).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eResearcher characteristics and reflexivity\u003c/h2\u003e \u003cp\u003eInterviews and coding were carried out by NR in part for completion of her dissertation research. She was trained in qualitative methods and was apprenticing under experienced qualitative researchers. Prior to initiation of the interview, the interviewer spent time discussing with participant the study\u0026rsquo;s goal and rationale. The interviewer was a member of a collaborative team working to study the effectiveness of an insertable device to manage fistula-related incontinence. She engaged in reflexivity throughout the research process by examining any potential researcher bias due to this endeavor.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSampling strategy\u003c/h2\u003e \u003cp\u003eStakeholders were recruited via purposive sampling through introduction to members of various national Obstetric Fistula Task Forces, an UNFPA-supported multi-sectoral group working to address fistula in their respective nations. Subsequent interviews were carried out via snowball sampling from those who agreed to participate. Participants were involved in addressing obstetric fistula in sub-Saharan Africa through advocacy, prevention, treatment, and/or reintegration in settings throughout Ghana, Nigeria, Ethiopia, Tanzania, Malawi, and the Democratic Republic of Congo. All invited participants consented to participate, except one who did not agree she was a stakeholder and instead directed the researcher to another contact. Participants were approached in-person and via email.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eSetting\u003c/h2\u003e \u003cp\u003eInterviews were carried out in-person in a fistula-endemic setting (n\u0026thinsp;=\u0026thinsp;7), in-person in the US (n\u0026thinsp;=\u0026thinsp;8), or over the phone (n\u0026thinsp;=\u0026thinsp;6). When possible, interviews were carried out face-to-face, but due to the global focus of this work, in-person interview was not always feasible. All interviews were one-on-one, except for one interview between the researcher and two clinicians. Additionally, the researcher observed at a fistula ward in an endemic setting and observed during community outreach to improve understanding of fistula care.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eData collection methods\u003c/h2\u003e \u003cp\u003eData collection occurred from November 2017 to March 2019. Primary data collection occurred at clinical or community sites for fistula care, in professional settings where fistula-related policy decisions are planned, and at relevant conferences. Most participants were interviewed only once, although a few (n\u0026thinsp;=\u0026thinsp;2) were contacted for a follow-up discussion when clarification was needed during the analysis stage. Participants reviewed a summary of research on an insertable device for self-management and a brief video of the device\u0026rsquo;s functionality and potential implementation. Interviews were carried out in English, recorded, and transcribed verbatim. Field notes were generated throughout recruitment and interview processes to purposively guide participant selection, as well as adapt the interview guide. On average, interviews lasted 50 minutes. Recruitment continued until data saturation was met, or the point at which no new codes were generated and the developed themes had sufficient coverage and could be supported with strong illustrative quotes (p.196) (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData collection instruments\u003c/h2\u003e \u003cp\u003eDevelopment of the in-depth interview content was informed by the CFIR (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e), which included the domains of the intervention characteristics, the process, the organizational characteristics (inner and outer setting), and the individual characteristics. The interview guide was pilot-tested and refined and the order of questions was subsequently modified to improve the flow of discussion.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eAnalysis of interviews was conducted by the primary author (NR). Each interview was first read in full, and a narrative summary was generated as a memo. Interviews were then coded deductively based on the CFIR domains and constructs. This was followed by inductive coding to capture additional content represented by the perspectives of the participants but not identified by the framework. To address the research question, constructs were categorized further as facilitator or barrier. Data management and analysis was carried out in NVivo v.12. Preliminary findings were formatively evaluated via member check: as the findings were generated from diverse stakeholders, emerging themes were shared with a selection of participants who were members of each stakeholder category to note whether interpretations were appropriate. Additionally, an audit trail was generated to capture the progression of the analysis and decisions that were being made regarding coding and the development of themes.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eInterviews with stakeholders identified a variety of potential facilitators and barriers to implementation of interventions for self-management of obstetric fistula across the five key CFIR domains: (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e) intervention characteristics, (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) characteristics of individuals, (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) inner setting, (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) outer setting, and (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e) process. Key facilitators and barriers to implementation are described below and presented in Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2. Barriers and facilitators to implementation of an innovation for self-management of obstetric fistula using the Consolidated Framework for Implementation Research (CFIR)\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"14.973958333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCFIR Domain\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003eConstruct\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u003cstrong\u003eBarriers\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u003cstrong\u003eFacilitators\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"14.973958333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003eINTERVENTION CHARACTERISTICS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003eRelative advantage\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u0026bull; Stakeholders needed to be reminded that the relative comparison was not to surgery, but to self-management tools. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;Individuals had questions about current non-surgical management options, which include fabrics, sanitary pads, diapers, and urethral plugs.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u0026bull; Innovations for self-management seen as an improvement upon options that are less sustainable, effective, or accessible. \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCost\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u0026bull; Women have limited finances and may not be able to purchase products for self-management.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u0026bull; Women are already using significant resources on concealing leaking and related odor. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;More effective innovations could be donated or subsidized by government or international health organizations, who could procure products at scale to reduce cost, and distributed by local civil society organizations already working in fistula programming.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"14.973958333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003eINDIVIDUAL CHARACTERISTICS\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003eKnowledge \u0026amp; beliefs about the intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u0026bull; Optimal user and comparative effectiveness between tools are unknown. \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; There is uncertainty regarding unintended consequences of innovations.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;Acceptability among providers would need to be addressed, and education of providers may be a greater challenge than education of users.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u0026bull; Stakeholders perceive the potential health and social impact of tools for self-management are probable.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; Distribution of tools could be integrated into programming for surgical management, as well as integrated into outreach services.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" width=\"14.973958333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003eINNER SETTING\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCulture\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u0026bull; There is a lack of political will to address this issue in many contexts where fistula persists. \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u0026bull; Common values emerged throughout.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;The values of global funding organizations aligned with (and potentially influenced) the values at lower-tier organizations regarding evidence-based decision making, multi-sectoral collaboration, a human-rights approach, a person-centered approach, and a focus on sustainability.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.926493108728943%\"\u003e\n \u003cp\u003e\u003cstrong\u003eImplementation climate\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"47.32006125574273%\"\u003e\n \u003cp\u003e\u0026bull; Obstetric fistula is just a small part of maternal health programming and therapeutic self-management of fistula will have lesser priority than interventions for fistula prevention or access to surgery.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"36.75344563552833%\"\u003e\n \u003cp\u003e\u0026bull; All stakeholders report some degree of hypothetical receptivity to implementation of tools for self-management of fistula -- from agreement to continue in general discussion, to specific advice on next steps for implementation and requests for establishing partnerships.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.926493108728943%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTension for change\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"47.32006125574273%\"\u003e\n \u003cp\u003e\u0026bull; A strong tension for change is qualified by the desire to confirm that women will not be harmed by an innovation.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"36.75344563552833%\"\u003e\n \u003cp\u003e\u0026bull; A clear tension for change for expansion of options for self-management was present amongst most stakeholders.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.926493108728943%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCompatibility\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"47.32006125574273%\"\u003e\n \u003cp\u003e\u0026bull; Some organizations were more focused on prioritizing prevention and treatment, rather than therapeutic self-management. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"36.75344563552833%\"\u003e\n \u003cp\u003e\u0026bull; Stakeholders could identify workflows, including integration into management options and task sharing for distribution.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" width=\"14.973958333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003eOUTER SETTING\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePatient needs and resources\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u0026bull; Unknown which user could benefit most from innovation.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u0026bull; Tools for self-management could provide a patient-centered approach that targets affected women\u0026rsquo;s needs.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.926493108728943%\"\u003e\n \u003cp\u003e\u003cstrong\u003eExternal policy and incentives\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"47.32006125574273%\"\u003e\n \u003cp\u003e\u0026bull; No examples.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"36.75344563552833%\"\u003e\n \u003cp\u003e\u0026bull; Some stakeholders are prepared to partner on this once effectiveness of self-management tools has been established.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull;\u0026nbsp;Globally, obstetric fistula programming is somewhat top-down, so getting buy-in at the top will facilitate implementation in multiple contexts.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"14.973958333333334%\"\u003e\n \u003cp\u003e\u003cstrong\u003ePROCESS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"13.541666666666666%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCollaboration\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"40.234375%\"\u003e\n \u003cp\u003e\u0026bull; No examples.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"31.25%\"\u003e\n \u003cp\u003e\u0026bull; Discussions with stakeholders served as a springboard for the development of partnerships for research and implementation of an innovation for self-management.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;[place Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e here]\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec11\"\u003e\n \u003ch2\u003eDomain: Intervention characteristics\u003c/h2\u003e\n \u003cp\u003eRelative advantage and cost emerged as important intervention characteristics that could potentially affect the implementation of an innovation for self-management of obstetric fistula.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec12\"\u003e\n \u003ch2\u003eRelative advantage\u003c/h2\u003e\n \u003cp\u003eOverall, there was low awareness of the various strategies women were already using to self-manage their fistula symptoms, of the comparative effectiveness of various strategies to conceal leaking and manage related odor, and of innovations either on the market or in the pipeline to support affected women. However, all participants perceived that novel tools for self-management had the potential to improve upon various harmful and less sustainable existing options, such as cloths that lead to skin irritation and cost-prohibitive disposable diapers or sanitary napkins.\u003c/p\u003e\n \u003cp\u003eSome researchers (n\u0026thinsp;=\u0026thinsp;5/11) and clinicians (n\u0026thinsp;=\u0026thinsp;2/4) had heard that homemade or easily available tools, like fabrics and other found absorptive materials, were used by women to manage leaking urine by between the leg placement; albeit, holding urine against the upper thighs and genitalia could lead to skin irritation and infection. They were also aware of women using sanitary pads for the same purpose, but these were comparatively more expensive and harder to access. Some stakeholders (n\u0026thinsp;=\u0026thinsp;3) discussed a more technocratic solution available for post-repair incontinence, the urethral plug. Inserted in the urethra to manage residual or stress incontinence, this tool was briefly mentioned but was generally perceived as inaccessible to most women in need and otherwise limited due to the need to replace it every few months. Although formative research on sanitary pad innovations (either disposable pads developed from local materials or highly absorbent, reusable pads) was cited by some researchers and representatives of civil service organizations, the comparative effectiveness and implementation of these innovations was unknown. It was unclear which women were the best candidates for the respective innovations. Clinicians seemed to have comparatively less understanding of women\u0026rsquo;s experience with and capacity for self-management, while researchers who had examined the lived experience of affected women shared why they believed appropriate technologies should be used for chronic management of fistula.\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cem\u003eI know women \u0026hellip;who were able to conceal their conditions for decades from everyone they knew, sometimes including their husband and it was exhausting. I mean you had women getting up in the middle of the night, going out in the middle of the bush to wash their pads, to dry them, to iron them, to put perfume on them. Hiding little bags of soiled pads in the middle of the night in spots in fields. Women went to extreme lengths\u0026hellip; Women currently have pretty good techniques for managing fistula. It\u0026rsquo;s just very time consuming and expensive, so expensive to be constantly buying fabric because the fabric gets deteriorated by the urine really quickly.\u003c/em\u003e (Researcher)\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003eMost participants, including all clinicians, needed clarification that non-surgical options for fistula management were not fistula treatment alternatives. These tools do not cure the injury but are rather intended to support coping with this chronic condition; therefore, the advantage of innovations for self-management like an insertable cup are relative to existing strategies for self-management, such as sanitary pads and rags.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec13\"\u003e\n \u003ch2\u003eCost\u003c/h2\u003e\n \u003cp\u003eCost was an anticipated barrier repeatedly mentioned throughout these discussions, particularly costs to the intended beneficiary of an innovation and for those implementing the innovation within difficult-to-reach populations. Stakeholders were concerned that many affected women already have limited disposable income prior to developing the injury, and the expense of concealing their fistula and seeking repair added an additional individual and household financial burden. Stakeholders discussed how an innovation would need to be donated or subsidized by government agencies in endemic settings and/or by civil service organizations active in fistula programming and policy globally. For the example of an insertable cup for self-management, stakeholders discussed the potential reduction in cost for implementers if the cup could be procured at scale for distribution across several settings. Sustainability was also mentioned when stakeholders discussed the need for products that are reusable and that have a long shelf-life.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec14\"\u003e\n \u003ch2\u003eDomain: Characteristics of individuals\u003c/h2\u003e\n \u003cp\u003eThe knowledge and beliefs participants shared regarding implementation emerged as the sole relevant construct within this domain. While stakeholders based their knowledge and beliefs regarding the intervention on a summary of existing research and an explanatory video shared by NR prior to the interview, their knowledge and beliefs regarding implementation were based on lessons learned implementing other intervention strategies in fistula-endemic settings.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec15\"\u003e\n \u003ch2\u003eKnowledge and beliefs about implementation\u003c/h2\u003e\n \u003cp\u003eStakeholders expressed various beliefs about the effectiveness of tools for self-management of incontinence, including beliefs about which user is most likely to benefit from different products targeting different types of urinary incontinence attributable to prolonged, obstructed labor. Perspectives on optimal beneficiaries included biological, social, and economic characteristics of women living with fistula-related incontinence or post-repair residual incontinence. Participants considered the appropriateness of these innovations based on how these tools could fit with women\u0026rsquo;s anatomical and physiological characteristics, their personal intentions, social expectations, livelihood priorities, as well as with surgical capacity and other health system factors. Stakeholders discussed their perspectives on the potential utility of an insertable cup as a temporary solution for incontinence management among women with certain fistula criteria, and how they might determine who the eligible population for such an intervention would be:\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cem\u003eI think we could categorize women in different ways. Maybe they\u0026apos;ve already been identified and are waiting for treatment, but the treatment isn\u0026apos;t scheduled until a few months down the road. Since they\u0026rsquo;re already identified by a health worker, that could be a kind of short-term intervention for that time before they get the surgical treatment. I think another potential category could be for women after having had treatment. If they still have a degree of incontinence, but it\u0026apos;s not warranting having another surgery or it\u0026apos;s decided either by the surgical team or by the woman herself that she doesn\u0026apos;t need or want to have another surgery, that this could be a potential intervention.\u003c/em\u003e (International health organization representative)\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003eMost (n\u0026thinsp;=\u0026thinsp;18/21) expressed beliefs regarding a theory of change that, if a tool for self-management can be used to increase control or maintain continence even temporarily among those who cannot access surgery, who failed repair, or who are inoperable, then positive health and social impact should follow. A reduction in stigma was one of the main indicators of potential social impact attributed to tools for self-management mentioned by stakeholders. Participants discussed the burden of stigma related to the condition itself (e.g., the deterioration or loss of relationships with loved ones), but also the potential for stigma related to seeking fistula treatment in these contexts (e.g., having to wear clothing that identifies them as fistula patients). Both should be considered when designing interventions to address the needs of women living with fistula.\u003c/p\u003e\n \u003cp\u003eStakeholders who had previously implemented novel insertable technologies for fistula symptom management like the urethral plug or had implemented innovations for family planning, maternal health, or menstrual hygiene in similar settings relayed their experiences that informed both positive and negative perceptions about implementation of tools for self-management. Stakeholders felt women needed more options for self-management but reiterated the need to monitor unintended consequences. They stressed that technocratic solutions cannot be implemented without understanding and addressing the accompanying user education and water, sanitation, and hygiene facilities needed to produce and maintain any positive impact. One clinician researcher with experience implementing family planning commodities in a fistula endemic setting discussed the need to prioritize educating all the various actors involved for successful implementation:\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cem\u003eWell, you [referring to someone delivering an implementation strategy to support adoption of these tools] have to do a lot more education on the provider side. The only education we really had to do on the provider side [for family planning implementation] was myth busting that patients would not want [commodities for family planning]... In the case of an unknown technology [referring to tools for self-management of fistula], you\u0026rsquo;re educating the patients, you\u0026rsquo;re also educating the staff, the providers, the administrators, and the whole.\u003c/em\u003e (Clinician researcher)\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003eOthers discussed the feasibility of community-based implementation of tools for self-management through use of task sharing with community health workers, midwives, fistula surgeons, and other clinicians. Distribution of tools could be integrated into non-surgical management, as well as into outreach programming.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec16\"\u003e\n \u003ch2\u003eDomain: Inner setting\u003c/h2\u003e\n \u003cp\u003eRegarding the inner setting domain, \u003cem\u003eorganizational culture, implementation climate, tension for change\u003c/em\u003e, and \u003cem\u003ecompatibility\u003c/em\u003e were the most relevant constructs.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec17\"\u003e\n \u003ch2\u003eOrganizational culture\u003c/h2\u003e\n \u003cp\u003eStakeholders were asked to identify the cultural characteristics of the organization they worked with that provided care to women with fistula (i.e., academic institution, clinical facility, government agency, international health organization, or civil society organization) including the norms, values, and basic assumptions that guide the decisions and actions of individuals in that organization. Discussions revealed that the top grant-funding organization\u0026rsquo;s values shaped the values and priorities at the lower-tier or funding-receiving organizations, in part. Overwhelmingly, representatives of organizations identified their organizational goals of \u0026lsquo;putting women first.\u0026rsquo; Other values mentioned included a human-rights approach, a person-centered approach, evidence-based decision-making regarding priority areas (prevention, repair, and rehabilitation), and a focus on sustainability. Evidence-based decision-making and sustainability, in particular, were cited as guiding the extent to which new ideas are embraced and used to make improvements within the respective organizations. However, the implementation of evidence-based interventions was still faced with barriers like lack of political will, either internal to or external to the organization.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec18\"\u003e\n \u003ch2\u003eImplementation climate\u003c/h2\u003e\n \u003cp\u003eThe level of receptivity to implementing tools for self-management seemed higher amongst those interested in evaluating the implementation (i.e., academic researchers), and somewhat tempered among the international health or civil society organizations who might be expected to in part fund implementation. One stakeholder reported receptivity to the innovation but anticipated competing needs in maternal health programming that might require horizontal rather than vertical integration (e.g., being implemented as one component of a comprehensive maternal health intervention strategy rather than being funded through fistula-specific programming).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec19\"\u003e\n \u003ch2\u003eTension for change\u003c/h2\u003e\n \u003cp\u003eVarious stakeholders stated that the current situation was untenable and that an innovation for self-management was needed. For example, one researcher expressed the need for a paradigm shift that would frame obstetric fistula as a chronic injury in need of self-management options to improve quality of life. She called for a transfer of power back to affected women by providing material support with tools that integrate into what women are already doing to self-manage, conceal, or cope. Almost all stakeholders (n\u0026thinsp;=\u0026thinsp;18/21) were eager to receive the results of future effectiveness and implementation trials and some expressed interest in developing partnerships to support this ongoing research.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec20\"\u003e\n \u003ch2\u003eCompatibility\u003c/h2\u003e\n \u003cp\u003eSome stakeholders expressed in detail how the intervention could be integrated into current organizational processes.\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eFirst of all, there should be a procurement plan. And to have a procurement plan, it means somebody has to foot it (pay for it). Is it [an international health organization]? Is it government? If it is government, then it means we have to carry the evidence and information to government and let them know. So, these are areas that agencies can help to advocate for so that we can procure them and ensure that the procurement is sustained\u0026hellip;Secondly, we need to have a distribution plan. It means that the [women] who have fistula need to be identified and be registered. And we must have a criteria for giving it to them. Because I\u0026rsquo;m sure that you don\u0026rsquo;t just go about giving it to every woman\u0026hellip;\u003c/em\u003e (International health organization representative)\u003c/p\u003e\n \u003cp\u003eSome stakeholders also expressed how the intervention will complement existing fistula\u003c/p\u003e\n \u003cp\u003eprogramming.\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cem\u003eOne area could be\u0026hellip;women who have been identified for a fistula camp that\u0026apos;s been set up for a certain part of the year, \u0026hellip;and because of scheduling, [local civil society organizations] have to say, \u0026lsquo;okay, [surgeries] can take place in six months\u0026rsquo; time, but let\u0026apos;s start recruiting the women now so that we have them ready to go when this [surgical] campaign is happening.\u0026rsquo; That could potentially be a situation where the women are recruited six or three months ahead of time, but that \u0026ldquo;In the meantime, here\u0026apos;s something else that we encourage you to use\u0026hellip;maybe this will help alleviate some of the symptoms you\u0026apos;re experiencing.\u0026rdquo;\u003c/em\u003e (International health organization representative)\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003eOverall, various stakeholders reported that self-management tools fit with their organization\u0026rsquo;s\u003c/p\u003e\n \u003cp\u003evalues and norms.\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cem\u003eI think it does fit because I see it as being an intervention for the individual person based on her own perception of the use of it and if it\u0026apos;s basically \u0026ldquo;Does this help me as an individual and help make my life better?\u0026rdquo; which I think speaks to the rights-based approach of [civil society organization].\u003c/em\u003e (Civil society organization representative)\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003eA potential barrier is that therapeutic management seemed to be less of a priority than access to successful repair or primary prevention.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec21\"\u003e\n \u003ch2\u003eDomain: Outer setting\u003c/h2\u003e\n \u003cp\u003ePatient needs and resources and external policy and incentives emerged as important characteristics of the outer setting that could potentially shape implementation.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec22\"\u003e\n \u003ch2\u003ePatient needs and resources\u003c/h2\u003e\n \u003cp\u003eVarious stakeholders agreed that tools for self-management could further strengthen a patient-centered approach to fistula management. Stakeholders postulated on the different types of fistula patients that could potentially benefit. There is a need to develop categories for potential users based on clinical needs and access to surgical resources; however, categorizing potential users is somewhat complicated by the lack of epidemiological evidence on the prevalence of this issue and lack of standardized categorization of types of fistula (\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec23\"\u003e\n \u003ch2\u003eExternal policy and incentives\u003c/h2\u003e\n \u003cp\u003eOver the years, there has been a growing policy focus on prevention of obstetric fistula through training midwives to refer for emergency obstetric care (EmOC). Stakeholders discussed the potential to integrate distribution of tools for self-management into existing guidelines and policies for midwives. As fistula programming is somewhat top-down, securing buy-in from particular international health organizations is crucial. Globally, a few large international health organizations set priorities, recommendations, and guidelines, while governments implement programs and share responsibility for funding.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec24\"\u003e\n \u003ch2\u003eDomain: Process\u003c/h2\u003e\n \u003cp\u003eCollaboration emerged as an important characteristic of the perceived implementation process.\u003c/p\u003e\n \u003cp\u003eThe interviews, in addition to providing findings as a deliverable or product, could also be conceptualized as a process. Throughout various interviews, the participants, many of whom had only recently discovered the possibility of self-management of this chronic condition, began to identify themselves as potential champions of this innovation, even suggesting possible design modifications to allow for greater storage capacity.\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003e\u003cem\u003eAnd so when you talk about these design modifications and the kinds of freedom that will be provided to women through the use of this, the way that they can control the smell and go to mosque and go to market or church or just be in their communities and sleep in the bed with someone else\u0026hellip; that\u0026apos;s a quality of life thing for which\u0026hellip; I feel like I\u0026rsquo;m trying to sell this concept to you.\u003c/em\u003e (Civil society organization)\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThrough interviews with diverse fistula stakeholders experienced in addressing the needs of women affected by fistula in multiple LMIC contexts, various facilitators and barriers to implementation of tools for self-management emerged. Stakeholder perceptions reveal that low-cost, accessible innovations for self-management would improve upon the few therapeutic options available and accessible. Such a tool could potentially fit within existing programs for fistula management, although the distribution channels are not yet clear. For example, an insertable device for incontinence management could be distributed by clinical providers in a facility, or, to markedly increase access, could potentially be distributed by a well-trained lower cadre of worker in the community. There is a clear tension for change for tools to improve the quality of life of women who have not yet accessed successful surgical repair, and this sentiment is in line with the commonly reported organizational goal of putting \u0026lsquo;the needs of women first.\u0026rsquo; Stakeholders\u0026rsquo; responses highlight the importance of building partnerships and the need for an evidence base related to comparative effectiveness, cost, and acceptability.\u003c/p\u003e \u003cp\u003eThe main barriers to implementation include implementer and user acceptability, a lack of political will, and ambiguity regarding who is the intended user of such an innovation. Stakeholders needed to know who the optimal user(s) of these tools would be, in part to inform implementation, as well as to ensure there would be no risk of safety concerns or unintended consequences. This knowledge will be particularly helpful to include during provider education. Acceptability among providers may be a particular challenge; therefore, implementer education will need to frame self-management of fistula as a means to support coping among affected women that can be offered as a complimentary option to accessing successful surgical repair. Strategies for educating providers should reiterate that implementation of therapeutic tools for self-management, similar to surgical intervention, aims to put \u0026lsquo;the needs of women first.\u0026rsquo; Strategies for educating users and implementers alike should allow for demonstration and the opportunity to ask questions. A lack of political will to implement non-surgical, therapeutic management of fistula in LMICs could be addressed by building the evidence base on effectiveness, cost, and sustainability, as well as by developing partnerships with or seeking funding from the private sector working on global health innovation or from others outside the traditional obstetric fistula programming funding sources. Additionally, government partnerships will be crucial to developing sustainability by establishing buy-in and ownership from ministries of health in LMICs where fistula is endemic. Additional challenges to address include access to resources that support the use of these tools, including water, soap, and private latrine facilities, as appropriate. Similarly, these factors have previously proven important for implementation of novel insertable devices for contraception, STI prevention, and menstrual hygiene management in LMICs (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e, \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn this study, the CFIR was used as intended by developers to guide both data collection and analysis, during the comparatively less studied pre-implementation period (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). This work suggests which constructs are seemingly most applicable for this stage (i.e., tension for change, compatibility) and which are less so (i.e., process constructs). As with previous applications (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e), sustainability emerged through inductive coding as a construct not identified in the framework. Sustainability might be particularly relevant for implementation of global health innovations in low-resource settings where cost is a particularly important issue that guides decision making. This is supported by the work of Means et al. (2020) who call for the optimization of the CFIR for low-resource settings like LMICs (\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe application of this framework at this stage supports preparation for the implementation process itself through supporting stakeholder partnership development and further elaborating on a theory of change. Similar to the critiques of Ilott et al., the framework lacks a consideration of scale-up, which should be integrated into the development of a theory of change even when used for intervention development. This allowed the authors to think broadly and draw on lessons learned from implementation strategies for other interventions. Drawing on the Expert Recommendations for Implementing Change (ERIC), which lists potential implementation strategies (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e), these findings seem to suggest that building a multi-sectoral coalition, developing academic partnerships, developing educational materials, and identifying and preparing champions could all be potentially effective implementation strategies for a novel tool to support women\u0026rsquo;s self-management of obstetric fistula in LMICs. However, this should be further examined in future research.\u003c/p\u003e \u003cp\u003eThis study has various strengths and limitations. It gathered perspectives from a diverse set of stakeholders to generate a broad understanding of facilitators and barriers for an innovation for self-management of obstetric fistula. The work employed various strategies for rigor with qualitative research, including developing an audit trail and carrying out member checking among stakeholders. Limitations include the fact that stakeholder categories are not equally represented (for example, almost half of the sample are researchers) and the fact that two important voices are not included among this sample of fistula stakeholders: affected women and community opinion leaders in fistula-endemic settings. This could provide an additional research opportunity to further examine implementation determinants, particularly at the community level. Lastly, one researcher (NR) conducted the coding, as is common for dissertation research; however, as the researcher reported out to her expert committee, the strategies for rigor employed likely addressed any potential faults in trustworthiness.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis paper makes an important contribution to our understanding of key perceived factors for successful implementation of an innovation for self-management of obstetric fistula. Early and continued engagement with stakeholders on identifying determinants of successful implementation will inform design and adaptation of implementation strategies for non-surgical management in various clinical and community settings wherein fistula care is provided. With a growing demand for provision of therapeutic options but with no accessible supply, stakeholder insights around implementation of an innovation for self-management will inform clinical practice and future research among those interested in integrating these user-controlled options into the provision of fistula care. \u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCFIR Consolidated Framework for Implementation Research\u003c/p\u003e\n\u003cp\u003eLMICs Low- and middle-income countries\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHuman subjects approval was obtained from the New York University NYU IRB/University Committee on Activities Involving Human Subjects (protocol number IRB-FY2017-1144). All participants underwent an informed consent process and participated voluntarily in the study. All methods were carried out in accordance with relevant guidelines and regulations.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets (i.e., transcripts, memos, field notes) generated and/or analyzed during the current study are not publicly available due to the fact that they cannot be readily deidentified, but are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported in part by the NYU CTSA grants UL1 TR0001445 and TL1 TR001447 from the National Center for Advancing Translational Sciences, National Institutes of Health.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNR AME GG LY JP BBA contributed to the conceptualization of this work. NR collected and analyzed the data and drafted the manuscript. NR AME GG LY JP BBA NVD EP contributed to interpretation. All authors have reviewed and approved the submitted version.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe wish to thank our interview participants for their time and effort.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eWHO. The World health report 2005: Make every mother and child count. 2005.\u003c/li\u003e\n \u003cli\u003eWall L. Obstetric vesicovaginal fistula as an international public-health problem. Lancet (London, England). 2006;368 (9542):1201\u0026ndash;9.\u003c/li\u003e\n \u003cli\u003eGharoro EP AK. Aspects of psychosocial problems of patients with vesico-vaginal fistula. Journal of Obstetrics \u0026amp; Gynaecology 2009;29(7)::644-7.\u003c/li\u003e\n \u003cli\u003eChong E. 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American Journal of Obstetrics \u0026amp; Gynecology. 2012;207(4):248\u0026ndash;58.\u003c/li\u003e\n \u003cli\u003ePope R. Research in Obstetric Fistula: Addressing Gaps and Unmet Needs. Obstetrics \u0026amp; Gynecology. 2018;131(5):863\u0026ndash;70.\u003c/li\u003e\n \u003cli\u003eHeller A. The Hidden Harm of Surgery. Anthropology News. 2018.\u003c/li\u003e\n \u003cli\u003eEpiu I, Alia G, Mukisa J, Tavrow P, Lamorde M, Kuznik A. Estimating the cost and cost-effectiveness for obstetric fistula repair in hospitals in Uganda: a low income country. Health Policy And Planning. 2018.\u003c/li\u003e\n \u003cli\u003ePolan ML, Sleemi A, Bedane MM, Lozo S, Morgan MA. Obstetric Fistula. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, editors. Essential Surgery: Disease Control Priorities, Third Edition (Volume 1). Washington (DC): The International Bank for Reconstruction and Development / The World Bank.; 2015.\u003c/li\u003e\n \u003cli\u003eKayondo M WS, Kabakyenga J, Mukiibi N, Jude Senkungu, Stenson A, et al.. Predictors and outcome of surgical repair of obstetric fistula at a regional referral hospital,Mbarara, western Uganda. BMC Urology. 2011;11(23).\u003c/li\u003e\n \u003cli\u003eJarvis K RS, Vallianatos H. Exploring the needs and challenges of women reintegrating after obstetric fistula repair in northern Ghana. Midwifery. 2017;50:55\u0026ndash;61.\u003c/li\u003e\n \u003cli\u003eEl Ayadi AM, Barageine J, Korn A, Kakaire O, Turan J, Obore S, et al. Trajectories of women\u0026apos;s physical and psychosocial health following obstetric fistula repair in Uganda: a longitudinal study. Tropical Medicine \u0026amp; International Health. 2019;24(1):53\u0026ndash;64.\u003c/li\u003e\n \u003cli\u003eMaulet N, Keita M, Macq J. Medico-social pathways of obstetric fistula patients in Mali and Niger: an 18-month cohort follow-up. Trop Med Int Health. 2013;18(5):524\u0026ndash;33.\u003c/li\u003e\n \u003cli\u003eSori DA, Azale AW, Gemeda DH. Characteristics and repair outcome of patients with Vesicovaginal fistula managed in Jimma University teaching Hospital, Ethiopia. BMC Urology. 2016;16(1):41.\u003c/li\u003e\n \u003cli\u003eDelamou A, Delvaux T, Utz B, Camara BS, Beavogui AH, Cole B, et al. Factors associated with loss to follow-up in women undergoing repair for obstetric fistula in Guinea. Trop Med Int Health. 2015;20(11):1454\u0026ndash;61.\u003c/li\u003e\n \u003cli\u003eRussell KW, Robinson RE, Mone MC, Scaife CL. Enterovaginal or Vesicovaginal Fistula Control Using a Silicone Cup. Obstet Gynecol. 2016;128(6):1365\u0026ndash;8.\u003c/li\u003e\n \u003cli\u003eNew Vision Reporter. Menstrual cup: Temporary relief for fistula patients. New Vision. 2012.\u003c/li\u003e\n \u003cli\u003eGoldberg L, Elsamra S, Hutchinson-Colas J, Segal S. Delayed Diagnosis of Vesicouterine Fistula After Treatment for Mixed Urinary Incontinence: Menstrual Cup Management and Diagnosis. Female Pelvic Med Reconstr Surg. 2016;22(5):e29-31.\u003c/li\u003e\n \u003cli\u003eGanyaglo GYK, Ryan N, Park J, Lassey AT. Feasibility and acceptability of the menstrual cup for non-surgical management of vesicovaginal fistula among women at a health facility in Ghana.. PLoS ONE. 2018;13(11).\u003c/li\u003e\n \u003cli\u003eDamschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation science: IS. 2009;4:50.\u003c/li\u003e\n \u003cli\u003eKirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implementation science: IS. 2016;11:72.\u003c/li\u003e\n \u003cli\u003ePadgett D. Qualitative and Mixed Methods in Public Health: Sage 2012.\u003c/li\u003e\n \u003cli\u003eN. R, press) KAi. Therapeutic management of obstetric fistula: learning from implementation of insertable devices to improve the health and well-being of women and girls in low- and middle-income countries In: LB Drew BR, DA Schwartz, editor. A Multidisciplinary Approach to Obstetric Fistula in Africa - Public Health, Anthropological, and Medical Perspectives: Springer; 2021.\u003c/li\u003e\n \u003cli\u003eTellier S, Hyttel M. Menstrual Health Management in East and Southern Africa: a Review Paper. United Nations Population Fund and WoMena; 2018.\u003c/li\u003e\n \u003cli\u003eIlott I, Gerrish K, Booth A, Field B. Testing the Consolidated Framework for Implementation Research on health care innovations from South Yorkshire. J Eval Clin Pract. 2013;19(5):915\u0026ndash;24.\u003c/li\u003e\n \u003cli\u003ePowell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implementation Science. 2015;10(1):21.\u003c/li\u003e\n \u003cli\u003eMeans, A.R., Kemp, C.G., Gwayi-Chore, MC. et al. Evaluating and optimizing the consolidated framework for implementation research (CFIR) for use in low- and middle-income countries: a systematic review. Implementation Sci 15, 17 (2020). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13012-020-0977-0\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Obstetric fistula, female genital fistula, device, incontinence management, self-management, non-surgical management, pre-implementation, consolidated framework for implementation research, theory of change","lastPublishedDoi":"10.21203/rs.3.rs-2051782/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2051782/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003e\u0026nbsp;Obstetric fistula, a debilitating maternal morbidity, occurs in contexts with poor access to and quality of emergency obstetric care, predominantly in sub-Saharan Africa. As many as two million women and girls suffer from fistula, which results in urinary incontinence, vulnerability to stigma for women and families, and economic consequences for the household and the healthcare system. Surgical repair, the gold standard for treatment, remains inaccessible to many and success is not guaranteed. Non-surgical, user-controlled fistula management options are not readily accessible, although some technologies, like insertable devices, have been found to have some level of feasibility and acceptability and provide short-term control over incontinence. As evidence for the effectiveness of tools to support self-management grows, the determinants of their implementation within various contexts remain unknown. The purpose of this qualitative study was to explore with key stakeholders, prior to implementation, those factors that could influence successful implementation of an innovation for self-management of obstetric fistula in a LMIC.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eStakeholders were purposefully identified from sectors that address the needs of women with obstetric fistula in sub-Saharan Africa: clinical care, academia, international health organizations, civil society, and government. Twenty-one key stakeholders were interviewed about their perceptions of innovations for fistula self-management and their implementation. The Consolidated Framework for Implementation Research (CFIR) guided data collection and analysis of transcripts from recorded interviews. Analyses were carried out within Nvivo v.12. Deductive coding focused on constructs within the CFIR, then inductive coding identified additional constructs relevant for implementation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003ePotential facilitators to implementation included a clear tension for change for low-cost, accessible innovations for self-management and a relative advantage over existing tools. The development of partnerships and identification of champions could also support implementation. Barriers included the lack of evidence identifying the optimal beneficiary and the need for educational strategies that encourage acceptability among clinical providers. Inductive coding revealed an additional relevant construct of sustainability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: Effectiveness and implementation of non-surgical tools for fistula self-management should be further examined in LMICs. Future research could inform comprehensive fistula care to reduce vulnerability to stigma and improve quality of life.\u003c/p\u003e","manuscriptTitle":"Tools for self-management of obstetric fistula in low- and middle-income countries: a qualitative study exploring pre-implementation barriers and facilitators among global stakeholders","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-09-20 16:03:35","doi":"10.21203/rs.3.rs-2051782/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"dbfd857f-4d6c-4e24-bf6c-a239099e441d","owner":[],"postedDate":"September 20th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2023-05-16T08:44:34+00:00","versionOfRecord":[],"versionCreatedAt":"2022-09-20 16:03:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-2051782","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2051782","identity":"rs-2051782","version":["v1"]},"buildId":"wLkW0s4AflPzk-lpfg-fK","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}