Identifying opportunities for prevention of adverse outcomes following female genital fistula repair: protocol for a mixed-methods study in Uganda.

BACKGROUND: Female genital fistula is a traumatic debilitating injury, frequently caused by prolonged obstructed labor, affecting between 500,000-2 million women in lower-resource settings. Vesicovaginal fistula causes urinary incontinence, and other morbidity may occur during fistula development. Women with fistula are stigmatized, limit social and economic engagement, and experience psychiatric morbidity. Improved surgical access has reduced fistula consequences yet post-repair risks impacting quality of life and well-being include fistula repair breakdown or recurrence and ongoing or changing urine leakage or incontinence. Limited evidence on risk factors contributing to adverse outcomes hinders interventions to mitigate adverse events. This study aims to quantify these adverse risks and inform clinical and counseling interventions to optimize women's health and quality of life following fistula repair through: identifying predictors and characteristics of post-repair fistula breakdown and recurrence (Objective 1) and post-repair incontinence (Objective 2), and to identify feasible and acceptable intervention strategies (Objective 3). METHODS: This mixed-methods study incorporates a prospective cohort of women with successful vesicovaginal fistula repair at approximately 12 fistula repair centers in Uganda (Objectives 1-2) followed by qualitative inquiry among key stakeholders (Objective 3). Cohort participants will have a baseline visit at the time of surgery followed by data collection at 2 weeks, 6 weeks, 3 months and quarterly thereafter for 3 years. Primary predictors to be evaluated include patient-related factors, fistula-related factors, fistula repair-related factors, and post-repair behaviors and exposures, collected via structured questionnaire at all data collection points. Clinical exams will be conducted at baseline, 2 weeks post-surgery, and for outcome confirmation at symptom development. Primary outcomes are fistula repair breakdown or fistula recurrence and post-repair incontinence. In-depth interviews will be conducted with cohort participants (n ~ 40) and other key stakeholders (~ 40 including family, peers, community members and clinical/social service providers) to inform feasibility and acceptability of recommendations. DISCUSSION: Participant recruitment is underway. This study is expected to identify key predictors that can directly improve fistula repair and post-repair programs and women's outcomes, optimizing health and quality of life. Furthermore, our study will create a comprehensive longitudinal dataset capable of supporting broad inquiry into post-fistula repair health. Trial Registration ClinicalTrials.gov Identifier: NCT05437939.

Female genital fistula is a traumatic birth injury which occurs where access to emergency childbirth care is poor. It causes uncontrollable urine leakage and is associated with other physical and psychological symptoms. Due to the urine leakage and its odor, women with fistula are stigmatized which has mental health and economic consequences. Ensuring women's access to fistula surgery and ongoing wellbeing is important for limiting the impact of fistula. After fistula surgery, health risks such as fistula repair breakdown or recurrence or changes to urine leakage can happen, but studies during this time are limited. Our study seeks to measure these health risks and factors influencing these risks quantitatively, and work with patients, community members, and fistula care providers to come up with solutions. We will recruit up to 1000 participants into our study at the time of fistula surgery and follow them for three years. We will collect data on patient sociodemographic characteristics, clinical history, and behavior after fistula repair through patient survey and medical record review. If participants have changes in urine leakage, they will be asked to return to the fistula repair hospital for exam. We will interview about 80 individuals to obtain their ideas for feasible and acceptable intervention options. We expect that this study will help to understand risk factors for poor health following fistula repair and, eventually, improve women's health and quality of life after fistula.

Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair: Protocol for a Mixed-Methods Study in Uganda.

Background: Female genital fistula is a traumatic debilitating injury, frequently caused by prolonged obstructed labor, affecting between 500,000-2 million women in lower-resource settings. Vesicovaginal fistula causes urinary incontinence. Other gynecologic, neurologic and orthopedic morbidity may occur during fistula development. Women with fistula are stigmatized; limit engagement in social, economic, or religious activities; and report high psychiatric morbidity. Improved global surgical access has reduced fistula consequences yet post-repair risks impacting quality of life and well-being include fistula repair breakdown or recurrence and ongoing or changing urine leakage or incontinence. Limited evidence on risk factors contributing to adverse outcomes hinders interventions to mitigate adverse events, protecting health and quality of life after surgery. This study seeks to identify predictors and characteristics of post-repair fistula breakdown and recurrence (Aim 1) and post-repair incontinence (Aim 2), and to identify feasible and acceptable intervention strategies (Aim 3). Methods: This mixed-methods study incorporates a prospective cohort study of women with successful vesicovaginal fistula repair at approximately 12 fistula repair centers and affiliated care sites in Uganda (Aims 1-2) followed by qualitative inquiry among key stakeholders (Aim 3). Cohort participants will have a baseline visit at the time of surgery followed by data collection at 2 weeks, 6 weeks, 3 months and quarterly thereafter for 3 years. Primary predictors to be evaluated include patient-related factors, fistula-related factors, fistula repair-related factors, and post-repair behaviors and exposures, collected via structured questionnaire at all data collection points. Clinical exams will be conducted at baseline, 2 weeks post-surgery, and for outcome confirmation at symptom development. Primary outcomes are fistula repair breakdown or fistula recurrence and post-repair incontinence. In-depth interviews will be conducted with cohort participants (n ~ 40) and other key stakeholders (~ 40 including family, peers, community members and clinical/social service providers) to develop feasible and acceptable intervention concepts for adjustment of identified risk factors. Discussion: Participant recruitment is underway. This study is expected to identify key predictors that can directly improve fistula repair and post-repair programs and women's outcomes, optimizing health and quality of life. Furthermore, our study will create a comprehensive longitudinal dataset capable of supporting broad inquiry into post-fistula repair health. Trial Registration: ClinicalTrials.gov Identifier: NCT05437939.

A cost-effectiveness analysis of surgical care delivery in Eastern Uganda-a societal perspective.

BACKGROUND: The mismatch between the global burden of surgical disease and global health funding for surgical illness exacerbates disparities in surgical care access worldwide. Amidst competing priorities, governments need to rationally allocate scarce resources to address local needs. To build an investment case for surgery, economic data on surgical care delivery is needed. This study focuses on femur fractures. METHODS: This prospective cohort study at Soroti Regional Referral Hospital (SRRH), captured demographic, clinical, and cost data from all surgical inpatients and their caregivers at SRRH from February 2018 through July 2019. We performed descriptive and inferential analyses. We estimated the cost effectiveness of intramedullary nailing relative to traction for femur fractures by using primary data and making extrapolations using regional data. RESULTS: Among the 546 patients, 111 (20.3%) had femur fractures and their median [IQR] length of hospitalization was 27 days [14, 36 days]. The total societal cost and Quality Adjusted Life Year (QALY) gained was USD 61,748.10 and 78.81 for femur traction and USD 23,809 and 85.47 for intramedullary nailing. Intramedullary nailing was dominant over traction of femur fractures with an Incremental Cost Effectiveness Ratio of USD 5,681.75 per QALY gained. CONCLUSION: Femur fractures are the most prevalent and most expensive surgical condition at SRRH. Relative to intramedullary nailing, the use of femur traction at SRRH is not cost effective. There is a need to explore and adopt more cost-effective approaches like internal fixation.

Etiology, Clinical Presentations, and Short-Term Treatment Outcomes of Extrahepatic Obstructive Jaundice in South-Western Uganda.

Background: The diagnosis of extrahepatic obstructive jaundice (EHOJ) remains a challenge and is often made late in low-resource settings. Systematic data are limited on the etiology and prognosis of patients with obstructive jaundice in Uganda. The objective of this study was to determine the etiology, clinical presentations, and short-term treatment outcomes of patients managed for EHOJ at Mbarara Regional Referral Hospital (MRRH) in south-western Uganda. Methods: Between September 2019 and May 2020, we prospectively enrolled a cohort of patients who presented with EHOJ at MRRH. A pretested, semi-structured data collection tool was used to abstract data from both the study participants and their files. Results: A total of 72 patients, 42 (58.3%) of whom were male with a median age of 56 (range of 2 months to 95 years) were studied. Forty-two (58.3%) participants had malignancies: Pancreatic head tumors 20 (27.8%), cholangiocarcinoma 13 (18.1%), duodenal cancers 5 (6.94%), and gall bladder cancer 4 (5.6%). The remaining 30 (41.7%) participants had benign etiologies: choledocholithiasis 10 (13.9%), biliary atresia 7 (9.7%), pancreatic pseudo cyst 6 (8.3%), Mirizzi syndrome 5 (6.9%) and 1 (1.4%) each of chronic pancreatitis and choledochal cyst. Sixty-seven (93.1%) patients presented with right upper quadrant tenderness, 65 (90.3%) abdominal pain and 55 (76.3%) clay-colored stool. Cholecystectomy 11 (25.6%) and cholecystojejunostomy + jejunojejunostomy 8 (18.6%) were the commonest procedures performed. Twelve (17.0%) of cases received chemotherapy (epirubicin/cisplatin/capecitabine) for pancreatic head tumors and (gemcitabine/oxaliplatine) for cholangiocarcinoma. Mortality rate was 29.2% in the study, of which malignancy carried the highest mortality 20 (95.24%). Conclusion: Malignancy was the main cause of EHOJ observed in more than half of the patients. Interventions aimed at early recognition and appropriate referral are key in this population to improve outcomes.

Urinary bladder cavernous hemangioma in a 3-year-old: A rare case report.

Cavernous hemangioma (CH) of urinary bladder occurs relatively infrequently, accounting for 0.6% of all bladder tumors. This tumor may occur sporadically or coexist with other benign and malignant vascular lesions. In this report, we present a rare case of CH in a 3-year-old Ugandan girl. A 3-year-old girl was referred to Mbarara Regional Referral Hospital (MRRH) for urological evaluation following a 3-year history of intravaginal swelling, dysuria, and heavy hematuria resulting in anemia. Imaging was consistent with polypoid bladder mass arising from the bladder trigone. Embryonal rhabdomyosarcoma was suspected based on clinical eyeballing. She was worked up for chemotherapy and received 26 cycles of vincristine sulfate, actinomycin-d, and cyclophosphamide (VAC). Biopsy and fulguration were performed after optimizing the patient. Histopathology confirmed CH. The surgery was uneventful and resulted in complete cure. CH should be considered in the differential diagnosis of childhood genitourinary masses. It is a rare entity in the real-life clinical practice and therefore can be overlooked. Excision biopsy and histology should be performed before initiating the patients to chemotherapy. CH is very insensitive to chemotherapy and therefore surgery maybe adequate in resource-limited settings.

The societal cost and economic impact of surgical care on patients' households in rural Uganda; a mixed method study.

BACKGROUND: The epidemiology and cost of surgical care delivery in low-and middle-income countries (LMICs) is poorly understood. This study characterizes the cost of surgical care, rate of catastrophic medical expenditure and medical impoverishment, and impact of surgical hospitalization on patients' households at Soroti Regional Referral Hospital (SRRH), Uganda. METHODS: We prospectively collected demographic, clinical, and cost data from all surgical inpatients and caregivers at SRRH between February 2018 and January 2019. We conducted and thematically analyzed qualitative interviews to discern the impact of hospitalization on patients' households. We employed the chi-square, t-test, ANOVA, and Bonferroni tests and built regression models to identify predictors of societal cost of surgical care. Out of pocket spending (OOPS) and catastrophic expenses were determined. RESULTS: We encountered 546 patients, mostly male (62%) peasant farmers (42%), at a median age of 22 years; and 615 caregivers, typically married (87%), female (69%), at a median age of 35 years. Femur fractures (20.4%), soft tissue infections (12.3%), and non-femur fractures (11.9%) were commonest. The total societal cost of surgical care was USD 147,378 with femur fractures (USD 47,879), intestinal obstruction (USD 18,737) and non-femur fractures (USD 10,212) as the leading contributors. Procedures (40%) and supplies (12%) were the largest components of societal cost. About 29% of patients suffered catastrophic expenses and 31% were medically impoverished. CONCLUSION: Despite free care, surgical conditions cause catastrophic expenses and impoverishment in Uganda. Femur fracture is the most expensive surgical condition due to prolonged hospitalization associated with traction immobilization and lack of treatment modalities with shorter hospitalization.

Cost-Effectiveness of Exploratory Laparotomy in a Regional Referral Hospital in Eastern Uganda.

BACKGROUND: Surgical disease increasingly contributes to global mortality and morbidity. The Lancet Commission on Global Surgery found that global cost-effectiveness data are lacking for a wide range of essential surgical procedures. This study helps to address this gap by defining the cost-effectiveness of exploratory laparotomies in a regional referral hospital in Uganda. MATERIALS AND METHODS: A time-and-motion analysis was utilized to calculate operating theater personnel costs per case. Ward personnel, administrative, medication, and supply costs were recorded and calculated using a microcosting approach. The cost in 2018 US Dollars (USD, $) per disability-adjusted life year (DALY) averted was calculated based on age-specific life expectancies for otherwise fatal cases. RESULTS: Data for 103 surgical patients requiring exploratory laparotomy at the Soroti Regional Referral Hospital were collected over 8 mo. The most common cause for laparotomy was small bowel obstruction (32% of total cases). The average cost per patient was $75.50. The postoperative mortality was 11.7%, and 7.8% of patients had complications. The average number of DALYs averted per patient was 18.51. The cost in USD per DALY averted was $4.08. CONCLUSIONS: This investigation provides evidence that exploratory laparotomy is cost-effective compared with other public health interventions. Relative cost-effectiveness includes a comparison with bed nets for malaria prevention ($6.48-22.04/DALY averted), tuberculosis, tetanus, measles, and polio vaccines ($12.96-25.93/DALY averted), and HIV treatment with multidrug antiretroviral therapy ($453.74-648.20/DALY averted). Given that the total burden of surgically treatable conditions in DALYs is more than that of malaria, tuberculosis, and HIV combined, our findings strengthen the argument for greater investment in primary surgical capacity in low- and middle-income countries.

Assessment of Blood Donation and Transfusion in Eastern Uganda: A Mixed-Methods Study.

BACKGROUND: Blood and blood products are essential in the management of injuries, medical illnesses, and childbirth. Chronic shortages in the blood supply perpetuates the high levels of morbidity and mortality from injury and treatable diseases. Patients in low- and middle-income countries are frequently unable to access blood units necessary for transfusion in a timely manner. OBJECTIVES: This study aimed to gain insight into the community and hospital factors that contribute to the observed insufficient supply of blood units available for transfusion at a regional referral hospital in rural Eastern Uganda. METHODS: A mixed-methods approach was utilized; community members were surveyed on knowledge, attitudes, and practices of blood donation and health professionals were queried on hospital factors affecting blood transfusions. Transfusion records were prospectively collected and analyzed, and the pathway of a single blood unit was observed and recorded. FINDINGS: Among the 82 community members that were surveyed, knowledge was poor (<50% correct) regarding age, weight, and volume of blood to be able to donate, but participants were overall knowledgeable on general characteristics that would exclude individuals from donating blood. Major themes elicited during qualitative interviews included a positive attitude towards and lack of information regarding blood donation. Health professionals expressed frustration in delayed testing of transfusion transmissible infections. The majority of blood transfusions were allocated to female patients (55.8%) and children under five years of age (33.2%). CONCLUSIONS: Broadened inclusion and education of the general population in blood donation and increased outreach programs may be promising interventions to increase the blood supply at the Soroti Regional Referral Hospital. To reduce the current bottleneck seen in TTI testing, the feasibility and cost-effectiveness of local TTI testing technology should be investigated further.

Identifying Information Gaps in a Surgical Capacity Assessment Tool for Developing Countries: A Methodological Triangulation Approach.

BACKGROUND: Surgical capacity assessment in low- and middle-income countries (LMICs) is challenging. The Surgeon OverSeas' Personnel Infrastructure Procedure Equipment and Supplies (PIPES) survey tool has been proposed to address this challenge. There is a need to examine the gaps in veracity and context appropriateness of the information obtained using the PIPES tool. METHODS: We performed a methodological triangulation by comparing and contrasting information obtained using the PIPES tool with information obtained simultaneously via three other methods: time and motion study (T&M); provider focus group discussions (FGDs); and a retrospective review of hospital records. RESULTS: In its native state, the PIPES survey does not capture the role of non-physician clinicians who contribute immensely to surgical care delivery in LMICs. The surgical workforce was more accurately captured by the FGDs and T&M. It may also not reflect the improvisations (e.g., patients sharing beds, partitioning the operating theater, and using preoperative rooms for surgery, etc.) that occur to expand surgical capacity to overcome the limited infrastructure and equipment. CONCLUSIONS: The PIPES tool captures vital surgical capacity information but has gaps that can be filled by modifying the tool and/or using ancillary methodologies. The interests of the researcher and the local stakeholders' perspectives should inform such modifications.

Barriers and facilitators of surgical care in rural Uganda: a mixed methods study.

BACKGROUND: Surgical care delivery is poorly understood in resource-limited settings. To effectively move toward universal health coverage, there is a critical need to understand surgical care delivery in developing countries. This study aims to identify the barriers and facilitators of surgical care delivery at Soroti Regional Referral Hospital in Uganda. METHODS: In this mixed methods study, we (1) applied the Surgeons OverSeas' Personnel, Infrastructure, Procedures, Equipment, and Supplies tool to assess surgical capacity; (2) retrospectively reviewed inpatient records; (3) conducted four semistructured focus group discussions with 18 purposively sampled providers involved in perioperative care; and (4) observed the perioperative process of care using a time and motion approach. Descriptive statistics were generated from quantitative data. Qualitative data were thematically analyzed. RESULTS: The Personnel, Infrastructure, Procedures, Equipment, and Supplies survey revealed severe deficiencies in workforce (P-score = 14) and infrastructure (I-score = 5). Equipment, supplies, and procedures were generally available. Male and female wards were overbooked 83% and 60% of the time, respectively. Providers identified lack of space, patient overload, and superfluous patients' attendants as barriers to surgical care. Workforce challenges were tackled using teamwork and task sharing. Inadequate equipment and processes were addressed using improvisations. All observed subjects (n = 31) received interventions. The median decision-to-intervention time was 2.5 h (Interquartile Range [IQR], 0.4, 21.4). However, 48% of subjects experienced delays. Median decision-to-intervention delay was 14.8 h (IQR, 0.9, 26.6). CONCLUSIONS: Despite severe workforce and physical infrastructural deficiencies at Soroti Regional Referral Hospital, providers are adjusting and innovating to deliver surgical care.