Equivalence between physicians and associate clinicians in the frequency of iatrogenic urogenital fistula following cesarean section in Tanzania and Malawi.

BACKGROUND: Physicians and associate (non-physician) clinicians conduct cesarean sections in Tanzania and Malawi. Urogenital fistulas may occur as complications of cesarean section. Location and circumstances can indicate iatrogenic origin as opposed to ischemic injury following prolonged, obstructed labor. METHODS: This retrospective review assessed the frequency of iatrogenic urogenital fistulas following cesarean sections conducted by either associate clinicians or physicians in Tanzania and Malawi. It focuses on 325 women with iatrogenic fistulas among 1290 women who had fistulas after cesarean birth in Tanzania and Malawi between 1994 and 2017. An equivalence test compared the proportion of iatrogenic fistulas after cesarean sections performed by associate clinicians and physicians (equivalence margin = 0.135). Logistic regression was used to model the occurrence of iatrogenic fistula after cesarean section, controlling for cadre, date, maternal age, previous abdominal surgery and parity. RESULTS: Associate clinicians attended 1119/1290 (86.7%) cesarean births leading to fistulas, while physicians attended 171/1290 (13.3%). Iatrogenic fistulas occurred in 275/1119 (24.6%) cesarean births by associate clinicians and in 50/171 (29.2%) cesarean births by physicians. The risk difference and 90% confidence interval were entirely contained within an equivalence margin of 13.5%, supporting a conclusion of equivalence between the two cadres. The odds of iatrogenic fistula after cesarean section were not statistically significantly different between associate clinicians and physicians (aOR 0.90; 95% CI 0.61-1.33). CONCLUSIONS: Associate clinicians appear equivalent to physicians performing cesarean sections in terms of iatrogenic fistula risk. Lower iatrogenic proportions for associate clinicians could reflect different caseloads. The occurrence of iatrogenic fistulas illustrates the importance of appropriate labor management and cesarean section decision-making, irrespective of health provider cadre. Given the noninferior performance and lower costs of employing associate clinicians, other countries with insufficient and/or unequally distributed health workforces could consider task-shifting cesarean sections to associate clinicians.

Iatrogenic genito-urinary fistula following cesarean birth in nine sub-Saharan African countries: a retrospective review.

BACKGROUND: Genito-urinary fistulas may occur as complications of obstetric surgery. Location and circumstances can indicate iatrogenic origin as opposed to pressure necrosis following prolonged, obstructed labor. METHODS: This retrospective review focuses on 787 women with iatrogenic genito-urinary fistulas among 2942 women who developed fistulas after cesarean birth between 1994 and 2017. They are a subset of 5469 women who sought obstetric fistula repair between 1994 and 2017 in Tanzania, Uganda, Kenya, Malawi, Rwanda, Somalia, South Sudan, Zambia, and Ethiopia. We compared genito-urinary fistula classifications following vaginal birth to classifications following cesarean birth. We assessed whether and how the proportion of iatrogenic genito-urinary fistula was changing over time among women with fistula, comparing women with iatrogenic fistulas to women with fistulas attributable to pressure necrosis. We used mixed effects logistic regression to model the rise in iatrogenic fistula among births resulting in fistula and specifically among cesarean births resulting in fistula. RESULTS: Over one-quarter of women with fistula following cesarean birth (26.8%, 787/2942) had an injury caused by surgery rather than pressure necrosis due to prolonged, obstructed labor. Controlling for age, parity, and previous abdominal surgery, the odds of iatrogenic origin nearly doubled over time among all births resulting in fistula (aOR 1.94; 95% CI 1.48-2.54) and rose by 37% among cesarean births resulting in fistula (aOR 1.37; 95% CI 1.02-1.83). In Kenya and Rwanda the rise of iatrogenic injury outpaced the increasing frequency of cesarean birth. CONCLUSIONS: Despite the strong association between obstetric fistula and prolonged, obstructed labor, more than a quarter of women with fistula after cesarean birth had injuries due to surgical complications rather than pressure necrosis. Risks of iatrogenic fistula during cesarean birth reinforce the importance of appropriate labor management and cesarean decision-making. Rising numbers of iatrogenic fistulas signal a quality crisis in emergency obstetric care. Unaddressed, the impact of this problem will grow as cesarean births become more common.

A retrospective review of genital fistula occurrence in nine African countries.

BACKGROUND: Female genital fistulas are abnormal communications that lead to urinary and/or fecal incontinence. This analysis compares the characteristics of women with fistulas to understand how countries differ from one another in the circumstances of genital fistula development. METHODS: This retrospective records review evaluated demographics and circumstances of fistula development for 6,787 women who sought fistula treatment between 1994 and 2017 in Tanzania, Uganda, Kenya, Malawi, Rwanda, Somalia, South Sudan, Zambia, and Ethiopia. RESULTS: Most women developed fistula during childbirth, whether vaginal (3,234/6,787, 47.6%) or by cesarean section (3,262/6,787, 48.1%). Others had fistulas attributable to gynecological surgery (215/6,787, 3.2%) or rare causes (76/6,787, 1.1%). Somalia, South Sudan, and Ethiopia had comparatively high proportions following vaginal birth and birth at home, where access to care was extremely difficult. Fistulas with live births were most common in Kenya, Malawi, Rwanda, Uganda, Tanzania, and Zambia, indicating more easily accessible care. CONCLUSIONS: Characteristics of women who develop genital fistula point to geographic differences in obstetric care. Access to care remains a clear challenge in South Sudan, Somalia, and Ethiopia. Higher proportions of fistula after cesarean birth and gynecological surgery in Kenya, Malawi, Rwanda, Uganda, Tanzania, and Zambia signal potential progress in obstetric fistula prevention while compelling attention to surgical safety and quality of care.

Rare causes of genital fistula in nine African countries: a retrospective review.

BACKGROUND: Most genital fistulas result from prolonged, obstructed labor or surgical complications. Other causes include trauma (from accidents, traditional healers, or sexual violence), radiation, carcinoma, infection, unsafe abortion, and congenital malformation. METHODS: This retrospective records review focuses on rare fistula causes among 6,787 women who developed fistula after 1980 and sought treatment between 1994 and 2017 in Tanzania, Uganda, Kenya, Malawi, Zambia, Rwanda, Ethiopia, Somalia, and South Sudan. We compare fistula etiologies across countries and assess associations between rare causes and type of incontinence (urine, feces, or both). RESULTS: Rare fistula accounted for 1.12% (76/6,787) of all fistulas, including traumatic accidents (19/6,787, 0.28%), traumatic sexual violence (15/6,787, 0.22%), traumatic injuries caused by traditional healers (13/6,787, 0.19%), unsafe abortion (10/6,791, 0.15%), radiation (8/6,787, 0.12%), complications of HIV infection (6/6,787, 0.09%), and congenital abnormality (5/6,787, 0.07%). Trauma caused by traditional healers was a particular problem among Somali women. CONCLUSION: Fistulas attributable to rare causes illuminate a variety of risks confronting women. Fistula repair training materials should distinguish trauma caused by traditional healers as a distinct fistula etiology. Diverse causes of fistula call for multi-pronged strategies to reduce fistula incidence.

Diagnosis and management of 365 ureteric injuries following obstetric and gynecologic surgery in resource-limited settings.

INTRODUCTION: Ureteric injuries are among the most serious complications of pelvic surgery. The incidence in low-resource settings is not well documented. METHODS: This retrospective review analyzes a cohort of 365 ureteric injuries with ureterovaginal fistulas in 353 women following obstetric and gynecologic operations in 11 countries in Africa and Asia, all low-resource settings. The patients with ureteric injury were stratified into three groups according to the initial surgery: (a) obstetric operations, (b) gynecologic operations, and (c) vesicovaginal fistula (VVF) repairs. RESULTS: The 365 ureteric injuries in this series comprise 246 (67.4%) after obstetric procedures, 65 (17.8%) after gynecologic procedures, and 54 (14.8%) after repair of obstetric fistulas. Demographic characteristics show clear differences between women with iatrogenic injuries and women with obstetric fistulas. The study describes abdominal ureter reimplantation and other treatment procedures. Overall surgical results were good: 92.9% of women were cured (326/351), 5.4% were healed with some residual incontinence (19/351), and six failed (1.7%). CONCLUSIONS: Ureteric injuries after obstetric and gynecologic operations are not uncommon. Unlike in high-resource contexts, in low-resource settings obstetric procedures are most often associated with urogenital fistula. Despite resource limitations, diagnosis and treatment of ureteric injuries is possible, with good success rates. Training must emphasize optimal surgical techniques and different approaches to assisted vaginal delivery.

Iatrogenic genitourinary fistula: an 18-year retrospective review of 805 injuries.

INTRODUCTION AND HYPOTHESIS: Genitourinary fistula poses a public health challenge in areas where women have inadequate access to quality emergency obstetric care. Fistulas typically develop during prolonged, obstructed labor, but providers can also inadvertently cause a fistula when performing obstetric or gynecological surgery. METHODS: This retrospective study analyzes 805 iatrogenic fistulas from a series of 5,959 women undergoing genitourinary fistula repair in 11 countries between 1994 and 2012. Injuries fall into three categories: ureteric, vault, and vesico-[utero]/-cervico-vaginal. This analysis considers the frequency and characteristics of each type of fistula and the risk factors associated with iatrogenic fistula development. RESULTS: In this large series, 13.2 % of genitourinary fistula repairs were for injuries caused by provider error. A range of cadres conducted procedures resulting in iatrogenic fistula. Four out of five iatrogenic fistulas developed following surgery for obstetric complications: cesarean section, ruptured uterus repair, or hysterectomy for ruptured uterus. Others developed during gynecological procedures, most commonly hysterectomy. Vesico-[utero]/-cervico-vaginal fistulas were the most common (43.6 %), followed by ureteric injuries (33.9 %) and vault fistulas (22.5 %). One quarter of women with iatrogenic fistulas had previously undergone a laparotomy, nearly always a cesarean section. Among these women, one quarter had undergone more than one previous cesarean section. CONCLUSIONS: Women with previous cesarean sections are at an increased risk of iatrogenic injury. Work environments must be adequate to reduce surgical error. Training must emphasize the importance of optimal surgical techniques, obstetric decision-making, and alternative ways to deliver dead babies. Iatrogenic fistulas should be recognized as a distinct genitourinary fistula category.

Factors associated with marital status of women with genital fistula after childbirth: a retrospective review in nine African countries.

OBJECTIVE: To examine characteristics associated with remaining married with fistula. DESIGN: Retrospective record review and logistic regression. SETTING: Tanzania, Uganda, Kenya, Malawi, Zambia, Rwanda, Ethiopia, Somalia and South Sudan. PARTICIPANTS: Women who developed fistula during childbirth (1975-2017) and sought treatment (1994-2017). OUTCOME MEASURE: Self-reported status of living with original husband at time of presentation for fistula repair. RESULTS: Over half of the women lived with their husbands at the time of fistula treatment (57.2%, 3375/5903). The strongest predictor of remaining married with fistula was either parity at fistula development (adjusted odds ratio [AOR] 1.4-4.4) or living kids at fistula repair (among women who had not given birth between fistula development and repair) (AOR 1.7-4.9). Predicted probability of remaining married declined sharply over the first 2 years of incontinence, levelling out thereafter. Predicted probability of remaining married was lower for women with both urinary and faecal incontinence (AOR 0.68) as compared with women with urinary incontinence alone. Probability of remaining married with fistula declined over time (AOR 1.03-0.57). The woman's education was not a statistically significant predictor, but the odds of remaining married were 26% higher if the husband had any formal schooling. CONCLUSION: Most husbands do not abandon wives with fistula following childbirth. Treatment, counselling, social support and rehabilitation must consider the circumstances of each woman, engaging men as partners where appropriate. Communities and facilities offering fistula repair services should stress the importance of early intervention.

Patient-reported outcomes for diabetes and hypertension care in low- and middle-income countries: A scoping review.

INTRODUCTION: Patient-reported outcome measures (PROMs) assess patients' perspectives on their health status, providing opportunities to improve the quality of care. While PROMs are increasingly used in high-income settings, limited data are available on PROMs use for diabetes and hypertension in low-and middle-income countries (LMICs). This scoping review aimed to determine how PROMs are employed for diabetes and hypertension care in LMICs. METHODS: We searched PubMed, EMBASE, and ClinicalTrials.gov for English-language studies published between August 2009 and August 2019 that measured at least one PROM related to diabetes or hypertension in LMICs. Full texts of included studies were examined to assess study characteristics, target population, outcome focus, PROMs used, and methods for data collection and reporting. RESULTS: Sixty-eight studies met the inclusion criteria and reported on PROMs for people diagnosed with hypertension and/or diabetes and receiving care in health facilities. Thirty-nine (57%) reported on upper-middle-income countries, 19 (28%) reported on lower-middle-income countries, 4 (6%) reported on low-income countries, and 6 (9%) were multi-country. Most focused on diabetes (60/68, 88%), while 4 studies focused on hypertension and 4 focused on diabetes/hypertension comorbidity. Outcomes of interest varied; most common were glycemic or blood pressure control (38), health literacy and treatment adherence (27), and acute complications (22). Collectively the studies deployed 55 unique tools to measure patient outcomes. Most common were the Morisky Medication Adherence Scale (7) and EuroQoL-5D-3L (7). CONCLUSION: PROMs are deployed in LMICs around the world, with greatest reported use in LMICs with an upper-middle-income classification. Diabetes PROMs were more widely deployed in LMICs than hypertension PROMs, suggesting an opportunity to adapt PROMs for hypertension. Future research focusing on standardization and simplification could improve future comparability and adaptability across LMIC contexts. Incorporation into national health information systems would best establish PROMs as a means to reveal the effectiveness of person-centered diabetes and hypertension care.

The perils of straying from protocol: sampling bias and interviewer effects.

Fidelity to research protocol is critical. In a contingent valuation study in an informal urban settlement in Nairobi, Kenya, participants responded differently to the three trained interviewers. Interviewer effects were present during the survey pilot, then magnified at the start of the main survey after a seemingly slight adaptation of the survey sampling protocol allowed interviewers to speak with the "closest neighbor" in the event that no one was home at a selected household. This slight degree of interviewer choice led to inferred sampling bias. Multinomial logistic regression and post-estimation tests revealed that the three interviewers' samples differed significantly from one another according to six demographic characteristics. The two female interviewers were 2.8 and 7.7 times less likely to talk with respondents of low socio-economic status than the male interviewer. Systematic error renders it impossible to determine which of the survey responses might be "correct." This experience demonstrates why researchers must take care to strictly follow sampling protocols, consistently train interviewers, and monitor responses by interview to ensure similarity between interviewers' groups and produce unbiased estimates of the parameters of interest.