A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania

Abstract
Background
Open tibia fractures are a major source of disability in low- and middle-income countries (LMICs) due to the high incidence of complications, particularly infection and chronic osteomyelitis. One proposed adjunctive measure to reduce infection is prophylactic local antibiotic delivery, which can achieve much higher concentrations at the surgical site than can safely be achieved with systemic administration. Animal studies and retrospective clinical studies support the use of gentamicin for this purpose, but no high-quality clinical trials have been conducted to date in high- or low-income settings.

Methods
We describe a protocol for a pilot study conducted in Dar es Salaam, Tanzania, to assess the feasibility of a single-center masked randomized controlled trial to compare the efficacy of locally applied gentamicin to placebo for the prevention of fracture-related infection in open tibial shaft fractures.

Discussion
The results of this study will inform the design and feasibility of a definitive trial to address the use of local gentamicin in open tibial fractures. If proven effective, local gentamicin would be a low-cost strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

Placental pathology and maternal factors associated with stillbirth: An institutional based case-control study in Northern Tanzania

Objective
To determine the placental pathologies and maternal factors associated with stillbirth at Kilimanjaro Christian Medical Centre, a tertiary referral hospital in Northern Tanzania.

Methods
A 1:2 unmatched case-control study was carried out among deliveries over an 8-month period. Stillbirths were a case group and live births were the control group. Respective placentas of the newborns from both groups were histopathologically analyzed. Maternal information was collected via chart review. Mean and standard deviation were used to summarize the numerical variables while frequency and percentage were used to summarize categorical variables. Crude and adjusted logistic regressions were done to test the association between each variable and the risk of stillbirth.

Results
A total of 2305 women delivered during the study period. Their mean age was 30 ± 5.9 years. Of all deliveries, 2207 (95.8%) were live births while 98 (4.2%) were stillbirths. Of these, 96 stillbirths (cases) and 192 live births (controls) were enrolled. The average gestational age for the enrolled cases was 33.8 ±3.2 weeks while that of the controls was 36.3±3.6 weeks, (p-value 0.244). Of all stillbirths, nearly two thirds 61(63.5%) were males while the females were 35(36.5%). Of the stillbirth, 41were fresh stillbirths while 55 were macerated. The risk of stillbirth was significantly associated with lower maternal education [aOR (95% CI): 5.22(2.01–13.58)], history of stillbirth [aOR (95%CI): 3.17(1.20–8.36)], lower number of antenatal visits [aOR (95%CI): 6.68(2.71–16.48), pre/eclampsia [aOR (95%CI): 4.06(2.03–8.13)], and ante partum haemorrhage [OR (95%CI): 2.39(1.04–5.53)]. Placental pathology associated with stillbirth included utero-placental vascular pathology and acute chorioamnionitis.

Conclusions
Educating the mothers on the importance of regular antenatal clinic attendance, monitoring and managing maternal conditions during antenatal periods should be emphasized. Placentas from stillbirths should be histo-pathologically evaluated to better understand the possible aetiology of stillbirths.

Efficacy of Trans-abdominis Plane Block for Post Cesarean Delivery Analgesia in Low-income Countries: a Phase Three Feasibility Study.

Background: Optimal pain control in a parturient woman undergoing caesarean section is essential for preventing complications such as venous thrombo-embolism and improving maternal satisfaction, early
functional recovery, mother-baby bond and breastfeeding. Intentional pain assessment and adequate management to acceptable pain severity using multimodal methods can be achieved in low-middle
income countries (LMICs).

Aim: Is to assess the efficacy of transversus abdominis plane (TAP) block and satisfaction post-cesarean delivery analgesia at Kilimanjaro Christian Medical Centre in Low-Income countries.
Methods: The study population consisted of 72 participants who met criteria posted for elective and emergency caesarean section. They were blindly assigned into two groups: group A was the interventional group which received TAP block and standard pain management according to local protocols and consisted of 41 participants and group B was the control group which received standard pain management without TAP block and consisted of 31 participants. In Group A 30ml of 0.25% bupivacaine single shot was deposited in the TAP plane bilaterally for postoperative analgesia. Participants were randomized using a parallel method. Their demographics were recorded before surgery and visual analogue scale was used to assess postoperative pain at rest and on movement, and maternal satisfaction at 0hrs, 6hrs, 12hrs and 24hrs.
Results: Total of 72 patients were analyzed using NRS with pain score at 0hr, 6hr and 12hr was significantly low by about 50% in Intervened group as compared to control group with (p-value (2 tail) of <0.001 however at 24 hrs. was 0.272. Participant in group A had extra movements at 0hr, 6hrs and 12hrs with p-value <0.001 as compare to control cut had no significant difference when coughing. Maternal
satisfaction with pain management was 95.1% with no reported adverse event.

Conclusions: Trans Abdominis Plane block when used as part of multimodal pain management is more effective in managing post-cesarean pain resulting in less physical limitation and high maternal satisfaction.

Assessment of Knowledge and Compliance to Evidence-Based Guidelines for VAP Prevention among ICU Nurses in Tanzania

Background: Implementation of evidence-based guidelines (EBGs) related to VAP is an effective measure for the prevention of ventilator-associated pneumonia (VAP). While low knowledge regarding the EBGs related to VAP prevention among ICU nurses is still a major concern among nurses in ICUs globally, the situation in Tanzania is scarcely known. This study aimed to assess the ICU nurses’ knowledge, compliance, and barriers toward evidence-based guidelines for the prevention of VAP in Tanzania.

Methods: A cross-sectional study, involving ICU nurses of major hospitals in Tanzania, was conducted. A structured questionnaire was administered among 116 ICU. Data analysis included descriptive statistics and independent t-test.

Results: The mean knowledge score was 38.6% which is lower than the lowest ever reported knowledge score for EBGs for VAP prevention. Nurses with a degree or higher level of nursing education performed significantly better than the nurses with a diploma or lower level of nursing education(p=0.004). The mean self-reported adherence score for EBGs for the prevention of VAP was 60.8%. The main barriers to the implementation of EBGs for VAP prevention were lack of skills (96.6%), lack of adequate staff (95.5%), and lack of knowledge (79.3%).

Conclusion: Considering the severity and impact of VAP, and the higher risks of HAIs in resource-limited countries like Tanzania, the lower level of knowledge and compliance implies the need for on-going educational interventions and evaluation of the implementation of the EBGs for VAP prevention by considering the local context.

Does health insurance contribute to improved utilization of health care services for the elderly in rural Tanzania? A cross-sectional study

Background: Health care systems in developing countries such as Tanzania depend heavily on out-of-pocket payments. This mechanism contributes to inefficiency, inequity and cost, and is a barrier to patients seeking access to care. There are efforts to expand health insurance coverage to vulnerable groups, including older adults, in Sub-Saharan African countries.

Objective: To analyse the association between health insurance and health service use in rural residents aged 60 and above in Tanzania.

Methods: Data were obtained from a household survey conducted in the Nzega and Igunga districts. A standardised survey instrument from the World Health Organization Study on global AGEing and adult health was used. This comprised of questions regarding demographic and socio-economic characteristics, health and insurance status, health seeking behaviours, sickness history (three months and one year prior to the survey), and the receipt of health care. A multistage sampling method was used to select wards, villages and respondents in each district. Local ward and hamlet officers guided the researchers in identifying households with older people. Crude and adjusted logistic regression methods were used to explore associations between health insurance and outpatient and inpatient health care use.

Results: The study sample comprised 1,899 people aged 60 and above of whom 44% reported having health insurance. A positive statistically significant association between health insurance and the utilisation of outpatient and inpatient care was observed in all models. The odds of using outpatient (adjusted OR = 2.20; 95% CI: 1.54, 3.14) and inpatient services (adjusted OR = 3.20; 95% CI: 2.46, 4.15) were higher among the insured.

Conclusion: Health insurance is a predictor of outpatient and inpatient health services in people aged 60 and above in rural Tanzania. Further research is needed to understand the perceptions of both the insured and uninsured regarding the quality of care received.

The Impact of Inadequate Soft-tissue Coverage following Severe Open Tibia Fractures in Tanzania

Background:
Managing lower extremity fractures complicated by large soft-tissue defects is challenging for surgeons in low- and middle-income countries, and long-term quality of life (QOL) for these patients is unclear.

Methods:
We examined QOL, surgical complications, and longitudinal outcomes in 10 patients with Gustilo-Anderson Classification Type IIIB open tibia fractures seen at an orthopedic institute in Tanzania, from December 2015 to March 2017. Patients completed follow-up at 2-, 6-, 12-, 26-, and 52-week time points, and returned for qualitative interviews at 2.5 years. The primary outcome was QOL, as measured using EuroQoL-5D scores and qualitative semi-structured interview responses. The secondary outcome was rate of complication, as defined by reoperation for deep infection or nonunion.

Results:
Ten patients enrolled in the study and 7 completed 1-year follow-up. All fractures were caused by road traffic accidents and treated by external fixation. No patients received initial soft-tissue (flap) coverage of the wound. All patients developed an infected nonunion. No patients returned to work at 6 weeks, 3 months, or 6 months. EQ-5D index scores at 1 year were poor (0.71 ± 0.09). Interview themes included ongoing medical complications, loss of employment, reduced income, and difficulty with activities of daily living.

Conclusions:
Patients in low- and middle-income countries with IIIB open tibia fractures not treated with appropriate soft-tissue coverage experience poor QOL, high complication rates, and severe socioeconomic effects as a result of their injuries. These findings illustrate the need for resources and training to build capacity for extremity soft-tissue reconstruction in LMICs.

Effects of helping mothers survive bleeding after birth in-service training of maternity staff : a cluster-randomized trial and mixed-method evaluation

Background: Postpartum Haemorrhage (PPH) causes a significant amount of morbidity and mortality among mothers giving birth in sub-Saharan Africa, Tanzania included. One root cause is the insufficient health worker skills to address postpartum haemorrhage. To combat this in-service training using competency-based simulation is proposed.

Aim: To assess the effectiveness of the Helping Mothers Survive Bleeding After Birth (HMS BAB) in-service training of maternity staff on PPH related health outcomes, and health workers’ skills. The thesis also assessed health workers’ perceptions of the training and facility preparedness to support care of women with PPH in Tanzania.

Methods: Study I was conceptualised as a cluster-randomized trial. Interrupted time-series analysis was used to compare the following PPH related health outcomes i) PPH near miss and ii) PPH case fatality between 10 intervention and 10 comparison clusters. Study II was a before-after study of health workers (n=636), and assessed skills change immediately and ten months after the training, as well as the association between health workers’ characteristics and skill change. Study III was a qualitative study using seven Focus Group Discussions (FGD) of health workers to explore their perceptions of the training implementation. A deductive theory-driven analysis informed by integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework was used. Study IV explored health workers (FGDs, n=7) and health managers (In-depth interviews, n=12) perceptions of health facility preparedness to support care given to women with PPH. The data was analysed using thematic analysis.

Results: There was a significant decline of severe PPH cases in intervention clusters compared to the comparison clusters observed immediately after the intervention. This was sustained in the post-intervention period (Study I). A small reduction in PPH case fatality was observed in intervention clusters during the post-intervention period. Health workers’ skills were significantly improved immediately after the training with a small decline at ten-months follow up (Study II). In Study III health workers reported positive perceptions of the training: the content, the training technique, use of simulated scenarios and peer practice facilitators enhanced learning. Challenges to successful training were related to organization of the training and allocating time for weekly skill practices. In Study IV health workers reported poor facility preparedness with inconsistencies and insufficiencies of resources, including few and overwhelmed maternity staff. This constrained their ability to use the new skills and to provide quality PPH-care. Additional challenges on human interactions such as communication, collaborations and leadership were highlighted.

Conclusion: The HMS BAB one-day training followed by eight weekly drills was effective in reducing PPH morbidities and mortality and improved health workers skills. Implementational challenges included i) organizational aspects of in-facility training, and ii) protected time for health workers to engage in weekly drills. Health providers voiced their struggle to put their new knowledge into practice highlighting insufficiencies in health facility readiness, such as lack of drugs and blood products.

An analysis of emergency care delays experienced by traumatic brain injury patients presenting to a regional referral hospital in a low-income country

Background
Trauma is a leading cause of death and disability worldwide. In low- and middle-income countries (LMICs), trauma patients have a higher risk of experiencing delays to care due to limited hospital resources and difficulties in reaching a health facility. Reducing delays to care is an effective method for improving trauma outcomes. However, few studies have investigated the variety of care delays experienced by trauma patients in LMICs. The objective of this study was to describe the prevalence of pre- and in-hospital delays to care, and their association with poor outcomes among trauma patients in a low-income setting.

Methods
We used a prospective traumatic brain injury (TBI) registry from Kilimanjaro Christian Medical Center in Moshi, Tanzania to model nine unique delays to care. Multiple regression was used to identify delays significantly associated with poor in-hospital outcomes.

Results
Our analysis included 3209 TBI patients. The most common delay from injury occurrence to hospital arrival was 1.1 to 4.0 hours (31.9%). Most patients were evaluated by a physician within 15.0 minutes of arrival (69.2%). Nearly all severely injured patients needed and did not receive a brain computed tomography scan (95.0%). A majority of severely injured patients needed and did not receive oxygen (80.8%). Predictors of a poor outcome included delays to lab tests, fluids, oxygen, and non-TBI surgery.

Conclusions
Time to care data is informative, easy to collect, and available in any setting. Our time to care data revealed significant constraints to non-personnel related hospital resources. Severely injured patients with the greatest need for care lacked access to medical imaging, oxygen, and surgery. Insights from our study and future studies will help optimize resource allocation in low-income hospitals thereby reducing delays to care and improving trauma outcomes in LMICs.

Day case laparoscopic cholecystectomy at Kilimanjaro Christian Medical Centre, Tanzania

Introduction: The Lancet Commission on Global Surgery has promoted the case for safe, affordable surgical care in low- and middle-income countries (LMICs). In 2017, Kilimanjaro Christian Medical Centre (KCMC) in Tanzania introduced a day case laparoscopic cholecystectomy (DCLC) service, the first of its kind in Sub-Saharan Africa (SSA). We aimed to evaluate this novel service in terms of safety, feasibility and acceptability by patients and staff.

Methods: This study used mixed methods and was split into two stages. In stage 1, we reviewed records of all laparoscopic cholecystectomies (LCs) comparing day cases and admissions. These patients were followed up with a telephone questionnaire to investigate complication rates and receive service feedback. Stage 2 consisted of semi-structured interviews with staff exploring the challenges KCMC faced in implementing DCLC.

Results: 147 laparoscopic cholecystectomies were completed: 109 were planned for DCLC, 82 (75.2%) of which were successful, whilst 27 (24.8%) patients were admitted. No variables significantly predicted unplanned admission, the commonest causes for which were pain and nausea. In the DCLC group there was 1 readmission. 62 patients answered the follow up questionnaire, 60 (97%) of which were satisfied with the service. Stage 2 interviews suggested staff to be motivated for DCLC but revealed poor organisation of the day case pathway.

Conclusion: High rates of DCLC combined with low rates of complications and readmission suggests DCLC is feasible at KCMC. However, staff interviews alluded to administrative problems preventing KCMC from reaching its full DCLC potential. A dedicated day case surgery unit would address most of these problems.

In-Hospital Postoperative Mortality Rates for Selected Procedures in Tanzania’s Lake Zone

Background
Postoperative mortality rate is one of six surgical indicators identified by the Lancet Commission on Global Surgery for monitoring access to high-quality surgical care. The primary aim of this study was to measure the postoperative mortality rate in Tanzania’s Lake Zone to provide a baseline for surgical strengthening efforts. The secondary aim was to measure the effect of Safe Surgery 2020, a multi-component intervention to improve surgical quality, on postoperative mortality after 10 months.

Methods
We prospectively collected data on postoperative mortality from 20 health centers, district hospitals, and regional hospitals in Tanzania’s Lake Zone over two time periods: pre-intervention (February to April 2018) and post-intervention (March to May 2019). We analyzed postoperative mortality rates by procedure type. We used logistic regression to determine the impact of Safe Surgery 2020 on postoperative mortality.

Results
The overall average in-hospital non-obstetric postoperative mortality rate for all surgery procedures was 2.62%. The postoperative mortality rates for laparotomy were 3.92% and for cesarean delivery was 0.24%. Logistic regression demonstrated no difference in the postoperative mortality rate after the Safe Surgery 2020 intervention.

Conclusions
Our results inform national surgical planning in Tanzania by providing a sub-national baseline estimate of postoperative mortality rates for multiple surgical procedures and serve as a basis from which to measure the impact of future surgical quality interventions. Our study showed no improvement in postoperative mortality after implementation of Safe Surgery 2020, possibly due to low power to detect change.