Evaluation of Intussusception Following Pentavalent Rotavirus Vaccine (RotaTeq) Administration in 5 African Countries.

BACKGROUND: A low-level risk of intussusception following rotavirus vaccination has been observed in some settings and may vary by vaccine type. We examined the association between RotaTeq vaccination and intussusception in low-income settings in a pooled analysis from 5 African countries that introduced RotaTeq into their national immunization program. METHODS: Active surveillance was conducted at 20 hospitals to identify intussusception cases. A standard case report form was completed for each enrolled child, and vaccination status was determined by review of the child's vaccination card. The pseudo-likelihood adaptation of self-controlled case-series method was used to assess the association between RotaTeq administration and intussusception in the 1-7, 8-21, and 1-21 day periods after each vaccine dose in infants aged 28-245 days. RESULTS: Data from 318 infants with confirmed rotavirus vaccination status were analyzed. No clustering of cases occurred in any of the risk windows after any of the vaccine doses. Compared with the background risk of naturally occurring intussusception, no increased risk was observed after dose 1 in the 1-7 day (relative incidence = 2.71; 95% confidence interval [CI] = 0.47-8.03) or the 8-21 day window (relative incidence = 0.77; 95%CI = 0.0-2.69). Similarly, no increased risk of intussusception was observed in any risk window after dose 2 or 3. CONCLUSIONS: RotaTeq vaccination was not associated with increased risk of intussusception in this analysis from 5 African countries. This finding mirrors results from similar analyses with other rotavirus vaccines in low-income settings and highlights the need for vaccine-specific and setting-specific risk monitoring.

Implementation of the World Health Organization Trauma Care Checklist Program in 11 Centers Across Multiple Economic Strata: Effect on Care Process Measures.

BACKGROUND: Trauma contributes more than ten percent of the global burden of disease. Initial assessment and resuscitation of trauma patients often requires rapid diagnosis and management of multiple concurrent complex conditions, and errors are common. We investigated whether implementing a trauma care checklist would improve care for injured patients in low-, middle-, and high-income countries. METHODS: From 2010 to 2012, the impact of the World Health Organization (WHO) Trauma Care Checklist program was assessed in 11 hospitals using a stepped wedge pre- and post-intervention comparison with randomly assigned intervention start dates. Study sites represented nine countries with diverse economic and geographic contexts. Primary end points were adherence to process of care measures; secondary data on morbidity and mortality were also collected. Multilevel logistic regression models examined differences in measures pre- versus post-intervention, accounting for patient age, gender, injury severity, and center-specific variability. RESULTS: Data were collected on 1641 patients before and 1781 after program implementation. Patient age (mean 34 ± 18 vs. 34 ± 18), sex (21 vs. 22 % female), and the proportion of patients with injury severity scores (ISS) ≥ 25 (10 vs. 10 %) were similar before and after checklist implementation (p > 0.05). Improvement was found for 18 of 19 process measures, including greater odds of having abdominal examination (OR 3.26), chest auscultation (OR 2.68), and distal pulse examination (OR 2.33) (all p < 0.05). These changes were robust to several sensitivity analyses. CONCLUSIONS: Implementation of the WHO Trauma Care Checklist was associated with substantial improvements in patient care process measures among a cohort of patients in diverse settings.

Diagnosis of advanced prostate cancer at the community level in Rwanda.

BACKGROUND: Prostate cancer is the second most common cancer in men and sixth leading cause of mortality. If not recognized early, patients with advanced prostate cancer can experience debilitating complications which can otherwise be prevented by early androgen deprivation therapy. This research intends to define clear diagnostic tools that will guide practitioners in the rural community setting toward early management of advanced prostate cancer. METHODS: We conducted a cross-sectional observational study at three referral hospitals in Kigali, Rwanda on patients who presented with clinical suspicion of advanced prostate cancer over a period of 6 months. All patients underwent prostate biopsy as well as metastatic work up (CT or MRI), for those who were eligible. Statistical analysis was done using STATA 14.2. RESULTS: 114 patients were included in the study. The median age was 70 years (interquartile range: 65-79 years). In total 14 (12.3%) patients were found to have benign disease, while 100 (87.7%) patients were found to have cancer. Among those who had cancer, 85 (85%) had advanced prostate cancer. 110/114 (96.5%) were symptomatic at presentation. Common presenting symptoms were lower urinary tract symptoms (80.7%), back pain (54.4%), and urinary retention (36.8%). Abnormal digital rectal examination (DRE) was a strong risk factor for both cancer and advanced disease. Prostate cancer was found in 92.2% of those with abnormal DRE compared to 41.7% in those with normal DRE (p = 0.001). Also, cancer was found in 96.1% of those with multinodular prostate on DRE (p = 0.02) and had high odds (OR 14.6; CI 3.41-62.25) of having advanced prostate cancer (p < 0.001). The mean (± SD) PSA was 643.3 ± 1829.8 ng/ml and the median (range) was 100 ng/ml (9.05-10,000 ng/ml) for the whole study population. All patients with prostatic-specific antigen (PSA) of 100 ng/ml or above had advanced prostate cancer. CONCLUSION: The results show that there is a significant correlation between clinical findings and advanced prostate cancer. All patients with abnormal DRE and PSA above 100 ng/ml had advanced prostate cancer. Diagnosis of advanced prostate cancer is possible at the community level if PSA testing is utilized and practitioners are well trained.

Preparing for safety monitoring after rotavirus vaccine implementation: a retrospective review of intussusception cases among children at a large teaching hospital in Rwanda, 2009-2012.

BACKGROUND: In some settings, rotavirus vaccines have been associated with a small risk of intussusception. This study describes the demographics, clinical characteristics and outcomes of children with intussusception in Rwanda before vaccine introduction in May 2012. METHODS: We retrospectively reviewed data on pediatric patients treated for intussusception at University Teaching Hospital of Kigali from January 2009 to June 2012. Hospital registries were reviewed to identify intussusception cases. Archived patient files were abstracted to collect data on demographics, clinical presentation, surgery and outcome. RESULTS: During the study period, 70 children ≤19 years of age were treated for intussusception and patient files were retrieved for 60 (86%) cases. Over half of patients (58%) were <1 year of age and 90% were transferred from a district hospital. Only 30% of patients presented within 3 days of symptom onset and 35% experienced a delay of ≥6 hours between surgical review and surgery. Surgical complications were experienced by 35% of children. Over 1 quarter (28%) of children died. Compared with children who survived, children who died were significantly more likely to have experienced complications (21% vs. 71%; P < 0.001) and to be female (28% vs. 65%; P = 0.009). DISCUSSION: Mortality due to intussusception was high among Rwanda children. Delays in presentation and treatment were common. Assessing trends in the number of cases to monitor for vaccine-associated intussusception will be difficult. Additional work is needed to further understand risk factors for mortality, to calculate incidence rates and to monitor the safety of the rotavirus vaccination program.