Application of the research electronic data capture (REDCap) system in a low- and middle income country- experiences, lessons, and challenges.

The challenges of reliably collecting, storing, organizing, and analyzing research data are critical in low- and middle-income countries (LMICs), particularly in Sub-Saharan Africa where several healthcare and biomedical research organizations have limited data infrastructure. The Research Electronic Data Capture (REDCap) System has been widely used by many institutions and hospitals in the USA for data collection, entry, and management and could help solve this problem. This study reports on the experiences, challenges, and lessons learned from establishing and applying REDCap for a large US-Nigeria research partnership that includes two sites in Nigeria, (the College of Medicine of the University of Lagos (CMUL) and Jos University Teaching Hospital (JUTH)) and Northwestern University (NU) in Chicago, Illinois in the United States. The largest challenges to this implementation were significant technical obstacles: the lack of REDCap-trained personnel, transient electrical power supply, and slow/intermittent internet connectivity. However, asynchronous communication and on-site hands-on collaboration between the Nigerian sites and NU led to the successful installation and configuration of REDCap to meet the needs of the Nigerian sites. An example of one lesson learned is the use of Virtual Private Network (VPN) as a solution to poor internet connectivity at one of the sites, and its adoption is underway at the other. Virtual Private Servers (VPS) or shared online hosting were also evaluated and offer alternative solutions. Installing and using REDCap in LMIC institutions for research data management is feasible; however, planning for trained personnel and addressing electrical and internet infrastructural requirements are essential to optimize its use. Building this fundamental research capacity within LMICs across Africa could substantially enhance the potential for more cross-institutional and cross-country collaboration in future research endeavors.

Serological and virological markers of nigerian patients with hepatitis B infection.

BACKGROUND: The natural history of chronic hepatitis B virus (HBV) infection and the spectrum of diseases attributable to chronic hepatitis B are diverse. It is estimated that 15%-25% of chronic carriers will die from complications of progressive disease such as liver cirrhosis, hepatocellular carcinoma, and hepatic decompensation. The main aim of this study is to evaluate the serological and virological profile of patients with hepatitis B infection to enhance the evaluation of the natural history of viral hepatitis in an endemic population. METHODS: Characteristics of hepatitis B surface antigen (HBsAg) patients (2010-2016) were extracted from the database of a reference laboratory in Lagos. These included serological tests for hepatitis B antigens (HBeAg, HBsAg), antibodies (anti-HBcIgM, anti-HBeAb) (DIA.PRO), and HBV DNA (Roche Diagnostics). SPSS version 20.0 was used for data analysis. RESULTS: Of the 1,983 patients, 1,252 were male and 731 female. HBeAg was detected in 8.0% (128/1,605) of the subjects, anti-HBe was positive in 90.0% (1,257/1,396), while HBcore subclass IgM antibody was detected in 12.6% (116/930). Detectable HBV DNA was identified in 1,781 (89%), with viral load exceeding 2,001 IU/mL in 712 (35.9%) subjects. HBV viral loads >200,000 IU/mL were more frequently detected in HBeAg-positive compared with HBeAg-negative subjects (65.7% vs 4.9%, P < 0.0001). CONCLUSION: We have demonstrated the predominance of low replicative phase HBV infection and highlighted the importance of HBeAg-negative infections that may require antiviral therapy. HBeAg-positive infections occurred significantly in younger adults with new or acute infections. Our findings have implications for patient evaluation and planning of hepatitis treatment programs.

Lipoatrophy among patients on antiretroviral therapy in Lagos, Nigeria: Prevalence, pattern and association with cardiovascular risk factors.

CONTEXT: Antiretroviral therapy (ART) is linked with morphologic abnormalities such as lipoatrophy (LA), which may accompany metabolic alterations (dysglycemias, dyslipidemia and insulin resistance) that increase cardiovascular disease risk. LA and its association with metabolic alterations have been infrequently studied amongst Nigerians on ART. AIMS: To determine the prevalence, pattern and association of LA with metabolic abnormalities and hypertension among patients on ART attending an ambulatory human immunodeficiency virus clinic in Lagos, Nigeria. SUBJECTS AND METHODS: A cross-sectional study was carried out among patients on ART using a structured interviewer administered questionnaire. Data obtained included patients and physician's assessment of body fat changes, drug history, blood pressure, body composition assessment using bioelectrical impedance analysis and biochemical evaluation (glucose, lipids). LA was defined clinically. Data were analyzed using IBM SPSS statistical software version 21. RESULTS: A total of 48 (33.1%) of the 145 patients had LA. The face was the most frequently affected body region. Patients with LA with lower body circumferences, skin-fold thickness and body fat (P < 0.05). The frequencies of lipid abnormalities were: Reduced high density lipoprotein-cholesterol (47.1%), elevated total cholesterol (35.6%), reduced low density lipoprotein-cholesterol (19.2%), elevated triglycerides (14.4%). Fasting plasma glucose (FPG)≥6.1 mmol/l and hypertension were present among 9.6% and 40.7% respectively. LA was not significantly associated with the presence of glucose intolerance, dyslipidemia or hypertension (P > 0.05). CONCLUSIONS: Lipoatrophy, though commonly encountered in patients on ART in Nigeria was not associated with the presence of dyslipidemia, abnormal FPG or hypertension. Regular monitoring by the physician and increased patients awareness are necessary to reduce its prevalence and impact.

Pharmacoepidemiology of antiretroviral drugs in a teaching hospital in Lagos, Nigeria.

OBJECTIVE: Prescribing, adherence, and adverse drug events to HAART in a large antiretroviral programme in Lagos was evaluated. DESIGN: A retrospective 5 year open cohort study. SETTING: The AIDS Prevention Initiative in Nigeria (APIN) clinic at LUTH is one of the United States Presidential Emergency Plan for AIDS Relief (PEP-FAR) funded centers for HIV relief program in Nigeria Participants The case files of 390 patients on HAART and attending the APIN clinic were reviewed sequel to random selection. MAIN OUTCOME MEASURES: Demographics of the patients and pattern of antiretroviral (ARV) combination drugs prescribed were extracted from their case files. The details of the adverse drug events (ADEs) were extracted from drug toxicity forms regularly filled for each patient. A Chi-square test with Yates correction was used to determine the association between adherence and therapeutic outcome. RESULTS: A total of 2944 prescriptions were assessed. Zidovudine + lamivudine + nevirapine (35.87%) and stavudine + lamivudine + nevirapine (35.63%) were the most frequently prescribed combinations. Over 2000 ADEs were reported with cough (13.3%), fever (8.75%) and skin rashes (8.01%) being the most frequently reported. Drug adherence was associated with good therapeutic outcome (χ(2) = 115.60, p<0.0001). CONCLUSIONS: Zidovudine + lamivudine + nevirapine was the most frequently prescribed ARV combination. Cough was the most frequently reported ADE. Interventions aimed at rational prescribing of ARV drugs and improving adherence to antiretroviral drugs is essential for good therapeutic outcome in the treatment of HIV infection.

Colonoscopy practice in lagos, Nigeria: a report of an audit.

Background. Colonoscopy effectiveness depends on the quality of the examination. Community-based report of quality of colonoscopy practice in a developing country will help in determining standard and also serve as a stimulus for improvement in service. Aim. To review the quality of colonoscopy practice and document pattern of colonic disease including polyp detection rate in Lagos, Nigeria. Method. A protocol that captured the patients' demographics, indication, and some quality indices of colonoscopy was developed and sent to all the identified colonoscopy units in Lagos to complete for all procedures performed between January 2011 and June 2012. All data were collated and analyzed. The quality indices studied were compared with guideline standard. Results. Twelve colonoscopy centers were identified but only nine centers responded. The gastroenterologist/endoscopists were physicians (3) and surgeons (5). Six hundred and seven colonoscopy procedures were performed during this period (M : F = 333 : 179) while the sex was not disclosed in 95 subjects. The examination indications were lower GI bleeding (24.2%), altered bowel habits (9.2%), lower abdominal pain (9.1%), screening for CRC (4.3%) and unspecified (46.8%). Conscious sedation was generally used while bowel preparation (good in 81.4%) was done with low residue diet and stimulant laxatives. Caecal intubation rate was 81.2%. Common endoscopic findings were haemorrhoids (43.2%), polyps/masses (13.4%), diverticulosis (11.1%), and no abnormality (23.4%). Polyp was detected in 6.8% of cases. Conclusion. Colonoscopy utilization is low, and the quality of practice is suboptimal; although limited resources could partly explain this, however it is not clear if the low rate of polyp detection is due to missed lesions or low population incidence.

The use of Helicobacter pylori stool antigen test for the diagnosis of Helicobacter pylori in Lagos, Nigeria.

OBJECTIVES: This study was carried out to screen the use of Helicobacter pylori stool antigen (HpSA) tests for diagnosis and monitoring of H pylori in Nigeria. METHODS: Seven hundred and forty participants were enrolled after informed consent was obtained, while 83 came back for a post-eradication test. The stool samples were taken from the patients at endoscopy and tested for HpSA. RESULTS: The proportion of patients that were positive at the pretest, 520 (70.3%) was significantly higher (Fisher's exact p = 0.001) than those positive at the post-test, 44 (53%). There was a significant difference (F = 4.106, p = 0.043) between the mean age of those that came for the pretest (40.0 +/- 14.5 years) and those that came for the post-test, 43.6 +/- 11.6 years. More males than females had the tendency to come back for a post-eradication test. CONCLUSION: Although potential bias was introduced during this study, HpSA using monoclonal antibody could still be used for diagnosis and monitoring of H pylori in Nigeria.

Hepatitis B viral load and risk for liver cirrhosis and hepatocellular carcinoma in The Gambia, West Africa.

The main objectives of this study were to define the occurrence and levels of hepatitis B virus (HBV) DNA in asymptomatic HBV carriers, cirrhosis patients and hepatocellular carcinoma (HCC) cases from The Gambia, and to evaluate the risk for cirrhosis or HCC associated with HBV viremia. We used sensitive real-time quantitative PCR assays to measure HBV DNA in samples from a case-control study consisting of 60 asymptomatic HBV carriers, 53 cirrhotic patients and 129 HCC cases. Logistic regression was used to estimate the risks of cirrhosis and HCC associated with HBV-DNA levels and HBV e antigenemia (HBeAg) detection (a surrogate marker for viral replication). Detectable HBV viremia and HBeAg positivity were both significantly associated with cirrhosis (increasing risk by fourfold and 11-fold respectively) and with HCC (increasing risk by sixfold and threefold respectively). HBV-DNA levels were significantly higher in both HCC cases and cirrhotic patients compared to asymptomatic carriers (P < 0.01 for both). High-level HBV DNA (>10,000 copies/mL) was strongly associated with both HCC and cirrhosis (17- and 39-fold increased risk). Lower level HBV viremia (200-10,000 copies/mL) conferred a significant risk of HCC, although the association with cirrhosis was not significant. In conclusion, we find that high HBV-DNA levels are strongly associated with the serious sequelae of HBV infection, independent of HBeAg status. While risk for cirrhosis and for HCC notably increases at HBV-DNA levels >or=10,000 copies/mL, low-level viremia was also associated with significant risk for HCC.

Research productivity of junior academic staff at a tertiary medical college in south west, Nigeria.

BACKGROUND: The research productivity of medical faculty has been well studied in developed countries, unlike in the developing countries. OBJECTIVES: This study proposes to assess the level of research productivity over a 2 year period and identify the challenges to conducting research among junior academic staff of the College of Medicine, University of Lagos. METHODS: An observational cross-sectional study in which the 120 junior academic staff from both basic sciences and clinical sciences were evaluated between January and September 2005. Data collection was by self-administered questionnaires distributed to the study population. RESULTS: There were 83 (69.1%) respondents comprising 38 males (45.6%) and 45 females (54.2%). The median age group was 31-40 years. Most respondents (57, 83%) spent less than 10 hours/week on research. On average they had completed 3-4 scholarly articles within the past 2 years. Nineteen (21.7%) of the subjects were considered to have optimal research productivity having completed over 5 scholarly research papers. The lecturers with optimal research productivity were significantly more likely to be male, and spent over 10 hours a week in hospital related clinical and laboratory related activities. (p = 0.02, and p = 0.03). Inadequate funding and laboratory facilities, and poor technological infrastructure were the most common causes of impediments to research reported by 78%, 69% and 55% of the lecturers respectively. CONCLUSION: Optimal research productivity was seen in about one quarter of the study population and was associated with male gender and prolonged duration of clinical/laboratory activities. Negligible research financing and poor laboratory support were major impediments to research productivity.

Hepatitis B and C virus infection in Nigerian patients with HIV/AIDS.

OBJECTIVES: This study was designed to assess the prevalence of HBV and HCV infection in HIV patients and evaluate the risk of infection compared with HIV negative control subjects. METHOD: This is a prospective case control study in which 240 HIV/AIDS patients and age and sex matched controls were evaluated. The diagnosis of HIV infection was based on a positive HIV screening test using Capillus test kits (Trinity Biotech PLC, Ireland) and confirmed using Western blot assay. HBsAg and anti-HCV were assayed by commercially available chromatographic immunoassay (SD BIOLINE). RESULTS: Eleven (9.2%) of the 120 HIV/AIDS patients and 8 (7%) of the 120 control subjects were positive for the HBsAg (OR=1, p=0.27). HBeAg was detected in 3 of the 11 (27.3%) subjects with HIV/HBV co infections. HIV positive patients were 7 times more likely to have HCV infection than control patients (5.8% compared with 0.8%, OR=7.3, p= 0.03). CONCLUSION: The lack of a strong association between HBV and HIV infection may be related to different exposure routes in this population where HBV infection is highly endemic and childhood infection almost universal. In this African population, HIV infection may be a super-infection of HBV infections contracted in childhood. This high HCV/HIV co-infection rate is consistent with the shared parenteral and sexual routes of transmission.

Hepatitis B surface antigenaemia and alpha-foetoprotein detection from dried blood spots: applications to field-based studies and to clinical care in hepatitis B virus endemic areas.

In many resource-limited regions with endemic hepatitis B virus (HBV), there is limited infrastructure to collect, process, transport, and store blood samples for identification of persons with chronic HBV infection or with hepatocellular carcinoma (HCC). We describe the application of a simple technique using commercially available kits for detection of HBV surface antigen (HBsAg) and alpha-foetoprotein (AFP) in dried blood spots (DBS) collected on filter paper. Study participants included subjects with and without chronic HBV infection and subjects with HCC or cirrhosis. Three to five blood drops were dried on filter paper. Dried blood (equivalent to 20 muL) was eluted and tested for HBsAg by Determine(TM) HBsAg and for AFP by counter-current immuno-electrophoresis and radio-immunoassay (RIA). The primary analysis focused on comparison of DBS results to serum testing results as the gold standard. The sensitivity of DBS for detecting chronic HBV infection was 96% (98-98) with specificity of 100% (CI 99-100). Sensitivity of DBS in detecting AFP compared with serum RIA was 73% (60-86) with specificity of 90% (81-98). Both HBsAg and AFP recovery were unaffected when DBS were left at room temperature (30-33 degrees C) and under humid conditions for up to 28 days prior to elution. We conclude that DBS can be reliably used as an economical and logical alternative for detection of HBsAg in chronically infected patients and for AFP-based diagnosis of HCC in clinical situations which preclude adequate collection and processing of blood samples. Both research-oriented field studies and routine clinical care may benefit from application of these techniques in resource-limited settings.

Chronic liver disease in Lagos: a clinicopathological study.

OBJECTIVE: To evaluate the clinical features and stage of chronic liver disease at presentation in Lagos. METHODS: Clinical features, hepatic functional reserve (Child-Pugh classification) and liver histopathology were evaluated in 74 patients with chronic liver disease (CLD). RESULTS: The average age of the patients was 44.1 +/- 14yr and most (57, 67% ) were male. Ascites, hepatomegaly and jaundice were noted in 66%, 51%, 47% respectively. Hepatocellular carcinoma, liver cirrhosis and chronic hepatitis were seen in 35, 29, and 10 patients respectively. Significant impairment of hepatic functional reserve was noted in most of the patients with liver cirrhosis (76% ) and carcinoma (68% ). Hepatitis B and C infections were identified in 58% and 12% of the patients respectively. CONCLUSION: The majority of clinically identified patients with CLD had severe impairment of hepatic function with underlying advanced liver cirrhosis or hepatocellular carcinoma at presentation. Viral hepatitis was associated with most CLD and thus is potentially preventable and treatable when detected early. Public enlightenment programmes on hepatitis, widespread implementation of HBV vaccination, and surveillance of individual at-risk are essential for the control of hepatitis infection and the early detection of compensated CLD.

Hepatitis C virus infection in patients with sickle cell anaemia at the Lagos University Hospital.

The objective of this studies is to determine the frequency of antibodies to Hepatitis C virus (anti-HCV), (2) assess the role of blood transfusion in transmission of infection, and (3) evaluate the clinical implication of anti-HCV sero-positivity in patients with Sickle cell anaemia (SCA). Two hundred and seventy-eight (278) patients with SCA were evaluated by questionnaire interviews for risk factors, clinical examination and serum testing for anti-HCV using a third generation ELISA kit. The overall anti-HCV prevalence was 5.0% (14/278). Anti-HCV was positive in 7% (5/76) of never transfused compared with 5% (9/202) of previously transfused sicklers. (p = 0.5). Clinically, splenomegaly alone or in combination with hepatomegaly was associated with a positive anti-HCV (p = 0.04 and 0.01 respectively). Anti-HCV was detected in 5% of adult patients with Sickle cell anaemia, especially in patients with persistent splenomegaly alone or in combination with hepatomegaly. Blood transfusion did not appear to be the major route of HCV transmission.

Obscure gastrointestinal bleeding: an approach to management.

Obscure gastrointestinal bleeding provides an uncommon but frustrating and resource-intensive challenge for clinicians. Such patients hemorrhage recurrently from sites within the gastrointestinal tract that are not detected by routine endoscopy or radiography, and require a special diagnostic approach to localize or exclude less common bleeding sources such as small bowel angioectasia or neoplasia. The differential diagnosis of obscure gastrointestinal hemorrhage is discussed, and the performance of available endoscopic, radiological and surgical diagnostic tools including enteroscopy are examined critically. A stepwise management algorithm that progresses from the history and physical examination to surgical exploration is offered to facilitate early and efficient diagnosis.