Evaluation of an alternative informed consent procedure for clinical trials conducted in The Gambia

Background: Comprehension of informed consent poses greater challenges to clinical trial participants in The Gambia because of low literacy and absence of standardised formats for writing the local languages. This thesis reports the development and evaluation of a locally developed informed consent tool that addresses these challenges. Objectives: 1. Develop and validate an audio digitised tool for assessment of comprehension of informed consent. 2. Develop a multimedia consent tool for Gambian research participants. 3. Evaluate acceptability and ease of use of the multimedia tool. 4. Assess the effectiveness of the multimedia tool compared to ‘standard’ consent among participants in a clinical trial. Methods: A 34-item questionnaire was developed and audio-recorded in three major Gambian languages. This was digitised and validated among clinical trial participants in Gambian urban and rural areas. The informed consent document of a malaria drug trial was developed into a multimedia tool which integrated video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the tool were assessed using quantitative and qualitative methods. Participants in the drug trial were randomised to either receive consent information through the multimedia tool or ‘standard’ procedure. Participant comprehension was assessed using the digitised questionnaire at baseline and follow-up visits. Results: The questionnaire was deemed to be valid and reliable (Cronbach’s alpha: 0.73- 0.79). Majority of the participants (70%) reported that the multimedia tool was clear and easy to understand. Participants in the intervention arm had significantly higher comprehension scores than those in the control arm at baseline and follow-up visits. Higher comprehension scores were associated with being a male participant (p=0.03), resident in a peri-urban area (p=0.02) and having basic formal education (p=0.005). Male participants (OR = 0.29, 95% CI: 0.12-0.70, p=0.006) and living in a peri-urban area (OR= 0.33, 95% CI: 0.13-0.82, p=0.017) were independent predictors of comprehension. Survival analysis showed that participants in the intervention arm took longer time to drop to 50% of the baseline comprehension scores than those in the control arm (hazard ratio=0.22, 95% CI: 0.16-0.31). Conclusions: A customised multimedia tool was more effective in delivering consent information and sustaining participant comprehension than ‘standard’ consent procedure. Further research is needed to compare the tool with conventional consent method in other sub-Saharan Africa settings

Roles of family dynamics on adherence to highly active antiretroviral therapy among people living with HIV/AIDS at a tertiary hospital in Osogbo, south-west Nigeria

Background: Adherence to highly active antiretroviral therapy (HAART) has been proven to be the only effective treatment for HIV/AIDS worldwide. Good adherence to HAART might require good family support.Objective: To determine the family dynamics and social support of people living with HIV/AIDS (PLWHA) and its roles on HAART adherence at an ARV treatment clinic in Osogbo, NigeriaMethod: Descriptive cross-sectional study. Consenting PLWHA on HAART were interviewed using pre-tested semistructured questionnaire incorporating Perceived Social Support- Family Scale and Family APGAR. HAART adherence was measured using patient self report.Results: A total of 379 PLWHA were interviewed. Their mean age was 40.8 (SD=9.9) years. Most (60.7%) were females. More than half (55.7%) were currently married and the majority (72.1%) had secondary education and were Yoruba (86.3%). Most respondents (95.5%) were adherent to HAART. Over 90% were satisfied with support received from their family while 82.3% were treated like other family members. Most attributed their HAART adherence to the care and support received from their family.Conclusion: Most PLWHA had good social support and were adherent to HAART.Keywords: Family dynamics; HAART adherence; NigeriaAfrican Health Sciences 2013; 13(4): 920 - 92

Prevalence of Chronic Kidney Disease in a Nigerian Family Practice Population

Background: Chronic kidney disease (CKD) is a global public health problem, with a greater burden and prohibitive cost of care particularly indeveloping countries. This study determined the prevalence of chronic kidney disease and identified its associated risk factors in patients attending the Family Practice Clinic, Wesley Guild Hospital, Ilesa, Nigeria.Method: Consecutive newly-registered patients who attended the Family Practice Clinic of Wesley Guild Hospital, Ilesa from August 2005 to January2006 were recruited and studied. Relevant data were collected by using an interviewer-administered questionnaire, and determining the spot urinaryACR (albumin-creatinine ratio) of the subjects by using Microalbustix™ reagent strips and using their serum creatinine concentration. The glomerular filtration rate (GFR) of each subject was estimated using the Modification of Diet in Renal Disease (MDRD) formula. A repeat urine test was done three months after the initial screening to identify subjects with persistent microalbuminuria.Results: The age of the study subjects ranged from 20 to 74 years, with a mean age of 50.52 + 13.03 years. There were 68 males and 182 females in the sample population, showing a male to female ratio of 1:2.7. One hundred and thirteen of the 250 subjects (45.2%) were found to have pathologic albuminuria at the initial screening, while 31 (12.4%) had persistent albuminuria three months later. Also, 51 subjects (20.4%) had estimated low GFR at the initial screening and 26 (10.4%) had persistent low GFR three months later. Significant risk factors for CKD in the study subjects were increasing age, elevated blood pressure, history of diabetes mellitus (DM), habitual intake of analgesics and herbs, and an abnormal waist to hip ratio (p < 0.05). The association between persistent abnormal ACR and low GFR did not reach statistical significance (p = 0.053). Habitual analgesic intake (p = 0.002) and age group (p = 0.0027) were true predictors of CKD among the study subjects.Conclusions: The prevalence of CKD in the study population was high and its association with modifiable risk factors was demonstrated. Familyphysicians have a unique opportunity to identify and address these factors in their patients. Routine screening for CKD in family practice clinics isindicated to reduce the burden of renal disease in the population

Survey of drug use among young people in Ife, Nigeria

The objectives of this study were to identify various drugs used by adolescents, the prevalence of such practices and the factors that influence in-school adolescents to use drugs. The study was conducted in the four local government areas of Ile-Ife, South-Western Nigeria, with a totalof 800 senior secondary school students. Permission for the survey and consent were obtained from appropriate school authorities. Relevant data were obtained using a modified version of a questionnaire designed by the United Nations for conducting school surveys on drug abuse. The toolkit had been previously validated in Nigeria. The questionnaire items solicited information on students’ drug use practices including the types of drugs, sources, frequency of administration and reasons for drug use. Students most widely used caffeine (19.8%), alcohol (5.6%), cigarette (6.3%) and occasionally marijuana (0.4%) as psychoactive substances. The substances were obtained from open drug market (23.5%), peers (5.2%) and village drug hawkers (0.6%). Reasons for drug use included; to keep awake (22.2%) to experience high feelings (21.8%), for body building (14.1%) and to moderate appetite (11.9%). The drugs were used mostly anytime and mainly by oral route of administration. There was a high frequency of psychotropic drug use among the students with caffeine being the most widely used. Drug use by the youths could be attributed to psychosocial perceptions of self need and peer influence.Key Words: Drug use, psychoactive substance abuse, secondary schools, adolescent

Clinico-pathological pattern of nasopharyngeal carcinoma in Ilorin, Nigeria

Nasopharyngeal carcinoma is an uncommon tumour in Nigeria but the burden of the disease in terms of morbidity and mortality is very high.The aim of the study was to document the clinic-pathological characteristics of nasopharyngeal carcinoma in Ilorin, North central Nigeria.This was a retrospective review of all patients seen in ENT department, University of Ilorin Teaching Hospital with the diagnosis of nasopharyngeal carcinoma between January 1st 1999 and December 31st,2008. The patient's biodata, clinical presentation and histopathological findings are presented. The histopathological diagnosis was in accordance with the 1991WHOclassification. A total of 30 patients with histologically confirmed nasopharyngeal carcinoma seen during the study period accounted for 2% of the total cancers recorded in Ilorin cancer registry. There were 20 males and 10 females with a mean age of 48.7 ± 15.9 years. The commonest presenting complaint was cervical lymphadenopathy in 96.7% of patients followed by epistaxis (66.7%) and hearing loss (66.7%). Identifiable riskfactors included regular intake of ungutted salted smoked fish (76.7%) and tobacco use (23.3%) with some having both risk factors. Histologically, undifferentiated carcinoma was the commonest (70%) followed by welldifferentiated keratinizing squamous cell carcinoma (20%) and differentiated nonkeratinizing squamous cell carcinoma (10%).Undifferentiated carcinoma was the commonest type of nasopharyngeal carcinoma reported from this study especially among males in the 4th and 5th decades of life. Identifiable risk factors included consumption of ungutted salted smoked fish with tobaccon usage. Early diagnosis with effective referral system and easy access to radiotherapy would improve the survival outcome in patients with the disease

Pattern of depression among patients in a Nigerian family practice population

Background: This study determines the pattern of depression among patients attending the Family Practice Clinic at Wesley Guild Hospital, Ilesa, Nigeria. Socio-demographic and clinical correlates associated with depression were identified. Methods: Two hundred and fifty (250) newly registered patients who attended the clinic between June and September 2005 were selected by the systematic random sampling method and studied. Relevant data were collected using a pre-tested interviewer- administered questionnaire that incorporated Zung\'s Depression Scale. Results: The age of the study subjects ranged from 16 to 84 years, with a mean age of 49.66 + 14.95 years. One hundred and forty-nine of the 250 subjects (59.6%) were found to have one form of depression or the other. Of these, one hundred and seven (42.8%) had mild depression, forty (16.0%) had moderate depression and only two (0.8%) had severe depression. Depression was found to be commoner in the age groups from 45 years and above, and there was a significant association between age and depression. There were 74 males and 176 females in the sample population, showing a male to female ratio of 1:2.4. Out of 149 depressed subjects, one hundred and four females (69.8%) had depression, while depression was present in 45 males (30.2%). Forty-seven (87.0%) of 54 subjects with no formal education had depression, while depression was found in 102 (52.0%) of the 196 educated subjects. Low educational status was significantly associated with depression in this study. Only two (0.8%) of the 250 subjects gave a positive family history of psychiatric illness, and these two subjects had mild to moderate depression. The proportion of depressed subjects who lived below the poverty level was significantly greater than that of non-depressed subjects. Substance use was also significantly more common among depressed subjects than the non-depressed group. Conclusion: The proportion of patients with depressive symptoms in family practice clinics is high, and it is highly correlated with socio-demographic factors and low socioeconomic status. Family physicians are hereby enjoined to pay greater attention to patients with these factors, as they are at increased risk of depression. In order to reduce the high proportion of depressive symptoms and its adverse impacts on patients seen in family practice clinics and in the community as a whole, there is a need for effective implementation of poverty-alleviation programmes and universal basic education. South African Family Practice Vol. 50 (2) 2008: pp. 63-63

Comparison of start back screening tool and simmonds physical performance based tests battery in prediction of disability risks among patients with chronic low-back pain

Objectives: This study identified disability sub-groups of patients with chronic low back pain (LBP) using the Subgroup for Targeted Treatment (or STarT) Back Screening Tool (SBST) and Simmonds Physical Performance Tests Battery (SPPTB). In addition, the study investigated the divergent validity of SBST, and compared the predictive validity of SBST and SPPTB among the patients with the aim to enhance quick and accurate prediction of disability risks among patients with chronic LBP. Methods: This exploratory cross-sectional study involved 70 (52.0% female and 47.1% male) consenting patients with chronic non-specific LBP attending out-patient physiotherapy and Orthopedic Clinics at the Obafemi Awolowo University Teaching Hospitals, Ile-Ife and Ladoke Akintola University of Technology Teaching Hospital, Osogbo, Nigeria. Disability risk subgrouping and prediction was carried out using the SBST and SPPTB (comprising six functional tasks of repeated trunk flexion, sit-to-stand, 360-degree rollover, Sorenson fatigue test, unloaded reach test, and 50 foot walk test). Pain intensity was assessed using the Quadruple Visual Analogue Scale. Data on age, sex, height, weight and BMI were also collected. Descriptive and inferential statistics were used to analyze data at p<0.05 Alpha level. Results: The mean age, weight, height and body mass index of the participants were 51.4±8.78 years, 1.61±0.76 m and 26.6±3.18 kg/m2 respectively. The mean pain intensity and duration were 5.37±1.37 and 21.2±6.68 respectively. The divergent validity of SBST with percentage overall pain intensity was r = 0.732; p = 0.001. Under SBST sub-grouping the majority of participants were rated as having medium disability risk (76%), whilst SPPTB sub-grouped the majority as having high disability risk (71.4%). There was a significant difference in disability risk subgrouping between SBST and SPPTB (χ²=12.334; p=0.015). SBST had no floor and ceiling effects, as less than 15% of the participants reached the lowest (2.9%) or highest (1.4%) possible score. Conversely, SPPBT showed both floor and ceiling effects, as it was unable to detect ‘1’ and ‘9’, the lowest and highest obtainable scores. The ‘Area Under Curve’ for sensitivity (0.83) and specificity (0.23) of the SBST to predict ‘high-disability risk’ was 0.51. The estimated prevalence for ‘high-disability risk’ prediction of SBST was 0.76. The estimate for true positive, false positive, true negative and false negative for prediction of ‘high-disability risk’ for SBST were 0.77, 0.23, 0.31, and 0.69 respectively

Kidney function of HIV-infected children in Lagos, Nigeria: using Filler's serum cystatin C-based formula

<p>Abstract</p> <p>Background</p> <p>Limited data is available on kidney function in HIV-infected children in sub-Saharan Africa. In addition, malnutrition in these children further reduces the utility of diagnostic methods such as creatinine-based estimates of glomerular filtration rate. We determined the serum cystatin C level and estimated glomerular filtration rate of 60 antiretroviral-naïve, HIV-infected children and 60 apparently healthy age and sex matched children.</p> <p>Methods</p> <p>Serum cystatin C level was measured using enzyme-linked immunosorbent assay technique, while glomerular filtration rate was estimated using Filler's serum cystatin C formula. Student t test, Mann Whitney U test, Pearson chi square and Fisher's exact test were used, where appropriate, to test difference between groups.</p> <p>Results</p> <p>Compared to the controls, the HIV-infected group had significantly higher median (interquartile range) serum cystatin C levels {0.77 (0.29) mg/l versus 0.66 (0.20) mg/l; p = 0.025} and a higher proportion of children with serum cystatin C level >1 mg/l {10 (16.7%) versus one (1.7%); p = 0.004}. The HIV-infected children had a mean (± SD) eGFR of 96.8 (± 36.1) ml/min/1.73 m²compared with 110.5 (± 27.8) ml/min/1.73 m²in the controls (p = 0.021). After controlling for age, sex and body mass index, only the study group (HIV infected versus control) remained a significant predictor of serum cystatin C level (β = -0.216, p = 0.021). The proportion of HIV-infected children with eGFR <60 ml/min/1.73 m²was eight (13.3%) versus none (0%) in the control group (p = 0.006). However, the serum cystatin C level, eGFR and proportions of children with serum cystatin C level >1 mg/l and eGFR <60 ml/min/1.73 m²were not significantly different between the HIV-infected children with advanced disease and those with milder disease.</p> <p>Conclusions</p> <p>HIV-infected children in Nigeria have higher serum cystatin C level and lower eGFR compared to age and sex matched controls.</p