Informed consent comprehension in African research settings.

OBJECTIVE: Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. METHODS: We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. RESULTS: Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. CONCLUSIONS: Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure.

Malariometric Indices among Nigerian Children in a Rural Setting.

Malaria contributes to high childhood morbidity and mortality in Nigeria. To determine its endemicity in a rural farming community in the south-south of Nigeria, the following malariometric indices, namely, malaria parasitaemia, spleen rates, and anaemia were evaluated in children aged 2-10 years. This was a descriptive cross-sectional survey among school-age children residing in a rubber plantation settlement. The children were selected from six primary schools using a multistaged stratified cluster sampling technique. They were all examined for pallor, enlarged spleen, or liver among other clinical parameters and had blood films for malaria parasites. Of the 461 children recruited, 329 (71.4%) had malaria parasites. The prevalence of malaria parasitaemia was slightly higher in the under fives than that of those ≥5 years, 76.2% and 70.3%, respectively. Splenic enlargement was present in 133 children (28.9%). The overall prevalence of anaemia was 35.7%. Anaemia was more common in the under-fives (48.8%) than in those ≥5 years (32.8%). The odds of anaemia in the under fives were significantly higher than the odds of those ≥5 years (OR = 1.95 [1.19-3.18]). Malaria is highly endemic in this farming community and calls for intensification of control interventions in the area with special attention to school-age children.

Oral iron supplements for children in malaria-endemic areas.

BACKGROUND: Iron-deficiency anaemia is common during childhood. Iron supplementation has been claimed to increase the risk of malaria. OBJECTIVES: To assess the effect of iron on malaria and deaths. SEARCH STRATEGY: We searched The Cochrane Library, PUBMED, MEDLINE, LILACS; and trial registry databases, all up to June 2011. We scanned references of included trials. SELECTION CRITERIA: Individually and cluster randomized controlled trials conducted in hypoendemic to holoendemic malaria regions and including children below 18 years of age. We included trials comparing orally administered iron, iron with antimalarial treatment, or iron with folic acid versus placebo or no treatment. Iron fortification was excluded. Antihelminthics could be administered to either group. Additional micronutrients had to be administered equally to both groups. DATA COLLECTION AND ANALYSIS: The primary outcomes were clinical (symptomatic) malaria, severe malaria, and death. Two authors independently selected the studies and extracted the data. We assessed heterogeneity and conducted subgroup analyses by the presence of anaemia at baseline, age, and malaria endemicity. We assessed risk of bias using domain-based evaluation. We performed a fixed-effect meta-analysis for all outcomes and random-effects meta-analysis for hematological outcomes. We adjusted analyses for cluster randomized trials. MAIN RESULTS: Seventy-one trials (45,353 children) were included. For clinical malaria, no significant difference between iron alone and placebo was detected, (risk ratio (RR) 0.99, 95% confidence intervals (CI) 0.90 to 1.09, 13 trials). The results were similar in the subgroups of non-anaemic children and children below 2 years of age. There was no significant difference in deaths in hyper- and holoendemic areas, risk difference +1.93 per 1000 children (95% CI -1.78 to 5.64, 13 trials, 17,898 children). Iron administered for treatment of anaemia resulted in a larger increase in haemoglobin than iron given for prevention, and the benefit was similar in hyper- or holoendemic and lower endemicity settings. Iron and folic acid supplementation resulted in mixed results for severe malaria. Overall, the risk for clinical malaria was higher with iron or with iron plus folic acid in trials where services did not provide for malaria surveillance and treatment. Iron with antimalarial treatment significantly reduced malaria. Iron supplementation during an acute attack of malaria did not increase the risk for parasitological failure, (RR 0.96, 95% CI 0.74 to 1.24, three trials) or deaths. AUTHORS' CONCLUSIONS: Iron alone or with antimalaria treatment does not increase the risk of clinical malaria or death when regular malaria surveillance and treatment services are provided. There is no need to screen for anaemia prior to iron supplementation.

Therapeutic interventions for Burkitt lymphoma in children.

BACKGROUND: Burkitt lymphoma (BL) is an important cancer found mostly in children but uncertainty remains as to the most effective form of management. In endemic areas, late-stage presentation as a result of delayed access to treatment compounds the situation. OBJECTIVES: To assess the evidence for chemotherapy, surgery, radiotherapy and immunotherapy in the treatment of children with endemic BL. SEARCH STRATEGY: We updated and re-ran the searches in the following electronic databases from the time of the first publication; the Cochrane Controlled Trials Register (CENTRAL) (Issue 1, 2011); MEDLINE (January 2011); EMBASE (January 2011); and the clinical trials registry (up to January 2011) to identify relevant trials. In addition, we also updated the search of the US clinical trials register for on-going and completed trials up to January 2011. We also updated the search terms and used the Cochrane filter for identifying randomised trials in MEDLINE. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of any duration. We included studies conducted in children with a confirmed diagnosis of BL. We did not restrict studies by geographical location or by language of publication. We considered any therapeutic intervention. The primary outcome was overall survival. DATA COLLECTION AND ANALYSIS: Two review authors assessed studies for relevance. We assessed studies that met the entry criteria for study quality. We independently extracted data and entered the data into Review Manager (RevMan). In this update, two review authors independently assessed citations from the updated search and reviewed abstracts for relevance. MAIN RESULTS: We included one new study in this update. In total, 13 trials involving 1824 participants met the inclusion criteria for this review however, data in usable format were only available in 10 trials (732 participants). Inadequate reporting of study methodology was a common feature of the trials preventing thorough assessment of study quality. We were unable to pool data for any of the outcomes due to the differences between the interventions assessed in the studies. Eight studies aimed to induce remission; overall survival did not differ significantly between treatment groups. Five studies aimed to maintain remission. In two out of three studies reporting survival, this was substantial but the difference was not statistically significant between treatment groups. Less aggressive treatment schedules appear to produce similar effects with less adverse event profiles. AUTHORS' CONCLUSIONS: This review notes a preference in more recent studies for less aggressive care options for treatment of BL. However, the evidence for the relative effectiveness of interventions to treat BL is not strong as studies were small, underpowered and prone to both systematic and random error. We included one additional trial without change of conclusions.

Prescribing practice for malaria following introduction of artemether-lumefantrine in an urban area with declining endemicity in West Africa.

BACKGROUND: The decline in malaria coinciding with the introduction of newer, costly anti-malarials has prompted studies into the overtreatment for malaria mostly in East Africa. The study presented here describes prescribing practices for malaria at health facilities in a West African country. METHODS: Cross-sectional surveys were carried out in two urban Gambian primary health facilities (PHFs) during and outside the malaria transmission season. Facilities were comparable in terms of the staffing compliment and capability to perform slide microscopy. Patients treated for malaria were enrolled after consultations and blood smears collected and read at a reference laboratory. Slide reading results from the PHFs were compared to the reference readings and the proportion of cases treated but with a negative test result at the reference laboratory was determined. RESULTS: Slide requests were made for 33.2% (173) of those enrolled, being more frequent in children (0-15 yrs) than adults during the wet season (p = 0.003). In the same period, requests were commoner in under-fives compared to older children (p = 0.022); however, a positive test result was 4.4 times more likely in the latter group (p = 0.010). Parasitaemia was confirmed for only 4.7% (10/215) and 12.5% (37/297) of patients in the dry and wet seasons, respectively. The negative predictive value of a PHF slide remained above 97% in both seasons. CONCLUSIONS: The study provides evidence for considerable overtreatment for malaria in a West African setting comparable to reports from areas with similar low malaria transmission in East Africa. The data suggest that laboratory facilities may be under-used, and that adherence to negative PHF slide results could significantly reduce the degree of overtreatment. The "peak prevalence" in 5-15 year olds may reflect successful implementation of malaria control interventions in under-fives, but point out the need to extend such interventions to older children.

Oral iron supplementation for preventing or treating anaemia among children in malaria-endemic areas.

BACKGROUND: Iron-deficiency anaemia is common during childhood. Iron supplementation has been claimed to increase the risk of malaria. OBJECTIVES: To assess the effect of iron on malaria and deaths. SEARCH STRATEGY: We searched The Cochrane Library (2009, issue 1); MEDLINE; EMBASE; LILACS and metaRegister of Controlled Trials, all up to March 2009. We scanned references of included trials. SELECTION CRITERIA: Individually and cluster-randomized controlled trials conducted in hypoendemic to holoendemic malaria regions and including children < 18 years. We included trials comparing orally administered iron with or without folic acid vs. placebo or no treatment. Iron fortification was excluded. Antimalarials and/or antiparasitics could be administered to either group. Additional micronutrients could only be administered equally to both groups. DATA COLLECTION AND ANALYSIS: The primary outcomes were malaria-related events and deaths. Secondary outcomes included haemoglobin, anaemia, other infections, growth, hospitalizations, and clinic visits. We assessed risk of bias using domain-based evaluation. Two authors independently selected studies and extracted data. We contacted authors for missing data. We assessed heterogeneity. We performed fixed-effect meta-analysis and presented random-effects results when heterogeneity was present. We present pooled risk ratios (RR) with 95% confidence intervals (CIs). We used adjusted analyses for cluster-randomized trials. MAIN RESULTS: Sixty-eight trials (42,981 children) fulfilled the inclusion criteria. Iron supplementation did not increase the risk of clinical malaria (RR 1.00, 95% CI 0.88 to 1.13; 22,724 children, 14 trials, random-effects model). The risk was similar among children who were non-anaemic at baseline (RR 0.96, 95% CI 0.85 to 1.09). An increased risk of malaria with iron was observed in trials that did not provide malaria surveillance and treatment. The risk of malaria parasitaemia was higher with iron (RR 1.13, 95% CI 1.01 to 1.26), but there was no difference in adequately concealed trials. Iron + antimalarial was protective for malaria (four trials). Iron did not increase the risk of parasitological failure when given during malaria (three trials). There was no increased risk of death across all trials comparing iron versus placebo (RR 1.11, 95% CI 0.91 to 1.36; 21,272 children, 12 trials). Iron supplementation increased haemoglobin, with significant heterogeneity, and malaria endemicity did not affect this effect. Growth and other infections were mostly not affected by iron supplementation. AUTHORS' CONCLUSIONS: Iron does not increase the risk of clinical malaria or death, when regular malaria surveillance and treatment services are provided. There is no need to screen for anaemia prior to iron supplementation.

Antimotility agents for chronic diarrhoea in people with HIV/AIDS.

BACKGROUND: AIDS-related diarrhoea is a common cause of morbidity and mortality in HIV positive individuals, especially in the sub-Saharan Africa where 70% of deaths from HIV occur. It often compromises quality of life both in those receiving antiretroviral therapy (ART) and the ART naive. Empirical antidiarrhoeal treatment may be required in about 50% of cases which are non-pathogenic or idiopathic and in cases resulting from antiretroviral therapy. Antimotility agents (Loperamide, Diphenoxylate, Codeine) and adsorbents (Bismuth Subsalicylate, Kaolin/Pectin, Attapulgite) are readily available, and have been found to be useful in this condition and so, are often used. Antimotilitics are opioids, decreasing stool output by reducing bowel activity thereby increasing fecal transit time in the gut, promoting fluid and electrolyte retention while adsorbents act by binding to fluids, toxins and other substances to improve stool consistency and eliminate the toxins. Due to its potential impact on the management of chronic diarrhoea in persons with HIV/AIDS, we reviewed the effectiveness of antimotility agents in controlling chronic diarrhoea in immunocompromised states caused by HIV/AIDS. OBJECTIVES: To assess the effectiveness of antimotility agents in controlling chronic diarrhoea in people with HIV/AIDS. SEARCH STRATEGY: We searched Medline, EMBASE, the Cochrane Controlled Trials Register, the Cochrane HIV/AIDS Register and AIDSearch databases in November 2006. We also contacted WHO, CDC, pharmaceutical companies and experts in the field for information on previous or on-going trials and checked reference list from retrieved studies, irrespective of language and publication status. SELECTION CRITERIA: Randomised controlled trials comparing an antimotility agent or an adsorbent with another antimotility agent, placebo, an adsorbent or no treatment in children and adults diagnosed with HIV and presenting with diarrhoea of three or more weeks duration. DATA COLLECTION AND ANALYSIS: Two authors independently undertook study selection and examined full articles of potentially eligible studies. MAIN RESULTS: One trial was found assessing the use of an adsorbent (attapulgite) compared to a placebo for chronic diarrhoea in people with HIV/AIDS. It included 91 adults (Aged 18 to 60), diagnosed with AIDS and experiencing diarrhoea for at least 7 days. There was no evidence that attapulgite is superior to placebo in controlling diarrhoea by reducing stool frequency and normalising stool consistency on days 1 (0.34 (95% CI 0.01 - 8.15)), 3 (1.35 (95% CI 0.51 - 3.62)) and 5 (1.74 (95% CI 0.89 - 3.38)). This was a small trial and may not have had enough power to show evidence of effects. Five deaths were reported which was not classified according to the arms of the study.Studies assessing the use of antimotility agents were not found. AUTHORS' CONCLUSIONS: This review highlights the absence of evidence for the use of antimotility agents and adsorbents in controlling diarrhoea in people with HIV/AIDS. While no trials assessing the use of Antimotilitics were found, the retrieved study showed that attapulgite was not better than placebo in controlling diarrhoea in HIV/AIDS patients . For optimum patient care, these agents can still be used, with greater emphasis placed on adjunct therapies like massive fluid replacement while evidence for practice is awaited from further studies and reviews.

Bacterial isolates from blood cultures of children with suspected septicaemia in Calabar, Nigeria.

BACKGROUND: Septicaemia is a common cause of morbidity and mortality among children in the developing world. This pattern has changed little in the past decade. Physical signs and symptoms, though useful in identifying possible cases have limited specificity. Definitive diagnosis is by bacteriologic culture of blood samples to identify organisms and establish antibiotic susceptibility. These results are usually not available promptly. Therefore a knowledge of epidemiologic and antimicribial susceptibility pattern of common pathogens is useful for prompt treatment of patients. This report highlights the pattern of bacterial isolates in our environment from a retrospective study of our patients' records. METHODS: One thousand, two hundred and one blood samples were analysed from children aged 0-15 years, admitted into the children's wards of the University of Calabar Teaching Hospital, Calabar, Nigeria with features suggesting septicaemia. Samples were collected under aseptic conditions and cultured for aerobic and anaerobic organisms. Isolates were identified using bacteriologic and biochemical methods and antibiotic sensitivity determined by agar diffusion method using standard antibiotic discs. RESULTS: Bacteria was isolated in 552 (48.9%) of samples with highest rates among newborns (271 : 50.8). The most frequent isolates were Staphylococcal aureus (48.7%) and Coliforms (23.4%). Results showed high susceptibilities to the Cephalosporins (Ceftriazone- 100%:83.2%, Cefuroxime-100%:76.5%) and Macrolides (Azithromycin-100%:92.9%) for S. aureus and coliforms respectively. This study underscores the importance of septicaemia as a common cause of febrile illness in children and provides information on common prevalent aetiologic agents and drug susceptibilities of the commonest pathogens. CONCLUSION: Staphylococcus aureus and coliforms were the leading causes of septicaemia in children in this locality, and the third generation cephalosporins and azithromycin were shown to be effective against these pathogens.