Informed consent comprehension in African research settings

ObjectivePrevious 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.MethodsWe 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.ResultsComprehension 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.ConclusionsComprehension 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.ObjectifLes normes éthiques élaborées selon les valeurs occidentales ne sont peut-être pas appropriées au contexte africain où les concepts de recherche ne sont pas familiers. Cette revue décrit comment la compréhension du consentement éclairé est définie et mesurée dans les cadres de recherche africains.MéthodesDes recherches ont été effectuées sur Medline, Embase, Global Health, EthxWeb, base de données de la Bioéthique Littérature, Index Medicus African et Google Scholar pour des publications pertinentes sur la compréhension du consentement éclairé dans les études cliniques menées en Afrique sub-saharienne. 29 études répondaient aux critères d'inclusion; une méta-analyse a été possible pour 21 études. La compréhension des participants sur les domaines du consentement éclairé dans toutes les études admissibles a été comparée directement.RésultatsLa compréhension des concepts clés du consentement éclairé varie considérablement selon les pays et dépend de la nature et de la complexité de l’étude. La méta-analyse a montré que 47% des participants ont compris la randomisation (IC95%: 13,9 - 80,9%), 48% ont compris le placebo (IC95%: 19,0 - 77,5%), 30% ont compris le concept de méprise thérapeutique (IC95%: 4,6 - 66,7%). Les outils de mesure de la compréhension du consentement éclairé étaient développés avec peu ou pas de validation.ConclusionsLa compréhension des concepts clés du consentement éclairé est faible en Afrique. Il y a une nécessité vitale d’élaborer une définition uniforme pour la compréhension du consentement éclairé dans les cadres de recherche avec un faible niveau d'alphabétisation en Afrique.ObjetivoLos estándares éticos desarrollados basándose en valores occidentales podrían no ser apropiados para emplazamientos Africanos en donde los conceptos de investigación no son familiares. En esta revisión se describe como la comprensión del consentimiento informado se define y mide en un centro de investigación Africano.MétodosSe buscaron publicaciones relevantes sobre la comprensión del consentimiento informado en estudios clínicos en África subsahariana en Medline, Embase, Global Health, EthxWeb, Bioethics Literature Database, African Index Medicus y Google Scholar. 29 estudios satisfacían los criterios de inclusión y el metaanálisis era posible para 21. La comprensión del consentimiento informado por parte de los participantes se comparó directamente en todos los estudios elegibles.ResultadosLa comprensión de conceptos claves del consentimiento informado varió de forma considerable entre países, y dependía de la naturaleza y de la complejidad del estudio. El meta-análisis mostró que un 47% entendía la aleatorización (IC 95% 13.9-80.9%); un 48% entendía el placebo (IC 95% 19.0-77.5%); y un 30% entendió el concepto terapéutico errado (IC 95% 4.6-66.7%). Las herramientas para medir la comprensión del consentimiento informado se desarrollaron con poca o ninguna validación.ConclusionesEn África, la comprensión de conceptos claves del consentimiento informado es pobre. Existe una necesidad vital de desarrollar una definición uniforme para la comprensión del consentimiento informado en lugares con bajos niveles de alfabetización en África

Arylsulfatase - producing bacteria in marine sediments

A total of 313 strains of bacteria which hydrolysed tripotassium phenolphthalein disulfate (PDS) were isolated from the sediments of three biotopes, namely, Vellar estuary, backwater and mangrove during the period of investigation. They were identified to the generic level. The following genera were encountered, namely, Vibrio, Bacillus, Alcaligenes, Micrococcus, Pseudomonas, Cytophaga-Flavobacterium, Aeromonas, Corynebacterium and members of Enterobacteriaceae. Vibrio and Bacillus were found to be the dominant groups representing 29.26% and 41.80% respectively of the total isolates. Because of the importance of the Vibrio group in marine environment these isolates were further identified to the species level and it included V. parahaemolyticus, V. alginolyticus, V. consticola, V. anguillarum and V. fischeri. These observations suggest that different groups of arylsulfatase – producing bacteria probably occur in marine sediments

Cultural conditions of arylsulfatase activity in Escherichia coli

Arylsulfatase activity and growth were estimated in Escherichia coli, isolated from marine sediment. Maximum activity was observed at pH 6.6 whereas the maximum growth was at pH 5.6. 2x10ˉ³ M is the optimum substrate concentration for the highest level of enzyme activity/synthesis as well as for its growth. In general higher substrate concentration tended to inhibit enzyme activity and also the growth of the bacterium. Maximum growth and highest enzyme activity occurred at 29°C and above this temperature decreased both of them. Besides these, glucose, sodium sulfate, sodium chloride, sodium dihydrogen phosphate, sodium acetate and ammonium chloride at higher concentrations were inhibiting the enzyme activity and growth. Above 0.2% of glucose, 3% of sodium chloride, 10x10ˉ³ M concentrations of sodium sulfate, sodium dihydrogen phosphate, sodium acetate and ammonium chloride inhibited the activity and growth also. These observations indicate that, to generalize a compound as inhibitor or activator it is difficult since this depends not only on its concentration but also on the source of the enzyme when more than one type is encountered in nature

The Pathological Roles of Ganglioside Metabolism in Alzheimer's Disease: Effects of Gangliosides on Neurogenesis

Conversion of the soluble, nontoxic amyloid β-protein (Aβ) into an aggregated, toxic form rich in β-sheets is a key step in the onset of Alzheimer's disease (AD). It has been suggested that Aβ induces changes in neuronal membrane fluidity as a result of its interactions with membrane components such as cholesterol, phospholipids, and gangliosides. Gangliosides are known to bind Aβ. A complex of GM1 and Aβ, termed “GAβ”, has been identified in AD brains. Abnormal ganglioside metabolism also may occur in AD brains. We have reported an increase of Chol-1α antigens, GQ1bα and GT1aα, in the brain of transgenic mouse AD model. GQ1bα and GT1aα exhibit high affinities to Aβs. The presence of Chol-1α gangliosides represents evidence for genesis of cholinergic neurons in AD brains. We evaluated the effects of GM1 and Aβ1–40 on mouse neuroepithelial cells. Treatment of these cells simultaneously with GM1 and Aβ1–40 caused a significant reduction of cell number, suggesting that Aβ1–40 and GM1 cooperatively exert a cytotoxic effect on neuroepithelial cells. An understanding of the mechanism on the interaction of GM1 and Aβs in AD may contribute to the development of new neuroregenerative therapies for this disorder

Effectiveness on Nodovenous shunts in filarial lymphedema of lower limbs: An Evaluation

INTRODUCTION: Filariasis is a name given for a group of diseases caused by nematodes belonging to the family Filaridae which are transmitted by haemophagus mosquito Culex fatigans. In India the causative organism are Wucheria Bancrofti and Brugia Malayi. About 250 million people live in the endemic area and about 32 million people are affected by it. Among these 90% of infected people comprise asymptomatic carriers. The management of the disease, apart from chemotherapy and surgery includes preventive aspect of vector control through Vector Research and Control Centre and through National Filarial Control programme launched in 1955. BACKGROUND OF STUDY: Since Thanjavur is an endemic filarial area, filarial lymphedema of lower limbs is one of the commonest problem we see in our out patient Department. We conduct filarial clinic on all mondays and treat around 4000 patients every year. Antibiotic prophylaxis and Diethyl carbamazine were given to all patients once in 15 days. We perform annually an average of 75 Nodovenous shunts and 30 cases of reduction annually. All the patients are classified into four grades according to the history, size of the limbs and skin changes. MATERIALS AND METHOD: This study was conducted in Thanjavur medical college during the year 2005-2007. A total of 100 patients were takenup for study which includes 60 females and 40 males. All patients were screened for caries tooth, inguinal adenitis,hydrocele and skin changes in lower limbs. All patients were subjected to regular Antibiotic prophylaxis, Compression garments and physical therapy for affected limbs. All lymphedematous patients were classified to grades I – IV. All grade I and II patients were grouped according to the presence or absence of enlarged inguinal node. Node positive patients were grouped for study. Node negative patients were taken as control. OBSERVATION: General Characters of Study Group - 100 patients of various grades of lower limb filarial lymphedema were included in the study. Among these 60 were grade I & II and another 40 were grade III & IV. 30 patients of grade I & II with enlarged inguinal lymphnodes were taken up for nodovenous shunt in addition to routine non surgical methods were taken for study. Another 30 patients of grade I and II without enlarged inguinal nodes managed with non surgical methods were kept as control group. 20 patients of grade III & IV were taken up as study group and equal number of 20 patints were taken as control group randomly. RESULTS OF THE STUDY: MEASUREMENTS IN GRADE I & II - In grade I & II patients there was reduction in size and volume in both control and study group. In study group there was volume reduction in 17 patients, 6 patients showed increase in volume measurement, 7 patients showed no change in volume measurement. In control group there was volume reduction in 7 patients, 19 patients showed increase in volume measurement, 4 patients showed no change in volume measurement. CONCLUSION: The evaluation of results in control and study group shows volume reduction in the study group who underwent nodovenous shunt in addition to all other measures followed in control groups is very significant. Filarial lymphedema is a common surgical problem around Thanjavur. In order to decompress the overloaded lymphatic system , lymphonodovenous shunts and drainage procedures are performed. The primary pathology in filarial lymphedema being in lymph nodes ( regional inguinal ) and the stasis in distal level is more a secondary effect. By passing the lymph to the venous blood by nodovenous shunt which done without microscope and which has produced consistant reduction in all stages of filarial lymphedema , , Nodovenous seems to be most appropriate surgical procedure suited for the magnitude of the problem and resources available. The initial reduction in thigh circumference of in grade III and IV is good and the resultant skin laxity is utilized for the excisional procedures followed here

Immunohistochemical detection of 8-hydroxy deoxyguanosine (8-OHdG): A Biomarker of oxidative DNA damage in oral submucous fibrosis

BACKGROUND: Oral submucous fibrosis (OSMF) is one of the common potentially malignant disorder prevailing in India. The primary etiological factors include tobacco and are canut which contain numerous Reactive Oxygen Species (ROS). The imbalance between ROS and antioxidant status creates oxidative stress. Reactive oxygen species attack guanine bases in DNA and form 8-Hydroxy Deoxyguanosine (8-OHdG) which can be detected in patients who have diseases associated with oxidative stress. The oxidative DNA damage produced by oxidative stress may induce malignant transformation. The aim of the present study is to detect the expression of 8 -OHdG in OSMF and compare the expression within the different grades and normal oral mucosa. AIM OF THE STUDY: To study the Immunohistochemical expression of 8-OHdG in oral submucous fibrosis. MATERIALS AND METHODS: A total of 30 samples were examined for the immunohistochemical expression of 8-OHdG. The control group includes 10 formalin fixed paraffin embedded tissue blocks of normal buccal mucosa. The study group includes 20 cases of formalin fixed paraffin embedded tissue blocks of oral submucous fibrosis (5cases of very early, early, moderately advanced, advanced cases of OSMF). 3 micron thickness sections were made from each sample and stained with 8-OHdG antibody. The expression is scored and analysed statistically. The results were statistically analysed using Kruskal-Wallis and Mann - Whitney U test. RESULTS: Statistically significant difference exists in the intensity of 8-OHdG expression between the study groups. Increased intensity in the oral submucous fibrosis samples were observed when compared with normal mucosa. The p value obtained was less than 0.001 which was highly statistically significant. Staining intensity was also compared with different grades of OSMF, the p value obtained was less than 0.01 which was statistically significant. CONCLUSION: Our present study is the first attempt to evaluate the expression of 8-OHdG in tissue samples that revealed the role of free radicals and oxidative DNA damage which enhances the initiation and progression of Oral submucous fibrosis. Further research with a larger sample size, clinicopathologic correlation and long term followup will shed more light on the pathogenesis of Oral submucous fibrosis. It will also be useful for the development of new therapeutic stratergies targeting treatment modalities for the oral submucous fibrosis

Tuberculosis and metastatic carcinoma coexistence in axillary lymph node: A case report

BACKGROUND: Coexistence of cancer and tuberculosis in axillary lymph nodes is rare. Only seven cases have been reported in the literature. CASE REPORT: We report here a case of infiltrating ductal carcinoma breast metastasizing to the axillary lymph node along with tubercular granuloma in the same lymph node without primary mammary or pulmonary tuberculosis. CONCLUSION: Primary tuberculosis coexisting with carcinoma is of rare occurrence. A possibility should always be borne in mind especially in patients from endemic areas

A Study on Foreign Direct Investment on Special Reference towards FDI Developed Countries

Foreign direct investment (FDI) has been one of the defining characteristics of the world economy during the last two decades. Some developing economies have emerged as major recipients of FDI flows in recent years, while many others have attempted to attract such flows, often by offering fiscal and financial value to foreign investors. This work reviews and discusses recent empirical studies on key development issues related to FDI. The literature review focuses on five main areas of interest to host economies: the FDI-growth nexus; FDI-trade linkages; FDI and technology transfer; FDI, privatization and corporate governance; and host- government policies for attracting FDI. Three of the conclusions reached in this study deserve special attention. First, a vast majority of existing empirical studies indicate that FDI does make an appositive contribution to both income growth and factor productivity in host economies. FDI tends to “crowd in” domestic investment, as the creation of complementary activities outweighs the displacement of domestic competitors. Similarly, in the North-South context, the relationship between FDI and trade is more one of complementarily than of substitution, owing to backward and forward linkages. Second, host countries will not be able to capture the full benefits associated with FDI until they reach a certain threshold level regarding educational attainment, provision of infrastructure services, local technological capabilities and the development of local financial markets. Third, their role of FDI in development goes beyond the traditional areas of growth, trade and technology transfer to cover emerging areas of policy concern, such as mergers and acquisitions, privatization, corporate governance and “policy competition.” The study concludes by stressing that host-government policies should attach greater importance to the stability and redictability of the local business environment in which MNE affiliates operate