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

OPTIMIZATION OF SURFACE ROUGHNESS OF AISI 304 AUSTENITIC STAINLESS STEEL IN DRY TURNING OPERATION USING TAGUCHI DESIGN METHOD

The present work is concentrated with the dry turning of AISI 304 Austenitic Stainless Steel (ASS). This paper presents the influence of cutting parameters like cutting speed, feed rate and depth of cut on the surface roughness of austenitic stainless steel during dry turning. A plan of experiments based on Taguchi’s technique has been used to acquire the data. An orthogonal array, the signal to noise (S/N) ratio and the analysis of variance (ANOVA) are employed to investigate the cutting characteristics of AISI 304 austenitic stainless steel bars using TiC and TiCN coated tungsten carbide cutting tool. Finally the confirmation tests that have been carried out to compare the predicted values with the experimental values confirm its effectiveness in the analysis of surface roughness

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

A Prospective study about complications of Laparoscopic Surgeries

INRODUCTION: Laparoscopic surgery also called minimally invasive surgery, minimal access surgery, band aid surgery or key hole surgery is a modern surgical technique in which operations in the abdomen performed through small incision (usually 0.5 — 1.5cm) as opposed to larger incisions need in laparotomy. The field of minimally invasive surgery as experienced an explosive growth in last decades. Though the art of surgery has gone through a complete evolutionary process due to antisepsis, antibiotics and anaesthesia, the field of laparoscopic surgery has undergone major changes in the recent past. Upto half of complications occur at the time if abdominal access for camera port placement. Complication may be associated with the anaesthetics, insertion of primary and secondary trocars. Induction of pneumoperitoneum, thermal instruments, mechanical instruments and other associated condition. Conversion to an open procedure may be needed to manage complications that have been identified intraoperatively. Severe complications such as vascular injury, bowel perforation can be catastrophic and are the main cause of procedure specific morbidity and mortality related to laparoscopic surgery. ATM OF THE STUDY: To evaluate the incidence of complications during intraoperative and post operative periods of laparoscopic surgeries done at Govt. Rajaji Hospital, Madurai. It includes Anaesthesia related complications, General complications of laparoscopic surgery, Laparoscopic surgery related complications, specially for Laparoscopic appendicectomy, Laparoscopic cholecystectomy, Laparoscopic Hernioplasty, Post operative complications, For analysis post operative complications and its association with pre operative risk factor. MATERIALS AND METHODS: This study was conducted at Government Rajaji Hospital, Madurai from March 2016 to August 2016. It includes data on complications of all patients who undergo laparoscopic surgeries in general surgery department. Before surgery, an informed consent was obtained from patients with awareness of the risks and complications of laparascopic procedures and a possibility to switch to laparatomy. Age and sex, body mass index of the patient were recorded. Presence of risk factors such as obesity, previous surgeries, type of scar, hypertension, diabetes mellitus, coronary artery disease, COPD were also noted. Inclusion criteria: Patients more than 15 years of age and less than 65 years age group in both sexes were selected for laparoscopic surgery. Selection of patients depend on patient's risk factor and diseases process. Patients signed in consent form for laparoscopic surgery according to designed proforma. Total number of patients registered during the 6 months period was 100 patients. RESULTS: Age of the patients included in the study ranges from 15-65 years. Mean age of the patient was 34.92 years. Complications has been divided into two categories: Intraoperative and post-operative complications. Intraoperative complication has been divided into a) Anaesthetic complication b) Complication unique to laparoscopy, c) Specific procedure related complications. In intraoperative period, I have observed 2 cases of hypertension, 2 cases of tachycardia during anaesthetics. While doing laparoscopic procedures, 1 case of subcutaneous emphysema, 2 cases of vascular injury (inferior epigastric artery), one retractor injury and one indirect electrosurgical injury happened. Out of 100 surgical procedures, 60 cases of laparoscopic appendicectomy accounted for major proportion. Next was 30 cases of laparoscopic cholecystectomy. While doing laparoscopic appendicectomy one case of stump appendicitis, and caecal injury happened out of 60 cases. Out of 30 cases, 3 cases of gallstone spillage, one case of bile duct injury, bile duct leak and pancreatitis were observed while doing laparoscopic cholecystectomy. I have registered 10cases of laparoscopy hermioplasty in my study period. Out of 10cases, 3 cases of bleeding from tacker site, one case of seroma were observed. After analysis of complications versus procedures, no procedures significantly associated with complications. CONCLUSION: The advent of laparoscopic surgery has provided surgeons with new techniques to deal with familiar problems. Laparoscopy can reduce hospital stay, decrease post-operative pain and hasten recovery time. The complication rates in individual category decreased significantly in this study compared to previous studies. It also confirms that laparoscopy is highly experience dependent. Some of the measures followed by us during laparoscopic procedures that helped in preventing complication are (a) ACCESS: While introducing trocar, we always introduce primary trocar by 'OPENTECHNIQUE' using blunt trocar. By following this method, we have not landed up in even single trocar injury during insertion. (b) PREUMOPERITONEUM: After introducing primary trocar by open technique, insufflation of carbondioxide is done by slow insufflation method using an intraabdominal pressure of 15mmHg at 2.5litres/minute. In open technique, it 1s important to monitor the pneumoperitoneum creation. Rapid insufflation may cause air getting trapped in circulation thereby causing gas embolism. So far, we have not encountered any pneumoperitoneum related complications. (c) PROCEDURE RELATED: (1) LAPAROSCOPIC CHOLECYSTECTOMY: We routinely use hemo-lock clips for clamping cystic duct and artery and till now, no complication has occured due to the safety action of these clips and a tube drain is routinely kept for 24 hours to watch for any complication and hemolock clips are very useful when cystic duct 1s short and dilated where it cannot be clipped by usual endoclips. (2) LAPAROSCOPIC APPENDICECTOMY: By routinely using bipolar diathermy for appendicectomy, we have not encountered any case of iatrogenic bowel injury. While using cautery, a complete knowledge of biophysics and mechanism of cautery 1s necessary. (3) LAPAROSCOPIC HERNIOPLASTY : We always use absorbable or delayed absorbable sutures for fixing the mesh using transfacial sutures because use of non — absorbable suture material may cause sinus formation

Comparative study of sensitivity and specificity of Ultrasonography and Computed Tomography in clinically suspected acute appendicitis as a diagnostic tool and further correlation with histopathological examination

INTRODUCTION: Acute appendicitis is one of the most common surgical emergencies in contemporary medicine. The diagnosis of acute appendicitis is essentially clinical. And advances in radiographic imaging have improved the diagnostic accuracy. This prospective study compared the sensitivity and specificity of Ultrasonography and Computed tomography in clinically suspected acute appendicitis as a diagnostic tool and further correlation with histopathological examination. STUDY DESIGN: One hundred and fourty nine patients with clinically suspected acute appendicitis, followed the following protocol. Ultrasonography was done to all these patients. When ultrasonography failed to support the diagnosis, the patients were subjected to computed tomography. All the confirmed patients by imaging studies and the clinically suspected acute appendicitis patients were taken up for the surgery. The results of ultrasonography and tomography were correlated with the histopathological examination and the follow up. RESULTS: The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy for ultrasonography were 63%, 75%, 90%, 36% and 66% respectively. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy for computed tomography were 91%, 92%, 95%, 85% and 91% respectively. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy for combined ultrasonography and computed tomography (in inconclusive ultrasonographic cases only) were 97%, 69%, 92%, 85% and 91% respectively. CONCLUSION: Computed tomography is better than ultrasonography in diagnosing acute appendicitis. Combined ultrasonography and computed tomography, only in ultrasonography inconclusive cases yielded a high diagnostic accuracy for acute appendicitis .It saved manpower, time ,cost and radiation

Sulfadoxine-Pyrimethamine Exhibits Dose-Response Protection Against Adverse Birth Outcomes Related to Malaria and Sexually Transmitted and Reproductive Tract Infections

: We conducted a prospective cohort study in Zambia among pregnant women who received intermittent preventive treatment using sulfadoxine-pyrimethamine (IPTp-SP). : We calculated the odds ratios (ORs) of adverse birth outcomes by IPTp-SP exposure, 0-1 dose (n = 126) vs ≥2 doses (n = 590) and ≥2 doses (n = 310) vs ≥3 doses (n = 280) in 7 categories of malaria infection and sexually transmitted and reproductive tract infections (STIs/RTIs). : We found no significant differences in baseline prevalence of infection across IPTp-SP exposure groups. However, among women given 2 doses compared to 0-1 dose, the odds of any adverse birth outcome were reduced 45% (OR, 0.55; 95% confidence interval [CI], 0.36, 0.86) and 13% further with ≥3 doses (OR, 0.43; 95% CI, 0.27, 0.68). Two or more doses compared to 0-1 dose reduced preterm delivery by 58% (OR, 0.42; 95% CI, 0.27, 0.67) and 21% further with ≥3 doses (OR, 0.21; 95% CI, 0.13, 0.35). Women with malaria at enrollment who received ≥2 doses vs 0-1 had 76% lower odds of any adverse birth outcome (OR, 0.24; 95% 0.09, 0.66), and Neisseria gonorrhoeae and/or Chlamydia trachomatis had 92% lower odds of any adverse birth outcome (OR, 0.08; 95% CI, 0.01, 0.64). Women with neither a malaria infection nor STIs/RTIs who received ≥2 doses had 73% fewer adverse birth outcomes (OR, 0.27; 95% CI, 0.11, 0.68). : IPTp-SP appears to protect against malaria, STIs/RTIs, and other unspecified causes of adverse birth outcome.<br/

EGFR/EGFRvIII-targeted immunotoxin therapy for the treatment of glioblastomas via convection-enhanced delivery

Glioblastoma is the most aggressive malignant brain tumor among all primary brain and central nervous system tumors. The median survival time for glioblastoma patients given the current standard of care treatment (surgery, radiation, and chemotherapy) is less than 15 months. Thus, there is an urgent need to develop more efficient therapeutics to improve the poor survival rates of patients with glioblastoma. To address this need, we have developed a novel tumor-targeted immunotoxin (IT), D2C7-(scdsFv)-PE38KDEL (D2C7-IT), by fusing the single chain variable fragment (scFv) from the D2C7 monoclonal antibody (mAb) with the Pseudomonas Exotoxin (PE38KDEL). D2C7-IT reacts with both the wild-type epidermal growth factor receptor (EGFRwt) and EGFR variant III (EGFRvIII), two onco-proteins frequently amplified or overexpressed in glioblastomas. Surface plasmon resonance and flow cytometry analyses demonstrated a significant binding capacity of D2C7-IT to both EGFRwt and EGFRvIII proteins. In vitro cytotoxicity data showed that D2C7-IT can effectively inhibit protein synthesis and kill a variety of EGFRwt-, EGFRvIII-, and both EGFRwt- and EGFRvIII-expressing glioblastoma xenograft cells and human tumor cell lines. Furthermore, D2C7-IT exhibited a robust anti-tumor efficacy in orthotopic mouse glioma models when administered via intracerebral convection-enhanced delivery (CED). A preclinical toxicity study was therefore conducted to determine the maximum tolerated dose (MTD) and no-observed-adverse-effect-level (NOAEL) of D2C7-IT via intracerebral CED for 72 hours in rats. Based on this successful rat toxicity study, an Investigational New Drug (IND) application (#116855) was approved by the Food and Drug Administration (FDA), and is now in effect for a Phase I/II D2C7-IT clinical trial (D2C7 for Adult Patients with Recurrent Malignant Glioma, https://clinicaltrials.gov/ct2/show/NCT02303678). While it is still too early to draw conclusions from the trial, results thus far are promising