Optimizing the HIV/AIDS informed consent process in India

Background

While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low.

Methods

In this study, we examined pregnant women's understanding of group education and counseling (GEC) about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues.

Results

We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%.

Conclusions

This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.     

Hemoglobin M equon beta 41 (C7) phenylalanine leads to tyrosine

A severe hemolytic crisis was observed in a 34-yr-old female of English- Irish extraction following a viral illness treated with acetaminophen. Heinz bodies and heat instability were present only during a transient hemolytic event. A challenge dose of acetaminophen caused no detectable hematologic abnormality. Structural studies of the hemoglobin during hemolysis and again after complete recovery localized the abnormality to tryptic peptide beta Tp-5, and automated sequencing of I 125-labeled beta chains indicated a replacement of phenylalanine (C7) beta 41 by tyrosine. Substitution of the next residue, phenylalanine (CD1) beta 42 by serine (Hb Hammersmith), has resulted in chronic severe Heinz body hemolytic anemia. The lack of chronic anemia in the present disorder may reflect the different relationships of beta41 and beta 42 and/or the similarities in volume and hydrophobicity of tyrosine and phenylalanine. It is suggested that substitution of tyrosine for phenylalanine in Hb Mequon may disturb the critical environment around the heme group and render it susceptible to oxidative denaturation in the presence of infections and/or drugs.     

FENTANYL THERAPY CONTROLS AUTONOMIC HYPERACTIVITY IN TETANUS

SUMMARY This report describes the use of fentanyl in severe tetanus after failure of established therapeutic modalities (heavy sedation, neuromuscular blockade and ventilation). Cardiovascular instability accompanying severe tetanus secondary to sympathetic overactivity and raised catecholamine levels is associated with a mortality of over 50%.¹ In this clinical situation, a variety of drugs with a primary or secondary action on the cardiovascular system has been used with varying success. The following case of severe generalised tetanus in the adult associated with autonomic hyperactivity, was successfully managed with large doses of intravenous fentanyl.     

Clinical experience with a new detection algorithm for differentiation of supraventricular from ventricular tachycardia in a dual-chamber defibrillator

INTRODUCTION: Inadequate therapy for supraventricular tachyarrhythmias (SVT) is a frequent problem of implantable cardioverter defibrillators (ICD). Dual-chamber ICDs have been developed to improve discrimination of SVT from ventricular tachycardia (VT). We investigated the positive predictivity, sensitivity, and specificity of a new algorithm, the SMART detection trade mark algorithm, incorporated in the Phylax AV (Biotronik) dual-chamber ICD. METHODS AND RESULTS: Two hundred nine patients (185 men, age 64 +/- 11 years) received a Phylax AV ICD with SMART detection trade mark activated. In 138 of these patients, 1,245 sustained tachycardia episodes with a detailed electrogram were stored in the device during a follow-up period of 10 +/- 6 months. Episodes were correctly classified as ventricular fibrillation (VF, n = 178) in 52 patients, VT (n = 641) in 98 patients, and SVT (n = 385) in 48 patients by the algorithm. Forty-one true SVT episodes (3.3%) were misclassified as VT: atrial fibrillation (n = 7) and flutter (n = 1), sinus tachycardia (n = 12), and other SVT (n = 21). The positive predictivity for VF/VT was 94.5% (95% CI 92.7-95.8) uncorrected and 94.5% (95% CI 92.9-95.8%) corrected with the generalized equation estimation (GEE) method. The positive predictivity for SVT was 100%. The specificity was 88.9% (95% CI 85.6-91.6%) uncorrected and 89.0% (95% CI 85.6-91.6%) corrected with the GEE method with a sensitivity of 100%. CONCLUSION: The SMART detection trade mark algorithm was safe and reliable for the detection of all ventricular tachycardias. Although its specificity was high, it should be improved with regard to SVT to avoid inappropriate ICD therapies.     

Detection of ovulation by a method of change in finger-finger electropotential readings

The purpose of this study was to determine whether ovulation can be detected by using a device (Ovultron^R) that measures electropotential differences in finger-to-finger contact. Daily basal body temperatures and five consecutive readings on the Ovultron^R were obtained each morning in 34 women for a three-month period. During one cycle an endometrial biopsy was taken and dated to document the time of ovulation. Our results showed that in only five out of 104 cycles did the device show an isolated change at the time of ovulation. This device is not a reliable method either for prediction of or the detection of ovulation. Therefore, one cannot effectively use this device alone as a basis for a rhythm method of contraception.