Ethical issues related to consent for intrapartum trials.

Informed consent is the heart of ethical research. For any consent to be ethically valid, it should meet certain critical criteria- disclosure and understanding of relevant information, decision making competency of the participants, voluntariness of the decision and documentation of the agreement. Meeting all these criteria to obtain ethically valid consent from laboring women while conducting intrapartum trials is challenging because there is little time available during labor to provide study specific information necessary for the participant to understand and decide to sign the consent form. Moreover, women during labor may be anxious and distressed due to labor pains which is thought to interfere with the capacity to make decisions in some cases. Emphasis on these concerns may ultimately lead to the exclusion of many eligible women in labor from intrapartum clinical trials. In this paper, we discuss the ethical challenges and also the proposed recommendations to obtain ethically valid consent from women for conducting intrapartum clinical trials.

Role of laparoscopy in the management of neonatal ovarian cysts.

AIM: Ovarian cysts in the newborn period are simple cysts which resolve on their own. Complications like torsion leading to loss of ovarian units are well documented. Surgical treatment should always be performed in a way to protect the ovaries and to ensure future fertility. The aim of this study was to study the safety and efficacy of laparoscopic management of neonatal ovarian cysts. MATERIALS AND METHODS: Neonates with ovarian cysts over last 6 years were retrospectively studied. Thirty seven ovarian cysts were detected antenatally and 32 of them persisted postnatally. All babies were asymptomatic. Nine babies with cyst size more than 5cms underwent laparoscopic deroofing, fenestration or cystectomy; the rest 23 babies were managed conservatively. Sonographic monitoring was done at monthly interval for change in contents, echogenicity of walls and features of torsion. Follow up was done with USG at 3 and 6 months and MRI after 1 year. RESULTS: No procedure related complications were seen in the laparoscopy group and no loss of ovarian units were seen in 1 year follow-up. In the observation group, cysts resolved in 3- 12 months period. Three babies developed complications and 4(17%) ovarian units were lost. CONCLUSION: Ovarian cysts are the most frequent among intra-abdominal cysts in newborns. Neonatal ovarian cysts are known to resolve spontaneously. Laparoscopic management of these cysts is safe and efficacious even in neonatal age and should be the treatment of choice when indicated.

Limb body wall complex: a rare anomaly.

We present autopsy findings of a case of limb body wall complex (LBWC). The fetus had encephalocele, genitourinary agenesis, skeletal anomalies and body wall defects. The rare finding in our case is the occurrence of both cranial and urogenital anomalies. The presence of complex anomalies in this fetus, supports embryonal dysplasia theory of pathogenesis for LBWC.

Cervical cancer screening by visual inspection with acetic acid--interobserver variability between nurse and physician.

OBJECTIVES: The objective of the study was to evaluate and compare the test performance of visual inspection with acetic acid (VIA) by a physician and nurse so as to evaluate the feasibility and efficacy of training a nurse in interpreting VIA. METHODS: It was a cross sectional study conducted in the colposcopy clinic at the University teaching hospital. 406 women who fulfilled the selection criteria underwent VIA done by both physician and nurse and the findings were interpreted independently. This was followed by colposcopy done by a gynecologist blinded to the results of VIA and directed biopsy was taken if indicated. The diagnostic efficacy was calculated separately for physician and nurse using threshold of cervical intraepithelial neoplasia (CIN) 2 and above and concordance of results between the physician and nurse was determined by kappa statistics. RESULTS: VIA by physician had a higher sensitivity (88.89% versus 80%) and a higher specificity (69.81% versus 54.85%) with disease threshold of CIN 2 and above. The concordance of results showed moderate agreement (kappa=0.366). CONCLUSION: Trained nurses can be an effective alternative human resource for cervical cancer screening using VIA as a preliminary screening method. Intensive training and periodic reinforcement sessions are needed so as to reduce the false positive results.

Cervical cancer screening by visual inspection with acetic acid - interobserver variability between nurse and physician.

OBJECTIVES: The objective of the study was to evaluate and compare the test performance of visual inspection with acetic acid (VIA) by a physician and nurse so as to evaluate the feasibility and efficacy of training nurses in interpreting VIA. METHODS: This cross sectional study was conducted in the colposcopy clinic at the University teaching hospital. A total of 406 women who fulfilled the selection criteria underwent VIA done by both physician and nurse and the findings were interpreted independently. This was followed by colposcopy carried out by a gynecologist blinded to the results of VIA and a directed biopsy was taken if indicated. The diagnostic efficacy was calculated separately for physician and nurse using threshold of cervical intraepithelial neoplasia (CIN) 2 and above and concordance of results between the physician and nurse was determined by kappa statistics. RESULTS: VIA by physician had a higher sensitivity (88.9% versus 80.0%) and a higher specificity (69.8% versus 54.9%) with a disease threshold of CIN 2 and above. The concordance of results showed moderate agreement (kappa=0.366). CONCLUSION: Trained nurses can be an effective alternative human resource for cervical cancer screening using VIA as a preliminary screening method. Intensive training and periodic reinforcement sessions are needed so as to reduce false positive results.