Federal university hospitals: heterogeneity in the coordination of clinical trials authorized by the National Health Surveillance Agency

Introduction: This study aimed to describe clinical trials approved by the Brazilian Health Surveillance Agency (ANVISA) and coordinated by federal university hospitals (FUHs), as well as to investigate the relationship between the number of clinical trials and the assistance provided by these FUHs. Methods: This is a cross-sectional study based on data obtained from the ANVISA clinical trial consultation system. The National Register of Health Care Facilities and the Ambulatory Care Information System of the Unified Health System (SUS) were used as sources of information on the assistance provided by FUHs, such as the mean number of specialized medical consultations and the number of beds. Scatter plot and Spearman's correlation coefficient analyses were used to verify the association between these aspects of FUHs and the number of clinical trials. Results: Between 2012 and 2013, ANVISA authorized 209 trials to be coordinated by 23 FUHs; 75% of the trials were coordinated by 7 FUHs, 69.8% were phase III trials, and 94% were multicenter studies. The number of clinical trials presented positive and statistically significant associations with the mean number of specialized medical consultations and the number of beds (Spearman's correlation coefficients r = +0.70 and r = +0.64, respectively). Conclusion: FUHs have a leadership role in the conduction of clinical trials in Brazil, but showed heterogeneity regarding their assistance capacities and the number of clinical trials. A predominance of phase III trials may be interpreted as a low use of the scientific potentiality of these facilities. (AU)

Obstetric hysterectomy: a 14-year experience of Rajavithi Hospital 1989-2002.

OBJECTIVES: To review and compare the incidence rate of obstetric hysterectomised patients between two seven-year periods. Theperiods were from October 1, 1988 to September 30, 1995 andfrom October P', 1995 to September 30th, 2002. The data included demographic characteristics, indications, possible risk factors, complications, and operative managements. MATERIAL AND METHOD: Retrospective analysis of the data that was collected from medical and labor records of the obstetric hysterectomised patientsfrom October 1, 1995 to September 30, 2002, the second seven-year period, compared with those in Pratumthong and Wattanaruangkowit's study from October 1, 1988 to September 30, 1995, the first seven-year period. RESULTS: Between 1998 and 2002, there were 201, 696 total deliveries with 111 obstetric hysterectomies. A significant increase in the average incidence rate of hysterectomy from 0.42 to 0.76/1000 deliveries and maternal age, placenta previa and blood transfusion in the second period compared with the first period (p < 0.05). Postoperative complications and the other risk factors of obstetric hysterectomy were not significant difference. CONCLUSION: The present study of obstetric hysterectomy demonstrates a significant increase in the incidence of hysterectomised rate, maternal age, blood transfusion, and placenta previa in the second period compared with the first period.