Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial.

OBJECTIVE: Women need products that protect against both pregnancy and sexually transmitted infections, including human immunodeficiency virus (HIV). The acid buffering gel is a nondetergent spermicide that may provide this dual protection by reinforcing normal vaginal acidity to inactivate both sperm and acid-sensitive sexually transmitted pathogens. The objective of this study was to assess the gel's contraceptive effects, safety, and acceptability. METHODS: We conducted a multicenter, randomized, double-masked, noninferiority study at 11 centers, comparing 621 women who used an acid buffering gel plus diaphragm with 300 women who used a nonoxynol-9 spermicide plus diaphragm for 6 months. A double-masked study extension followed 234 women for an additional 6 months of use. RESULTS: The 6-month pregnancy rate per hundred women was 10.1% (95% confidence interval [CI] 7.1-13.1%) for acid buffering gel and 12.3 (95% CI 7.7-16.9) for nonoxynol-9 spermicide users. The difference in rates was -2.2% with a 95% CI -7.7 to 3.3%. Consistent and correct use 6-month pregnancy rates were 4.7% for acid buffering gel and 6.1% for nonoxynol-9 spermicide users, calculated from those cycles where diary entries indicated such use. Adverse events and acceptability were similar between the two groups. Pregnancy probabilities were similar between groups participating in the 12-month study extension. CONCLUSION: An acid buffering gel used with a diaphragm is a safe, acceptable contraceptive with efficacy comparable to that of a common commercial spermicide with diaphragm. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00065858 LEVEL OF EVIDENCE: I.

Detection and fate of Bacillus anthracis (Sterne) vegetative cells and spores added to bulk tank milk.

A preparation of Bacillus anthracis (Sterne strain) spores was used to evaluate commercially available reagents and portable equipment for detecting anthrax contamination by using real-time PCR and was used to assess the fate of spores added directly to bulk tank milk. The Ruggedized Advanced Pathogen Identification Device (RAPID) was employed to detect spores in raw milk down to a concentration of 2,500 spores per ml. Commercially available primers and probes developed to detect either the protective antigen gene or the lethal factor gene both provided easily read positive signals with the RAPID following extraction from milk with a commercially available DNA extraction kit. Nucleotide sequence analysis of the vrrA gene with the use of DNA extracted from spiked milk provided molecular data that readily identified the spores as B. anthracis with a 100% BLAST match to the Sterne and Ames strains and easily distinguished them from B. cereus. Physical-fate and thermal-stability studies demonstrated that spores and vegetative cells have a strong affinity for the cream fraction of whole milk. A single treatment at standard pasteurization temperatures, while 100% lethal to vegetative cells, had no effect on spore viability even 14 days after the treatment. Twenty-four hours after the first treatment, a second treatment at 72 degrees C for 15 s reduced the viability of the population by ca. 99% but still did not kill all of the spores. From these studies, we conclude that standard pasteurization techniques for milk would have little effect on the viability of B. anthracis spores and that raw or pasteurized milk poses no obstacles to the rapid detection of the spores by molecular techniques.

Usefulness of the BASIS-32 in evaluating program level outcomes.

The Behavior and Symptom Identification Scale (BASIS-32) is a survey used to collect clients' reported perceptions of their symptoms and functioning. This article assesses the usefulness of the BASIS-32 for evaluating program outcomes in California's statewide performance outcome system for adults with serious mental illnesses. The authors found that, while the instrument could be useful at the clinical level, it did not work well when data were aggregated at the program or system level. Not only did clients drastically under-report their symptoms, but improvements over time, although statistically significant, were negligible and of little practical use for assessing system-level outcomes. In addition, the costs and logistical complexities associated with site licensing became increasingly difficult to justify when compared to obtaining similar information from other sources.

Queensland emergency medical system: a structural and organizational model for the emergency medical system in Australia.

OBJECTIVE: The emergency medical system (EMS) can be defined as a comprehensive, coordinated and integrated system of care for patients suffering acute illness and injury. The aim of the present paper is to describe the evolution of the Queensland Emergency Medical System (QEMS) and to recommend a strategic national approach to EMS development. METHODS: Following the formation of the Queensland Ambulance Service in 1991, a state EMS committee was formed. This committee led the development and approval of the cross portfolio QEMS policy framework that has resulted in dynamic policy development, system monitoring and evaluation. This framework is led by the Queensland Emergency Medical Services Advisory Committee. RESULTS: There has been considerable progress in the development of all aspects of the EMS in Queensland. These developments have derived from the improved coordination and leadership that QEMS provides and has resulted in widespread satisfaction by both patients and stakeholders. CONCLUSIONS: The strategic approach outlined in the present paper offers a model for EMS arrangements throughout Australia. We propose that the Council of Australian Governments should require each state and Territory to maintain an EMS committee. These state EMS committees should have a broad portfolio of responsibilities. They should provide leadership and direction to the development of the EMS and ensure coordination and quality of outcomes. A national EMS committee with broad representation and broad scope should be established to coordinate the national development of Australia's EMS.

Effects of late loss of arterial inflow on free flap survival.

Greater than 80 percent of free flap thromboses have been shown to occur within the first three postoperative days, warranting immediate re-exploration and restoration of adequate vessel patency. The infrequency of thromboses beyond this period is reflected in the lack of reported cases in the literature and the absence of accepted guidelines for the treatment of such delayed complications. A single study reported free flap survival in vessel thromboses only when encountered after postoperative day (POD) 7 in a pig model. Since 1990, over 800 free tissue transfers have been done at the University of Rochester. A total of ten cases of late (defined as after POD 7) arterial inflow loss were identified and examined. A retrospective chart review recorded patient demographics, site of tissue defect, free tissue transferred, major co-morbidities, preoperative XRT, timing of arterial inflow loss, nature of inflow loss, and flap survival. The mean POD of arterial inflow loss was 53 days (range: 8 to 166). The mean age of patients was 58 years. No major co-morbidities correlated with late arterial inflow loss. Loss of inflow occurred as anastomotic rupture (5), occlusion of recipient bypass graft in lower extremity cases (3), primary donor arterial thrombosis (1), and pedicle avulsion during re-exploration for seroma (1). Five flaps survived, one sustained partial necrosis, and four were completely lost. Of the five surviving flaps, three were inset into healthy recipient sites. One was utilized on a dysvascular lower extremity, and another was used in an irradiated neck defect. Of the four failed flaps, all were placed in recipient beds compromised by radiation, ischemia, or scarring. Two exemplary case reports are presented. The timing of late loss of arterial inflow does not appear to be the primary determinant of free tissue survival. The condition and quality of the recipient site plays a large role in survival of these flaps. Ischemic, irradiated, and scarred beds are inadequate in providing late flap neovascularization, compared to healthy recipient sites. When encountering late loss of arterial inflow in flaps placed on such compromised beds, the microsurgeon should not anticipate survival based on surrounding vessel ingrowth. More aggressive salvage attempts may be warranted.