Application of a decision analytic framework for adoption of clinical trial results: are the data regarding TARGIT-A IORT ready for prime time?

The results from randomized clinical trials are often adopted slowly. This practice potentially prevents many people from benefiting from more effective care. Provide a framework for analyzing clinical trial results to determine whether and when early adoption of novel interventions is appropriate. The framework includes the evaluation of three components: confidence in trial results, impact of early, and late adoption if trial results are reversed or sustained. The adverse impact of early adoption, and the opportunity cost of late adoption are determined using Markov modeling to simulate the impact of early and late adoption in terms of quality of life years and resources gained or lost. We applied the framework to the TARGIT-A randomized clinical trial comparing intraoperative radiation (IORT) to standard external beam radiation (EBRT) and considered these results in the context of trials comparing endocrine therapy with and without radiation therapy in postmenopausal women. Confidence in the TARGIT-A trial 4 year results is high because the peak hazard for local recurrence in the trial is between 2 and 3 years. This is consistent with most trials, and no second peak has been observed in similar patient populations, suggesting that the TARGIT-A trial results are stable. The interventions offer approximately equivalent life expectancy. If IORT local recurrences rate were as high as 10 % at 10 years (which is higher than expected), we would project only 0.002 fewer expected life years (less than 1 day) compared to EBRT if IORT is adopted early. However, there is a $1.7 billion opportunity cost of waiting an additional 5 years to adopt IORT in low risk, hormone-receptor-positive, postmenopausal women. EBRT costs an additional $1467 in indirect costs per patient. Applying an evaluative framework for the adoption of clinical trial results to the TARGIT-A IORT therapy trial results in the assessment that the trial results are stable, early adoption would lead to minimal adverse impact, and substantially less resource use. Both IORT and no radiation are reasonable strategies to adopt.

An investigation of the subtype diversity of clinical isolates of Irish Clostridium difficile ribotypes 027 and 078 by repetitive-extragenic palindromic PCR.

A repetitive-extragenic palindromic PCR (rep-PCR) subtyping method (DiversiLab) in conjunction with ribotyping, toxinotyping and antimicrobial-susceptibility testing was used to detect subtypes within Clostridium difficile ribotypes 027 and 078. Clinical isolates of ribotypes 027 (toxinotype III) (n = 30) and 078 (toxinotype V) (n = 23) were provided by health-care facilities across the Republic of Ireland over 2 months in 2006 and 1 month in 2009. Ribotype 027 isolates were significantly more related to each other (9 different subtype profiles) when compared to ribotype 078 isolates (14 different profiles) (P = 0.001; cut-off >90 % similarity). Almost half of ribotype 078 isolates (45.5 %) showed no relationship to each other. The clonality of ribotype 027 isolates suggests effective adaptation to the human niche, whereas the considerable genetic diversity within ribotype 078 isolates suggests that they may have originated from a variety of sources. Subtyping correlated well with antimicrobial susceptibility, in particular clindamycin susceptibility for ribotype 027, but diverse antimicrobial-susceptibility profiles were seen in ribotype 078 isolates, even within a single health-care facility. Between 2006 and 2009, a change in the predominant subtype of ribotype 027 was seen, with the recent clone representing half of all ribotype 027 isolates studied. This strain exhibited 89 % similarity to a rep-PCR profile of the North American NAP-1 strain.

Comparison of the Glidescope, the Pentax AWS, and the Truview EVO2 with the Macintosh laryngoscope in experienced anaesthetists: a manikin study.

BACKGROUND: The Pentax Airwayscope, the Glidescope, and the Truview EVO2 constitute three novel laryngoscopes that facilitate visualization of the vocal cords without alignment of the oral, pharyngeal, and tracheal axes. We compared these devices with the Macintosh laryngoscope in a simulated easy and difficult laryngoscopy. METHODS: Thirty-five experienced anaesthetists were allowed up to three attempts to intubate in each of four laryngoscopy scenarios in a Laerdal SimMan manikin. The time required to perform tracheal intubation, the success rate, number of intubation attempts and of optimization manoeuvres, and the severity of dental compression were recorded. RESULTS: In the simulated easy laryngoscopy scenarios, there was no difference between the study devices and the Macintosh in success of tracheal intubation. In more difficult tracheal intubation scenarios, the Glidescope and Pentax AWS, and to a lesser extent the Truview EVO2 laryngoscope demonstrated advantages over the Macintosh laryngoscope including a better view of the glottis, greater success of tracheal intubation, and ease of device use. The Pentax AWS was more successful in achieving tracheal intubation, required less time to successfully perform tracheal intubation, caused less dental trauma, and was considered by the anaesthetists to be easier to use. CONCLUSIONS: The Pentax AWS laryngoscope demonstrated more advantages over the Macintosh laryngoscope than either the Truview EVO2 or the Glidescope laryngoscope, when used by experienced anaesthetists in difficult tracheal intubation scenarios.

A change from the top. One system self-manages its reorganization project.

Changes in healthcare arising from economic, legislative, social, and medical pressures will place greater demands on senior managers' future decision making. To maintain its position as a healthcare leader during these volatile times, the Sisters of Charity of the Incarnate Word Health Care System (SCH), Houston, embarked on a self-managed reorganization project in January 1989. The system's senior management team (SMT) established guiding principles that served as the basis for its goals and objectives. A mission statement helped keep the team focused on its goals. A revised SCH Strategic Direction served as the foundation for change. After analyzing the corporate office organizational chart in light of the new strategic direction, the SMT began a reorganization process. This involved the redefinition of many roles, elimination of some positions, and relocation of some functions. Staff attended workshops to adjust to the reorganization. At the workshops employees were given the opportunity to ask questions and participate in the organization's reshaping. The new collaborative management style has been in place two years. As staff develop more supportive cross-functional teams and specialized committees, they are able to tap deeper into their extensive creative resources and collaborate on a vision for SCH.

Heparin kinetics in vascular surgery.

Currently there is little information available about the efficacy of heparin during vascular surgery or of the effects of surgical trauma on heparin kinetics. This study was undertaken to evaluate the kinetics of heparin therapy during vascular surgery. Nine patients undergoing major vascular surgery (one carotid, one common iliac and seven aortic operations) were studied both preoperatively and intra-operatively, each patient acting as his own control. Following determination of control activated partial thromboplastin time (APTT) and plasma heparin levels, heparin (100 u/kg body weight) was administered intravenously. Heparin dosage ranged form 4500 units to 8600 units with a mean dose of 6500 units. Plasma heparin and APTT levels were then measured at 10 minute intervals for 1 hour and 20 minute intervals for a second hour. The mean pre-operative and intra-operative APTT levels at ten minutes attained maximal values of 6.6 +/- 3.7 and 8.8 +/- 1.7 times the control respectively. At the end of 2 hours the mean APTT remained greater than 2.5 times the control in both groups. Mean plasma heparin level was 0.83 +/- 0.04 units at 10 minutes and was almost identical in both groups. Heparin level was not a reliable indicator of anticoagulant effect as most patients achieved the same levels but had markedly differing APTT results. The results of this study suggest that excessive doses of heparin may be used in vascular surgery and that surgical trauma does not significantly alter sensitivity to heparin.(ABSTRACT TRUNCATED AT 250 WORDS)

The acute geriatric psychiatry service: a suggested model.

In general hospitals, especially on acute medical-surgical, and general psychiatric units, geriatric patients are often exposed to attitudes of resentment or rejection. Individuals with treatable mental illnesses may be relatively neglected or dismissed as "senile," and their special needs not attended to. This tends to occur when the particular psychological issues of elderly patients are not shared by most of the other patients, and also when staff members are prejudiced about old people, either because of fear about their own aging or because of unresolved difficulties with parents or grandparents. The authors believe that age-specific geriatric units are the most effective treatment format for the elderly in need of psychiatric care. One example of such a unit opened in 1980, the Geriatric Psychiatry Unit currently in operation at the Johnston R. Bowman Health Center for the Elderly, a part of Rush-Presbyterian-St. Luke's Medical Center in Chicago, is described.