Despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin, as compared with the lysine analogues, precludes its use in high-risk cardiac surgery. (Current Controlled Trials number, ISRCTN15166455 [controlled-trials.com].).

The classical criteria for the evaluation of clinical trials in cancer reflect alterations in physical well-being, but are insensitive to other important factors, such as psychosocial state, sociability, and somatic sensation that may play a critical role in determining the patients' functional response to their illness and its treatment. The Functional Living Index-Cancer is designed for easy, repeated patient self-administration. It is a 22-item questionnaire that has been validated on 837 patients in two cities over a three-year period. Criteria for validity include stability of factor analysis, concurrent validation studies against the Karnofsky, Beck Depression, Spielberger State and Trait Anxiety, and Katz Activities of Daily Living scales, as well as the scaled version of The General Health Questionnaire and The McGill/ Melzack Pain Index. The index is uncontaminated by social desirability issues. The validation studies demonstrate the lack of correlation between traditional measures of patient response and other significant functional factors such as depression and anxiety (r = 0.33), sociability and family interaction, and nausea. These findings elucidate the frequently observed discrepancies between traditional assessments of clinical response and overall functional patient outcome. The index is proposed as an adjunct to clinical trials assessment and may provide additional patient functional information on which to analyse the outcome of clinical trials or offer specific advice to individual patients.

Depression and anxiety disorders are thought to be common in palliative cancer care, but there is inconsistent evidence regarding their relevance for other aspects of quality of life. In the Canadian National Palliative Care Survey, semi-structured interviews assessing depression and anxiety disorders were administered to 381 patients who were receiving palliative care for cancer. There were 212 women and 169 men, with a median survival of 63 days. We found that 93 participants (24.4%, 95% confidence interval=20.2-29.0) fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnostic criteria for at least one anxiety or depressive disorder (20.7% prevalence of depressive disorders, 13.9% prevalence of anxiety disorders). The most frequent individual diagnosis was major depression (13.1%, 95% confidence interval=9.9-16.9). Comorbidity was common, with 10.2% of participants meeting criteria for more than one disorder. Those diagnosed with a disorder were significantly younger than other participants (P=0.002). They also had lower performance status (P=0.017), smaller social networks (P=0.008), and less participation in organized religious services (P=0.007). In addition, they reported more severe distress on 14 of 18 physical symptoms, social concerns, and existential issues. Of those with a disorder, 39.8% were being treated with antidepressant medication, and 66.7% had been prescribed a benzodiazepine. In conclusion, it appears that depression and anxiety disorders are indeed common among patients receiving palliative care. These disorders contribute to a greatly diminished quality of life among people who are dying of cancer.

Data obtained using the Ottawa GRS in measuring CRM performance during high-fidelity simulation scenarios support evidence of construct validity. Data also indicate the presence of acceptable interrater reliability when using the Ottawa GRS.