Advanced coronary artery disease: Appropriate end points for trials of novel therapies.

BACKGROUND: The segment of patients with advanced coronary artery disease, or disease that is not amenable to conventional revascularization therapies, continues to grow. Because the natural history of these patients is less defined, the appropriate end points for trials of novel revascularization therapies involving patients with advanced coronary artery disease are not certain. METHODS AND RESULTS: The Mediators of Social Support Study (MOSS) prospectively followed up outcomes of long-term survival, quality of life, resource use, and costs for 1189 patients and compared outcomes of patients with advanced coronary artery disease with those of a reference group who underwent bypass surgery or angioplasty. CONCLUSIONS: Despite greater disease burden, cost, and mortality for patients with advanced coronary artery disease, a number of self-reported measures of general health status improved in a similar fashion to that of patients eligible for angioplasty or bypass surgery. These findings should inform the design of trials involving novel therapies, suggesting that angina status and mortality be included as primary end points in the consideration of efficacy. This work also suggests that additional studies of novel therapies involving larger sample sizes may be required to confidently characterize efficacy.

A prospective study of weight change and health-related quality of life in women.

CONTEXT: The mean body weight of US adults increased by 3.6 kg (7.6 lb) during the past 15 years, but few studies exist that examine the impact of such weight change on functional health status. OBJECTIVE: To investigate, prospectively, the association between weight change and health-related quality of life in women. DESIGN AND SETTING: Nurses' Health Study, a 4-year prospective observational study from 1992 to 1996, using the Medical Outcomes Study Short-Form 36 Health Status Survey (a self-administered 36-item questionnaire) to measure quality of life. PARTICIPANTS: A cohort of 40098 women (from 46-71 years old in 1992) grouped according to 3 patterns of weight change over the 4-year period: women whose weight remained within 2.25 kg (5 lb) of their baseline weight, women who lost 2.25 kg (5 lb) or more, and women who gained 2.25 kg (5 lb) or more. MAIN OUTCOME MEASURES: Change in scores on 7 health-related quality-of-life dimensions: physical functioning, vitality, bodily pain, limitations in role functioning due to emotional or physical problems, social functioning, and mental health, measured by the Short-Form 36 Health Status Survey. RESULTS: A total of 15602 women (39%) maintained their weight, 15160 (38%) gained between 2.25 and 9.0 kg (5-20 lb), and 6667 (17%) lost between 2.25 and 9.0 kg (5-20 lb). Weight gain was associated with decreased physical function and vitality, and increased bodily pain regardless of baseline weight. For example, the odds ratio for developing role limitations due to physical problems was 2.05 (95% confidence interval, 1.69-2.49) for the leanest women who gained 9.0 kg (20 lb) or more. Weight loss in overweight women was associated with improved physical function and vitality as well as decreased bodily pain. Weight change was more strongly associated with physical rather than mental health. The impact of weight change, especially weight gain, was just as strong in women 65 years and older as in women younger than 65 years. CONCLUSIONS: These longitudinal data support current US guidelines for women of all body mass index levels to avoid weight gain. Weight maintenance and, in cases of overweight, weight loss are desirable and likely to be beneficial for physical function, vitality, and bodily pain.

Health related quality of life outcomes in patients treated for metastatic kidney cancer: a pilot study.

PURPOSE: We assessed health related quality of life in patients with advanced renal cell carcinoma treated with nephrectomy and tumor infiltrating lymphocyte therapy in combination with interleukin-2. MATERIALS AND METHODS: A total of 20 patients with advanced renal cell carcinoma who underwent nephrectomy and combination immunotherapy with tumor infiltrating lymphocytes and interleukin-2 completed a retrospective, cross-sectional health related quality of life instrument. Established reference populations with other chronic medical conditions, or breast, prostate or other cancers were used for comparison of health related quality of life scores. General health related quality of life was measured with a RAND 36-Item Health Survey 1.0. Cancer targeted quality of life was measured with the Cancer Rehabilitation Evaluation System-Short Form. Sociodemographic and co-morbidity variables were also collected. RESULTS: General health related quality of life in patients treated with tumor infiltrating lymphocytes and interleukin-2 was significantly better than that in heart failure patients on 1 of 8 scales but significantly worse than in the general population on 6 of 8 scales. General health related quality of life in the former patients was also significantly worse than in those with hypertension on 5 of 8 scales and significantly worse than in diabetics on 2 scales. Cancer targeted health related quality of life in patients given immunotherapy was significantly better than in men with prostate cancer on 1 of 5 scales, significantly better than in women with breast cancer on 2 of 5 scales and significantly better than patients with other cancers (nonbreast and nonprostate) on 3 of 5 scales. CONCLUSIONS: Patients undergoing nephrectomy and adjuvant tumor infiltrating lymphocytes plus interleukin-2 therapy for advanced renal cell carcinoma report better health related quality of life than those with other malignancies and better physical function than patients with congestive heart failure. However, health related quality of life is worse than in the general population and similar or worse than in patients with hypertension or type II diabetes. This surveyed population is selective and may represent the best responders among survivors of a highly toxic therapy. Nevertheless, quality and quantity of life should be addressed with patients when considering immunotherapy for metastatic kidney cancer.

Bone-scan appearance of benign oral pathologic conditions.

Bone scans and dental examinations were completed on 22 patients. Results indicate that periodontal and periapical inflammation, healing wounds, traumatized alveolar ridges, and multiple cementomas result in positive scans. These areas should be recognized as benign dental disease and not misinterpreted as malignant lesions.

A short measure of Eriksonian ego identity.

Developed a new measure of Erikson's (1950, 1959) concept of ego identity which would meet the following criteria: (a) that it be short, with an acceptable level of reliability; (b) that it be objective and easily scored; and (c) that it be free of response set contamination. A 12-item scale (Ego Identity Scale) with a forced choice format was constructed. Two further studies were conducted to test the validity of the scale. These studies showed that the Ego Identity Scale correlated as predicted with measures Of locus of control, intimacy, dogmatism, Tomkins' Left, occupational commitment, and political commitment. It also correlated in the predicted direction with measures of interpersonal trust and moral commitment though these correlations did not reach statistical significance.