Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items

Background  The use of global health items permits an efficient way of gathering general perceptions of health. These items provide useful summary information about health and are predictive of health care utilization and subsequent mortality. Methods  Analyses of 10 self-reported global health items obtained from an internet survey as part of the Patient-Reported Outcome Measurement Information System (PROMIS) project. We derived summary scores from the global health items. We estimated the associations of the summary scores with the EQ-5D index score and the PROMIS physical function, pain, fatigue, emotional distress, and social health domain scores. Results  Exploratory and confirmatory factor analyses supported a two-factor model. Global physical health (GPH; 4 items on overall physical health, physical function, pain, and fatigue) and global mental health (GMH; 4 items on quality of life, mental health, satisfaction with social activities, and emotional problems) scales were created. The scales had internal consistency reliability coefficients of 0.81 and 0.86, respectively. GPH correlated more strongly with the EQ-5D than did GMH (r = 0.76 vs. 0.59). GPH correlated most strongly with pain impact (r = −0.75) whereas GMH correlated most strongly with depressive symptoms (r = −0.71). Conclusions  Two dimensions representing physical and mental health underlie the global health items in PROMIS. These global health scales can be used to efficiently summarize physical and mental health in patient-reported outcome studies.     

An innovative symptom monitoring tool for people with advanced lung cancer: a pilot demonstration

Treatment for advanced lung cancer is not curative; therefore, the primary goals of its care are to maximize symptom management and minimize treatment toxicity. Increasingly, patient-reported symptoms and health-related quality of life (HRQL) outcomes have been accepted as important endpoints; several validated measures have gained wide acceptance in research, but their use in practice has been limited. Computer technology increasingly is used to reduce patient and administrative burden in conducting assessments to produce a real-time presentation of symptom and HRQL data.This paper describes a technology-based monitoring system developed for patients with advanced lung cancer who were starting chemotherapy. Among the 90 participants, compliance with the weekly symptom survey was 92%. Patient acceptability of the system was high, as evidenced by 30 patients who elected to complete an additional monitoring interval beyond the 12-week study period. Of patients who reported discussing their responses with a provider (95%), a majority (69%) stated that the questionnaire helped them to focus on issues to be discussed with their physicians. The system also was favorably reviewed by physicians, who indicated that the report helped them to compare patients' responses over time. Next steps will include a randomized trial to test the system's efficacy in improving symptom management.     

Use of a single-item screening tool to detect clinically significant fatigue, pain, distress, and anorexia in ambulatory cancer practice

Fatigue, pain, distress, and anorexia are four commonly encountered symptoms in cancer. To evaluate the usefulness of a single-item screening for these symptoms, 597 ambulatory outpatients with solid tumors were administered a self-report screening instrument within the first 12 weeks of chemotherapy. Patients rated the severity of each symptom on a 0-10 scale, at its worst over the past three days, with higher ratings associated with higher symptom levels. From this sample, 148 patients also completed a more comprehensive assessment of these symptoms. Two criteria were used to determine optimal cut-off scores on the screening items: 1) the sensitivity and specificity of each screening item to predict clinical cases using receiver-operating characteristics analysis and 2) the proportion of patients at each screening score who reported that some relief of the target symptom would significantly improve their life. Optimal cut-off scores ranged from 4 to 6 depending on the target symptom (area under the curve range=0.68-0.88). Use of single-item screening instruments for fatigue, pain, distress, and anorexia may assist routine clinical assessment in ambulatory oncology practice. In turn, such assessments may improve identification of those at risk of morbidity and decreased quality of life due to excess symptom burden.     

A qualitative study of quality of life after stroke: the importance of social relationships

BACKGROUND: Stroke is a leading cause of long-term disability in the USA; however, we have an incomplete understanding of how stroke affects long-term quality of life. METHODS: We report here findings from focus groups with 9 long-term stroke survivors and 6 caregivers addressing patients' post-stroke quality of life. RESULTS: Key themes identified by patients were: social support, coping mechanisms, communication, physical functioning and independence. Role changes in patients were important to caregivers. Much of the discussion with patients and caregivers described specific ways in which the stroke altered social relationships. CONCLUSION: These findings are consistent with prior research indicating the importance of social factors to quality of life following stroke. Our findings suggest that measures of stroke-related quality of life should include assessment of social function and social support.     

Quality of life in renal transplant patients over 60 years of age

Kidney transplantation not only drastically improves the life-expectancy of hemodialyzed patients, but it also affords psychological and social advantages with improvements in short- and long-term personal and working lives. Quality of life (QoL) is one of the parameters of psychological well-being. There is an improvement of QoL from pre- to posttransplant, but it is not to the level of healthy samples. The aim of this study was to examine QoL in older renal transplant recipients. All recipients older than age 60 were included, with a minimum follow-up of 12 months. To measure QoL, the nationally standardized ShortForm-36 (SF-36) questionnaire was administered. The SF-36 responses by our patients were compared with national age- and gender-appropriate norms, and also between genders. The enrolled population included 19 women (36.5%) and 33 men (63.5%), with a mean age of 66.8 years (range, 60-73 years). Enrolled women reported significant limitations compared to gender- and age-matched norms in social activities (42.11 vs 70.58), perception of pain (22.11 vs 59.17), and general health perception (39.58 vs 48.69). Enrolled men reported significant limitations compared to gender- and age-matched norms in social activities (46.59 vs 78.35), perception of pain (18.18 vs 73.62), psycho-physical energy (50.15 vs 67.88), and general health perception (37.33 vs 61.66). No significant differences were noted between the genders. This study clearly showed how the psychological state was not as good as the clinico-physical recovery following renal transplantation in older recipients.     

Cost-effectiveness analysis of anastrozole versus tamoxifen as primary adjuvant therapy for postmenopausal women with early breast cancer: a US healthcare system perspective. The 5-year completed treatment analysis of the ATAC (‘Arimidex’, Tamoxifen Alone or in Combination) trial

Background This study evaluated the cost-effectiveness of anastrozole versus generic tamoxifen for primary adjuvant treatment of postmenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC), from a US healthcare perspective. Methods A probabilistic Markov model was developed using the 5-year completed treatment analysis of the ATAC (‘Arimidex’, Tamoxifen Alone or in Combination) trial (ISRCTN 18233230) to project outcomes for anastrozole and tamoxifen to 25 years. Resource utilization data were obtained primarily from published literature and a physician survey (including expert opinion from ATAC Steering Committee members). Drug costs were taken from published wholesale acquisition costs (anastrozole $6.56/day, generic tamoxifen $1.33/day). Other unit costs ($US 2003–4) were from standard sources. Utility estimates of relevant health states, used to compute quality-adjusted life-years (QALYs), were collected using the standard gamble technique in a cross-sectional sample of 44 patients. Costs and benefits were discounted 3% annually. Results In a cohort of 1000 postmenopausal women with HR+ EBC, the model showed anastrozole treatment (versus tamoxifen) would lead to 257 QALYs gained (0.26 QALYs gained per patient), at an additional cost of $5.21 million over 25 years ($5,212 per patient). The estimated incremental cost-effectiveness ratio (ICER) of anastrozole compared with tamoxifen was $20,246 per QALY gained ($23,541 per life-year gained). Cost-effectiveness acceptability curves indicated a >90% probability that the cost per QALY gained with anastrozole would be <$50,000. Results were robust in a sensitivity analysis. Conclusion Anastrozole is a cost-effective alternative to tamoxifen for the primary adjuvant treatment of postmenopausal women with HR+ EBC.     

Synergistic effect of growth hormone-releasing hormone (GHRH) and clonidine in stimulating GH release in young and old dogs

The effect of acute administration of growth hormone-releasing hormone (GHRH), clonidine (CLO), an alleged GHRH releaser, or GHRH and clonidine given simultaneously was studied in young and old dogs. Simultaneous administration of CLO induced in young dogs an additive effect on GH release and potentiated in old dogs the GHRH-induced GH release, with the GH response being clearly higher than the sum of the GH responses to GHRH or CLO alone. These data suggest that CLO promotes GH release in the dog also by inhibition of somatostatin release.