This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs.

Urban immigrant workers have increased risk of occupational injuries, with adverse outcomes.

Severe gout is associated with poor HRQOL and disability, especially for patients who experience more gout flares and have a greater number of involved joints. Subject perceptions of gout-related functioning and pain severity appear to be highly sensitive indicators of HRQOL and disability.

Background The outcomes of treatment for work‐related injuries and illnesses are multidimensional and complex, but have rarely been explored in detail. This study was intended to provide information on a sample of workers representing a range of jobs and employers typical of the workers compensation system. Methods A mailed, self‐report survey measuring multiple dimensions was conducted. Identified through the New Hampshire Division of Workers' Compensation First Report of Injury database, a sample of workers with injuries to their lower back (60%) or upper extremities (40%) a year prior to the study were surveyed. Response rate was 80% (N=169; upper extremity cases=70; low back cases=99). Results Most (82.8%) were working one year post‐injury. Over half reported residual effects of the injury on work or activities of daily living. Many working subjects reported persistent injury‐related anxiety and pain at the end of the work day, worse in those with low back pain compared to those with upper extremity injuries. Almost 40% of those who returned to work suffered a reinjury. Forty‐four percent of respondents suffered significant injury‐related financial problems, which were worse in those who had been out of work for longer periods. Conclusions Occupational musculoskeletal injuries do result in significant, long‐term adverse physical, economic, and psychological consequences, as demonstrated in self‐reported surveys. Am. J. Ind. Med. 37:400–409, 2000. © 2000 Wiley‐Liss, Inc.

Older workers appear to fare better than younger workers after a work injury; their relative advantage may be primarily due to longer workplace attachment and the healthy worker effect.

Evaluations of work status and work ability are common PCP activities, but little formal training has been provided in this area. Rehabilitation professionals can have a significant role through provider education, developing improved systems for communication with employers, and encouraging employers to provide more alternative duty assignments.

In 1993, the Health Services Research Committee of the American Society of Clinical Oncology (ASCO) charged an Outcomes Working Group with defining the outcomes of adult and pediatric cancer treatment to be used for technology assessment and development of cancer treatment guidelines. The Working Group defined by consensus outcomes for technology assessment and guideline development, focusing on cancer treatments. The Working Group considered a variety of perspectives on outcomes, including those of patients, physicians, clinical investigators, ASCO, and policy makers. Because ASCO's guidelines will define what constitutes the best treatment and not whether that treatment should be paid for, the Working Group gave higher priority to the clinical and clinical research perspectives than to the health policy perspective. Survival is the most important outcome of cancer treatment. An improvement in at least disease-free survival is a prerequisite for recommending adjuvant therapy. In the case of metastatic cancer, treatment can be recommended even without an improvement in survival, if it improves quality of life. Quality of life includes global quality of life, as well as its physical, psychologic, and social dimensions. To be an outcome of cancer treatment, quality-of-life measures must be sensitive to clinically meaningful changes produced by treatment; evaluations must control for placebo effects and determinants of quality of life not related to cancer or its treatment. Toxicity, both short and long term, is vitally important, with the latter being particularly critical in children. The value of cancer outcomes like tumor response (eg, complete or partial response) and biomarkers (eg, CA-125) for technology assessment and guideline development depends on their ability to predict patient outcomes (survival and quality of life) or to influence decisions about treatment. Complete response is an important outcome when it predicts survival. Progression is important because it signals the need to change or stop treatment. Cost-effectiveness is an especially important outcome to consider when the benefits of treatment are modest or the costs are high. Patient outcomes (eg, survival and quality of life) should receive higher priority than cancer outcomes (eg, response rate), but both types of outcomes are important in technology assessment and guideline development. Multiple outcomes should be considered because no single outcome adequately describes the results of cancer treatment. In general, there is no minimum benefit above which treatments are justified; rather, benefits should be balanced against toxicity and cost.

These factors may represent opportunities for early identification and intervention with individuals at high risk for poor post-injury outcomes. Longitudinal studies are needed to confirm the importance of these preliminary findings.