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Background: Patient-reported outcome measures (PROMs) are often used in clinical research, but little is known about their performance as longitudinal outcomes. Methods: We used data from ASCEND, a large SPMS trial (n = 889), to investigate changes on the Short Form Health Survey 36 (SF-36 v2) and the Multiple Sclerosis Impact Scale (MSIS-29) over 2 years of follow-up. Results: PROM scores changed little over the 2 years of follow-up. In contrast to physical disability measures, there was no consistent trend in PROM change: significant worsening occurred about as often as improvement. Using a 6-month confirmation reduced the number of both worsening and improvement events without altering their relative balance. There was no clear difference in worsening events in groups based on population characteristics, nor was there a noticeable effect using different thresholds for clinically significant change. Conclusion: We found little consistent change in MSIS-29 and SF-36 over 2 years of follow-up in people with SPMS. Our findings show a disconnect between disability worsening and PROM change in this population. Our findings raise caution about the use of these PROMs as primary outcome measures in SPMS trials and call for a critical reappraisal of the longitudinal use of these measures in SPMS trials. [ABSTRACT FROM AUTHOR]

The present article discusses the nature of quality of life (QOL) in general and critically evaluates its application in the area of health and illness. As regards health related quality of life (HRQoL), it is now widely recognised that treating a disease in a purely biomedical framework, where emphasis is only on curing the disease and on providing prolonged life to the patient, is not sufficient. Now the focus is also on how to enhance the QOL of patients. In this context this article attempts to identify and critically evaluate some of the contemporary issues relevant in the area of HRQoL. The issues covered in this article include relatively simple issues related to the meaning, importance, usefulness and prevalent approaches in the area of HRQoL research and complex issues such as (i)who would be accountable for a patient's HRQoL (ii)being HRQoL stable or it changing over time (response shift) for people facing chronic diseases and (iii)whether gender differences exist in this regard. Lastly, the article also discusses the implication of HRQoL in the area of health management and intervention. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQoL) is an important outcome measure in patients with systemic lupus erythematosus (SLE). A review was undertaken of the literature relating to HRQoL in SLE. MEDLINE, EMBASE, CINAHL, Allied and Complimentary Medicine were searched to locate full papers in the English language reporting on HRQoL in adult SLE patients published between 1990 and 2005. In total 53 papers were included and the review was subdivided into: 1) description of HRQoL in SLE patients; 2) HRQoL and disease activity and/or damage; 3) the impact of other variables on HRQoL; and 4) HRQoL measures used in clinical trials in SLE patients. The findings were as follows: HRQoL is reduced in SLE patients; HRQoL is not correlated to disease activity or damage; age appears to have a negative impact on HRQoL especially physical health but the effect of disease duration is unclear; other potentially modifiable variables such as fatigue and psychosocial factors impact on HRQoL in a complex manner; and HRQoL measures which are sensitive to change should be an essential outcome measure in all clinical trials on SLE patients. [ABSTRACT FROM AUTHOR]

The study of systemic lupus erythematosus (SLE) is a challenging undertaking. It is difficult to assess outcomes in SLErandomized controlled trials (RCTs), and this is illustrated by the lack of new therapies approved for use in lupus. In a disease that is waxing and waning, and requires constantly changing medications, identifying treatment effects of new therapies may be difficult, and the use of potentially toxic therapies requires a rigorous understanding of the benefit to risk ratio. Some issues that need to be considered by the investigator in designing these studies include: 1)should the trialfocus on patients with active or inactive disease; 2) which of the measures of disease activity should be used or should prevention of flares be examined; 3) should the study focus on defined organ specific endpoints or utilize one of the available disease activity indices to identify changes in disease activity; 4) should the trial be a superiority trial or an equivalence trial. This review summarizes the critical issues involving the design of studies in lupus and provides the reader with suggestions and recommendations for consideration before embarking on trials in this area. [ABSTRACT FROM AUTHOR]