1996 OPEN FORUM Abstracts
How Much? How Often? - The San Diego Study
Andrew L. Ries, MD Monday, November 4, 1996
In recent years, there has been growing interest in pulmonary medicine in assessing health outcomes of medical interventions in terms of psychosocial and behavioral measures in addition to the traditional physiological indices. Pulmonary rehabilitation provides an ideal model for evaluating such outcomes in chronic lung disease because the intervention itself includes both physiological and psychosocial methods. The Pulmonary Rehabilitation Program at the University of California, San Diego, has been involved in clinical trials in pulmonary rehabilitation that utilize a variety of physiological and psychosocial measures in an attempt to answer key questions about the measurable benefits of such programs.
One of the clinical trials conducted at UCSD was a study sponsored by the NIH to examine the outcomes of pulmonary rehabilitation. The objective was to compare comprehensive pulmonary rehabilitation versus education alone on a variety of physiological and psychosocial outcomes. In the initial phase of the study, 350 patients were recruited and screened in 18 months; 119 patients with COPD (87 males, 32 females) were subsequently enrolled and randomly assigned to the rehabilitation or education control program. The study was extended to allow six years of follow-up on all subjects in order to evaluate both short- and long-term outcomes. Mortality has been followed for eight years at present. The main results of the completed study have been published and can be summarized as follows:
1. Compared to education controls, subjects in the comprehensive pulmonary rehabilitation group demonstrated highly significant changes in several measures of exercise performance, symptoms, and psychosocial variables following the interventions. However, measured quality of life (using the Quality of Well-Being Scale) did not change significantly for either the experimental or control group.
2. Significant differences in outcome measures between groups after the 8 week rehabilitation program were present over 12 to 18 months of follow-up and diminished after that time.
3. As expected, these patients with disabling lung disease demonstrated high mortality (42/119 in six years, 64/119 in eight years) and morbidity making it progressively difficult to fully evaluate survivors. Nevertheless, there was no significant differential loss to follow-up and measured variables remained similar between groups.
The results of this study highlight the importance of using a variety of outcome measures in assessing chronic disease interventions such as pulmonary rehabilitation. It is clear that much still needs to be learned about the appropriate use of such measures in patients with chronic lung diseases. Not all lung diseases are the same. Given the range of illnesses encountered in pulmonary medicine, it is likely that a variety of measures will be needed for different patient groups in different situations.
Ries AL, Kaplan RM, Limberg TM, Prewitt LM. Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease. Ann Intern Med 1995;122:823-32