Purpose: This randomized controlled clinical trial examined the usefulness of including an assessment of health-related quality of life (HRQL) in the routine clinical care of lung-transplant patients. We hypothesized that the inclusion of HRQL in routine clinical care would improve patient-clinician communication, affect clinical management, and improve patients' HRQL.
Methods: At the outpatient clinic, University of Alberta Hospital, patients were randomly assigned to intervention (completion of Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) on touch-screen computer with feedback to clinicians) and control group (completion of HUI2 and HUI3 on touch-screen computer without feedback). Feedback involved a graphical representation included in patients' chart. All clinical encounters were audio-taped. Changes in clinical management (medication changes, number of referrals and test ordered) were summed to produce an overall management composite. At the end of every visit, patients completed the EQ-5D.
Results: Two hundred and thirteen patients were randomized (108 to intervention and 105 to control groups). There were statistically significant differences between the groups in mean number of issues discussed per encounter (P = 0.003; Cohen's d = 0.03) and mean management composite score (P = 0.001; Cohen's d = 0.41). EQ-5D index was not statistically significant different between the groups (P = 0.48).
Conclusions: We detected very small effects on patient-clinician communication and small effects on patient management, without detecting improvement in patient outcome.