Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
An Assessment of the Effects of the Use of Measures of Health-related Quality of Life in Routine Clinical Care:an Application to Lung Transplantation.
The objective of this study is to assess the effects of using HRQL measures in the clinical
care of pre- and post-lung transplant patients.
The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System
Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant
patients, will: 1) improve patient-clinician communication;2) affect patient management; 3)
improve patients' HRQL.
Recently there has been increasing interest in the use of health-related quality of life
(HRQL) measures in routine clinical practice. Traditionally, patient care has been based on
laboratory results, medical history, and signs and symptoms diagnosed by clinicians. The
inclusion of HRQL measures in routine practice may provide important and often otherwise
missing information, revealing the impact of the disease or its treatment on the patient's
physical, emotional and social well-being, and may assist in patient management. HRQL
assessments may assist in changing the medical paradigm from a disease-centered approach to a
patient-centered one.
Several studies in mental health and oncology discuss the application of HRQL measures in
clinical practice. Taenzer et al (2000) and Detmar et al. (2002) provide evidence that using
HRQL measures improves patient-clinician communication. Velikova et al (2004) detected
impacts on communication and the emotional well-being of patients.
Using a framework based on these previous studies and the methods for the health technology
assessment of diagnostic technologies (Guyatt et al. 1986), we will assess the effects of
including HRQL assessments in the routine clinical care of patients undergoing solid organ
transplantation (lung).
We expect that the routine use of HRQL measures in clinical practice will affect
patient-clinician communication, patient management, and patient outcome.
Lung transplantation trades a fatal disease (end-stage pulmonary disease) for a chance at
prolonged survival and improved quality of life, albeit with immunosuppression. In this
context, generic preference-based measures such as HUI2 and HUI3 are preferred to specific
measures, because they measure a broader range of health dimensions, including pain,
ambulation and emotional issues that are expected to be relevant. Preference-based measures
provide scores on the conventional 0.00 (dead) to 1.00 (perfect health) scale that allows for
the integration of morbidity and mortality effects and calculation of quality adjusted life
years (QALYs) and health-adjusted life expectancy (HALE).
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