The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study.

OBJECTIVE: To examine the effect of both prevalent and incident vertebral fractures on health-related quality of life (HRQOL) in postmenopausal women with osteoporosis and to characterize the effect of prevalent vertebral fractures on HRQOL with respect to number, location, severity, and adjacency. METHODS: Participants were a subset of women (n = 1,395, mean age 68.5 years) from the Multiple Outcomes of Raloxifene Evaluation trial who had low bone mineral density and/or prevalent vertebral fractures. Vertebral fractures were measured by radiography at baseline, 2 years, and 3 years. HRQOL was assessed using the Osteoporosis Assessment Questionnaire (OPAQ), a validated disease-targeted instrument, at baseline and annually for 3 years. RESULTS: Both prevalent and incident radiographic vertebral fractures were associated with decreased HRQOL. At baseline, women with a prevalent vertebral fracture had significantly lower OPAQ scores on physical function, emotional status, clinical symptoms, and overall HRQOL compared with women without a prevalent fracture (all P < 0.01). HRQOL scores were lower with each subsequent fracture. The effect of prevalent vertebral fracture was dependent on the location within the spine and was strongest in the lumbar region (L1-L4). Incident vertebral fractures significantly decreased OPAQ scores on physical function, emotional status, clinical symptoms, and overall HRQOL (all P < 0.001). CONCLUSION: Our findings demonstrate the importance of treating postmenopausal women who have prevalent vertebral fractures to prevent further decreases in HRQOL associated with subsequent incident vertebral fracture.

Health-related quality of life in postmenopausal women with low BMD with or without prevalent vertebral fractures.

Fractures and subsequent morbidity determine the impact of established postmenopausal osteoporosis. Health-related quality of life (HRQOL) has become an important outcome criterion in the assessment and follow-up of osteoporotic patients. As part of the baseline measurements of the Multiple Outcomes of Raloxifene Evaluation (MORE) study, HRQOL was assessed in 751 osteoporotic (bone mineral density [BMD] T score > or = -2.5) women from Europe with or without vertebral fractures (VFX). This was done using the quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO), Nottingham Health Profile (NHP) and the EQ-5D (former EuroQol). QUALEFFO contains questions in five domains: pain, physical function, social function, general health perception, and mental function. Each domain score and QUALEFFO total scores are expressed on a 100-point scale, with 0 corresponding to the best HRQOL. In comparison with patients without VFX, those with VFX were older (66.2 +/- 5.9 years vs. 68.8 +/- 6.3 years; p < 0.001), had higher prevalence of nonvertebral fractures (25% vs. 36%; p = 0.002), and higher QUALEFFO scores (worse HRQOL; total score, 26 +/- 14 vs. 36 +/- 17; p < 0.001). QUALEFFO scores increased progressively with increasing number of VFX, especially lumbar fractures (p < 0.001). Patients with a single VFX already had a significant increase in QUALEFFO scores (p < 0.05). Similar, though weaker, associations were seen for NHP and EQ-5D scores. This study confirms decreased HRQOL for patients with prevalent VFX. In osteoporotic patients, QUALEFFO scores change in relation to the number of VFX. QUALEFFO is suitable for clinical studies in patients with postmenopausal osteoporosis.

Pharmacoeconomics research credibility: a controversial and recurring theme in health outcomes research.

OBJECTIVE: This paper provides a framework for and discussion of the continued development and adoption of good health outcomes practice with application to health outcomes research. METHODS: We explored the issue of credibility in health outcomes research, including efforts within academia, governments, industry, and other interested parties to elevate the standard of health outcomes research to that currently expected of clinical research. A large percentage of health outcomes research programs are designed, implemented, and funded through efforts of the pharmaceutical industry; this fact casts doubt on the validity of study findings, with the result that these results often may be disregarded entirely. CONCLUSIONS: The constantly increasing need to demonstrate value for money in the context of health-care interventions is likely to continue as the need for continued high quality medical care persists and health-care budgets decline. Efforts aimed at guiding healthcare expenditures, such as health outcomes research, require further examination and attention.

Review of the pharmacoeconomic research on gemcitabine in the treatment of advanced non-small cell lung cancer.

BACKGROUND: Gemcitabine is a novel nucleoside analogue with unique activity against a range of solid tumors including non-small cell lung cancer (NSCLC) and pancreatic cancer. STUDY DESIGN AND METHODOLOGY: This report reviews a series of retrospective economic evaluations that have taken place over the past 4 years comparing gemcitabine, both as a single agent and in combination therapy, with other treatment modalities for NSCLC in the following countries: United States, Spain, Germany, Sweden, Belgium, Canada, and Italy. These economic evaluations were in the form of simple cost identification, cost minimization, and cost-effectiveness in order to estimate the economic impact of gemcitabine in NSCLC treatment compared with other treatment modalities. RESULTS AND CONCLUSIONS: The results of these retrospective economic evaluations suggest that gemcitabine as monotherapy or in a combination regimen may be cost saving or perhaps even cost effective. This is largely because the chemotherapy can be administered in an outpatient setting and because the side-effect and toxicity profile is lower. This economic advantage assumes equivalent efficacy of gemcitabine and other treatment modalities for treatment of NSCLC.