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Review
. 2008 Jul 15;5(5):623-30.
doi: 10.1513/pats.200802-020SK.

Health-related quality of life and patient-reported outcomes in pulmonary arterial hypertension

Affiliations
Review

Health-related quality of life and patient-reported outcomes in pulmonary arterial hypertension

Hubert Chen et al. Proc Am Thorac Soc. .

Abstract

Advances in our understanding of the basic pathophysiology of pulmonary arterial hypertension (PAH) has led to an expanding number of therapeutic options. The ultimate goals of therapy are to lengthen survival while improving symptoms and quality of life. A wealth of research in other conditions has established health-related quality of life (HRQoL) to be an important clinical endpoint. Until recently, however, little was known about HRQoL in PAH, and how best to measure it. Over the past few years, several studies have begun contributing to this growing area of research. Instruments used to assess HRQoL have varied between studies. The extent to which these instruments are valid in PAH depend on their specific measurement properties. In this article, we provide an overview of the different types of patient-reported outcomes (PROs) used in PAH, focusing in particular on the measurement of HRQoL. In the process, we review the current literature on HRQoL in PAH, summarize the available data from randomized controlled trials, and discuss the implications of these findings on future research. Despite significant progress, the study of HRQoL in PAH remains a nascent field relative to other conditions. As the use of PROs continues to increase, additional work will be needed to begin standardizing the reporting and interpretation of such outcomes in future clinical trials.

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Figures

<b>Figure 1.</b>
Figure 1.
Simplified conceptual model depicting the relationship between different types of endpoints used in studies of pulmonary arterial hypertension.

References

    1. Hoeper MM, Oudiz RJ, Peacock A, Tapson VF, Haworth SG, Frost AE, Torbicki A. End points and clinical trial designs in pulmonary arterial hypertension: clinical and regulatory perspectives. J Am Coll Cardiol 2004;43:48S–55S. - PubMed
    1. Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, Rothman M. Recommendations on health-related quality of life research to support labeling and promotional claims in the united states. Qual Life Res 2000;9:887–900. - PubMed
    1. Schipper H, Clinch J, Powell V. Definitions and conceptual issues. In: Spilker B, editor. Quality of life assessments in clinical trials. New York: Raven Press; 1990. pp. 11–24.
    1. US Food and Drug Administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. Draft Guidance. 2006. [accessed 2007 Sep 2]. Available from: http://www.fda.gov/cder/guidance/5460dft.pdf - PMC - PubMed
    1. Doward LC, McKenna SP. Defining patient-reported outcomes. Value Health 2004;7:S4–S8. - PubMed

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