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Symptom and Health-Related Quality-of-Life Measures for Use in Selected Gastrointestinal Disease Studies

A Review and Synthesis of the Literature

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Abstract

Patient-rated symptom and health-related quality-of-life (HR-QOL) outcomes are important end-points for clinical trials of medical treatments for gastrointestinal (GI) disorders. Based on this review, patient outcomes research is focused on gastroesophageal reflux disease and dyspepsia, with a growing interest in irritable bowel syndrome but little research in gastroparesis. State-of-the-art for patient-rated symptom scales is rudimentary with an abundance of scales and little attention to systematic instrument development or comprehensive psychometric evaluation. Generally, disease-specific HR-QOL measures have been more systematically developed and evaluated psychometrically, but few have been incorporated into clinical trials. More comprehensive outcome assessments are needed to determine the effectiveness of new medical treatments for functional GI disorders. Future clinical trials of GI disorders should combine clinician assessments of outcomes and symptoms with patient-rated symptom and HR-QOL end-points.

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Acknowledgements

The authors would like to thank Karin Coyne, PhD, of MEDTAP International for her comments on an earlier version of this paper. This work was supported by Janssen Pharmaceutica. The paper was presented at the Annual Conference of the International Society for Quality of Life Research in Barcelona, November 1999.

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Authors and Affiliations

  1. Center for Health Outcomes Research, MEDTAP International, Inc., 7101 Wisconsin Avenue, Suite 600, Bethesda, Maryland, 20814, USA

    Anne M. Rentz (MSPH), Carmelina Battista, Sonika Mathur, Lori Frank & Dennis A. Revicki

  2. MAPI Values, Lyon, France

    Elyse Trudeau

  3. Health Economics, Johnson & Johnson, Titusville, New Jersey, USA

    Robert Jones

  4. Janssen Pharmaceutica, Titusville, New Jersey, USA

    Patricia Robinson & Sheldon Sloan

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Correspondence to Anne M. Rentz.

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Rentz, A.M., Battista, C., Trudeau, E. et al. Symptom and Health-Related Quality-of-Life Measures for Use in Selected Gastrointestinal Disease Studies. Pharmacoeconomics 19, 349–363 (2001). https://doi.org/10.2165/00019053-200119040-00003

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