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Do Clinical Marker States Improve Responsiveness and Construct Validity of the Standard Gamble and Feeling Thermometer: A Randomized Multi-Center Trial in Patients with Chronic Respiratory Disease

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Abstract

Background: Optimizing the validity and responsiveness of utility measures will enhance their usefulness in randomized trials. We evaluated the impact of clinical marker state (CMS) rating prior to patients’ rating their own health on two utility instruments (feeling thermometer (FT) and standard gamble (SG)) in patients with chronic respiratory disease (CRD). Methods: We randomized 182 patients with CRD to complete the FT (self-administered) and SG with CMS (FT+/SG+, n=91) or without marker states (FT−/SG−, n=91) before and after undergoing respiratory rehabilitation in a multi-center trial. Results: Use of CMS did not influence baseline utility scores. Improvement after therapy on the scale from 0 (dead) to 1.0 (full health) was 0.04 both in FT+ (p=0.03) and FT− (p=0.02; the difference between FT+ and FT− was 0.00, p=0.83). Improvement on the SG was 0.05 in both SG+ (p=0.08) and SG− (p=0.04; difference between SG+ and SG− 0.00, p=0.95). Correlations with other health related quality of life scores were highest for FT+. Conclusion: Administration of CMS did not improve responsiveness of the FT but may have improved construct validity. The SG showed limited construct validity and responsiveness that was not influenced by CMS use.

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Authors and Affiliations

  1. Division of Clinical Research Development and INFORMAtion Translation/INFROMA, Italian National Cancer Institute Regina Elena, Rome, Italy

    Holger J. Schünemann & M. Jeffery Mador

  2. Department of Medicine, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, USA

    Holger J. Schünemann

  3. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

    Holger J. Schünemann, Lauren E. Griffith, Peggy Austin & Gordon H. Guyatt

  4. Department of Medicine, University of Toronto, Toronto, Ontario, Canada

    Roger Goldstein & Ahmed M. Bayoumi

  5. University of Ottawa, Ontario, Canada

    Douglas McKim

  6. AstraZeneca R & D, Lund, Sweden

    Elisabeth Stahl

  7. Department of Medicine, McMaster University, Hamilton, Ontario, Canada

    Gordon H. Guyatt

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  1. Holger J. Schünemann
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Correspondence to Holger J. Schünemann.

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Schünemann, H.J., Goldstein, R., Mador, M.J. et al. Do Clinical Marker States Improve Responsiveness and Construct Validity of the Standard Gamble and Feeling Thermometer: A Randomized Multi-Center Trial in Patients with Chronic Respiratory Disease. Qual Life Res 15, 1–14 (2006). https://doi.org/10.1007/s11136-005-0126-x

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