Skip to main content
SpringerLink
Log in

Assessment of Health Related Quality of Life

  • Chapter
Fundamentals of Clinical Trials

  • 111k Accesses

Abstract

The major goal of randomized clinical trials is to determine the potential benefits and harms of an intervention. The benefits of most available interventions in medicine are symptom improvements. Thus, relief or reduction of symptoms is a common primary outcome in clinical trials (Chap. 3). Most of the adverse effects of interventions are also symptom-related (Chap. 12). Any changes in symptomatology are subjective and reported by trial participants. A special form of participant reported outcomes relate to various types of functioning, traditionally covered by the term health-related quality of life (HRQL) [1–4].

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 39.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 54.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 89.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Quality of Life Assessment in Cancer Clinical Trials. Report of the Workshop on Quality of Life Research in Cancer Clinical Trials. USDHHS, Bethesda, Maryland, 1991.

    Google Scholar 

  2. Spilker B (ed.). Quality of Life and Pharmacoeconomics in Clinical Trials. Philadelphia: Lippincott-Raven Publishers, 1996.

    Google Scholar 

  3. Fairclough DL. Design and Analysis of Quality of Life Studies in Clinical Trials (Interdisciplinary Statistics). Boca Raton, Florida: Chapter & Hall/CRC, 2002.

    Book  Google Scholar 

  4. Fayers P, Machin D. Quality of Life: The Assessment, Analysis and Interpretation of Patient-Reported Outcomes. Chichester: John Wiley & Sons, Ltd., 2007.

    Book  Google Scholar 

  5. Snyder CF, Jensen RE, Segal JB, Wu AW. Patient-Reported Outcomes (PROs): Putting the patient perspective in patient-centered outcomes research. Med Care 2013;51:S73-S79.

    Article  Google Scholar 

  6. Calvert M, Blazeby J, Altman DG, Revicki DA, et al. for the CONSORT PRO Group. Reporting of Patient-Reported Outcomes in randomized trials. The CONSORT PRO extension. JAMA 2013;309:814-822.

    Google Scholar 

  7. Calvert M, Brundage M, Jacobsen PB, et al. The CONSORT Patient-Reported Outcome (PRO) extension: Implications for clinical trials and practice. Health Qual Life Outcomes 2013;11:184-190.

    Article  Google Scholar 

  8. Food and Drug Administration. Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring, MD: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration, 2009.

    Google Scholar 

  9. Berzon R, Hays RD, Shumaker SA. International use, application and performance of health-related quality of life instruments. Qual Life Res 1993;2:367-368.

    Article  Google Scholar 

  10. Mossey JM, Shapiro E. Self-rated health: A predictor of mortality among the elderly. Am J Public Health 1982;72:800-808.

    Article  Google Scholar 

  11. Kaplan GA, Camacho T. Perceived health and mortality: A nine-year follow-up of the human population laboratory cohort. Am J Epidemiol 1983;117:292-304.

    Article  Google Scholar 

  12. Oei TP, McAlinden NM, Cruwys T. Exploring mechanisms of change: The relationships between cognitions, symptoms, and quality of life over the course of group cognitive-behaviour therapy. J Affect Disord 2014;168:C72-C77.

    Article  Google Scholar 

  13. Schron EB, Shumaker SA. The integration of health quality of life in clinical research: Experiences from cardiovascular clinical trials. Prog Cardiovasc Nurs 1992;7:21-28.

    Google Scholar 

  14. Sugarbaker PH, Barofsky I, Rosenberg SA, Gianola FJ. Quality of life assessment of patients in extremity sarcoma clinical trials. Surgery 1982;91:17-23.

    Google Scholar 

  15. The Women’s Health Initiative Study Group. Design of the Women’s Health Initiative Clinical Trial and Observational Study. Control Clin Trials 1998;19:61-109.

    Article  Google Scholar 

  16. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002;288:321-333.

    Article  Google Scholar 

  17. The Women’s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. JAMA 2004;291:1701-1712.

    Article  Google Scholar 

  18. Naughton MJ, Jones AS, Shumaker SA. When practices, promises, profits, and policies outpace hard evidence: The post-menopausal hormone debate. J Soc Issues 2005;61:159-179.

    Article  Google Scholar 

  19. Hays J, Ockene JK, Brunner RL, et al for the Women’s Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003;348:1839-1854.

    Google Scholar 

  20. Brunner RL, Gass M, Aragaki A, et al for the Women’s Health Initiative Investigators. Effects of conjugated equine estrogen on health-related quality of life in postmenopausal women with hysterectomy: results from the Women’s Health Initiative Randomized Clinical Trial. Arch Intern Med 2005;165:1976-1986.

    Google Scholar 

  21. Richardson LP, Ludman E, McCauley E, et al. Collaborative care for adolescents with depression in primary care: a randomized clinical trial. JAMA 2014;312:809-816.

    Article  Google Scholar 

  22. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med 2001;16:606–613.

    Article  Google Scholar 

  23. Poznanski E, Mokros H. Children’s Depression Rating Scale-Revised (CDRS-R). Los Angeles, CA: WPS, 1996.

    Google Scholar 

  24. Bird HR, Andrews H, Schwab-Stone M, et al. Global measures of impairment for epidemiologic and clinical use with children and adolescents. Int J Methods Psychiatr Res 1996;6:295-307.

    Article  Google Scholar 

  25. Brittenden J, Cotton SE, Elders A, et al. A randomized trial comparing treatments for varicose veins. N Engl J Med 2014;371:1218-1227.

    Article  Google Scholar 

  26. Garratt AM, Macdonald LM, Ruta DA, et al. Towards measurement of outcome for patients with varicose veins. Qual Health Care 1993;2:5-10.

    Article  Google Scholar 

  27. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). 1. Conceptual framework and item selection. Med Care 1992;30:473-483.

    Article  Google Scholar 

  28. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001;33:337-343.

    Article  Google Scholar 

  29. Shumaker SA, Anderson R, Berzon R, Hayes R (eds.) International use, application and performance of health-related quality of life measures. Qual Life Res 1993;2:367-368.

    Google Scholar 

  30. Cella DF, Wiklund I, Shumaker SA, et al. Integrating health-related quality of life into cross-national clinical trials. Qual Life Res 1993;2:433-440.

    Article  Google Scholar 

  31. Naughton MJ, Shumaker SA, Anderson R, Czajkowski S. Psychological Aspects of Health-Related Quality of Life Measurement: Tests and Scales. In Spilker B (ed.), Quality of Life and Pharmacoeconomics in Clinical Trials. Philadelphia: Lippincott-Raven Publishers, 1996.

    Google Scholar 

  32. Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 2013;22:1889-1905.

    Article  Google Scholar 

  33. Wu AW, Bradford AN, Velanovich V, et al. Clinician’s checklist for reading and using an article about patient-reported outcomes. Mayo Clin Proc 2014;89:653-661.

    Article  Google Scholar 

  34. Hays RD, Revicki DA. Reliability and validity (including responsiveness). In: Fayers P, Hays R (eds.). Assessing quality of life in clinical trials (2ndedition). New York: Oxford University Press, 2005.

    Google Scholar 

  35. Hardy JR, Edmonds P, Turner R, et al. The use of the Rotterdam Symptom Checklist in palliative care. J Pain Symptom Manage 1999;18:79–84.

    Article  Google Scholar 

  36. Portenoy RK, Thaler HT, Kornblith AB, et al. The Memorial Symptom Assessment Scale: An instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer 1994;30:1326-1336.

    Article  Google Scholar 

  37. National Institutes of Health, Patient-Reported Outcomes Measurement Information Systems website: www.nihPROMIS.org.

  38. Varni JW, Seid M, Kurtin PS. PedsQLTM 4.0: Reliability and validity of The Pediatric Quality of Life Inventory™ version 4.0 Generic Core Scales in healthy and patient populations. Med Care 2001;39:800–812.

    Article  Google Scholar 

  39. Ravens-Sieberer U, Gosch A, Rajmil L, et al. KIDSCREEN-52 quality-of-life measure for children and adolescents. Expert Rev Pharmacoecon Outcomes Res 2005;5:353–364.

    Article  Google Scholar 

  40. Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993;11:570-579.

    Article  Google Scholar 

  41. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-376.

    Article  Google Scholar 

  42. Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Appl Psych Meas 1977;1:385-401.

    Article  Google Scholar 

  43. McNair DM, Loor M, Droppleman LF. Profile of Mood States. San Diego, CA: Educational and Industrial Testing Service, 1981.

    Google Scholar 

  44. Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: A reliability study. Int Disabil Stud 1988;10:61-63.

    Article  Google Scholar 

  45. Wilkin D, Hallam L, Doggett M. Measures of Need and Outcome for Primary Health Care. New York, NY: Oxford Medical Publications, 1992.

    Google Scholar 

  46. McDowell I. Measuring Health: A Guide to Rating Scales and Questionnaires. New York: Oxford University Press, 2006.

    Book  Google Scholar 

  47. Website for the International Society for Quality of Life Research (ISOQOL): www.ISOQOL.org

  48. Reeve BB, Mitchell SA, Dueck A, et al. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst 2014;106.

    Google Scholar 

  49. Anderson BL, DeRubeis RJ, Berman BS. Screening, assessment, and care of anxiety and depressive symptoms in adults with cancer: An American Society of Clinical Oncology guideline adaptation. J Clin Oncol 2014;32:1605-1619.

    Article  Google Scholar 

  50. Revicki DA, Osoba D, Fairclough D, et al. 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.

    Article  Google Scholar 

  51. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 2008;61:102-109.

    Article  Google Scholar 

  52. Jaeschke R, Singer J, Guyatt G. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1991;12:S266-S269.

    Google Scholar 

  53. Guyatt G, Walter S, Norman G. Measuring change over time: Assessing the usefulness of evaluative instruments. J Chronic Dis 1987;40:171-178.

    Article  Google Scholar 

  54. Guyatt G, Osoba D, Wu AW. Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002;77:371-383.

    Article  Google Scholar 

  55. Weinstein MC, Torrance G, McGuire A. QALYs: The basics. Value Health 2009;12:S5-S9.

    Article  Google Scholar 

  56. Revicki DA, Kaplan RM. Relationship between psychometric and utility-based approaches to the measurement of health-related quality of life. Qual Life Res 1993;2;477-487.

    Article  Google Scholar 

  57. Neumann PJ, Auerbach HR, Cohen JT, Greenberg D. “Low-value” services in value-based insurance design. Am J Manag Care 2010;16:280-286.

    Google Scholar 

  58. Greenberg D, Rosen AB, Wacht O, et al. A bibliometric review of cost-effectiveness analysis in the economic and medical literature, 1976-2007. Medical Decis Making 2010;30:320-327.

    Article  Google Scholar 

  59. Greenberg D, Earle CC, Fang CH, et al. When is cancer care cost-effective? A systematic overview of cost-utility studies in oncology. J Natl Cancer Inst 2010;102:82-88.

    Article  Google Scholar 

  60. Kaplan RM, Feeny D, Revicki DA. Methods for assessing relative importance in preference based outcome measures. Qual Life Res 1993;2:467-475.

    Article  Google Scholar 

  61. Clark PM, Hayes AJ, Glasziou PG, et al. Using the EQ-5D index score as a predictor of outcomes in patients with type 2 diabetes. Med Care 2009;47:61-68.

    Article  Google Scholar 

  62. Moving the QALY forward: Building a pragmatic road. Value Health 2009;12:S1-S39

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. North Bethesda, MD, USA

    Lawrence M. Friedman

  2. Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA

    Curt D. Furberg

  3. Department Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA

    David L. DeMets

  4. Department of Biostatistics, Wake Forest School of Medicine, Winston-Salem, NC, USA

    David M. Reboussin

  5. Department of Medicine, Duke University, Durham, NC, USA

    Christopher B. Granger

  6. The Ohio State University, Columbus, OH, USA

    Michelle J. Naughton Ph.D.

  7. Wake Forest School of Medicine, Winston-Salem, NC, USA

    Sally A. Shumaker Ph.D.

Authors
  1. Lawrence M. Friedman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Curt D. Furberg
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. David L. DeMets
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. David M. Reboussin
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Christopher B. Granger
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Michelle J. Naughton Ph.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Sally A. Shumaker Ph.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

© 2015 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Friedman, L.M. et al. (2015). Assessment of Health Related Quality of Life. In: Fundamentals of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-18539-2_13

Download citation

Publish with us

Policies and ethics

Search

Navigation