Abstract
Background
A series of six manuscripts with an introduction appeared in the Mayo Clinic Proceedings, based upon the collective effort of 30 individuals with an interest and expertise in assessing the clinical significance of quality of life (QOL) assessments. The series of manuscripts described the state of the science of QOL assessments in oncology clinical research and practice and included extensive literature and theoretical justification for the continued inclusion of QOL in oncology clinical research and practice.
Objectives
The purpose of this paper is to produce a summary of these articles and to supplement these works with additional information that was gleaned from subsequent meetings and discussions of this material. The primary aim of this paper is to present a cogent and concise description for clinicians to facilitate the incorporation of QOL assessments into oncology clinical research and practice. The theoretical discussion is supplemented with an example of how the various ideas can be operationalized in an oncology clinical trial.
Similar content being viewed by others
References
Bergman B, Aaronson NK, Ahmedzai S et al (1994) The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. Eur J Cancer 30A:635–642
Berzon RA (1994) Quality of life determinations in chronic conditions: perspectives of the pharmaceutical industry. In: Trimble MR, Dodson WE (eds) Epilepsy and quality of life. Raven, New York
Brown DJ, McMillan DC, Milroy R (2005) The correlation between fatigue, physical function, the systemic inflammatory response, and psychological distress in patients with advanced lung cancer. Cancer 103:213–215
Cella DF (1996) Quality of life outcomes: measurement and validation. Oncology 10:233–246
Cella DF, Tulsky DS, Gray G et al (1993) The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579
Cella DF, Bonomi AE, Lloyd SR et al (1995) Reliability and validity of the Functional Assessment of Cancer Therapy–Lung (FACT-L) quality of life instrument. Lung Cancer 12:199–220
Cella D, Bullinger M, Scott C et al (2002) Group versus individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc 77:384–392
Cella D, Eton DT, Fairclough DL et al (2002) What is a clinically meaningful change on the Functional Assessment of Cancer Therapy–Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) study 5592. J Clin Epidemiol 55:265–295
Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE (2002) Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 24:547–561
Chassany O, Sagnier P, Marquis P et al (2002) Patient-reported outcomes: the example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J 36:209–238
Cleeland CS, Ryan KM (1994) Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 23:129–138
Cohen J (1998) Statistical power analysis for the behavioral sciences, 2nd edn. Hillsdale, New Jersey
Cortesi E, Gascon P, Henry D, Littlewood T, Milroy R, Pronzato P, Reinhardt U, Shasha D, Thatcher N, Wilkinson P (2005) Standard of care for cancer-related anemia: improving hemoglobin levels and quality of life. Oncology 68:22–32
Cox DR, Fitzpatrick R (1992) Quality-of-life assessment: can we keep it simple? J R Stat Soc 155:353–393
Cull A, Gould A, House A, Smith A, Strong V, Velikova G, Wright P, Selby P (2001) Validating automated screening for psychological distress by means of computer touchscreens for use in routine oncology practice. Br J Cancer 85:1842–1849
Curran SL, Andrykowski MA, Studts JL (1985) Short form of the profile of mood states (POMS-SF): psychometric information. Psychol Assess 7:80–83
Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ (2000) Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist 5:353–360
Davis K, Cella D (2002) Assessing quality of life in oncology clinical practice: a review of barriers and critical success factors. J Clin Outcomes Manag 9:327–332
Detmar SB, Muller MJ, Schornagel JH, Wever LDV, Aaronson NK (2002) Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 288:3027–3034
Donaldson GW, Moinpour CM (2002) Individual differences in quality of life treatment response. Med Care 40:III-39–III-53
Frost MH, Sloan JA (2002) Quality of life measurements: a soft outcome—or is it? Am J Manag Care 8:S574–S579
Frost MH, Bonomi AE, Ferrans CE et al (2002) Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clin Proc 77:488–494
Funch DP (1988) Predictors and consequences of symptom reporting behaviors in colorectal cancer patients. Med Care 26:1000–1008
Ganz P, Lee J, Siau J (1991) Quality of life assessment: an independent prognostic variable for survival in lung cancer. Cancer 67:3131–3135
Ganz PA, Moinpour CM, McCoy S (2004) Predictors of vitality (energy/fatigue) in early stage Hodgkin’s disease (HD): results from Southwest Oncology Group (SWOG) study 9133. J Clin Oncol 22:14S (abstract 6546)
Greenhalgh J, Meadows K (1999) The effectiveness of the use of patient-based measures of health in routine practice in improving the process and outcomes of patient care: a literary review. J Eval Clin Pract 5:401–416
Groenvold M, Klee MC, Sprangers MAG et al (1997) Validation of the EORTC QLQ-C30 Quality of Life Questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol 50:441–450
Guyatt GH, Osoba D, Wu AW et al (2002) Methods to explain the clinical significance of health status measures. Mayo Clin Proc 77:371–383
Hollen PJ, Gralla RJ, Kris MG et al (1999) Normative data and trends in quality of life from the Lung Cancer Symptom Scale (LCSS). Support Care Cancer 7:140–148
Justice AC, Aiken LH, Smith HL et al (1996) The role of functional status in predicting inpatient mortality with AIDS: a comparison with current predictors. J Clin Epidemiol 49:193–201
Karnofsky DA (1967) Clinical evaluation of anticancer drugs. Gann Monogr Cancer Res 2:223–234
Kazis LE, Anderson JJ, Meenan RF (1989) Effect sizes for interpreting changes in health status. Med Care 27:S178–S189
King MT (1996) The interpretation of scores from the EORTC Quality of Life Questionnaire QLQ-C30. Qual Life Res 5:555–567
Levinson W, Roter D (1995) Physicians’ psychosocial beliefs correlate with their patient communication skills. J Gen Intern Med 10:375–379
Lydick E, Epstein RS (1993) Interpretation of quality of life changes. Qual Life Res 2:221–226
McCorkle R, Cooley ME, Shea JA (1998) A user’s manual for the Symptom Distress Scale. University of Pennsylvania, Philadelphia
Moinpour CM, Lyons B, Grevstad PK et al (2002) Quality of life in advanced non-small lung cancer: results of a Southwest Oncology Group randomized trial. Qual Life Res 11:115–126
Mor V, Laliberte L, Morris JN et al (1984) The Karnofsky Performance Status scale: an examination of its reliability and validity in a research setting. Cancer 53:2002–2007
Non-small Cell Lung Cancer Collaborative Group (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. BMJ 311:899–909
Norman GR, Gwadry Sridhar F et al (2001) The relation of distribution- and anchor-based approaches in interpretation of changes in health related quality of life. Med Care 39:1039–1047
Norman GR, Sloan JA, Wyrwich KW (2003) Interpretation of changes in health-related quality of life. The remarkable universality of a half a standard deviation. Med Care 41:582–592
Nunnally CC, Bernstein IH (1994) Psychometric theory, 3rd edn. McGraw-Hill, USA
Osoba DA (2002) Taxonomy of the uses of health-related quality-of-life instruments in cancer care and the clinical meaningfulness of the results. Med Care 40:III-31–III-38
Osoba D, Rodrigues G, Myles J et al (1998) Interpreting the significance of changes in health-related quality of life scores. J Clin Oncol 16:139–144
Schipper H, Clinch J, McMurray A et al (1984) Measuring the quality of life of cancer patients: the Functional Living Index–Cancer: development and validation. J Clin Oncol 2:472–483
Sloan JA, Dueck A (2004) Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials. J Biopharm Stat 14:73–96
Sloan JA, Loprinzi CL, Kuross SA et al (1998) Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol 16:3662–3673
Sloan JA, Aaronson N, Cappelleri JC (2002) Assessing the clinical significance of single items relative to summated scores. Mayo Clin Proc 77:479–487
Sloan JA, Cella D, Frost M et al (2002) Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc 77:367–370
Sloan J, Symonds T, Vargas-Chanes D et al (2003) Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 37:23–31
Sloan JA, Vargas-Chanes D, Kamath CC et al (2003) Detecting worms, ducks and elephants: a simple approach for defining clinically relevant effects in quality-of-life measures. J Cancer Integ Med 1:41–47
Spitzer WO, Dobson AJ, Hall J et al (1981) Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis 34:585–597
Sprangers MAG, Moinpour CM, Moynihan TJ et al (2002) Assessing meaningful change in quality of life over time: a user’s guide for clinicians. Mayo Clin Proc 77:561–571
Symonds T, Berzon R, Marquis P et al (2002) The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clin Proc 77:572–583
Tamburini M, Brunelli C, Rosso S et al (1996) Prognostic value of quality of life scores in terminal cancer patients. J Pain Symptom Manage 11:32–41
Taylor KM, Macdonald KG, Bezjak A, Ng P, DePetrillo AD (1996) Physicians’ perspective on quality of life: an exploratory study of oncologists. Qual Life Res 5:5–14
Unruh ML, Weisbord SD, Kimmel PL (2005) Health-related quality of life in nephrology research and clinical practice. Semin Dial 18:82–90
Valderas JM, Alonso J, Prieto L, Espallargues M, Castells X (2004) Content-based interpretation aids for health-related quality of life measures in clinical practice. An example for the Visual Function Index (VF-14). Qual Life Res 13:35–44
Velikova G, Brown JM, Smith AB, Selby PJ (2002) Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology. Br J Cancer 86:51–59
Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ (2004) Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 22:714–724
Ware JE, Kosinski M, Keller SD (1994) SF-36 physical and mental health summary scales: a user’s manual. Health Institute, New England Medical Center, Boston, Massachusetts
Wright EP, Selby PJ, Crawford M, Gillibrand A, Johnston C, Perren TJ, Rush R, Smith A, Velikova G, Watson K, Gould A, Cull A (2003) Feasibility and compliance of automated measurement of quality of life in oncology practice. J Clin Oncol 21:374–382
Wyrwich KW, Nienaber NA, Tierney WM et al (1999) Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 37:469–478
Author information
Authors and Affiliations
Consortia
Corresponding author
Additional information
List of Clinical Significance Consensus Meeting Group contributors to this article: Neil Aaronson, Ph.D., Division of Psychosocial Research, Cancer Institute, Amsterdam, The Netherlands; Ivan Barofsky, Ph.D., Quality of Life Institute, East Sandwich, MA, USA; Amy Bonomi, MPH, MacColl Institute for Healthcare Innovation, Seattle, WA, USA; Monika Bullinger, Ph.D., University of Hamburg, Hamburg, Germany; Joseph Cappelleri, Ph.D., Global Research and Development, Pfizer Incorporated, Groton, CT, USA; Diane Fairclough, Ph.D., University of Colorado Health Sciences Center Denver, CO, USA; Larry Gorkin, Ph.D., Pfizer Incorporated, New York, NY, USA; Ron Hays, Ph.D., UCLA Division of GIM and Health Services Research, UCLA Department of Health Sciences, UCLA AIDS Institute, Los Angeles, CA, USA; Patrick Marquis, M.D., MBA, Mapi Values, Boston, MA, USA; Tim Moynihan, M.D., Department of Medical Oncology, Mayo Clinic Rochester, Rochester, MN, USA; Geoff Norman, Ph.D., McMaster University, Hamilton, Ontario, Canada; David Osoba, M.D., QOL Consulting, West Vancouver, BC, Canada; Donald Patrick, Ph.D., Department Health Services, University of Washington, Seattle, WA, USA; Dennis Revicki, Ph.D., MEDTAP International Incorporated, Bethesda, MD, USA; Theresa Rummans, M.D., Department of Psychiatry, Mayo Clinic Rochester, Rochester, MN, USA; Charles Scott, Ph.D., American College of Radiology, Philadelphia, PA, USA; Tara Symonds, Ph.D., Outcomes Research, Pfizer, Global Research and Development, Sandwich, Kent, UK; Claudette Varricchio, Ph.D., RN, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA; Gilbert Wong, M.D., Department of Anesthesiology, Mayo Clinic Rochester, Rochester, MN, USA; Albert Wu, M.D., Department of Health Policy and Management, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, MD, USA; Kathleen Wyrwich, Ph.D., Saint Louis University, St. Louis, MO, USA.
Rights and permissions
About this article
Cite this article
Sloan, J.A., Frost, M.H., Berzon, R. et al. The clinical significance of quality of life assessments in oncology: a summary for clinicians. Support Care Cancer 14, 988–998 (2006). https://doi.org/10.1007/s00520-006-0085-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-006-0085-y