Skip to main content

Advertisement

SpringerLink
Log in

Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials

  • Original Article
  • Published:
Supportive Care in Cancer Aims and scope Submit manuscript

Abstract

Background

The aim of this study was to determine the smallest changes in health-related quality of life (HRQOL) scores in a subset of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scales, which could be considered as clinically meaningful in patients with non-small-cell lung cancer (NSCLC).

Methods

WHO performance status (PS) and weight change were used as clinical anchors to determine minimal important differences (MIDs) in HRQOL change scores (range, 0–100) in the EORTC QLQ-C30 scales. Selected distribution-based methods were used for comparison.

Findings

In a pooled dataset of 812 NSCLC patients undergoing treatment, the values determined to represent the MID depended on whether patients were improving or deteriorating. MID estimates for improvement (based on a one-category change in PS, 5 − <20% weight gain) were physical functioning (9, 5); role functioning (14, 7); social functioning (5, 7); global health status (9, 4); fatigue (14, 5); and pain (16, 2). The respective MID estimates for deterioration (based on PS, weight loss) were physical (4, 6); role (5, 5); social (7, 9); global health status (4, 4); fatigue (6, 11); and pain (3, 7).

Interpretation

Based on the selected QLQ-C30 scales, the MID may depend upon whether the patients’ PS is improving or worsening, but our results are not definitive. The MID estimates for the specified scales can help clinicians and researchers evaluate the significance of changes in HRQOL and assess the value of a health care intervention or compare treatments. The estimates also can be useful in determining sample sizes in the design of future clinical trials.

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

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Jaeschke R, Singer J, Guyatt GH (1989) Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 10:407–415

    Article  PubMed  CAS  Google Scholar 

  2. Guyatt GH, Osoba D, Wu AW, Clinical Significance Consensus Meeting Group et al (2002) Methods to explain the clinical significance of health status measures. Mayo Clin Proc 77:371–383

    Article  PubMed  Google Scholar 

  3. Schünemann HJ, Guyatt GH (2005) Goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res 40:593–597

    Article  PubMed  Google Scholar 

  4. Schünemann HJ, Puhan M, Goldstein R, Jaeschke R, Guyatt GH (2005) Measurement properties and interpretability of the Chronic Respiratory Disease Questionnaire (CRQ). COPD 2:81–89

    Article  PubMed  Google Scholar 

  5. King MT, Stockler MS, Cella D, Osoba D, Eton D, Thompson J, Eisenstein A (2010) Meta-analysis provides evidence-based effect sizes for a cancer-specific quality of life questionnaire, the FACT-G. J Clin Epidemiol 63:270–281

    Article  PubMed  Google Scholar 

  6. Lydick F, Epstein RS (1993) Interpretation of quality of life changes. Qual Life Res 2:221–226

    Article  PubMed  CAS  Google Scholar 

  7. Cohen J (1988) Statistical power analysis for the behavioural sciences. Academic, New York

    Google Scholar 

  8. Crosby RD, Kolotkin RL, Williams GR (2003) Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 56:395–407

    Article  PubMed  Google Scholar 

  9. Samsa G, Edelman D, Rothman ML et al (1999) Determining clinically important differences in health status measures: a general approach with illustration to the health utilities index mark II. Pharmacoeconomics 15:141–155

    Article  PubMed  CAS  Google Scholar 

  10. Norman GR, Sloan JA, Wyrwich KW (2003) Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 41:582–592

    PubMed  Google Scholar 

  11. Beaton DE (2003) Simple as possible? Or too simple? Possible limits to the universality of the one-half standard deviation (comment). Med Care 41:593–596

    PubMed  Google Scholar 

  12. Farivar SS, Kiu H, Hays RD (2004) Another look at the half standard deviation estimate of the minimally important difference in health-related quality of life scores. Expert Rev PharmacoEcon Outcomes Res 4(5):521–529

    Article  Google Scholar 

  13. Cella D, Eton DT, Lai J, 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

    Article  PubMed  Google Scholar 

  14. Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health related quality-of-life scores. J Clin Oncol 16:139–144

    PubMed  CAS  Google Scholar 

  15. Ringash J, O’Sullivan B, Bezjak A, Redelmeier DA (2007) Interpreting clinically significant changes in patient-reported outcomes. Cancer 110(1):196–202

    Article  PubMed  Google Scholar 

  16. King MT (1996) The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res 5:555–567

    Article  PubMed  CAS  Google Scholar 

  17. Cocks K, King MT, Velikova G, Fayers PM, Brown JM (2008) Quality, interpretation and presentation of European organization for research and treatment of cancer quality of life questionnaire core 30 data in randomized controlled trials. Eur J Cancer 44:1793–1798

    Article  PubMed  Google Scholar 

  18. Smit EF, van Meerbeeck JPAM, Lianes P, Debruyne C, Legrand C, Schramel F et al (2003) Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol 21:3909–3917

    Article  PubMed  CAS  Google Scholar 

  19. Giacconne G, Splinter TAW, Debruyne C, Khot GS, Lianes P, van Zandwijk N et al (1998) Randomized study of paclitaxel–cisplatin versus cisplatin–teniposide in patients with advanced non-small cell lung cancer. J Clin Oncol 16:2133–2141

    Google Scholar 

  20. Fayers P, Aaronson N, Bjordal K, Groenvold M, Curran D, Bottomley A (2001) EORTC QLQ-C30 Scoring Manual, 3rd edn. EORTC Quality of life Study Group, Brussels

    Google Scholar 

  21. Ringash J, Bezjak A, O'Sullivan B, Redelmeier D (2004) Interpreting small differences in quality of life: the FACT-H&N in laryngeal cancer patients. Qual Life Res 13(4):721–729

    Article  Google Scholar 

  22. Cella D, Eton DT, Fairclough DL, Bonomi P, Heyes AE, Silberman C 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 55:285–295

    Article  PubMed  Google Scholar 

  23. National Cancer Institute (2003) Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, DCTD, NCI, NIH, DHHS 2003. http://ctep.cancer.gov. Accessed 28 Sept 2010

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

    Article  PubMed  Google Scholar 

  25. Hjermstad MJ, Fossa SD, Bjordal K, Kaasa S (1995) Test/retest study of the European organization for research and treatment of cancer core quality of life questionnaire. J Clin Oncol 13:1249–1254

    PubMed  CAS  Google Scholar 

  26. Cella D, Hahn EA, Dineen K (2002) Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res 11(3):207–221

    Article  PubMed  Google Scholar 

  27. Weinstein ND (1989) Optimistic biases about personal risks. Science 246:1232–1233

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgements

This study was funded by an unrestricted academic grant from the Pfizer Foundation. We thank the EORTC clinical Lung Group and their clinical investigators and all the patients who participated in these trials.

Conflict of interest statement

The authors indicated no potential conflicts of interest.

Author information

Authors and Affiliations

  1. Quality of Life Department, EORTC, Brussels, Belgium

    John T. Maringwa, Chantal Quinten, Corneel Coens, Francesca Martinelli, Jurgen Vercauteren & Andrew Bottomley

  2. Psycho-oncology Co-operative Research Group, University of Sydney, Sydney, Australia

    Madeleine King

  3. The Princess Margaret Hospital, University of Toronto, Toronto, Canada

    Jolie Ringash

  4. Quality of Life Consulting, West Vancouver, Vancouver, Canada

    David Osoba

  5. Department of Symptom Research, University of Texas, Houston, TX, USA

    Charles S. Cleeland

  6. Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany

    Henning Flechtner

  7. School of Population and Public Health, University of British Columbia, Vancouver, Canada

    Carolyn Gotay

  8. Obstetrics and Gynecology, Medical University Graz, Graz, Austria

    Eva Greimel

  9. VU Medical Center, Amsterdam, Netherlands

    Martin J. Taphoorn

  10. Division of Cancer Control and Population Science, National Cancer Institute, Bethesda, USA

    Bryce B. Reeve

  11. Medical Ethics, University of Regensburg, Regensburg, Germany

    Joseph Schmucker-Von Koch

  12. Tumor Biology Center, University Freiburg, Freiburg, Germany

    Joachim Weis

  13. Department of Pulmonary Diseases, Vrije Universiteit VUMC, Amsterdam, Netherlands

    Egbert F. Smit

  14. Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium

    Jan P. van Meerbeeck

  15. Medical Center Haaglanden, The Hague, Netherlands

    Martin J. Taphoorn

Authors
  1. John T. Maringwa
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Chantal Quinten
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Madeleine King
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jolie Ringash
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. David Osoba
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Corneel Coens
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Francesca Martinelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Jurgen Vercauteren
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Charles S. Cleeland
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Henning Flechtner
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Carolyn Gotay
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Eva Greimel
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Martin J. Taphoorn
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Bryce B. Reeve
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Joseph Schmucker-Von Koch
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Joachim Weis
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Egbert F. Smit
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Jan P. van Meerbeeck
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. Andrew Bottomley
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

on behalf of the EORTC PROBE project and the Lung Cancer Group

Corresponding author

Correspondence to John T. Maringwa.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Maringwa, J.T., Quinten, C., King, M. et al. Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials. Support Care Cancer 19, 1753–1760 (2011). https://doi.org/10.1007/s00520-010-1016-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00520-010-1016-5

Keywords

Search

Navigation