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Br J Cancer. May 2001; 84(9): 1156–1165.
PMCID: PMC2363885

Clinical relevance of single item quality of life indicators in cancer clinical trials

Abstract

We investigated the hypothesis that global single-item quality-of-life indicators are less precise for specific treatment effects (discriminant validity) than multi-item scales but similarly efficient for overall treatment comparisons and changes over time (responsiveness) because they reflect the summation of the individual meaning and importance of various factors. Linear analogue self-assessment (LASA) indicators for physical well-being, mood and coping were compared with the Hospital Anxiety and Depression Scale (HAD), the Mood Adjective Check List (MACL) and the emotional behaviour and social interaction scales of the Sickness Impact Profile (SIP) in 84 patients with early breast cancer receiving adjuvant therapy. Discriminant validity was investigated by multitrait-multimethod correlation, responsiveness by standardized response mean (SRM). Discriminant validity of the indicators was present at baseline but less under treatment. Responsiveness was demonstrated by the expected pattern among treatments (P = 0.008). In patients without chemotherapy, the SRMs indicated moderate (0.5–0.8) to large (>0.8) improvements in physical well-being (0.70), coping (0.92), HAD anxiety (0.89) and depression (1.19), and MACL mental well-being (0.68). In patients with chemotherapy for the first 3 months, small but clinically significant improvements (>).2) included mood (0.38), coping (0.41), HAD axiety (0.31) and MACL mental well-being (0.35). Patients with 6 months chemotherapy showed no changes. The indicators also reflected mood disorders (HAD) and marked psychosocial dysfunction (SIP) at baseline and under treatment according to pre-defined cut-off levels. Global indicators were confirmed to be efficient for evaluating treatments overall and changes over time. The lower reliability of single as opposed to multi-item scales affects primarily their discriminant validity. This is less decisive in large sample sizes. © 2001 Cancer Research Campaign http://www.bjcancer.com

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Selected References

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  • Ahlmén EM, Bengtsson CB, Sullivan BM, Bjelle A. A comparison of overall health between patients with rheumatoid arthritis and a population with and without rheumatoid arthritis. Scand J Rheumatol. 1990;19(6):413–421. [PubMed]
  • Bergner M, Bobbitt RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care. 1981 Aug;19(8):787–805. [PubMed]
  • Bernhard J, Hürny C, Coates AS, Peterson HF, Castiglione-Gertsch M, Gelber RD, Goldhirsch A, Senn HJ, Rudenstam CM. Quality of life assessment in patients receiving adjuvant therapy for breast cancer: the IBCSG approach. The International Breast Cancer Study Group. Ann Oncol. 1997 Sep;8(9):825–835. [PubMed]
  • Bernhard J, Castiglione-Gertsch M, Schmitz SF, Thürlimann B, Cavalli F, Morant R, Fey MF, Bonnefoi H, Goldhirsch A, Hürny C. Quality of life in postmenopausal patients with breast cancer after failure of tamoxifen: formestane versus megestrol acetate as second-line hormonal treatment. Swiss Group for Clinical Cancer Research (SAKK). Eur J Cancer. 1999 Jun;35(6):913–920. [PubMed]
  • Bernhard J, Thürlimann B, Schmitz SF, Castiglione-Gertsch M, Cavalli F, Morant R, Fey MF, Bonnefoi H, Goldhirsch A, Hürny C. Defining clinical benefit in postmenopausal patients with breast cancer under second-line endocrine treatment: does quality of life matter? J Clin Oncol. 1999 Jun;17(6):1672–1679. [PubMed]
  • Butow P, Coates A, Dunn S, Bernhard J, Hürny C. On the receiving end. IV: Validation of quality of life indicators. Ann Oncol. 1991 Sep;2(8):597–603. [PubMed]
  • Coates A, Gebski V, Bishop JF, Jeal PN, Woods RL, Snyder R, Tattersall MH, Byrne M, Harvey V, Gill G. Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Engl J Med. 1987 Dec 10;317(24):1490–1495. [PubMed]
  • Coates A, Glasziou P, McNeil D. On the receiving end--III. Measurement of quality of life during cancer chemotherapy. Ann Oncol. 1990;1(3):213–217. [PubMed]
  • Coates A, Gebski V, Signorini D, Murray P, McNeil D, Byrne M, Forbes JF. Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. Australian New Zealand Breast Cancer Trials Group. J Clin Oncol. 1992 Dec;10(12):1833–1838. [PubMed]
  • Coates A, Thomson D, McLeod GR, Hersey P, Gill PG, Olver IN, Kefford R, Lowenthal RM, Beadle G, Walpole E. Prognostic value of quality of life scores in a trial of chemotherapy with or without interferon in patients with metastatic malignant melanoma. Eur J Cancer. 1993;29A(12):1731–1734. [PubMed]
  • Fallowfield LJ, Hall A, Maguire GP, Baum M. Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial. BMJ. 1990 Sep 22;301(6752):575–580. [PMC free article] [PubMed]
  • Hall A, A'Hern R, Fallowfield L. Are we using appropriate self-report questionnaires for detecting anxiety and depression in women with early breast cancer? Eur J Cancer. 1999 Jan;35(1):79–85. [PubMed]
  • Hürny C, Bernhard J, Gelber RD, Coates A, Castiglione M, Isley M, Dreher D, Peterson H, Goldhirsch A, Senn HJ. Quality of life measures for patients receiving adjuvant therapy for breast cancer: an international trial. The International Breast Cancer Study Group. Eur J Cancer. 1992;28(1):118–124. [PubMed]
  • Hürny C, Bernhard J, Bacchi M, van Wegberg B, Tomamichel M, Spek U, Coates A, Castiglione M, Goldhirsch A, Senn HJ, et al. The Perceived Adjustment to Chronic Illness Scale (PACIS): a global indicator of coping for operable breast cancer patients in clinical trials. Swiss Group for Clinical Cancer Research (SAKK) and the International Breast Cancer Study Group (IBCSG). Support Care Cancer. 1993 Jul;1(4):200–208. [PubMed]
  • Hürny C, Bernhard J, Coates A, Peterson HF, Castiglione-Gertsch M, Gelber RD, Rudenstam CM, Collins J, Lindtner J, Goldhirsch A, et al. Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial. Med Care. 1996 Mar;34(3):234–248. [PubMed]
  • Hürny C, Bernhard J, Coates AS, Castiglione-Gertsch M, Peterson HF, Gelber RD, Forbes JF, Rudenstam CM, Simoncini E, Crivellari D, et al. Impact of adjuvant therapy on quality of life in women with node-positive operable breast cancer. International Breast Cancer Study Group. Lancet. 1996 May 11;347(9011):1279–1284. [PubMed]
  • Katz JN, Larson MG, Phillips CB, Fossel AH, Liang MH. Comparative measurement sensitivity of short and longer health status instruments. Med Care. 1992 Oct;30(10):917–925. [PubMed]
  • Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care. 1990 Jul;28(7):632–642. [PubMed]
  • Manne SL, Sabbioni M, Bovbjerg DH, Jacobsen PB, Taylor KL, Redd WH. Coping with chemotherapy for breast cancer. J Behav Med. 1994 Feb;17(1):41–55. [PubMed]
  • Maraste R, Brandt L, Olsson H, Ryde-Brandt B. Anxiety and depression in breast cancer patients at start of adjuvant radiotherapy. Relations to age and type of surgery. Acta Oncol. 1992;31(6):641–643. [PubMed]
  • Maunsell E, Brisson J, Deschênes L. Psychological distress after initial treatment of breast cancer. Assessment of potential risk factors. Cancer. 1992 Jul 1;70(1):120–125. [PubMed]
  • Maunsell E, Brisson J, Deschênes L, Frasure-Smith N. Randomized trial of a psychologic distress screening program after breast cancer: effects on quality of life. J Clin Oncol. 1996 Oct;14(10):2747–2755. [PubMed]
  • McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007–1019. [PubMed]
  • McHorney CA, Ware JE, Jr, Rogers W, Raczek AE, Lu JF. The validity and relative precision of MOS short- and long-form health status scales and Dartmouth COOP charts. Results from the Medical Outcomes Study. Med Care. 1992 May;30(5 Suppl):MS253–MS265. [PubMed]
  • Priestman TJ, Baum M. Evaluation of quality of life in patients receiving treatment for advanced breast cancer. Lancet. 1976 Apr 24;1(7965):899–900. [PubMed]
  • Sjöberg L, Svensson E, Persson LO. The measurement of mood. Scand J Psychol. 1979;20(1):1–18. [PubMed]
  • Sullivan M, Ahlmén M, Archenholtz B, Svensson G. Measuring health in rheumatic disorders by means of a Swedish version of the sickness impact profile. Results from a population study. Scand J Rheumatol. 1986;15(2):193–200. [PubMed]
  • Sullivan M, Karlsson J, Sjöström L, Backman L, Bengtsson C, Bouchard C, Dahlgren S, Jonsson E, Larsson B, Lindstedt S, et al. Swedish obese subjects (SOS)--an intervention study of obesity. Baseline evaluation of health and psychosocial functioning in the first 1743 subjects examined. Int J Obes Relat Metab Disord. 1993 Sep;17(9):503–512. [PubMed]
  • Watson D, Pennebaker JW. Health complaints, stress, and distress: exploring the central role of negative affectivity. Psychol Rev. 1989 Apr;96(2):234–254. [PubMed]
  • Watson M, Greer S, Rowden L, Gorman C, Robertson B, Bliss JM, Tunmore R. Relationships between emotional control, adjustment to cancer and depression and anxiety in breast cancer patients. Psychol Med. 1991 Feb;21(1):51–57. [PubMed]
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361–370. [PubMed]

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