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“Quality of Life” Assessment in Multiple Sclerosis Clinical Trials: Current Status and Strategies for Improving Multiple Sclerosis Clinical Trial Design

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Multiple Sclerosis

Abstract

Sometime in the future, a multiple sclerosis (MS) patient comes to see the neurologist. Neurologist: “Well, your MRI looks great!” Patient: “That’s wonderful doc, because my life is falling apart, I feel lousy and that medication you gave me made me sicker than my MS did”. This situation is mirrored in clinical trials in which statistical imperatives dictate that outcomes be narrowly defined, often in terms of a single primary outcome measure. Although this strategy may help to avoid the type of error that occurs when so many outcomes are examined, it is problematic because a broad spectrum of other clinically relevant outcomes may be discounted.

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References

  • Archibald CJ, McGrath T, Ritvo PG, Fisk JD, Murray TJ (1994) Pain in multiple sclerosis: prevelance, severity, and impact on mental health. Pain 58: 89–93

    Article  PubMed  CAS  Google Scholar 

  • Bergner M, Bobbitt RA, Carter WB, Gilson BS (1981) The Sickness Impact Profile: development and final revision of a health status measure. Med Care 19: 787–805

    Article  PubMed  CAS  Google Scholar 

  • Brandt J (1991) The Hopkins Verbal Learning Test: development of a new memory test with six equivalent forms. Clin Neuropsychol 5:125–142

    Google Scholar 

  • Consortium of Multiple Sclerosis Centers (1994) Charter and bylaws. Consortium of Multiple Sclerosis Centers, Teaneck, NJ

    Google Scholar 

  • Cubbon J (1991) The principle of QALY maximisation as the basis for allocating health care resources. J Med Ethics 17: 181–184

    Article  PubMed  CAS  Google Scholar 

  • Deyo RA, Centor RM (1986) Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chron Dis 39: 897–906

    Article  PubMed  CAS  Google Scholar 

  • Davies AR, Sherbourne CD, Peterson JR, Ware JE (1988) Scoring manual: adult health status and patient satisfaction measures used in RAND’s Health Insurance Experiment, N-2190-HHS. The RAND Corporation, Santa Monica, CA

    Google Scholar 

  • Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ (1994) The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 21: 9–14

    PubMed  CAS  Google Scholar 

  • Foley FW (1993) Foreword: Comprehensive evaluation of outcome of care in multiple sclerosis. J Neurol Rehabil 7: 85–86

    Google Scholar 

  • Gelber RD, Goldhirsch A (1986) A new endpoint for the measuremen of adjuvant therapy in postmenopausal women with operable breast cancer. J Clin Oncol 4:1772–1779

    Google Scholar 

  • Gelber RD, Goldhirsch A, Simes RJ, Glasziou P, Castiglione M (1989) Integration of quality-of-life issues into clinical trials of breast cancer. In: Cavalli F (ed) Endocrine therapy of breast cancer oI Springer, Heidelberg,pp 27–36

    Google Scholar 

  • Gelber RD, Lenderking WR, Cotton DJ et al. (1992) Quality-of-life evaluation in a clinical trial of zidovudine therapy in patients with mildly symptomatic HIV infection. Ann Intern Med 116: 961–966

    PubMed  CAS  Google Scholar 

  • Goodkin DE, Hertsgaard D, Seminary J (1988 ) Upper extremity function in multiple sclerosis:improving assessment sensitivity with Box and Block and Nine Hole Peg Tests. Arch Phys Med Rehabil 69:850–854

    PubMed  CAS  Google Scholar 

  • Gronwell DMA (1977) Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills 44: 67–373

    Google Scholar 

  • Guyatt GH, Townsend M, Berman LB, Pugsley SO (1987) Quality of life in patients with chronic airflow limitation. Br J Dis Chest 81: 45–54

    Article  PubMed  CAS  Google Scholar 

  • Guyatt GH, Feeney DH, Patrick DL (1993) Measuring health-related quality of life. Ann Intern Med 118: 622–629

    PubMed  CAS  Google Scholar 

  • Haber A, LaRocca NG (1985) Minimal Record of Disability in multiple sclerosis. National Multiple Sclerosis Society, New York

    Google Scholar 

  • Harris J (1987) QALYfying the value of life. J Med Ethics 13: 117–123

    Article  PubMed  CAS  Google Scholar 

  • Hauser SL, Dawson DM, Lehrich JR et al. (1983) Intensive immunosuppression in progressive multiple sclerosis: a randomized three-arm study o high dose intravenous cyclophosphamide, plasma exchange, and ACTH. N Engl J Med 308: 173–180

    Article  PubMed  CAS  Google Scholar 

  • Hunt SM, McKenna SP, Williams J (1981) Reliability f a population survey tool for measurin perceived health problems: a study of patients with coxarthrosis. J Epidemiol Community Health 35: 297–300

    Article  PubMed  CAS  Google Scholar 

  • Kaplan f life assessment for cost/utility studies in cancer. Cancer Treat (Suppl A):85–96

    Google Scholar 

  • Kaplan mm. Anderson JP (1990) The general health policy model: an integrated approach. In: Spilker B (ed) Quality of life ass t in clinical trials Raven Press, New York, 131–149

    Google Scholar 

  • Karnofsky DA, Burchenal JH (1949) Clinical evaluation of ch mh mu nts in cancer. In: McLeod CM (ed) Evaluation of chemotherapeutic agents. Columbia University Press, New York, 191–205

    Google Scholar 

  • Karnofsky DA,Abelmann WH,Craver LF,Bburchenal JH (1949) The use of the nitrogen mustards in the palliative treatment of carcinoma. Cancer 20:634–656

    Google Scholar 

  • Kurtzke JF (1983) Rating neurological impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33: 1444–1452

    PubMed  CAS  Google Scholar 

  • LaPuma J, Lawlor EF (1990) Quality-adjusted life-years. JAMA 263: 2917–2921

    Article  CAS  Google Scholar 

  • Levine MN, Guyatt GH, Gent M et al. (1988) Quality of life in stage II breast cancer: an instrument for clinical trials. J Clin Oncol 6: 1798–1810

    PubMed  CAS  Google Scholar 

  • Llewellyn-Thomas HA, Sutherland HJ, Hogg SA et al. (1984) Linear-analogue self assessment of voice quality in laryngeal cancer. J Chron Dis 73: 917–924

    Article  Google Scholar 

  • Meenan RF, Gertman PM, Mason JH (1980) Measuring health status in arthritis: the arthritis impact measurement scale. Arthritis Rheum 23: 146–152

    Article  PubMed  CAS  Google Scholar 

  • National Institutes of Health (1993) Quality of life assessment: practice, problems, and promise (NIH Publication no. 93–3505 ). US Department of Health and Human Services, Washington, DC

    Google Scholar 

  • Patrick DL, Bergner M (1990) Measurement of health status in the 1990s. Ann Rev Public Health 11: 165–183

    Article  CAS  Google Scholar 

  • Patrick DL, Erickson P (1993) Health status and health policy: quality of life in health care evaluation and resource allocation. Oxford University Press, New York

    Google Scholar 

  • Russell D, Peplau LA, Cutrona CE (1980) The revised UCLA loneliness scale: concurrent and discriminant validity evidence. J Pers Soc Psycho! 39: 472–480

    Article  CAS  Google Scholar 

  • Sanford ME, Petajan JH (1990) Effects of multiple sclerosis on daily living. In: Rao SM (ed) Neurobehavioral aspects of mulitple sclerosis. Oxford University Press, New York, pp 251–265

    Google Scholar 

  • Schretlen D, Bobholz JH (1992) Standardization and initial validation of a brief test of executive attentional ability. J Clin Exp Neuropsychol 14: 65 (abstract)

    Google Scholar 

  • Schumacher M, Olschewski M, Schulgen G (1991) Assessment of quality of life in clinical trials. Stat Med 10: 1915–1930

    Article  PubMed  CAS  Google Scholar 

  • Schwartz CE, Cole BF, Gelber RD (1995) Measuring patient-centered outcomes in neurologic disease: extending the Q-TWiST methodology. Arch Neurol 52: 754–762

    PubMed  CAS  Google Scholar 

  • Schover LR, Jensen SB (1988) Sexuality and chronic illness: a comprehensive approach. Guilford Press, New York

    Google Scholar 

  • Sherbourne CD, Stewart AL (1991) The MOS Social Support Survey. Soc Sci Med 32: 705–714

    Article  PubMed  CAS  Google Scholar 

  • Smith A (1973) Symbol Digit Modalities Test manual. Western Psychological Services, Los Angeles, CA

    Google Scholar 

  • Stewart AL, Hayes RD, Ware JE (1992) Health perceptions, energy, fatigue, and health distress measures. In: Stewart AL, Ware JE (eds) Measuring functioning and well being. Duke University Press, Durham, NC, pp 143–172

    Google Scholar 

  • Sullivan MJL, Edgley K, Dehoux E (1990) A survey of multiple sclerosis. Part 1: perceived cognitive problems and compensatory strategy use. Can J Rehabil 4: 99–105

    Google Scholar 

  • Torrance GW, Feeny D (1989) Utilities and quality-adjusted life years. Int J Technol Assess Health Care 5: 559–575

    Article  PubMed  CAS  Google Scholar 

  • Veit CT, Ware JE (1983) The structure of psychological distress and well-being in general populations. J Consult Clin Psychol 51: 730–732

    Article  PubMed  CAS  Google Scholar 

  • Vickrey BG, Hays RD, Engel J et al. (1995a) Outcome assessment for epilepsy surgery: the impact of measuring health-related quality of life. Ann Neurol 37: 158–166

    Article  PubMed  CAS  Google Scholar 

  • Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW (1995b) A health-related quality of life measure for multiple sderosis. Qual Life Res 4: 187–206

    Article  PubMed  CAS  Google Scholar 

  • Ware JE, Sherbourne CD (1992) The MOS 36-item Short Form Health Survey (SF-36). Med Care 30: 473–481

    Article  PubMed  Google Scholar 

  • Ware JE, Snow KK, Kosinski M, Gandek B (1993) SF-36 Health Survey: manual and interpretation guide. The Health Institute, New England Medical Center, Boston, MA

    Google Scholar 

  • Wiklund I, Dimenas E, Wahl M (1990) Factors of importance when evaluating quality of life in clinical trials. Control Clin Trials 11: 169–179

    Article  PubMed  CAS  Google Scholar 

  • World Health Organization (1947) The constitution of the World Health Organization. WHO, Geneva, Chron 1: 29

    Google Scholar 

  • World Health Organization (1980) International Classification of Impairments, Disabilities, and Handicaps. WHO, Geneva

    Google Scholar 

Download references

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© 1996 Springer-Verlag London Limited

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LaRocca, N.G., Ritvo, P.G., Miller, D.M., Fischer, J.S., Andrews, H., Paty, D.W. (1996). “Quality of Life” Assessment in Multiple Sclerosis Clinical Trials: Current Status and Strategies for Improving Multiple Sclerosis Clinical Trial Design. In: Goodkin, D.E., Rudick, R.A. (eds) Multiple Sclerosis. Springer, London. https://doi.org/10.1007/978-1-4471-1271-6_7

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  • DOI: https://doi.org/10.1007/978-1-4471-1271-6_7

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-85233-033-0

  • Online ISBN: 978-1-4471-1271-6

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