Quality of Life Research

, Volume 4, Issue 1, pp 47–52 | Cite as

Sensitivity to change of health status measures in a randomized controlled trial: comparison of the COOP charts and the SF-36

  • C. Jenkinson
  • K. Lawrence
  • D. McWhinnie
  • J. Gordon
Research Papers


This study compared the sensitivity to change of comparable dimensions of a multi-item multi-dimensional health status measure (the SF-36) with the equivalent single item domains on the Dartmouth COOP charts. One hundred and twenty nine patients were randomized to either day case laparoscopic surgery (n=60) or open inguinal hernia repair (n=69). Respondents completed the SF-36 and COOP charts at baseline (prior to surgery) and at follow up at 10 days and 6 weeks. Equivalent dimensions of physical functioning, mental health/emotional condition, social activities, pain and overall condition/general health on the two questionnaires were compared. Despite slightly different pictures of change provided by the physical functioning and ‘overall condition/general health’ dimensions the general picture of change provided by the two instruments was similar. At 10 days, patients who underwent open surgery reported far greater levels of dysfunction than those who underwent laparoscopic surgery on both questionnaires. At 6 weeks the pain dimension of both questionnaires indicated a large improvement from baseline, whilst no other domain on either questionnaire for either group indicated such improvement. The general picture of change provided by the two measures was similar. The results suggest that both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials. Differences on certain domains were caused in large measure by the nature of the questions posed. The study once again highlights the importance of checking item content to determine the suitability of any particular measure for a given study.

Key words

COOP SF-36 Randomized controlled trials surgical trials 


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  1. 1.
    HopkinsA. Measuring the Quality of Medical Care. London: Royal College of Physicians, 1990.Google Scholar
  2. 2.
    AlbrechtG. Subjective health assessment. In JenkinsonC (Ed) Measuring Health and Medical Outcomes. London: UCL Press, 1994.Google Scholar
  3. 3.
    SpilkerB, MolinekF, JohnstonK, SimpsonR, TilsonH. Quality of life bibliography and indexes. Med Care 1990; 28: DS1-DS77.Google Scholar
  4. 4.
    SpilkerB. Quality of Life Assessments in Clinical Trials. New York: Raven Press, 1990.Google Scholar
  5. 5.
    GoughIR, FurnivalCM, SchilderL, GroveW. Assessing the quality of life of patients with advanced cancer. Eur J Cancer Clin Oncol 1983; 19: 1161–1165.Google Scholar
  6. 6.
    TestaMA, AndersonRB, NackleyJF, HollenbergNK, and the Quality of Life Hypertension Group. Quality of life and antihypertensive therapy in men. A comparison of captopril with enalapril. N Engl J Med 1993; 328: 907–913.Google Scholar
  7. 7.
    CroogSH, LevineS, TestaM et al. The effects of antihypertensive therapy on the quality of life. N Engl J Med 1986; 26: 1657–1664.Google Scholar
  8. 8.
    HylandME, KenyonCAP, JacobsPA. Sensitivity of quality of life domains and constructs to longitudinal change in a clinical trial comparing salmeterol with placebo in asthmatics. Qual Life Res 1994; 3: 121–126.Google Scholar
  9. 9.
    TandonPK, StanderH, SchwarzRP. Analysis of quality of life data from a randomized, placebo controlled heart-failure trial. J Clin Epidemiol 1989; 42: 955–962.Google Scholar
  10. 10.
    SoperNJ, BruntLM, KerblK. Laparoscopic general surgery. N Engl J Med 1994; 330: 409–419.Google Scholar
  11. 11.
    WareJE, SherbourneC. The MOS 36 item short-form health survey 1: conceptual framework and item selection. Med Care 1992; 30: 473–483.Google Scholar
  12. 12.
    BeaufaitDW, NelsonEC, LandgrafJM, et al. COOP measures of functional status. In StewartM, TudiverF, BassMJ, DunnEV, NortonPG (eds.) Tools for Primary Care Research. London: Sage, 1992.Google Scholar
  13. 13.
    McHorneyCA, WareJE, RaczekAE. The MOS 36-item health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993; 31: 247–263.Google Scholar
  14. 14.
    McHorneyCA, WareJE, LuJFR, SherbourneCD. The MOS 36-item health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994; 1: 40–66.Google Scholar
  15. 15.
    JenkinsonC, WrightL, CoulterA. Criterion validity and reliability of the SF-36 in a population sample. Qual Life Res 1994; 3: 7–12.Google Scholar
  16. 16.
    GarrattAM, RutaDA, AbdallaMI, BuckinghamJK, RussellIT. The SF 36 health survey questionnaire: An outcome measure suitable for routine use within The NHS? Br Med J 1993; 306: 1440–1444.Google Scholar
  17. 17.
    LyonsRA, LoSV, LittlepageBNC. Comparative health status of patients with 11 common illnesses in Wales. J Epidemiol Community Health 1994; 48: 388–390.Google Scholar
  18. 18.
    LyonsRA, PerryHM, LittlepageBNC. Evidence for the validity of the Short-form 36 (SF-36) in an elderly population. Age Ageing 1994; 23: 182–184.Google Scholar
  19. 19.
    JenkinsonC, PetoV, CoulterA. Measuring change over time: A comparison of results from a global single item of health status and the multi dimensional SF36 in patients with menorrhagia. Qual Life Res 1994; 3: 317–321.Google Scholar
  20. 20.
    CoulterA, PetoV, JenkinsonC. Quality of life and patient satisfaction following treatment for menorrhagia. Fam Pract 1994; 11: 394–401.Google Scholar
  21. 21.
    BrazierJE, HarperR, JonesNMB, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Br Med J 1993; 305: 160–164.Google Scholar
  22. 22.
    JenkinsonC, CoulterA, WrightL. Short form 36 (SF36) health survey questionnaire: Normative data for adults of working age. Br Med J 1993; 306: 1437–1440.Google Scholar
  23. 23.
    JenkinsonC, WrightL, CoulterA. Quality of Life Measurement in Health Care: A Review of Measures and Population Norms for the UK SF-36. Oxford: Health Services Research Unit (University of Oxford), 1993.Google Scholar
  24. 24.
    NelsonEC, LandgrafJM, HaysRD, WassonJH, KirkJW. The functional status of patients: how can it be measured in physicians' offices? Med Care 1990; 28: 1111–1126.Google Scholar
  25. 25.
    WassonJ, KellerA, RubensteinL, et al. Benefits and obstacles of health status assessment in ambulatory settings: The clinician's point of view. Med Care 1992; 30: MS42-MS49.Google Scholar
  26. 26.
    McHorneyCA, WareJE, RogersW, RaczekAE, LuJFR. The validity and relative precision of MOS short- and long-form health status measures and Dartmouth COOP charts: Results from the Medical Outcomes Study. Med Care 1992; 30: MS253-MS265.Google Scholar
  27. 27.
    KazisLE, AndersonJJ, MeenanRF. Effect sizes for interpreting changes in health status. Med Care 1989; 27: S178-S189.Google Scholar
  28. 28.
    SiuAL, OuslanderJG, OsterweilD, ReubenDB, HaysRD. Change in self-reported functioning in older persons entering a residential care facility. J Clin Epidemiol 1993; 46: 1093–1101.Google Scholar
  29. 29.
    FitzpatrickR, ZieblandS, JenkinsonC, MowatA, MowatA. Importance of sensitivity to change as a criterion for selecting health status measures. Qual Health Care 1992; 1: 89–93.Google Scholar
  30. 30.
    JenkinsonC, ZieblandS, FitzpatrickR, MowatA, MowatA. Hospitalization and its influence upon results from health status questionnaires. Int J Health Sci 1993; 4: 13–18.Google Scholar
  31. 31.
    ZieblandS, FitzpatrickR, JenkinsonC. Assessing short term outcome. Qual Health Care 1992; 1: 141–142.Google Scholar

Copyright information

© Rapid Communications of Oxford Ltd 1995

Authors and Affiliations

  • C. Jenkinson
    • 1
  • K. Lawrence
    • 1
  • D. McWhinnie
    • 2
  • J. Gordon
    • 1
  1. 1.Health Services Research UnitUniversity of Oxford, Department of Public Health and Primary Care, Radcliffe InfirmaryOxfordUK
  2. 2.Nuffield Department of SurgeryUniversity of Oxford, John Radcliffe HospitalOxfordUK

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