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An evaluation of patient-reported outcome measures in lower limb reconstruction surgery

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Abstract

Purpose

To assess the measurement properties (acceptability, validity, reliability and responsiveness), of the MOS 36-Item Short-Form Health Survey (SF-36), the EQ-5D, the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Musculoskeletal Functional Assessment Instrument (MFA), in patients who have undergone limb reconstruction surgery (LRS).

Methods

Four instruments measuring patient-reported outcome were completed at baseline and 12 months from surgery.

Results

101 LRS patients were recruited with 95 responding at baseline and 71 at a 12-month follow-up. Response rates at baseline were over 94%. In three instruments, there was evidence of floor or ceiling effect, the exception being the EQ-5D. Cronbach’s α statistics of internal consistency reliability were acceptable at ≥0.80 for all dimensions of the MFA, the SF-MPQ PRI(S) and seven of the SF-36 dimensions. When comparing mean changes in scores between baseline and 12 months, the most responsive measure was the SF-36 with an average Standardised Response Mean of 0.48 for those who reported their health as better. Statistically significant differences were observed between the health change groups (‘worse’, ‘better’ and ‘same’) for four dimensions of the SF-36, the two summary scores and the SF-6D.

Conclusions

Variation and poor performance of some of the instruments resulted in a recommendation of using the SF-36 and the SF-6D for LRS patients.

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Abbreviations

LRS:

Limb reconstruction surgery

QoL:

Quality of life

PRO:

Patient-reported outcome

PROMs:

Patient-reported outcome measures

SF-36:

Short-form 36

SF-MPQ:

Short-form McGill Pain Questionnaire

MFA:

Musculoskeletal Functional Assessment Instrument

PCS:

Physical component summary score

MCS:

Mental component summary score

VAS:

Visual Analogue Scale

PF:

Physical function

RP:

Role-physical

SF:

Social functioning

RE:

Role-emotional

BP:

Bodily pain

MH:

Mental health

VT:

Vitality and energy

GHP:

General health perception

SG:

Standard gamble

PRI:

Pain rating index

PRI(S):

Pain rating index-sensory

PRI(A):

Pain rating index-affective

PPI:

Present pain intensity

SRM:

Standardised response mean

TC:

Treatment complete

TI:

Treatment incomplete

MCID:

Minimal clinical important difference

References

  1. Kaye, J. A., & Jick, H. (2004). Epidemiology of lower limb fractures in general practice in the United Kingdom. Injury Prevention, 10, 368–374.

    Article  PubMed  CAS  Google Scholar 

  2. Saleh, M., Yang, L., & Sims, M. (1999). Limb reconstruction after high energy trauma. British Medical Bulletin of Traum, 55, 870.

    Article  CAS  Google Scholar 

  3. Walters, S. J. (2009). Quality of life outcomes in clinical trials and health care evaluation: A practical guide to analysis and interpretation. Chichester: Wiley.

    Book  Google Scholar 

  4. Ware, J. E., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36) 1. Conceptual framework and item selection. Medical Care, 30, 473–483.

    Google Scholar 

  5. Brazier, J., Roberts, J., & Deverill, M. (2002). The estimation of a preference-based measure of health from the SF-36. Journal of Health Economics, 21, 271.

    Article  PubMed  Google Scholar 

  6. The EuroQol Group. (1990). A facility for the measurement of health-related quality of life. Health Policy, 16, 99–2078.

    Google Scholar 

  7. Melzack, R. (1987). The short-form McGill pain questionnaire. Pain, 30, 191–197.

    Article  PubMed  CAS  Google Scholar 

  8. Martin, D. P., Engelberg, R., Agel, J., Snapp, D., & Swiontkowski, M. (1996). Development Of a musculoskeletal extremity health status instrument: The musculoskeletal function assessment instrument. Journal of Orthopaedic Research, 14, 173–181.

    Article  PubMed  CAS  Google Scholar 

  9. Ware, J. E. J., Kosinski, M., & Keller, S. D. (1994). SF-36 physical and mental health summary scales: A user’s manual. Boston: Health Institute.

    Google Scholar 

  10. Ruta, D. A., Hurst, N. P., Kind, P., Hunter, M., & Stubbings, A. (1998). Measuring health status in British patients with rheumatoid arthritis: Reliability, validity and responsiveness of the short form 36-item health survey (SF-36). British Journal of Rheumatology, 37, 425–436.

    Article  PubMed  CAS  Google Scholar 

  11. Brazier, J. E., Ratcliffe, J., Tsuchiya, A., & Solomon, J. (2007). Measuring and valuing health for economic evaluation. Oxford: Oxford University Press.

    Google Scholar 

  12. Torrance, G. W. (1987). Utility approach to measuring health-related quality of life. Journal of Chronic Diseases, 40, 593–600.

    Article  PubMed  CAS  Google Scholar 

  13. Streiner, D. L., & Norman, G. R. (2003). Health measurement scales a practical guide to their development and use. Oxford: Oxford Medical Publication.

    Google Scholar 

  14. Dolan, P. (1997). Modeling valuations for EuroQol health states. Medical Care, 11, 1095–1108.

    Article  Google Scholar 

  15. Hurst, N. P., Kind, P., Ruta, D., Hunter, M., & Stubbings, A. (1997). Measuring health-related quality of life in rheumatoid arthritis: Validity, responsiveness and reliability of EuroQol (EQ-5D). British Journal of Rheumatology, 36, 551–559.

    Article  PubMed  CAS  Google Scholar 

  16. Garratt, A. M., Klaber Moffett, J., & Farrin, A. J. (2001). Responsiveness of generic and specific measures of health outcome in low back pain. Spine, 26, 71–77.

    Article  PubMed  CAS  Google Scholar 

  17. Guyatt, G. H., Kirshner, B., & Jaeschke, R. (1992). Measuring health status: What are the necessary measurement properties? Journal of Clinical Epidemiology, 45, 1341–1345.

    Article  PubMed  CAS  Google Scholar 

  18. Fitzpatrick, R., Davey, C., Buxton, M. J., & Jones, D. R. (1998). Evaluating patient-based outcome measures for use in clinical trials. Health Technology Assessment, 2, 1–74.

    PubMed  CAS  Google Scholar 

  19. Guyatt, G. H., Eagle, D. J., Sackett, B., Willan, A., Griffith, L. E., McLlroy, W., et al. (1993). Measuring quality of life in the frail elderly. Journal of Clinical Epidemiology, 46, 1433–1444.

    Article  PubMed  CAS  Google Scholar 

  20. Bernhard, J., Gusset, H., & Hurny, C. (1995). Quality-of-life assessment in cancer clinical trials: Intervention by itself? Support. Care Cancer, 3, 66–71.

    Article  CAS  Google Scholar 

  21. Walters, S., Morrell, C., & Dixon, S. (1999). Measuring health-related quality of life in patients with venous leg ulcers. Quality of Life Research, 4, 327–336.

    Article  Google Scholar 

  22. Lerner, R. K., Esterhai, J. L., Polomano, R. C., Cheatle, M. D., & Heppenstall, R. B. (1993). Quality Of life assessment of patients with post traumatic fracture non-union, chronic refractory osteomyelitis and lower-extremity amputation. Clinical Orthopaedics & Related Research, 295, 28–36.

    Google Scholar 

  23. Cattaneo, R., Catagni, M., & Johnson, E. E. (1992). The treatment of infected nonunions and segmental defects of the tibia by the methods of Ilizarov. Clinical Orthopaedics and Related Research, 280, 143–152.

    Google Scholar 

  24. Caudle, R., & Stern, P. J. (1987). Severe open tibial fractures of the tibia. Journal of Bone and Joint Surgery. American Volume, 69(6), 801–807.

    CAS  Google Scholar 

  25. Cohen, J. (1988). Statistical power analysis for the behavioural sciences. New Jersey: Lawrence Earlbaum.

    Google Scholar 

  26. Nunnally, J. C. (1978). Psychometric theory. New York: McGraw-Hill.

    Google Scholar 

  27. Munro, B. H. (2001). Statistical methods for health care research (4th ed., Chap. 10). Philadelphia: Lippincott, Williams, & Wilkins.

  28. Walters, S. J., & Brazier, J. E. (2003). What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D. Health Qual Life Outcomes, 1, 4.

    Article  PubMed  Google Scholar 

  29. Ware, J. E., Kosinski, M., & Dewey, J. E. (2000). How to score version 2 of the SF-36 health survey. Lincoln, RE: QualityMetric Incorporated.

    Google Scholar 

  30. Swiontkowski, M. F., Engelberg, R., Martin, D. P., & Agel, J. (1999). Short musculoskeletal function assessment questionnaire: Validity, reliability, and responsiveness. Journal Bone & Joint Surgery, 81-A.

  31. Harper, R., Brazier, J. E., & Waterhouse, J. C. (1997). Comparison Of outcome measures for patients with chronic obstructive pulmonary disease (COPD) in an outpatient setting. Thorax, 52, 879–887.

    Article  PubMed  CAS  Google Scholar 

  32. Grafton, K. V., & Foster, N. (2005). Test-retest reliability of the short-form McGill pain questionnaire: Assessment of intraclass correlation coefficients and limits of agreement in patients with osteoarthritis. The Clinical Journal of Pain, 21, 73–82.

    Article  PubMed  Google Scholar 

  33. Lee, H., Nicholson, L. L., Adams, R. D., Maher, C. G., Halaki, M., & Bae, S. (2006). Development and psychometric testing of Korean language versions of 4 neck pain and disability questionnaires. Spine (Phila Pa 1976), 31, 1841–1845.

    Article  Google Scholar 

  34. Georgoudis, G., Watson, P. J., & Oldham, J. A. (2000). The development and validation of a Greek version of the short-form McGill pain questionnaire. European Journal of Pain, 4, 275–281.

    Article  PubMed  CAS  Google Scholar 

  35. Strand, L. I., Ljunggren, A. E., Bogen, B., Ask, T., & Johnsen, T. B. (2008). The short-form McGill pain questionnaire as an outcome measure: Test-retest reliability and responsiveness to change. European Journal of Pain, 12, 917–925.

    Article  PubMed  Google Scholar 

  36. Dogra, A. S., Ruiz, A. L., & Marsh, D. R. (2002). Late outcome of isolated tibial fractures treated by intramedullary nailing: The correlation between disease-specific and generic outcome measures. Journal of Orthopaedic Trauma, 16, 245–249.

    Article  PubMed  CAS  Google Scholar 

  37. Timmins, N. (2008). NHS goes to the PROMS. BMJ, 336, 1464.

    Article  PubMed  Google Scholar 

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Acknowledgments

Trent Research and Development for the financial support of the project.

Author information

Authors and Affiliations

  1. Centre for Health and Social Care Research, Sheffield Hallam University, Montgomery House, Collegiate Campus, Sheffield, S10 2BP, UK

    M. Burton

  2. Department of Medical Statistics and Clinical Trials, School for Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

    S. J. Walters

  3. Department of Trauma and Orthopaedics, University of Sheffield, Sheffield, UK

    M. Saleh

  4. Norfolk and Norwich University Hospital, Norwich, UK

    M. Saleh

  5. Department of Health Economics, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

    J. E. Brazier

Authors
  1. M. Burton
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  2. S. J. Walters
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  3. M. Saleh
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  4. J. E. Brazier
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Correspondence to M. Burton.

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Burton, M., Walters, S.J., Saleh, M. et al. An evaluation of patient-reported outcome measures in lower limb reconstruction surgery. Qual Life Res 21, 1731–1743 (2012). https://doi.org/10.1007/s11136-011-0090-6

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