Abstract
Patients undergoing limb salvage surgery for bone and soft tissue sarcoma of the extremities experience significant physical disability as a result of life-preserving treatment. The existing health status measures do not adequately evaluate physical function from the patient's perspective. This paper presents the developmental studies item selection, of a new measure, The Toronto Extremity Salvage Score (TESS). Patients with bone and soft tissue sarcoma (76 upper and 83 lower extremity) were randomly selected and mailed the TESS. Patients rated the severity and importance of physical disabilities; the response options included a ‘not applicable’; category and open-ended questions that allowed patients to suggest additional items for inclusion in the questionnaire. Therefore, patient perceptions were used to determine item content. Difficulty and importance frequencies were calculated and items rated “totally unimportant’ or ‘not applicable’ by 30% of the sample were eliminated. Extra items identified 30% of the time were added to the questionnaire. Internal consistency was evaluated by Cronbach's alpha. Test-retest reliability and validity were evaluated on subsequent patient samples. The intraclass correlation coefficient (ICC) was calculated for test-retest reliability and correlations with The Musculoskeletal Tumour Society Rating Scale (MSTS) were calculated for construct validity. Standardized effect sizes were calculated as a measure of responsiveness. Fifty upper extremity and sixty-six lower extremity patients responded to the mailed questionnaire. No items were eliminated based on importance or not applicable ratings. Sporting activities were identified as additional items in both the upper and lower extremity questionnaire. High internal consistency was demonstrated: 0.94 for the lower and 0.92 for the upper extremity questionnaires respectively. Test-retest reliability was evaluated at multiple time-points and the intraclass correlation coefficient was greater than 0.87 in all instances. Construct validity was shown by a moderate correlation with the MSTS. The effect sizes were large demonstrating responsiveness. The use of patients' perceptions in determining the content of the TESS has resulted in a reliable and valid measure that is able to detect change over time.
References
Simon MA. Current concepts review, limb salvage for osteosarcoma. J Bone Joint Surg 1989; 70A: 307–310.
Bergner, M. Quality of life, health status, and clinical research. Med Care 27(3): S148–S156.
Liang MH. The historical and conceptual framework for functional assessment in rheumatic disease. J Rheum 1987; 14(Suppl): 2–5.
Patrick DL, Bergner M. Measurement of health status in the 1990's. Ann Rev Pub Health 1990; 11: 165–183.
Ware JE. Conceptualizing and Measuring Generic Health Outcomes. Cancer 1991; Suppl 1: 774–779.
Patrick DL, Erikson P. Health Status and Health Policy Allocating Resources to Health Care. New York: Oxford University Press, 1993.
Bell RS, O'Sullivan B, Langer FL. Complications and functional results after limb salvage surgery and radiology for difficult mesenchymal neoplasms. Can J Surg 1989; 32: 69–73.
Bell RS, O'Sullivan B, Davis AM, et al. Functional outcome in soft tissue sarcoma treated by surgery and irradiation. J Surg Oncol 1991; 48: 224–231.
Capanna R, Ruggieri P, Biagini R, et al. The effect of quadriceps excision on functional results after distal femoral resection and prosthetic replacement of bone tumors. Clin Ortho 1991; 267: 186–196.
Davis AM, Bell RS, Allan DG, et al. Functional outcome of fresh osteochondral allografts following tumour resection. Transplantation Implantation 1991; 8: 9–12.
Gebhardt MC, Roth YF, Mankin HJ. Osteoarticular allografts for reconstruction in the proximal part of the humerus after excision of a musculoskeletal tumor. J Bone Joint Surg 1990; 72(3): 334–345.
Harris IE, Leff AR, Gitelis S, et al. Function after amputation, arthrodesis, or arthroplasty for tumors about the knee. J Bone Joint Surg 1990; 72(10): 1477–1485.
Bergner M, Bobbit RA, Pollard WE, et al. The sickness impact profile: validation of a health status measure medical care. J Med Care 1976; 14: 57–67.
Bergner M, Bobbitt RA, Carter WN, et al. The sickness impact profile: development and final revision of a health status measure. Med Care 1981; 19: 787–805.
Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Brit Med J 1992; 305(6846): 160–164.
Hunt SM, McEwen J, McKenna SP, Measuring health status: A new tool for clinicians and epidemiologists. J R Col Gen Pract 1985; 35: 185–188.
McHorney CA, Ware JEJr, Raczek AE. The MOS SF-36 short-form health survey (SF-36): II psychometric and clinical test of validity in measuring physical and mental health constructs. Med Care 1993; 31(3): 247–263.
Ware JEJr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36) I Conceptual framework and item selection. Med Care 1992; 30(6): 473–483.
Ware JEJr. SF-36 Health Survey: Manual and Interpretation Guide. Boston, MA: Nimrod Press, 1993.
Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer-QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. JNCI 1993; 85(5): 365–376.
Ganz PA, Schag CAC, Lee JJ, et al. The CARES: A generic measure of health-related quality of life for patients with cancer. Qual Life Res 1992; 1: 19–29.
Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: Development and validation of the general measure. J Clin Oncol 1993; 11(3): 570–579.
Enneking WF. Modification of the system for functional evaluation in the surgical management of musculoskeletal tumours. In: Enneking WF, ed. Limb Salvage in Musculoskeletal Oncology. New York, NY: Churchill Livingston, 1987: 626–639.
Enneking WF, Dunham W, Gebhardt MC, et al. A system for the functional evaluation of reconstructive procedures after surgical treatment of tumors of the musculoskeletal system. CORR 1993; 286: 241–246.
Meenan RF. The AIMS approach to health status measurement: conceptual background and measurement properties. J Rheum 1982; 9(5): 785–788.
Spiegel JS, Leake B, Spiegel TM, et al. What are we measuring? An examination of self-reported functional status measures. Arth Rheum 1988; 31(6): 721–728.
Bombardier C, Tugwell PA. Methodological framework to develop and select indices for clinical trials: statistical and judgmental approaches. J Rheum 1982; 9(5): 753–757.
MacKenzie CR, Charleson ME, DiGioia D, et al. Patientspecific measure of change in maximal function. Arch Int Med 1986; 146: 1325–1329.
Tugwell PX, Bombardier C. A methodological framwork for developing and selecting endpoints in clinical trials. J Rheum 1982; 9(5): 758–762.
Feinstein AR, Clinimetrics, New Haven, CN: Yale University Press, 1987.
Wright JG, Feinstein AR. A comparative contrast of clinimetric and psychometric methods for constructing indexes and rating scales. J Clin Epidemiol 1992; 45(11): 1201–1218.
Guyatt G, Bombardier C, Tugwell PX. Measuring diseasespecific quality of life in clinical trials. CMAJ 1986; 134: 889–895.
Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951; 16(3): 297–334.
Nunnally JC. Psychometric Theory (2nd edition). New York, NY: Oxford University Press, 1978.
Fleiss JL. The Design and Analysis of Clinical Experiments. New York, NY: John Wiley and Sons, 1986.
Kazis LE, Anderson JL, Meenan RF, Efect sizes for interpreting changes in health status. Med Care 1989; 27: S178-S189.
Cohen J. Statistical Power Analysis for the Behavioral Sciences (Revised Edition). New York, NY: Academic Press, 1988.
Wright JG, Rudicel S, Feinstein AR. Asking patients what they want: a method for evaluating the complaints of individual patients receiving total hip replacements. J Bone Joint Surg 1994; 76: 229–234.
Author information
Authors and Affiliations
Additional information
Work completed at the University Musculoskeletal Oncology Unit, University of Toronto and Mount Sinai Hospital, Toronto.
This work was completed as partial requirement for Master's of Science, Clinical Epidemiology, University of TOronto.
Dr. Wright is supported by a Medical Research Council of Canada Scholarship.
Rights and permissions
About this article
Cite this article
Davis, A.M., Wright, J.G., Williams, J.I. et al. Development of a measure of physical function for patients with bone and soft tissue sarcoma. Qual Life Res 5, 508–516 (1996). https://doi.org/10.1007/BF00540024
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF00540024