Minimal clinically important differences in SF-36 global score: Current value in orthopedic oncology

Koichi Ogura, Meredith K Bartelstein, Mohamed A Yakoub, Zarko Nikolic, Patrick J Boland, John H Healey, Koichi Ogura, Meredith K Bartelstein, Mohamed A Yakoub, Zarko Nikolic, Patrick J Boland, John H Healey

Abstract

The SF-36 is widely used to evaluate the health-related quality of life (HRQoL) of patients with musculoskeletal tumors. Instead of typical methods, calculating the SF-36 Global Score has recently become an increasingly common reporting approach. However, numerical changes lack clear clinical relevance. The minimal clinically important difference (MCID) is useful for interpreting changes in functional scores by defining the smallest change patients may perceive as clinically meaningful. The aim of this study is to determine the MCID of the SF-36 Global Score in orthopedic oncology patients, which has not been reported to date. Three-hundred ten patients who underwent surgery and completed two surveys during postoperative follow-up were reviewed. The two most common methods for calculating the SF-36 Global Score were used: (1) anchor-based methods and receiver operating characteristic analysis based on one-half of the SD of change score and standard error of measurement at baseline and; (2) distribution-based methods. Using anchor-based methods, the MCIDs of SF-36 Global Scores #1 and #2 were 2.7 (area under the curve [AUC] = 0.85) and 2.5 (AUC = 0.79) for improvement, and -1.5 (AUC = 0.81) and -0.6 (AUC = 0.83) for deterioration, respectively. Using distribution-based methods, the MCIDs of SF-36 Global Scores #1 and #2 were 4.1 and 4.4 by half SD, and 4.1 and 4.5 by standard error of measurement, respectively. Our findings provide benchmark values, which can serve as a reference for future studies in musculoskeletal tumor patients using the SF-36 Global Score as a single measure for HRQoL.

Keywords: SF-36 Global Score; anchor-based method; distribution-based method; health-related quality of life (HRQoL); minimal clinically important difference (MCID); sarcoma.

Conflict of interest statement

Competing interests

The authors declare that they have no competing interests.

© 2020 Orthopaedic Research Society. Published by Wiley Periodicals LLC.

Figures

Figure 1.
Figure 1.
Flow diagram showing patient eligibility criteria for analysis.
Figure 2.
Figure 2.
Box-and-whiskers plots demonstrate the relationship between change of SF-36 Global Scores #1 (A) and #2 (B) and also displays answers to each anchor question.
Figure 2.
Figure 2.
Box-and-whiskers plots demonstrate the relationship between change of SF-36 Global Scores #1 (A) and #2 (B) and also displays answers to each anchor question.
Figure 3.
Figure 3.
The ROC curves for improvement (A) and deterioration (B) plots the true positive rate (sensitivity) against the false-positive rate (1 - specificity) for SF-36 Global Scores #1 (green line), and #2 (blue line).
Figure 3.
Figure 3.
The ROC curves for improvement (A) and deterioration (B) plots the true positive rate (sensitivity) against the false-positive rate (1 - specificity) for SF-36 Global Scores #1 (green line), and #2 (blue line).

References

    1. Coens C, van der Graaf WT, Blay JY, et al. 2015. Health-related quality-of-life results from PALETTE: A randomized, double-blind, phase 3 trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or after prior chemotherapy-a European Organization for research and treatment of cancer soft tissue and bone sarcoma group global network study (EORTC 62072). Cancer 121:2933–2941.
    1. Laucis NC, Hays RD, Bhattacharyya T. 2015. Scoring the SF-36 in Orthopaedics: A Brief Guide. J Bone Joint Surg Am 97:1628–1634.
    1. Picavet HS, Hoeymans N. 2004. Health related quality of life in multiple musculoskeletal diseases: SF-36 and EQ-5D in the DMC3 study. Ann Rheum Dis 63:723–729.
    1. Uehara K, Ogura K, Akiyama T, et al. 2017. Reliability and Validity of the Musculoskeletal Tumor Society Scoring System for the Upper Extremity in Japanese Patients. Clin Orthop Relat Res 475:2253–2259.
    1. Badhiwala JH, Witiw CD, Nassiri F, et al. 2018. Minimum Clinically Important Difference in SF-36 Scores for Use in Degenerative Cervical Myelopathy. Spine 43:E1260–E1266.
    1. Copay AG, Glassman SD, Subach BR, et al. 2008. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J 8:968–974.
    1. Kosinski M, Zhao SZ, Dedhiya S, et al. 2000. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum 43:1478–1487.
    1. Yuksel S, Ayhan S, Nabiyev V, et al. 2019. Minimum clinically important difference of the health-related quality of life scales in adult spinal deformity calculated by latent class analysis: is it appropriate to use the same values for surgical and nonsurgical patients? Spine J 19:71–78.
    1. Pellegrini MJ, Schiff AP, Adams SB Jr., et al. 2015. Conversion of Tibiotalar Arthrodesis to Total Ankle Arthroplasty. J Bone Joint Surg Am 97:2004–2013.
    1. Queen RM, Sparling TL, Butler RJ, et al. 2014. Patient-Reported Outcomes, Function, and Gait Mechanics After Fixed and Mobile-Bearing Total Ankle Replacement. J Bone Joint Surg Am 96:987–993.
    1. Tidermark J, Bergstrom G, Svensson O, et al. 2003. Responsiveness of the EuroQol (EQ 5-D) and the SF-36 in elderly patients with displaced femoral neck fractures. Qual Life Res 12:1069–1079.
    1. Johanson NA, Liang MH, Daltroy L, et al. 2004. American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments. Reliability, validity, and sensitivity to change. J Bone Joint Surg Am 86:902–909.
    1. Brazier JE, Harper R, Jones NM, et al. 1992. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Bmj 305:160–164.
    1. Ware JE, Bjoner JB, Turner-Bowker DM, Gandek B, Maruish ME. 2008. User’s manual for the SF-36 v2 Health Survey. Philadelphia, PA: Springer;
    1. Ware JE. 2001. SF-36 physical & mental health summary scales: a manual for users of version 1. Philadelphia, PA: Springer;
    1. Lins L, Carvalho FM. 2016. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med 4:2050312116671725.
    1. Copay AG, Subach BR, Glassman SD, et al. 2007. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 7:541–546.
    1. Brigden A, Parslow RM, Gaunt D, et al. 2018. Defining the minimally clinically important difference of the SF-36 physical function subscale for paediatric CFS/ME: triangulation using three different methods. Health Qual Life Outcomes 16:202.
    1. Norman GR, Sloan JA, Wyrwich KW. 2003. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 41:582–592.
    1. Crosby RD, Kolotkin RL, Williams GR. 2003. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 56:395–407.
    1. Maltenfort M, Diaz-Ledezma C. 2017. Statistics In Brief: Minimum Clinically Important Difference-Availability of Reliable Estimates. Clin Orthop Relat Res 475:933–946.
    1. Rai SK, Yazdany J, Fortin PR, et al. 2015. Approaches for estimating minimal clinically important differences in systemic lupus erythematosus. Arthritis Res Ther 17:143.
    1. Hamidou Z, Dabakuyo TS, Bonnetain F. 2011. Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials. Expert Rev Pharmacoecon Outcomes Res 11:549–559.
    1. Ousmen A, Touraine C, Deliu N, et al. 2018. Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: a structured review. Health Qual Life Outcomes 16:228.
    1. Leopold SS, Porcher R. 2017. Editorial: The Minimum Clinically Important Difference-The Least We Can Do. Clin Orthop Relat Res 475:929–932.
    1. Ware JE Jr. 2000. SF-36 health survey update. Spine (Phila Pa 1976) 25:3130–3139.
    1. Hanley JA, McNeil BJ. 1982. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 143:29–36.
    1. Lemieux J, Brundage MD, Parulekar WR, et al. 2018. Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years. J Clin Oncol 36:563–571.
    1. Ranft A, Seidel C, Hoffmann C, et al. 2017. Quality of Survivorship in a Rare Disease: Clinicofunctional Outcome and Physical Activity in an Observational Cohort Study of 618 Long-Term Survivors of Ewing Sarcoma. J Clin Oncol 35:1704–1712.
    1. van Wulfften Palthe ODR, Janssen SJ, Wunder JS, et al. 2017. What questionnaires to use when measuring quality of life in sacral tumor patients: the updated sacral tumor survey. Spine J 17:636–644.
    1. Bekkering WP, van Egmond-van Dam JC, Bramer JAM, et al. 2017. Quality of life after bone sarcoma surgery around the knee: A long-term follow-up study. Eur J Cancer Care (Engl) 26.
    1. Rivard JD, Puloski SS, Temple WJ, et al. 2015. Quality of life, functional outcomes, and wound complications in patients with soft tissue sarcomas treated with preoperative chemoradiation: a prospective study. Ann Surg Oncol 22:2869–2875.
    1. Anagnostopoulos F, Niakas D, Pappa E. 2005. Construct validation of the Greek SF-36 Health Survey. Qual Life Res 14:1959–1965.
    1. Cookson MS, Dutta SC, Chang SS, et al. 2003. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol 170:1926–1930.
    1. Maruish ME. 2011. User’s manual for the SF-36v2 Health Survey (3rd ed.). Lincoln, RI: QualityMetric Incorporated;
    1. Campbell H, Rivero-Arias O, Johnston K, et al. 2006. Responsiveness of objective, disease-specific, and generic outcome measures in patients with chronic low back pain: an assessment for improving, stable, and deteriorating patients. Spine (Phila Pa 1976) 31:815–822.
    1. Hagg O, Fritzell P, Nordwall A. 2003. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J 12:12–20.
    1. Mannion AF, Porchet F, Kleinstuck FS, et al. 2009. The quality of spine surgery from the patient’s perspective: part 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index. Eur Spine J 18 Suppl 3:374–379.
    1. Brazier J, Roberts J, Deverill M. 2002. The estimation of a preference-based measure of health from the SF-36. J Health Econ 21:271–292.
    1. Brazier J, Usherwood T, Harper R, et al. 1998. Deriving a preference-based single index from the UK SF-36 Health Survey. J Clin Epidemiol 51:1115–1128.
    1. Harvie HS, Honeycutt AA, Neuwahl SJ, et al. 2019. Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse. Am J Obstet Gynecol 220:265.e261–265.e211.
    1. Walters SJ, Brazier JE. 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.
    1. Walters SJ, Brazier JE. 2005. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 14:1523–1532.
    1. Drummond M 2001. Introducing economic and quality of life measurements into clinical studies. Ann Med 33:344–349.
    1. Malek F, Somerson JS, Mitchel S, et al. 2012. Does limb-salvage surgery offer patients better quality of life and functional capacity than amputation? Clin Orthop Relat Res 470:2000–2006.
    1. Jayadevappa R, Cook R, Chhatre S. 2017. Minimal important difference to infer changes in health-related quality of life-a systematic review. J Clin Epidemiol 89:188–198.

Source: PubMed

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