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Published in: Health and Quality of Life Outcomes 1/2003

Open Access 01-12-2003 | Research

What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D

Authors: Stephen J Walters, John E Brazier

Published in: Health and Quality of Life Outcomes | Issue 1/2003

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Abstract

Background

The SF-6D is a new single summary preference-based measure of health derived from the SF-36. Empirical work is required to determine what is the smallest change in SF-6D scores that can be regarded as important and meaningful for health professionals, patients and other stakeholders.

Objectives

To use anchor-based methods to determine the minimally important difference (MID) for the SF-6D for various datasets.

Methods

All responders to the original SF-36 questionnaire can be assigned an SF-6D score provided the 11 items used in the SF-6D have been completed. The SF-6D can be regarded as a continuous outcome scored on a 0.29 to 1.00 scale, with 1.00 indicating "full health".
Anchor-based methods examine the relationship between an health-related quality of life (HRQoL) measure and an independent measure (or anchor) to elucidate the meaning of a particular degree of change. One anchor-based approach uses an estimate of the MID, the difference in the QoL scale corresponding to a self-reported small but important change on a global scale. Patients were followed for a period of time, then asked, using question 2 of the SF-36 as our global rating scale, (which is not part of the SF-6D), if there general health is much better (5), somewhat better (4), stayed the same (3), somewhat worse (2) or much worse (1) compared to the last time they were assessed. We considered patients whose global rating score was 4 or 2 as having experienced some change equivalent to the MID. In patients who reported a worsening of health (global change of 1 or 2) the sign of the change in the SF-6D score was reversed (i.e. multiplied by minus one). The MID was then taken as the mean change on the SF-6D scale of the patients who scored (2 or 4).

Results

This paper describes the MID for the SF-6D from seven longitudinal studies that had previously used the SF-36.

Conclusions

From the seven reviewed studies (with nine patient groups) the MID for the SF-6D ranged from 0.010 to 0.048, with a weighted mean estimate of 0.033 (95% CI: 0.029 to 0.037). The corresponding Standardised Response Means (SRMs) ranged from 0.11 to 0.48, with a mean of 0.30 and were mainly in the "small to moderate" range using Cohen's criteria, supporting the MID results. Using the half-standard deviation (of change) approach the mean effect size was 0.051 (range 0.033 to 0.066). Further empirical work is required to see whether or not this holds true for other patient groups and populations.
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Literature
1.
go back to reference Sloan JA, Cella D, Frost M, Guyatt GH, Sprangers M, Symonds T, and the Clinical Significance Consensus Meeting Group: Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clinic Proceedings 2002,77(4):367–370.PubMedCrossRef Sloan JA, Cella D, Frost M, Guyatt GH, Sprangers M, Symonds T, and the Clinical Significance Consensus Meeting Group: Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clinic Proceedings 2002,77(4):367–370.PubMedCrossRef
2.
go back to reference Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, and the Clinical Significance Consensus Meeting Group: Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings 2002,77(4):371–383.PubMedCrossRef Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, and the Clinical Significance Consensus Meeting Group: Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings 2002,77(4):371–383.PubMedCrossRef
3.
go back to reference Cella D, Bullinger M, Scott C, Barofsky I, and the Clinical Significance Consensus Meeting Group: Group vs. individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clinic Proceedings 2002,77(4):384–392.PubMedCrossRef Cella D, Bullinger M, Scott C, Barofsky I, and the Clinical Significance Consensus Meeting Group: Group vs. individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clinic Proceedings 2002,77(4):384–392.PubMedCrossRef
4.
go back to reference Sloan JA, Aaronson N, Cappelleri JC, Fairclough DL, Varricchio C, Clinical Significance Consensus Meeting Group: Assessing the clinical significance of single items relative to summated scores. Mayo Clinic Proceedings 2002,77(5):479–487.PubMedCrossRef Sloan JA, Aaronson N, Cappelleri JC, Fairclough DL, Varricchio C, Clinical Significance Consensus Meeting Group: Assessing the clinical significance of single items relative to summated scores. Mayo Clinic Proceedings 2002,77(5):479–487.PubMedCrossRef
5.
go back to reference Frost MH, Bonomi AE, Ferrans CE, Wong GY, Hays RD, and the Clinical Significance Consensus Meeting Group: Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clinic Proceedings 2002,77(5):488–494.PubMedCrossRef Frost MH, Bonomi AE, Ferrans CE, Wong GY, Hays RD, and the Clinical Significance Consensus Meeting Group: Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clinic Proceedings 2002,77(5):488–494.PubMedCrossRef
6.
go back to reference Sprangers MA, Moinpour CM, Moynihan TJ, Patrick DL, Revicki DA, and the Clinical Significance Consensus Meeting Group: Assessing meaningful change in quality of life over time: a users' guide for clinicians. Mayo Clinic Proceedings 2002,77(6):561–571.PubMedCrossRef Sprangers MA, Moinpour CM, Moynihan TJ, Patrick DL, Revicki DA, and the Clinical Significance Consensus Meeting Group: Assessing meaningful change in quality of life over time: a users' guide for clinicians. Mayo Clinic Proceedings 2002,77(6):561–571.PubMedCrossRef
7.
go back to reference Symonds T, Berzon R, Marquis P, Rummans TA, and the Clinical Significance Consensus Meeting Group: The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clinic Proceedings 2002,77(6):572–583.PubMedCrossRef Symonds T, Berzon R, Marquis P, Rummans TA, and the Clinical Significance Consensus Meeting Group: The clinical significance of quality-of-life results: practical considerations for specific audiences. Mayo Clinic Proceedings 2002,77(6):572–583.PubMedCrossRef
8.
go back to reference Fayers PM, Machin DM: Quality of Life: Assessment, Analysis & Interpretation Chichester: Wiley 2000.CrossRef Fayers PM, Machin DM: Quality of Life: Assessment, Analysis & Interpretation Chichester: Wiley 2000.CrossRef
9.
go back to reference Jaeschke R, Singer J, Guyatt GH: Measurement of Health Status. Ascertaining the Minimal Clinically Important Difference. Controlled Clinical Trials 1989, 10: 407–415. 10.1016/0197-2456(89)90005-6PubMedCrossRef Jaeschke R, Singer J, Guyatt GH: Measurement of Health Status. Ascertaining the Minimal Clinically Important Difference. Controlled Clinical Trials 1989, 10: 407–415. 10.1016/0197-2456(89)90005-6PubMedCrossRef
10.
go back to reference Sloan J, Symonds T, Vargas-Chanes D, Fridley B: Practical Guidelines for Assessing the Clinical Significance of Health-Related Quality of Life Changes within Clinical Trials. Drug Information Journal 2003,37(1):23–31. Sloan J, Symonds T, Vargas-Chanes D, Fridley B: Practical Guidelines for Assessing the Clinical Significance of Health-Related Quality of Life Changes within Clinical Trials. Drug Information Journal 2003,37(1):23–31.
11.
go back to reference Juniper EF, Guyatt GH, Willan A, Griffith LE: Determining a minimal important change in a disease-specific Quality of Life Questionnaire. Journal of Clinical Epidemiology 1994,47(1):81–87.PubMedCrossRef Juniper EF, Guyatt GH, Willan A, Griffith LE: Determining a minimal important change in a disease-specific Quality of Life Questionnaire. Journal of Clinical Epidemiology 1994,47(1):81–87.PubMedCrossRef
12.
go back to reference Norman GR, Sridhar FG, Guyatt GH, Walter SD: The Relation of Distribution- and Anchor-Based Approaches in Interpretation of Changes in Health Related Quality of Life. Medical Care 2001,39(10):1039–1047. 10.1097/00005650-200110000-00002PubMedCrossRef Norman GR, Sridhar FG, Guyatt GH, Walter SD: The Relation of Distribution- and Anchor-Based Approaches in Interpretation of Changes in Health Related Quality of Life. Medical Care 2001,39(10):1039–1047. 10.1097/00005650-200110000-00002PubMedCrossRef
13.
go back to reference Cohen J: Statistical Power Analysis for the Behavioural Sciences 2 Edition New Jersey: Lawrence Earlbaum 1988. Cohen J: Statistical Power Analysis for the Behavioural Sciences 2 Edition New Jersey: Lawrence Earlbaum 1988.
14.
go back to reference Staquet MJ, Hays RD, Fayers PM: Quality of Life Assessment in Clinical Trials: Methods and Practice Oxford University Press: Oxford 1998. Staquet MJ, Hays RD, Fayers PM: Quality of Life Assessment in Clinical Trials: Methods and Practice Oxford University Press: Oxford 1998.
15.
go back to reference Kazis LE, Anderson JJ, Meenan RF: Effect Sizes for Interpreting Changes in Health Status. Medical Care 1989,27(3):S178-S189.PubMedCrossRef Kazis LE, Anderson JJ, Meenan RF: Effect Sizes for Interpreting Changes in Health Status. Medical Care 1989,27(3):S178-S189.PubMedCrossRef
16.
go back to reference Liang MH, Larson MG, Gullen KE, Schwartz JA: Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Arthritis & Rheumatology 1985, 28: 545–547. Liang MH, Larson MG, Gullen KE, Schwartz JA: Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Arthritis & Rheumatology 1985, 28: 545–547.
17.
go back to reference Liang MH, Fossel AH, Larson MG: Comparisons of Five Health Status Instruments for Orthopaedic Evaluation. Medical Care 1990,28(7):632–642.PubMedCrossRef Liang MH, Fossel AH, Larson MG: Comparisons of Five Health Status Instruments for Orthopaedic Evaluation. Medical Care 1990,28(7):632–642.PubMedCrossRef
18.
go back to reference Guyatt GH, Walter S, Norman G: Measuring change over time: assessing the usefulness of evaluative instruments. Journal of Chronic Disease 1987, 40: 171–178.CrossRef Guyatt GH, Walter S, Norman G: Measuring change over time: assessing the usefulness of evaluative instruments. Journal of Chronic Disease 1987, 40: 171–178.CrossRef
19.
go back to reference Norman GR, Stratford P, Regehr G: Methodological Problems in the Retrospective Computation of Responsiveness to Change: The Lesson of Cronbach. J Clinical Epidemiology 1997,50(8):869–879. 10.1016/S0895-4356(97)00097-8CrossRef Norman GR, Stratford P, Regehr G: Methodological Problems in the Retrospective Computation of Responsiveness to Change: The Lesson of Cronbach. J Clinical Epidemiology 1997,50(8):869–879. 10.1016/S0895-4356(97)00097-8CrossRef
20.
go back to reference Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care 1992, 30: 473–483.PubMedCrossRef Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care 1992, 30: 473–483.PubMedCrossRef
21.
go back to reference Ware JE Jr, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey Manual and Interpretation Guide Boston, MA: The Health Institute, New England Medical Centre 1993. Ware JE Jr, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey Manual and Interpretation Guide Boston, MA: The Health Institute, New England Medical Centre 1993.
22.
go back to reference Angst F, Aeschlimann A, Stucki G: Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis & Rheumatism 2001, 4: 384–391. Publisher Full Text 10.1002/1529-0131(200108)45:4<384::AID-ART352>3.0.CO;2-0CrossRef Angst F, Aeschlimann A, Stucki G: Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis & Rheumatism 2001, 4: 384–391. Publisher Full Text 10.1002/1529-0131(200108)45:4<384::AID-ART352>3.0.CO;2-0CrossRef
23.
go back to reference Hays RD, Morales LS: The RAND-36 measure of health-related quality of life. Annals of Medicine 2001,33(5):350–357.PubMedCrossRef Hays RD, Morales LS: The RAND-36 measure of health-related quality of life. Annals of Medicine 2001,33(5):350–357.PubMedCrossRef
24.
go back to reference Brazier J, Usherwood T, Harper R, Thomas K: Deriving a Preference-based Single Index from the UK SF-36 Health Survey. J Clin Epidemiol 1998,51(11):1115–1128. 10.1016/S0895-4356(98)00103-6PubMedCrossRef Brazier J, Usherwood T, Harper R, Thomas K: Deriving a Preference-based Single Index from the UK SF-36 Health Survey. J Clin Epidemiol 1998,51(11):1115–1128. 10.1016/S0895-4356(98)00103-6PubMedCrossRef
25.
go back to reference Brazier JE, Roberts JF, Deverill MD: The estimation of a preference based measure of health from the SF-36. Health Economics 2002, 21: 271–292. 10.1016/S0167-6296(01)00130-8CrossRef Brazier JE, Roberts JF, Deverill MD: The estimation of a preference based measure of health from the SF-36. Health Economics 2002, 21: 271–292. 10.1016/S0167-6296(01)00130-8CrossRef
26.
go back to reference Morrell CJ, Walters SJ, Dixon S, Collins KA, Brereton LML, Peters J, Brooker CGD: Cost-effectiveness of community leg ulcer clinics: randomised controlled trial. British Medical Journal 1998, 316: 1487–1491.PubMedCentralPubMedCrossRef Morrell CJ, Walters SJ, Dixon S, Collins KA, Brereton LML, Peters J, Brooker CGD: Cost-effectiveness of community leg ulcer clinics: randomised controlled trial. British Medical Journal 1998, 316: 1487–1491.PubMedCentralPubMedCrossRef
27.
go back to reference Walters SJ, Munro JF, Brazier JE: Using the SF-36 with older adults: cross-sectional community based survey. Age & Ageing 2001, 30: 337–343. 10.1093/ageing/30.4.337CrossRef Walters SJ, Munro JF, Brazier JE: Using the SF-36 with older adults: cross-sectional community based survey. Age & Ageing 2001, 30: 337–343. 10.1093/ageing/30.4.337CrossRef
28.
go back to reference Akehurst RL, Brazier JE, Mathers N, Healy C, Kaltenthaler E, Morgan AM, Platts M, Walters SJ: Health-related Quality of Life and Cost Impact of Irritable bowel Syndrome in a UK Primary Care Setting. Pharmacoeconomics 2002,20(7):455–462.PubMedCrossRef Akehurst RL, Brazier JE, Mathers N, Healy C, Kaltenthaler E, Morgan AM, Platts M, Walters SJ: Health-related Quality of Life and Cost Impact of Irritable bowel Syndrome in a UK Primary Care Setting. Pharmacoeconomics 2002,20(7):455–462.PubMedCrossRef
29.
go back to reference Harper R, Brazier JE, Waterhouse JC, Walters SJ, Jones NMB, Howard P: Comparison of outcome measures for patients with chronic obstructive pulmonary disease (COPD) in an outpatient setting. Thorax 1997, 52: 879–887.PubMedCentralPubMedCrossRef Harper R, Brazier JE, Waterhouse JC, Walters SJ, Jones NMB, Howard P: Comparison of outcome measures for patients with chronic obstructive pulmonary disease (COPD) in an outpatient setting. Thorax 1997, 52: 879–887.PubMedCentralPubMedCrossRef
30.
go back to reference Brazier JE, Harper R, Munro JF, Walters SJ, Snaith ML: Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rhemautology 1999, 38: 870–877. 10.1093/rheumatology/38.9.870CrossRef Brazier JE, Harper R, Munro JF, Walters SJ, Snaith ML: Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rhemautology 1999, 38: 870–877. 10.1093/rheumatology/38.9.870CrossRef
31.
go back to reference Petitti D-B: Meta-analysis, Decision Analysis, Cost-Effectiveness Analysis. Methods for Quantitative Synthesis in Medicine Oxford, Oxford University Press 1994. Petitti D-B: Meta-analysis, Decision Analysis, Cost-Effectiveness Analysis. Methods for Quantitative Synthesis in Medicine Oxford, Oxford University Press 1994.
32.
go back to reference Armitage P, Berry G, Matthews JNS: Statistical Methods in Medical Research 4 Edition Oxford: Blackwell 2002.CrossRef Armitage P, Berry G, Matthews JNS: Statistical Methods in Medical Research 4 Edition Oxford: Blackwell 2002.CrossRef
33.
go back to reference Efron B, Tibshirani RJ: An Introduction to the Bootstrap New York: Chapman & Hall 1993.CrossRef Efron B, Tibshirani RJ: An Introduction to the Bootstrap New York: Chapman & Hall 1993.CrossRef
34.
go back to reference Wyrwich KW, Metz SM, Babu AN, Kroenke K, Tierney WM, Wolinsky FD: The reliability of retrospective change assessments. Quality of Life Research 2002,11(7):636. Wyrwich KW, Metz SM, Babu AN, Kroenke K, Tierney WM, Wolinsky FD: The reliability of retrospective change assessments. Quality of Life Research 2002,11(7):636.
35.
go back to reference Jacobson NS, Truax P: Clinical Significance: A Statistical Approach to defining Meaningful Change in Psychotherapy Research. Journal of Consulting and Clinical Psychology 1991,59(1):12–19. 10.1037//0022-006X.59.1.12PubMedCrossRef Jacobson NS, Truax P: Clinical Significance: A Statistical Approach to defining Meaningful Change in Psychotherapy Research. Journal of Consulting and Clinical Psychology 1991,59(1):12–19. 10.1037//0022-006X.59.1.12PubMedCrossRef
36.
go back to reference Fergason RJ, Robinson AB, Spaine M: Use of the Reliable Change Index to evaluate clinical significance in SF-36 outcomes. Quality of Life Research 2002, 11: 509–516. 10.1023/A:1016350431190CrossRef Fergason RJ, Robinson AB, Spaine M: Use of the Reliable Change Index to evaluate clinical significance in SF-36 outcomes. Quality of Life Research 2002, 11: 509–516. 10.1023/A:1016350431190CrossRef
37.
go back to reference Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD: Linking Clinical Relevance and Statistical Significance in Evaluating Intra-Individual Changes in Health-Related Quality of Life. Medical Care 1999,37(5):469–478. 10.1097/00005650-199905000-00006PubMedCrossRef Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD: Linking Clinical Relevance and Statistical Significance in Evaluating Intra-Individual Changes in Health-Related Quality of Life. Medical Care 1999,37(5):469–478. 10.1097/00005650-199905000-00006PubMedCrossRef
38.
go back to reference Wyrwich KW, Tierney WM, Wolinsky FD: Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire. Quality of Life Research 2002, 11: 1–7. 10.1023/A:1014485627744PubMedCrossRef Wyrwich KW, Tierney WM, Wolinsky FD: Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire. Quality of Life Research 2002, 11: 1–7. 10.1023/A:1014485627744PubMedCrossRef
39.
go back to reference Drummond MF: Introducing economic and quality of life measures into clinical studies. Ann Med 2001, 33: 344–349.PubMedCrossRef Drummond MF: Introducing economic and quality of life measures into clinical studies. Ann Med 2001, 33: 344–349.PubMedCrossRef
40.
go back to reference Walters SJ, Campbell MJ, Paisley S: Methods for determining sample sizes for studies involving quality of life measures: a tutorial. Health Services & Outcomes Research Methodology 2001, 2: 83–99. 10.1023/A:1020102612073CrossRef Walters SJ, Campbell MJ, Paisley S: Methods for determining sample sizes for studies involving quality of life measures: a tutorial. Health Services & Outcomes Research Methodology 2001, 2: 83–99. 10.1023/A:1020102612073CrossRef
Metadata
Title
What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D
Authors
Stephen J Walters
John E Brazier
Publication date
01-12-2003
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2003
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-1-4

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