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Erschienen in: Quality of Life Research 12/2019

10.09.2019

Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome

verfasst von: Manshu Yang, San Keller, Jin-Mann S. Lin

Erschienen in: Quality of Life Research | Ausgabe 12/2019

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Abstract

Purpose

To evaluate the psychometric properties of the Patient-Reported Outcome Measurement Information System® Fatigue Short Form 7a (PROMIS F-SF) among people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Methods

Analyses were conducted using data from the Multi-Site Clinical Assessment of ME/CFS study, which recruited participants from seven ME/CFS specialty clinics across the US. Baseline and follow-up data from ME/CFS participants and healthy controls were used. Ceiling/Floor effects, internal consistency reliability, differential item functioning (DIF), known-groups validity, and responsiveness were examined.

Results

The final sample comprised 549 ME/CFS participants at baseline, 386 of whom also had follow-up. At baseline, the sample mean of PROMIS F-SF T-score was 68.6 (US general population mean T-score of 50 and standard deviation of 10). The PROMIS F-SF demonstrated good internal consistency reliability (Cronbach’s α = 0.84) and minimal floor/ceiling effects. No DIF was detected by age or sex for any item. This instrument also showed good known-groups validity with medium-to-large effect sizes (η2 = 0.08–0.69), with a monotonic increase of the fatigue T-score across ME/CFS participant groups with low, medium, and high functional impairment as measured by three different variables (p < 0.01), and with significantly higher fatigue T-scores among ME/CFS participants than healthy controls (p < 0.0001). Acceptable responsiveness was found with small-to-medium effect sizes (Guyatt’s Responsiveness Statistic = 0.28–0.54).

Conclusions

Study findings support the reliability and validity of PROMIS F-SF as a measure of fatigue for ME/CFS and lend support to the drug development tool submission for qualifying this measure to evaluate therapeutic effect in ME/CFS clinical trials.
Literatur
2.
Zurück zum Zitat United States Food and Drug Administration. (2013). The voice of the patient: Chronic fatigue syndrome and myalgic encephalomyelitis. Bethesda: United States Food and Drug Administration. United States Food and Drug Administration. (2013). The voice of the patient: Chronic fatigue syndrome and myalgic encephalomyelitis. Bethesda: United States Food and Drug Administration.
4.
Zurück zum Zitat Jason, L. A., Richman, J. A., Rademaker, A. W., Jordan, K. M., Plioplys, A. V., Taylor, R. R., et al. (1999). A community-based study of chronic fatigue syndrome. Archives of Internal Medicine,159(18), 2129–2137.CrossRefPubMed Jason, L. A., Richman, J. A., Rademaker, A. W., Jordan, K. M., Plioplys, A. V., Taylor, R. R., et al. (1999). A community-based study of chronic fatigue syndrome. Archives of Internal Medicine,159(18), 2129–2137.CrossRefPubMed
10.
Zurück zum Zitat Fukuda, K., Straus, S. E., Hickie, I., Sharpe, M. C., Dobbins, J. G., & Komaroff, A. (1994). The chronic fatigue syndrome: A comprehensive approach to its definition and study International. Chronic Fatigue Syndrome Study Group. Annals of Internal Medicine,121(12), 953–959.CrossRefPubMed Fukuda, K., Straus, S. E., Hickie, I., Sharpe, M. C., Dobbins, J. G., & Komaroff, A. (1994). The chronic fatigue syndrome: A comprehensive approach to its definition and study International. Chronic Fatigue Syndrome Study Group. Annals of Internal Medicine,121(12), 953–959.CrossRefPubMed
11.
Zurück zum Zitat Carruthers, B. M., Jain, A. K., De Meirleir, K. L., Peterson, D. L., Klimas, N. G., Lerner, A. M., et al. (2003). Myalgic encephalomyelitis/chronic fatigue syndrome: Clinical working case definition, diagnostic and treatment protocols. Journla of Chronic Fatigue Syndrome,11(1), 7–115.CrossRef Carruthers, B. M., Jain, A. K., De Meirleir, K. L., Peterson, D. L., Klimas, N. G., Lerner, A. M., et al. (2003). Myalgic encephalomyelitis/chronic fatigue syndrome: Clinical working case definition, diagnostic and treatment protocols. Journla of Chronic Fatigue Syndrome,11(1), 7–115.CrossRef
16.
Zurück zum Zitat Chalder, T., Berelowitz, G., Pawlikowska, T., Watts, L., Wessely, S., Wright, D., et al. (1993). Development of a fatigue scale. Journal of Psychosomatic Research,37(2), 147–153.CrossRefPubMed Chalder, T., Berelowitz, G., Pawlikowska, T., Watts, L., Wessely, S., Wright, D., et al. (1993). Development of a fatigue scale. Journal of Psychosomatic Research,37(2), 147–153.CrossRefPubMed
19.
Zurück zum Zitat Unger, E. R., Lin, J.-M. S., Tian, H., Natelson, B. H., Lange, G., Vu, D., et al. (2017). Multi-site clinical assessment of myalgic encephalomyelitis/chronic fatigue syndrome (MCAM): Design and Implementation of a prospective/retrospective rolling cohort study. American Journal of Epidemiology,185(8), 617–626. https://doi.org/10.1093/aje/kwx029.CrossRefPubMed Unger, E. R., Lin, J.-M. S., Tian, H., Natelson, B. H., Lange, G., Vu, D., et al. (2017). Multi-site clinical assessment of myalgic encephalomyelitis/chronic fatigue syndrome (MCAM): Design and Implementation of a prospective/retrospective rolling cohort study. American Journal of Epidemiology,185(8), 617–626. https://​doi.​org/​10.​1093/​aje/​kwx029.CrossRefPubMed
21.
Zurück zum Zitat Embretson, S. E., & Reise, S. P. (2013). Item response theory. Rotterdam: Psychology Press.CrossRef Embretson, S. E., & Reise, S. P. (2013). Item response theory. Rotterdam: Psychology Press.CrossRef
23.
Zurück zum Zitat Cai, L., Thissen, D., & du Toit, S. H. C. (2011). IRTPRO: Flexible, multidimensional, multiple categorical IRT modeling. Lincolnwood, IL: Scientific Software International. Cai, L., Thissen, D., & du Toit, S. H. C. (2011). IRTPRO: Flexible, multidimensional, multiple categorical IRT modeling. Lincolnwood, IL: Scientific Software International.
24.
Zurück zum Zitat SAS Institute Inc. (2002–2014). SAS®9.4 Help and Documentation. Cary, NC: SAS Institute Inc. SAS Institute Inc. (2002–2014). SAS®9.4 Help and Documentation. Cary, NC: SAS Institute Inc.
26.
Zurück zum Zitat Terwee, C. B., Bot, S. D., de Boer, M. R., van der Windt, D. A., Knol, D. L., Dekker, J., et al. (2007). Quality criteria were proposed for measurement properties of health status questionnaires.,60(1), 34–42. Terwee, C. B., Bot, S. D., de Boer, M. R., van der Windt, D. A., Knol, D. L., Dekker, J., et al. (2007). Quality criteria were proposed for measurement properties of health status questionnaires.,60(1), 34–42.
27.
Zurück zum Zitat Nunnally, J., & Bernstein, I. (1978). Psychometric Theory McGraw-Hill New York Google Scholar. Nunnally, J., & Bernstein, I. (1978). Psychometric Theory McGraw-Hill New York Google Scholar.
28.
Zurück zum Zitat Lohr, K N J Qo L R. (2002). Assessing health status and quality-of-life instruments: Attributes and review criteria. Quality of Life,11(3), 193–205.CrossRef Lohr, K N J Qo L R. (2002). Assessing health status and quality-of-life instruments: Attributes and review criteria. Quality of Life,11(3), 193–205.CrossRef
29.
Zurück zum Zitat Bartlett, S. J., Orbai, A.-M., Duncan, T., DeLeon, E., Ruffing, V., Clegg-Smith, K., et al. (2015). Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS ONE,10(9), e0138543.CrossRefPubMedPubMedCentral Bartlett, S. J., Orbai, A.-M., Duncan, T., DeLeon, E., Ruffing, V., Clegg-Smith, K., et al. (2015). Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS ONE,10(9), e0138543.CrossRefPubMedPubMedCentral
30.
Zurück zum Zitat Yost, K. J., Eton, D. T., Garcia, S. F., & Cella, D. J. J. O. C. E. (2011). Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. Journal of Clinical Epidemiology,64(5), 507–516.CrossRefPubMedPubMedCentral Yost, K. J., Eton, D. T., Garcia, S. F., & Cella, D. J. J. O. C. E. (2011). Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. Journal of Clinical Epidemiology,64(5), 507–516.CrossRefPubMedPubMedCentral
31.
Zurück zum Zitat Lord, F. M. (1980). Applications of item response theory to practical testing problems. Hillsdale, NJ: Lawrence Erlbaum Associates. Lord, F. M. (1980). Applications of item response theory to practical testing problems. Hillsdale, NJ: Lawrence Erlbaum Associates.
32.
Zurück zum Zitat Langer, M. M. (2008). A Reexamination of Lord’s Wald Test for Differential Item Functioning Using Item Response Theory and Modern Error Estimation. Doctoral Dissertation, University of North Carolina at Chapel Hill. Langer, M. M. (2008). A Reexamination of Lord’s Wald Test for Differential Item Functioning Using Item Response Theory and Modern Error Estimation. Doctoral Dissertation, University of North Carolina at Chapel Hill.
33.
Zurück zum Zitat Rusu, C., Gee, M. E., Lagacé, C., & Parlor, M. (2015). Chronic fatigue syndrome and fibromyalgia in Canada: Prevalence and associations with six health status indicators. Health Promotion and Chronic Disease Prevention in Canada: Research, Policy and Practice,35(1), 3–11.CrossRef Rusu, C., Gee, M. E., Lagacé, C., & Parlor, M. (2015). Chronic fatigue syndrome and fibromyalgia in Canada: Prevalence and associations with six health status indicators. Health Promotion and Chronic Disease Prevention in Canada: Research, Policy and Practice,35(1), 3–11.CrossRef
34.
Zurück zum Zitat Benjamini, Y., & Hochberg, Y. (1995). Controlling the false discovery rate: A practical and powerful approach to multiple testing. Journal of the Royal Statistical Society. Series B (Methodological),57(1), 289–300.CrossRef Benjamini, Y., & Hochberg, Y. (1995). Controlling the false discovery rate: A practical and powerful approach to multiple testing. Journal of the Royal Statistical Society. Series B (Methodological),57(1), 289–300.CrossRef
37.
Zurück zum Zitat Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates.
38.
Zurück zum Zitat Miles, J., & Shevlin, M. (2001). Applying regression & correlation: A guide for students and researchers (1st ed.). Thousand Oaks, CA: Sage. Miles, J., & Shevlin, M. (2001). Applying regression & correlation: A guide for students and researchers (1st ed.). Thousand Oaks, CA: Sage.
41.
Metadaten
Titel
Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome
verfasst von
Manshu Yang
San Keller
Jin-Mann S. Lin
Publikationsdatum
10.09.2019
Verlag
Springer International Publishing
Erschienen in
Quality of Life Research / Ausgabe 12/2019
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-019-02289-4

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