Skip to main content
Top
Gepubliceerd 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

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

Gepubliceerd in: Quality of Life Research | Uitgave 12/2019

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

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.
Literatuur
2.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
go back to reference 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.
Metagegevens
Titel
Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome
Auteurs
Manshu Yang
San Keller
Jin-Mann S. Lin
Publicatiedatum
10-09-2019
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 12/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-019-02289-4

Andere artikelen Uitgave 12/2019

Quality of Life Research 12/2019 Naar de uitgave