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Assessment of Fatigue: Review and Future Directions

Assessment of Fatigue: Review and Future Directions. Zeeshan Butt, Ph.D. Research Scientist, Center on Outcomes, Research, and Education (CORE)/ENH Research Assistant Professor, Northwestern University Feinberg School of Medicine z-butt@northwestern.edu

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Assessment of Fatigue: Review and Future Directions

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  1. Assessment of Fatigue:Review and Future Directions Zeeshan Butt, Ph.D. Research Scientist, Center on Outcomes, Research, and Education (CORE)/ENH Research Assistant Professor, Northwestern University Feinberg School of Medicine z-butt@northwestern.edu AGS/NIA/Hartford Conference: Idiopathic Fatigue of Aging September 5, 2008

  2. Overview Self-report Fatigue measurement Existing instruments Future directions: PROMIS

  3. Fatigue Clinically important, but non-specific symptom present across a number of chronic illnesses and health conditions Given the subjective nature of fatigue, self-report may be the best way to assess the symptom.

  4. Fatigue Self-report • Subjective nature suggests reliance on self-report • Several validated tools exist for measuring fatigue • no instrument is the clear gold-standard method • Many instruments tend to assess fatigue as multidimensional concept • dimensions: temporal characteristics, severity, impact • manifestations: physical, cognitive, emotional, behavioral

  5. Multidimensional Scales Fatigue Assessment Instrument Fatigue Impact Scale Fatigue Symptom Inventory Multidimensional Assessment of Fatigue and the Global Fatigue Index Multidimensional Fatigue Inventory Multidimensional Fatigue Symptom Inventory Piper Fatigue Scale

  6. Revised Piper Fatigue Scale (PFS) Sample Question “To what degree is fatigue you are feeling now causing you distress?” (0=no distress, 10=great deal of distress) “To what degree would you describe fatigue which you are experiencing now as being:” (0=pleasant, 10=unpleasant) “To what degree are you now feeling:” (0=lively, 10=listless) “To what degree are you now feeling:” (0=able to think clearly, 10=unable to think clearly) Subscale Behavioral/severity(6 items) Affective meaning(5 items) Sensory(5 items) Cognitive/mood(6 items) Piper et al. Oncol Nurs Forum. 1998;25:677-684. 22 items with 4 subscales

  7. Fatigue Symptom Inventory (FSI) Sample Question “Rate your level of fatigue on the average in the last week” (0=not at all fatigued, 10=as fatigued as could be)“Rate how much, in the past week, fatigue interfered with your normal work activity” (0=no interference, 10=extreme interference)“Indicate how much of the day, on average, you felt fatigued in the past week” (0=none of the day, 10=the entire day)“Indicate which of the following best describes the daily pattern of your fatigue” (0=not fatigued, 1=worse in morning, 2=worse in afternoon, 3=worse in evening, 4=no consistent pattern) Dimension Intensity(4 items)Interference(7 items)Duration(2 items)Daily pattern(1 item) 14 items assessing 4 dimensions Hann et al. Qual Life Res. 1998;7:301-310.

  8. Fatigue Measurement • Many instruments tend to assess fatigue as a multidimensional concept BUT, there may be little difference in scores produced by items rated for intensity vs. frequency Chang, Cella et al, 2003, Palliat Supp Care

  9. Fatigue Measurement AND results of bi-factor analysis suggests that fatigue measurement is sufficiently unidimensional THIS IS GOOD NEWS!!! (stay tuned) Lai et al, 2006, Qual Life Res

  10. Single-ItemAssessments

  11. Single-Item Assessments Greater levels of fatigue associated with worse overall health-related quality of life, F(4, 524) = 70.88, p < 0.0001. Butt et al., 2008, JNCCN

  12. “On a 0-10 scale where 0 means no fatigue and 10 means the worst fatigue imaginable, how would you rate your fatigue at its worst over the past 3 days?” Single-Item Assessments Butt et al., 2008, JPSM

  13. Unidimensional Scales Brief Fatigue Inventory Fatigue Severity Scale Functional Assessment of Chronic Illness Therapy – Fatigue Global Vigour and Affect Schedule of Fatigue and Anergia

  14. Brief Fatigue Inventory (BFI) Please rate: As bad as you can imagine No fatigue • Your fatigue right NOW • Your level of fatigue during the past 24 hours • Usual • Worst • How much, during the past • 24 hours, fatigue has • interfered with: • General activity • Mood • Walking ability • Normal work • Relations with other people 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 Completely interferes Does not interfere 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 Mendoza et al. Cancer. 1999;85:1186-1196.

  15. Sample FACIT-F Subscale Items Response format 0 = Not at all 1 = a little bit 2 = somewhat 3 = quite a bit 4 = very much • Fatigue component • I feel fatigued • I feel weak all over • I feel listless (“washed out”) Yellen et al. J Pain Symptom Manage. 1997;13:63-74.

  16. FACIT-FatigueExamples

  17. Fatigue in Men and Women over 50 Cella et al., 2002, Cancer

  18. Fatigue Across the Lifespan LESS fatigue Across both groups, there was evidence for increased fatigue with age (F(6, 1797) = 3.53, p < 0.01) but no group x age interaction (p > 0.25). MOREfatigue Butt et al., under review

  19. Group 1 (EPO, n=32  Placebo, n=30) Group 2 (Placebo, n=26  EPO, n=24) Phase 2 Phase 1 Changes in Hemoglobin and Fatigue 13.1 (Hb) 13.1 (Hb) ΔFatigue = -6.1 ΔFatigue = 9.5 13.3 (Hb) FACIT Fatigue Subscale 10.8 (Hb) 10.5 (Hb) ΔFatigue = 4.8 10.8 (Hb) 10.9 (Hb) ΔFatigue = 3.9 10.6 (Hb) Agnihotri, Telfer, Butt, et al. (2007) JAGS 0 16 17 32 Note: Minimally important difference on the FACIT Fatigue subscale is 3 points. Week

  20. FACIT-F, SF-36 and MAF in RA anti-TNF Trial (N=625) Cella et al., 2005, J Rheumatol

  21. PROMIS

  22. PROMIS • “The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) that are relevant across common medical conditions.” http://www.nihpromis.org

  23. Broad Objectives • Develop and test a large bank of items measuring PROs, including fatigue • Create a CAT for efficient assessment of PROs across a range of chronic diseases • Create a publicly available, adaptable and sustainable system allowing clinical researchers access to a common item repository and CAT

  24. Patient-Reported Outcomes (PROs) Preliminary PROMIS Domains shaded G Upper Extremities: grip, buttons, etc [dexterity] G Lower Extremities: walking, arising, etc [mobility] GFunction/Disability G Central: neck and back (twisting, bending, etc) G Activities: Instrumental Activities of Daily Living [IADL] (e.g. errands) G Physical Health G Pain [intensity, duration, frequency, interference, affect] Satisfaction G Symptoms G Fatigue Other G Anxiety G Health G Depression Satisfaction G Anger/Aggression GEmotional Distress G Substance Abuse Negative Impacts of Illness Cognitive Function G Mental Health Subjective Well-Being (positive affect) Satisfaction Meaning and Coherence (spirituality) Positive Psychological Functioning Mastery and Control (self-efficacy) Positive Impacts of Illness Performance G Role Participation G Social Health Satisfaction Social Support Satisfaction ADL – Activities of Daily Living IADL – Instrumental Activities of Daily Living G – Global Item

  25. Domain Hierarchy Exhaustive Item Banking – All Available Questions Item Reduction – Qualitative Item Review Qualitative Processes Item Reduction – Patient Input Item Improvement – Clarity, Floors, Ceilings,Response Categories, New Items Item Reduction – Item Response Theory (IRT) Final Domain Mapping Unidimensionality Quantitative Processes Development of “Short Forms” Computerized Adaptive Testing (CAT) Validation – Responsiveness – Internet and Devices Adoption and Dissemination PROMIS Process

  26. Items from Instrument A Items from Instrument B Items from Instrument C New Items Item Pool Evaluated by expert and patient review, focus groups, cognitive testing        Questionnaire administered to large representative sample    Item Response Theory (IRT) Item Bank (IRT-calibrated items reviewed for reliability, validity, and sensitivity) CAT Short Form Instruments

  27. IRT Item Response Theory (IRT) models enable reliable and precise measurement of PROs • Fewer items needed for equal precision • Making assessment briefer • More precision gained by adding items • Reducing error and sample size requirements • Error is understood at the individual level • Enabling practical individual assessment

  28. 6.61 People with low fatigue High perf response categories Ceilingeffect (7/301=2.3%) Gap (4.2 – 4.8) 3.35 0.09 -3.17 Low perf response categories Mean=-1.00  1.22 Median = -1.03 Mean= 0.55  1.89 Median = 0.29 People with high fatigue -5.62 Count Count 40 30 20 10 10 20 30 40 Fatigue (in logits) Proficiency of a Fatigue IB Patients (frequency distribution) Items (response category measure)

  29. Item Selection • Emotional Distress • Prostate • Cancer • Item40 • Item38 • Item34 • Item32 • Item26 • Item 22 • Item 18 • Item 16 • Item 8 • Item 2 • Breast • Cancer • Item 36 • Item 34 • Item 32 • Item 28 • Item 26 • Item 22 • Item 14 • Item 10 • Item 2 • Brain • Tumor • Item 40 • Item 32 • Item 24 • Item 16 • Item 8 • Pain • Fatigue Item Bank • Item40 • Item38 • Item36 • Item34 • Item32 • Item30 • Item28 • Item26 • Item24 • Item22 • Item20 • Item18 • Item16 • Item14 • Item12 • Item10 • Item8 • Item6 • Item4 • Item2 • 3 Diseases • 3 Trials • 3 Unique Instruments • Each based on content interest of individual researchers Uses for Item Banks • Short Forms • 5-7 Items in each HRQL Area • Constructed to cover full range of trait • OR • Multiple forms constructed to only cover a narrow range of trait (eg., high, medium, or low) • Computerized Adaptive Testing (CAT) • Custom individualized assessment • Suitable for clinical use • Accuracy level chosen by researcher Gershon et al, Exp Rev Pharmoecon Outcomes Res. (2003)

  30. CAT Simulation - Fatigue 0 10 20 30 40 50 60 70 80 90 100 Item Meas SE

  31. SE=0.32 (r=0.90) SE=0.22 (r=0.95) Comparison of Measurement Precision Full-length Item Bank vs. CAT vs. Short-form 7-item Short-form 7-item CAT Full-length item Bank Standard Error No Fatigue Severe Fatigue

  32. SE=0.32 (r=0.90) Standard Error SE=0.22 (r=0.95) No Fatigue Severe Fatigue Precision Comparison: 3 short-forms Short Form -- High End (i.e., severe fatigue) Short Form – Lower End (i.e., no/mild fatigue) Short Form – Cover the whole fatigue continuum

  33. PROMIS • …is a fully encompassing replacement for existing instruments • ...allows cross-walk to FACIT-Fatigue, SF-36 vitality, etc. • …offers flexibility to researchers

  34. Conclusions • Fatigue is best assessed by self-report. • Many instruments assess fatigue as a multi-dimensional concept • Fatigue is sufficiently unidimensional, from a measurement perspective. • This measurement property allows for IRT-based measurement applications.

  35. Conclusions • PROMIS allows for flexible assessment of fatigue with use of psychometrically robust short forms and CAT. • Fatigue as a vital sign? • May be useful to consider fatigue as a measurable property -- like temperature, blood pressure, etc – not a disease- or treatment-specific variable.

  36. Questions? Zeeshan Butt, Ph.D. Research Scientist, Center on Outcomes, Research, and Education (CORE) Research Assistant Professor, Northwestern University Feinberg School of Medicine 224-364-7596 z-butt@northwestern.edu

  37. Reprinted with permission of the PROMIS Health Organization and the PROMIS Cooperative Group © 2007. PROMIS Fatigue Short-Form Garcia et al (2007) Journal of Clinical Oncology

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