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Assessment of Fatigue: Review and Future Directions Zeeshan Butt, Ph.D. Research Scientist, Center on Outcomes, Research, and Education (CORE)/ENH Research.

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Presentation on theme: "Assessment of Fatigue: Review and Future Directions Zeeshan Butt, Ph.D. Research Scientist, Center on Outcomes, Research, and Education (CORE)/ENH Research."— Presentation transcript:

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 AGS/NIA/Hartford Conference: Idiopathic Fatigue of Aging September 5, 2008

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

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

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

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

6 Revised Piper Fatigue Scale (PFS) Subscale Behavioral/severity (6 items) Affective meaning (5 items) Sensory (5 items) Cognitive/mood (6 items) 22 items with 4 subscales 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) Piper et al. Oncol Nurs Forum. 1998;25:

7 Fatigue Symptom Inventory (FSI) Dimension Intensity (4 items) Interference (7 items) Duration (2 items) Daily pattern (1 item) 14 items assessing 4 dimensions 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) Hann et al. Qual Life Res. 1998;7:

8 Fatigue Measurement Many instruments tend to assess fatigue as a multidimensional concept 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 Lai et al, 2006, Qual Life Res THIS IS GOOD NEWS!!! (stay tuned)

10 Single-Item Assessments

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

12 Single-Item Assessments Butt et al., 2008, JPSM 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?

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

14 Brief Fatigue Inventory (BFI) 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 Mendoza et al. Cancer. 1999;85: Please rate: No fatigue As bad as you can imagine Does not interfere Completely interferes

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

16 FACIT-Fatigue Examples

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

18 Fatigue Across the Lifespan Butt et al., under review LESS fatigue MORE fatigue Across both groups, there was evidence for increased fatigue with age (F(6, 1797) = 3.53, p 0.25).

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

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. 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.

23 Broad Objectives Develop and test a large bank of items measuring PROs, including fatigue 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 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 Create a publicly available, adaptable and sustainable system allowing clinical researchers access to a common item repository and CAT

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

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

26 Items from InstrumentA Item Pool Evaluated by expert and patient review, focus groups, cognitive testing Items from InstrumentB InstrumentC New Items Item Bank (IRT-calibrated items reviewed for reliability, validity, and sensitivity) ItemResponseTheory(IRT) Questionnaire administered to large representative sample CAT Short Form Instruments

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

28 Proficiency of a Fatigue IB Items (response category measure) Patients (frequency distribution) Mean= Median = Mean= Median = 0.29 Fatigue (in logits) High perf response categories People with low fatigue Count Ceiling effect (7/301=2.3%) Gap (4.2 – 4.8) People with high fatigue Low perf response categories

29 Uses for Item Banks Emotional Distress Pain Fatigue Item Bank Item40 Item38 Item36 Item34 Item32 Item30 Item28 Item26 Item24 Item22 Item20 Item18 Item16 Item14 Item12 Item10 Item8 Item6 Item4 Item2 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 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 3 Diseases 3 Trials 3 Unique Instruments Each based on content interest of individual researchers Item Selection Gershon et al, Exp Rev Pharmoecon Outcomes Res. (2003)

30 CAT Simulation - Fatigue Item Meas SEQuestionResponse 1. I have a lack of energy. Very much 2. I have had enough energy to eat. Most of the time 3. I have had enough energy to take a bath or shower. Some of the time 4. I have had enough energy to read. Some of the time 5. I have had enough energy to leave the house. Most of the time

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32 7-item Short-form 7-item CAT Full-length item Bank No Fatigue Severe Fatigue 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 Standard Error

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

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

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

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

37 Questions? Zeeshan Butt, Ph.D. Research Scientist, Center on Outcomes, Research, and Education (CORE) Research Assistant Professor, Northwestern University Feinberg School of Medicine

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


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