Effects of Milnacipran on the Multidimensional Aspects of Fatigue and the Relationship of Fatigue to Pain and Function

Mease, Philip J.; Palmer, Robert H.; Wang, Yong

doi:10.1097/rhu.0000000000000103

Cited by 11 publications

(10 citation statements)

References 52 publications

(57 reference statements)

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“…These would be a reasonable choice for phenotyping fatigue; the MFI in particular has been used in multiple pharmacologic treatment studies of patients with chronic pain [6;170]. Sleep disruption and fatigue often co-occur within symptom clusters in the context of a variety of persistent pain conditions [176;241], but to date, no published studies appear to have examined pre-treatment fatigue phenotypes as predictors of analgesic outcomes.…”

Section: Phenotypic Domainsmentioning

confidence: 99%

Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

Edwards

Dworkin

Turk

et al. 2016

Pain

298

261

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There is tremendous inter-patient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for “precision medicine”, or personalized pain therapeutics (i.e., empirically-based algorithms that determine the optimal treatments, or treatment combinations, for individual patients) that would presumably improve both the clinical care of patients with pain, and the success rates for putative analgesic drugs in Phase 2 and 3 clinical trials. However, before implementing this approach, the characteristics of individual patients or subgroups of patients that increase or decrease the response to a specific treatment need to be identified. The challenge is to identify the measurable phenotypic characteristics of patients that are most predictive of individual variation in analgesic treatment outcomes, and the measurement tools that are best suited to evaluate these characteristics. In this article, we present evidence on the most promising of these phenotypic characteristics for use in future research, including psychosocial factors, symptom characteristics, sleep patterns, responses to noxious stimulation, endogenous pain-modulatory processes, and response to pharmacologic challenge. We provide evidence-based recommendations for core phenotyping domains and recommend measures of each domain.

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Section: Phenotypic Domainsmentioning

confidence: 99%

Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

Edwards

Dworkin

Turk

et al. 2016

Pain

298

261

View full text Add to dashboard Cite

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“…Therapy-Fatigue 133,242 Measures fatigue during the previous week. Global score, 5 response options: 0 = not at all; 4 = very much so; total score (0-52).…”

Section: Functional Assessment Of Chronic Illnessmentioning

confidence: 99%

“…117 These would be a reasonable choice for phenotyping fatigue; the Multidimensional Fatigue Inventory in particular has been used in multiple pharmacologic treatment studies of patients with chronic pain. 5,133 Sleep disruption and fatigue often co-occur within symptom clusters in the context of a variety of persistent pain conditions, but to date, no published studies appear to have examined pretreatment fatigue phenotypes as predictors of variability in analgesic outcomes.…”

Section: Assessment Of Sleep and Fatiguementioning

confidence: 99%

Assessment of Psychosocial and Functional Impact of Chronic Pain

Turk

Fillingim

Ohrbach

et al. 2016

The Journal of Pain

266

198

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“…There is a growing body of evidence from both clinical and regulatory communities supporting FM-related fatigue as a multidimensional concept [1, 9–11]. Additional research on this phenomenon is needed within the context of clinical studies to fully understand the dimensionality as well as ascertain the ability of a single measure to saturate the construct of fatigue.…”

Section: Introductionmentioning

confidence: 99%

Multidimensional daily diary of fatigue-fibromyalgia-17 items (MDF-fibro-17): part 2 psychometric evaluation in fibromyalgia patients

Morris

Cole

et al. 2017

BMC Musculoskelet Disord

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BackgroundThe Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 instrument (MDF-Fibro-17) has been developed for use in fibromyalgia (FM) clinical studies and includes 5 domains: Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Psychometric properties of the MDF-Fibro-17 needed to demonstrate the appropriateness of using this instrument in clinical studies are presented.MethodsPsychometric analyses were conducted to evaluate the factor structure, reliability, validity, and responsiveness of the MDF-Fibro-17 using data from a Phase 2 clinical study of FM patients (N = 381). Confirmatory factor analyses (CFA) were performed to ensure understanding of the multidimensional domain structure, and a secondary factor analysis of the domains examined the appropriateness of calculating a total score in addition to domain scores. Longitudinal psychometric analyses (test-retest reliability and responder analysis) were also conducted on the data from Baseline to Week 6.ResultsThe CFA supported the 17-item, 5 domain structure of this instrument as the best fit of the data: comparative fit index (CFI) and non-normed fit index (NNFI) were 0.997 and 0.992 respectively, standardized root mean square residual (SRMR) was 0.010 and the root mean square error of approximation (RMSEA) was 0.06. In addition, total score (CFI and NNFI both 0.95) met required standards. For the total and 5 domain scores, reliability and validity data were acceptable: test-retest and internal consistency were above 0.9; correlations were as expected with the Global Fatigue Index (GFI) (0.62-0.75), Fibromyalgia Impact Questionnaire (FIQ) Total (0.59–0.71), and 36-Item Short Form Health Survey (SF-36) vitality (VT) (0.43–0.53); and discrimination was shown using quintile scores for the GFI, FIQ Total, and Pain Numeric Rating Scale (NRS) quartiles. In addition, sensitivity to change was demonstrated with an overall mean responder score of -2.59 using anchor-based methods.ConclusionThe MDF-Fibro-17 reliably measures 5 domains of FM-related fatigue and psychometric evaluation confirms that this measure meets or exceeds each of the predefined acceptable thresholds for evidence of reliability, validity, and responsiveness to changes in clinical status. This suggests that the MDF-Fibro-17 is an appropriate and responsive measure of FM-related fatigue in clinical studies.

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Effects of Milnacipran on the Multidimensional Aspects of Fatigue and the Relationship of Fatigue to Pain and Function

Cited by 11 publications

References 52 publications

Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations

Assessment of Psychosocial and Functional Impact of Chronic Pain

Multidimensional daily diary of fatigue-fibromyalgia-17 items (MDF-fibro-17): part 2 psychometric evaluation in fibromyalgia patients

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