Correlation of self-assessed fatigue and alertness in multiple sclerosis

Weinges-Evers, Nicholetta; Brandt, Alexander U.; Böck, Markus; Pfueller, Caspar F.; Dörr, Jan; Bellmann‐Strobl, Judith; Scherer, P.; Urbanek, Carsten; Boers, Claudia; Ohlraun, Stephanie; Zipp, Frauke; Paul, Friedemann

doi:10.1177/1352458510374202

Cited by 88 publications

(64 citation statements)

References 37 publications

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“…There was no evidence of measuring fatigability before and after a demanding task. Other studies have used a similar approach 22,24 . The theory and construct underpinning such methods is not clear.…”

Section: Challenges With Existing Measuresmentioning

confidence: 99%

“…The fact that some of the studies listed in Table 1 have used varied study designs and metrics that are inconsistent with existing operational definitions may be a symptom of this problem. For example, Parmenter et al tested pwMS during periods of high, and relatively low, self-reported fatigue over two separate testing periods on different days 8 , and similar to other studies 22,24 , did not assess a decline in either information processing speed, reaction time or accuracy over time on continuous performance task, or probe task given before and immediately after completing a demanding cognitive task 1,5 , nor explicitly define how they operationalised cognitive fatigability 8,24 .…”

Section: Challenges With Existing Measuresmentioning

confidence: 99%

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Operationalising cognitive fatigability in multiple sclerosis: A Gordian knot that can be cut?

2016

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Background: Researchers have attempted to operationalise objective measures of cognitive fatigability in MS to overcome the perceived subjectivity of patient reported outcomes of fatigue (PROs). Measures of cognitive fatigability examine decrements in performance during sustained neurocognitive tasks.Objective: This editorial briefly summarises available evidence for measures of cognitive fatigability in MS and considers their overall utility.Results: Findings Studies suggest there may be a construct that is distinct from self-reported fatigue, reflecting a new potential intervention target. However, assessments vary and findings across and within measures are inconsistent. Few measures have been guided by a coherent theory, and those identified are likely to be influenced by other confounds, such as cognitive impairment caused more directly by disease processes, depression, and assessment biases.Conclusions: Future research may benefit from (a) developing a guiding theory of cognitive fatigability, (b) examining ecological and construct validity of existing assessments, and (c) exploring whether the more promising cognitive fatigability measures are correlated with impaired functioning after accounting for possible confounds. Given the issues raised, we caution that our purposes as researchers may be better served by continuing our search for a more objective cognitive fatigability construct that runs in parallel with improving, rather than devaluing, current PROs.

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Section: Challenges With Existing Measuresmentioning

confidence: 99%

Section: Challenges With Existing Measuresmentioning

confidence: 99%

Operationalising cognitive fatigability in multiple sclerosis: A Gordian knot that can be cut?

2016

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“…17 However, studies that tried to quantify the incidence of cognitive impairment in patients with MS showed large inconsistencies ranging from 5.5% of a cohort exhibiting cognitive impairment 18 to 59.7%. 19 The differences are probably due to the diverse methodology used to measure cognitive function.…”

Section: Patient-reported Outcomes Focussed On the Expectations Of Pamentioning

confidence: 99%

The regulator’s perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?

Crommelin

Broich

Holloway³

et al. 2016

Mult Scler

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Abstract:Background: Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. Objective: The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Conclusion: Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients.

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“…With the increasing recognition of MS as a progressive neurodegenerative disease from the very beginning, it is questionable whether relapse rate and inflammatory lesions on brain MRI (variables in the suggestive term 'freedom of disease activity') that have been applied in the CLARITY study and other recent large Phase III MS trials are still adequate measures for the evaluation of new MS therapies. 'Freedom of disease activity' disregards other relevant aspects of the disease, such as progressive brain atrophy, cognitive dysfunction, sleep disorders and fatigue [20][21][22][23] --factors that may have a substantial negative impact on the patients' quality of life [24]. New potential surrogate markers, such as optical coherence tomography, are emerging that may prove useful to monitor neurodegeneration and neuroprotection in MS trials [25,26].…”

mentioning

confidence: 99%

Cladribine in multiple sclerosis: pitfalls in a new treatment landscape

Paul

2012

Expert Opinion on Pharmacotherapy

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Correlation of self-assessed fatigue and alertness in multiple sclerosis

Abstract: The alertness subtest of the Test of Attentional Performance may offer an objective method of evaluating self-reported fatigue, and may therefore - in addition to the Fatigue Severity Scale - be a suitable tool for the assessment of multiple sclerosis patients complaining of fatigue.

Cited by 88 publications

References 37 publications

Operationalising cognitive fatigability in multiple sclerosis: A Gordian knot that can be cut?

Operationalising cognitive fatigability in multiple sclerosis: A Gordian knot that can be cut?

The regulator’s perspective: How should new therapies and follow-on products for MS be clinically evaluated in the future?

Cladribine in multiple sclerosis: pitfalls in a new treatment landscape

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