Quality of life complements traditional outcome measures in immune-mediated polyneuropathies

OBJECTIVES: To determine whether quality of life complements traditional outcome measures in immune-mediated polyneuropathies using the Medical Outcome Study 36-item short-form health status scale (SF-36). The validity, reliability, and responsiveness of the SF-36 were also analyzed. METHODS: SF-36 and three other measures (Medical Research Council sumscore, sensory sumscore, and Hughes functional scale) were assessed in 114 stable patients (83 with Guillain-Barré syndrome (GBS), 23 with chronic inflammatory demyelinating polyneuropathy (CIDP), eight with a gammopathy-related polyneuropathy) and serially in 20 patients with recently diagnosed GBS (n = 7) or CIDP (n = 13) with changing conditions. The SF-36 values were compared with reported healthy Dutch community scores (controls). The SF-36 validity and reliability were examined by correlation and regression studies with the other measures and by calculating its internal consistency. The standardized response mean and effect size techniques were applied to determine its responsiveness. RESULTS: In the stable group, all SF-36 scores were substantially lower (indicating worse clinical condition) compared with control subjects (p < 0.0001). Improvement in the longitudinal group resulted in a gradual shift of all SF-36 scores toward normal values. Acceptable validity and internal consistency values and moderate to good standardized response mean and effect size scores were demonstrated for the SF-36. The Medical Research Council sumscore and sensory sumscore explained SF-36 values only partially. CONCLUSION: The SF-36 as a generic health status complemented traditional strength and sensory measures in patients with immune-mediated polyneuropathies and appears to be a potentially valuable instrument for measuring quality of life in these conditions.     

A comparison of fatigue measures in Parkinson's disease

Fatigue is a common problem in Parkinson's disease (PD). The Parkinson's Fatigue Scale (PFS) designed for measurement of fatigue in PD has not been validated in the US. The objective of this study was to validate the PFS by comparing it to the Fatigue Severity Scale (FSS). Fifty PD patients and 16 controls completed PFS, FSS and semi-structured interview. FSS and PFS were strongly correlated with one another and had high internal consistency, indicating that both are reliable scales. PD patients and healthy controls differed significantly on both measures. PD patients endorsed significantly more fatigue. The PFS is a reliable, valid fatigue measure.     

Assessing fatigue in multiple sclerosis: Dutch modified fatigue impact scale

The aim of this study is to evaluate the reliability, validity and responsiveness of the Dutch version of the Modified Fatigue Impact Scale. Fifty-one randomly selected subjects with definite multiple sclerosis (MS) (mean age 51.9 +/- 10.5 years, 25 women) and 20 healthy controls (mean age 50.6 +/- 14.0 years, 13 women) filled in the Modified Fatigue Impact Scale (MFIS), the Fatigue Severity Scale (FSS) and the fatigue subscale of Guy's Neurological Disability Scale (GNDS). All tests were repeated with an interval of maximum three days. The hospitalised individuals with MS (n = 20) were assessed at intake and discharge. No significant difference was found between first and second administration of MFIS (z = -.519, p = .603, Wilcoxon signed ranks test), with a good correlation (.729). MFIS was able to distinguish individuals with MS from controls, and subjects with fatigue from the non-fatigued group. MFIS showed no floor or ceiling effect. MFIS correlated moderately with Fatigue Severity Scale (.447) and the fatigue subscale of GNDS (.487). The 20 hospitalised subjects had significant lower MFIS scores (z = -3.401, p = .001) after a four-week rehabilitation programme, whereas the FSS did not change. This study indicates that the Dutch version of the MFIS is a reliable, valid and responsive tool to assess the impact of MS-related fatigue on daily life.     

The influence of fatigue on health-related quality of life in patients with Parkinson's disease

OBJECTIVE: To examine the correlation between fatigue and health-related quality of life (HRQL) in patients with Parkinson's disease (PD). PATIENTS AND METHODS: Sixty-six patients with idiopathic PD. The patients did not have a depressive mood disorder or cognitive impairment. Fatigue was measured by the Fatigue Severity Scale (FSS). HRQL was measured by the Parkinson's Disease Questionnaire (PDQ-39) and the Short-Form 36 (SF-36). RESULTS: Thirty-three (50%) of the patients had significant fatigue. Patients with fatigue had a more advanced disease than those without fatigue, measured by the UPDRS scale, including a higher Hoehn and Yahr stage and lower Schwab and England score. Patients with fatigue reported more distress in the dimensions of emotional well-being and mobility (PDQ-39) and also had a significantly higher PDQ summary index. On the SF-36 patients with fatigue reported more problems in the areas of physical functioning, role limitation (physical), social functioning and vitality. Correlations between the FSS and the HRQL scales were highest for the summary index of PDQ-39 and in the dimensions of ADL, mobility and emotional well-being (PDQ-39) and physical functioning, role limitation (physical), social functioning, general health and vitality (SF-36). CONCLUSIONS: PD has a substantial negative impact on HRQL. We found a strong correlation between fatigue and high distress scores on HRQL scales in a population of patients with PD who were not depressed or demented. The diversity of symptoms and high prevalence of non-motor features, including fatigue, is important to take into account in our efforts to optimize treatment and care for this patient group.     

Psychometric evaluation of a new sensory scale in immune-mediated polyneuropathies. Inflammatory Neuropathy Cause and Treatment (INCAT) Group

OBJECTIVE: To perform a psychometric evaluation of the inflammatory neuropathy cause and treatment (INCAT) sensory sumscore (ISS) in sensory-motor immune-mediated polyneuropathies. This new sensory scale was evaluated to strive for uniformity in assessing sensory deficit in these disorders. METHODS: The ISS comprises vibration and pinprick sense plus a two-point discrimination value and ranges from 0 (normal sensation) to 20 (maximum sensory deficit). Before its clinical use, a panel of expert neurologists concluded that the ISS has face and content validity. The construct validity of the ISS was investigated by correlation and regression studies with additional scales (Nine-Hole Peg Test, 10-Meter Walking Test, a disability sumscore). All scales were applied in 113 patients with a stable neurologic condition (83 patients who experienced Guillain-Barre syndrome [GBS] in the past, 22 with chronic inflammatory demyelinating polyneuropathy [CIDP], 8 patients with a monoclonal gammopathy associated polyneuropathy), and 10 patients with recently diagnosed GBS or CIDP with changing clinical conditions. Reliability of the ISS was evaluated in the stable patients. Its responsiveness was investigated in the patients examined longitudinally. RESULTS: A moderate to good validity was obtained for the ISS (stable group: r = 0.38 to 0.56, p < or = 0.006; longitudinal group: R = 0.60 to 0.82, p < or = 0.007, except for the association with the 10-Meter Walking Test [p = 0.08]). Acceptable internal consistency, and inter- and intraobserver reliability were demonstrated for the ISS (alpha = 0.68 to 0.87; R = 0.85 to 0.89, p < 0.0001). Standardized response mean scores for the ISS were high (> or =0.8), indicating good responsiveness. CONCLUSIONS: All psychometric requirements are provided for the the inflammatory neuropathy cause and treatment sensory sumscore. The use of this scale is therefore suggested for bedside evaluation of sensory deficit in the individual patient with a sensory-motor immune-mediated polyneuropathy as well as in clinical trials.     

The relation of testosterone levels with fatigue and apathy in Parkinson's disease

Objective

Fatigue and apathy are frequent in patients with Parkinson's disease (PD). Testosterone deficiency in male patients may contribute in development of fatigue and apathy as well. We investigated whether a possible relation exists between serum testosterone levels, fatigue and apathy in male PD patients.

Materials and methods

We included 29 non-demented and non-depressed PD patients and 30 age- and sex-matched healthy subjects. Fatigue Severity Scale (FSS) and Apathy Evaluation Scale (AES-C) were used for the evaluations. In PD patients and healthy subjects, a relationship between FSS, AES-C scores and plasma testosterone levels were assessed. In addition, a correlation between FSS, AES-C and Unified Parkinson's Disease Rating Scale was investigated in PD group.

Results

The mean scores of FSS and AES-C were significantly higher in PD patients than those of the control group. The Unified Parkinson's Disease Rating Scale (UPDRS) scores were significantly correlated with FSS and AES-C scores. Mean free testosterone level was significantly lower in PD patients than controls (p = 0.008). f-Testosterone levels of PD patients were not correlated with FSS or AES-C scores.

Conclusion

Apathy and fatigue are frequent in PD and show significant correlation with the severity of the disease. f-Testosterone levels are not related with apathy or fatigue in male PD patients and the role of testosterone in the pathophysiology of these non-motor symptoms is still controversial.     

"Fatigue" in multiple sclerosis. Development and and validation of the "Würzburger Fatigue Inventory for MS"

BACKGROUND: Fatigue is one of the most common, yet poorly defined, disabling symptoms in patients with multiple sclerosis (MS). Several fatigue scales have been developed, but rigorous psychometric methods have not always been applied and validation was mainly based on small numbers of patients. We therefore assembled a new fatigue scale from a set of widely used scales and assessed its psychometric properties in a large sample of MS patients. PATIENTS AND METHODS: Fatigue was assessed in 158 MS patients by four published quantitative scales: the Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS), MS-specific Fatigue Severity Scale (MFSS), and Visual Analogue Scale. From these a new fatigue scale, the Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS), was assembled. It contains 17 items with values from 0 to 4. The WEIMuS scale was validated in a subgroup of 67 patients and a control group of 68 patients. RESULTS: The MFIS and FSS but not the MFSS showed high internal consistency and split-half reliability. After applying factor analysis within the scales, fairly reliable and valid items originally found in the MFIS and FSS were selected to construct the final 17-item WEIMuS scale, which showed a high degree of reliability. In the validation study, varimax rotated factor analysis extracted two main factors corresponding to both cognitive and physical fatigue. CONCLUSION: The new, two-dimensional WEIMuS showed good psychometric properties, is easy to use, and may therefore be a useful tool for the assessment of MS-associated fatigue. Multiple sclerosis patients suffer from different types of fatigue which could be attributed to cognitive and physical fatigue. Thus, MS-associated fatigue is different from common tiredness.     

High rates of fatigue and sleep disturbances in dystonia

Background: Nonmotor symptoms in dystonia are increasingly recognized to impair the quality of life. The primary objective of this study was to determine the prevalence of fatigue and sleep disturbances in dystonia and to ascertain their impact on quality of life using standardized questionnaires. Methods: Dystonia patients presenting to a Botulinum toxin clinic were prospectively administered Fatigue Severity Scale (FSS), Multidimensional Fatigue Inventory (MFI), Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS) for assessment of fatigue and sleep disturbances. Health-related Quality of life (HRQOL) was determined using MOS SF-36 scale and depressive symptoms were assessed using the Beck Depression Inventory II. Results: Ninety-one patients with dystonia participated (66 women, 25 men, mean age 60 ± 17 years). Nine subjects had generalized dystonia, 18 segmental dystonia and 64 had focal dystonia. Moderate to severe fatigue was present in 43% of the cohort (FSS), excessive daytime somnolence in 27% (ESS) and other sleep disturbances in 26% (PDSS). FSS and MFI scores correlated significantly with HRQOL even when controlled for depression and sleep disturbances. Excessive daytime somnolence and nocturnal sleep disturbances correlated significantly with the HRQOL; however, these effects were not seen for daytime somnolence when controlled for depression. Psychometric testing found adequate reliabilities and convergent validities for both fatigue and sleep scales. Conclusion: Fatigue and sleep disturbances revealed high prevalence rates in this large, first of its dystonia study. They negatively impacted the quality of life even when controlled for comorbid depression.     

Fatigue in early Parkinson’s disease. Minor inconvenience or major distress?

Background and purpose: Although fatigue is recognized as a common and debilitating symptom in patients with Parkinson’s disease (PD), little is known on how and when this symptom emerges during disease progression. The aim of the study was to explore the presence and severity of fatigue in patients with PD at the time of diagnosis, before dopaminergic treatment has been instituted. Methods: The present study is part of the Norwegian ParkWest project, a large cohort study of patients with incident PD in Norway. PD was diagnosed according to the Gelb criteria. The study population comprised 199 patients with untreated, newly diagnosed PD and 172 control subjects, matched for gender and age. Fatigue was measured by the Fatigue Severity Scale (FSS). Results: Fifty‐five percent of the patients with PD had clinical significant fatigue (FSS > 4), compared with about 20% of the controls (RR = 2.9). The mean score in patients on the FSS was 4.4 (SD 1.7) and in controls 3.1 (SD 1.3). In addition, there were highly significant differences between patients and controls in each of the nine FSS items. In a regression analysis, only the Montgomery and Åsberg Depression Rating Scale and Unified Parkinson’s Disease Rating Scale‐Activities of Daily Living scores were significantly associated with fatigue. There was no correlation between fatigue and cognitive impairment and hypersomnia. Conclusion: Fatigue is a common symptom in PD, also in patients with early, untreated disease, and it has a negative impact on these patients’ activity of daily living. Also in early PD, fatigue is an important consideration in the management of patients with the disease.     

Fatigue,self-efficacy and psychiatric symptoms influence the quality of life in patients with myasthenia gravis in Tianjin,China

BackgroundMuscle weakness related to myasthenia gravis (MG) limits the daily functioning of patients. MG patients often experience subjective symptoms including psychiatric disorders, fatigue, and reduction in self-efficacy. All of which ultimately influence their life. The relationship between the subjective symptoms and health-related quality of life (HRQoL) has never been systematically explored among MG patients.ObjectiveThis study aimed to evaluate the HRQoL of patients with MG in China, and to assess the impact of potential predictors of HRQoL.MethodsThis was a cross-sectional observational study in patients with confirmed diagnosis of MG. Patients with MG were assessed using the 36-Item Short-Form Health Survey (SF-36) questionnaire, Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Fatigue Severity Scale (FSS), and Self-Efficacy for Managing Chronic Disease 6 items scale (SES6G). Disease severity was evaluated by two specialists at the same time.ResultsPatients had significantly lower mean SF-36 scores for the categories role physical and general health (GH). The mean physical and mental composite scores were 57.76 ± 21.28 and 60.03 ± 23.75. Sex and unemployment influenced the QoL. Financial burden was negatively associated with total SF-36 scores. Compared to the control group, patients with generalized symptoms (MGFA II and III) had lower SF-36 scores, but the patients with pure ocular symptoms (MGFA I) had not significant difference, except GH. The SF-36 scores were highly correlated with the severity of the disease, the states of mood, fatigue, and self-efficacy.ConclusionsThe decrease in the HRQoL of patients with MG was related not only to the gender, severity of disease, and unemployment but also to the subjective experience including depressive and anxiety disorders, fatigue, and self-efficacy. In the course of treatment, the evaluation of HRQoL should be included in the routine assessment of patients with MG. Psychosocial treatment, social support, and health education should be advocated.     

早期帕金森病患者健康相关生活质量

目的 研究中国早期帕金森病(PD)患者健康相关生活质量(health related quality of life,HR-QOL)的特点;探讨运动症状和非运动症状对早期PD患者HR-QOL的影响.方法 在全国范围内共筛选出391例早期PD患者入组.采用统一帕金森病评分表(UPDRS)和Hoehn-Yahr评价运动症状,采用流行病学研究中心编制的抑郁量表(CES-D)、匹兹堡睡眠质量指数(PSQI)、疲劳量表(FSS)、阿尔茨海默病评定量表的认知部分(ADAS-Cog)和便秘量表分别对抑郁、睡眠障碍、疲劳、认知功能和便秘等非运动症状进行评价;采用36条目简化医疗结局调查问卷(SF-36)评价HR-QOL.比较PD患者与同龄健康老年人SF-36分值的差异.采用逐步多元线性回归分析深入探讨各种运动及非运动症状变量对HR-QOL的影响.结果 早期PD患者除SF-36躯体疼痛维度外,其余各维度分值较同龄健康老年人均下降.UPDRS第3部分分值(23.8±11.8)、Hoehn-Yahr分期(2.0±0.7)和强直分值(4.4±3.1)仅能解释SF-36总分变化的18.9%(R2=0.189).CES-D、FSS和PSQI分值等非运动症状变量引入回归方程后,SF-36总分可被解释的部分由18.9%增加至61.7%(R2=0.617).并且,引入CES-D分值后,SF-36总分可被解释的部分增加了43.3%(R2=0.433).结论 PD症状严重影响早期患者的HR-QOL.运动症状对HR-QOL存在影响,但影响作用有限.抑郁、疲劳和睡眠障碍这3个非运动症状是导致早期PD患者HR-QOL恶化的主要原因.其中,抑郁症状是HR-QOL恶化的最强预测因素.临床上,应重视非运动症状,运动和非运动症状兼治,才能真正提高疗效显著改善患者的HR-QOL.     

How to measure fatigue in epilepsy? The validation of three scales for clinical use

Fatigue can be defined as extreme and persistent tiredness, weakness or exhaustion that could be mental, physical or both. The main objective of this study is to validate three instruments to measure fatigue (Fatigue Symptom Inventory--FSI, Fatigue Assessment Instrument--FAI, Fatigue Severity Scale--FSS) in patients with epilepsy (PWE). We used concurrent validity as a method of validation. Reliability of the fatigue scales was assessed in PWE. We applied the three selected questionnaires plus the Beck Depression Inventory (BDI) in PWE, healthy volunteers (HV) and patients with other neurological conditions. We studied 67 PWE, 34 HV and 56 patients with different neurological conditions. The mean fatigue scores in each group were as follows: (a) for the FSS, the score in HV was 2.6±1.1, in PWE 4.2±1.5, in Patients with multiple Sclerosis (PMS) 4.8±1.4, in Patients with Migraine (PWM) 4.4±1.9, in Patients with radiculopathy (PR) 4.5±0.9. (b) For the FSI, the score in HV was 2.2±1.3, in PWE 3.9±2.3, in PMS 4.1±1.9, in PWM 4.5±2.5, and in PR 5.4±1.4. (c) For the FAI in HV was 3.0±1.1, in PWE 4.2±1.3, in PMS 4.5±0.9, PWM 4.3±1.5, and in PR 4.4±1.4. The correlation between the BDI and the FSS was 0.52 (p<0.001), between the BDI and the FSI was 0.62 (p<0.001), and between the BDI and the FAI was 0.54 (p<0.001). Patients with epilepsy have consistently higher fatigue scores compared healthy controls, and scores that are comparable with other neurological conditions. The FSI, FAI and FSS display concurrent validity and high intra-observer reliability in PWE, indicating that these scales could be utilized for further study of fatigue in epilepsy.     

Fatigue: an important feature of late-onset Pompe disease

Abstract Objective To investigate the prevalence and severity of fatigue in adult patients with Pompe disease. Methods The Fatigue Severity Scale (FSS) was assessed in an international population of 225 adults with Pompe disease, a metabolic disorder presenting as a slowly progressive proximal myopathy. The FSS scores were compared to those of healthy controls and the relationship between the level of fatigue and other patient characteristics was investigated. Results The mean age of the participants was 47 (SD 13) years and the mean disease duration 11 (SD 8) years. 43% used a wheelchair and 46% had respiratory support, 29% needed both. 67% of the participants had a FSS score ≥5, indicating severe fatigue. The mean FSS score was 5.2 (SD 1.5), which was significantly higher than that of healthy controls (p < 0.001). Fatigue was not related to age, sex or disease duration. Patients who used a wheelchair or respiratory support were on average more fatigued than those who did not (p = 0.01). However, of the patients who did not use these aids, 59% also had a FSS score ≥5. FSS scores were highest among patients who reported a high frequency of sleep disorders, but patients who never experienced sleep difficulties were also fatigued (mean FSS score = 4.8). Conclusion Fatigue is highly prevalent among both mildly and severely affected adult patients with Pompe disease. The FSS appears a useful tool in assessing fatigue in Pompe disease.     

Amantadine for treatment of fatigue in Guillain-Barre syndrome: a randomised, double blind, placebo controlled, crossover trial

OBJECTIVE: Fatigue is a major complaint in patients with immune mediated polyneuropathies. Despite apparently good physical recovery after Guillain-Barré syndrome (GBS), many patients remain restricted in daily and social activities, and have a decreased quality of life. In this trial, the effect of amantadine on severe fatigue related to GBS was studied. METHODS: During the pre-treatment phase, all patients were monitored for 2 weeks. Only patients with severe fatigue, defined as a mean fatigue score of > or = 5.0 on the Fatigue Severity Scale (FSS), were randomised for this double blind, placebo controlled, crossover study. Primary outcome measure was improvement of at least 1 point on the FSS. Secondary outcome measures were impact of fatigue, anxiety and depression, handicap, and quality of life. RESULTS: In total, 80 patients with GBS were randomised, of whom 74 were included for analysis. Fatigue appeared to be reduced already during the pre-treatment phase (p = 0.05), probably due to increased attention provided to the patients. No significant differences in any of the primary and secondary outcome measures were found. CONCLUSIONS: Amantadine was not superior to placebo. Because fatigue remains a serious complaint, other studies evaluating new treatment options are strongly recommended.     

Autonomic instability,as measured by pupillary unrest,is not associated with multiple sclerosis fatigue severity

Multiple sclerosis (MS) fatigue is one of the most common symptoms in MS, but its pathophysiology is still not understood Sympathovagal imbalance was suggested as a reason for fatigue in chronic fatigue syndrome. We examined the role of an imbalance in the central autonomic nervous system (ANS) as a cause of MS fatigue in 51 MS patients and a control group of 22 healthy volunteers. Fatigue was assessed with the revised MS Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS). Depression was evaluated with the Beck Depression Inventory (BDI). Disintegration of the central ANS expressed by pupillary fatigue waves was measured with pupillography and documented in the pupillary unrest index (PUI). All subjects had less than five points on the seven-point Stanford Sleepiness Scale and were therefore not sleepy. MS patients had significant higher mean FSS scores (p=0.001) and mean MFIS scores (p=0.003) than our control group. Mean BDI scores were significant higher (p=0.001) in the MS group, but were in the lowest score range (0-10 points) in both groups. Surprisingly, we found a statistically significant inverse correlation between PUI values and either FSS scores (p=0.001; r=-0.521) or MFIS scores (p=0.002; r=-0.423) in the MS group, but not in healthy participants. We therefore conclude that autonomic instability, as measured by pupillary unrest is not associated with MS fatigue severity.     

Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality

OBJECTIVES: In a series of 504 patients with multiple sclerosis (MS), quality of life (QOL) and its main clinical and demographic determinants were assessed in comparison with healthy individuals. MATERIALS AND METHODS: A postal questionnaire with self-completed measures of disability (Expanded Disability Status Scale, EDSS), QOL (Quality of Life Index, QLI), depressive mood (Self-rating Depression Scale, SDS), fatigue severity (Fatigue Severity Scale, FSS) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) was sent to this sample of MS patients. RESULTS: Most patients were severely disabled; almost half were mildly to severely depressed, suffering from reduced sleep quality and/or fatigue. The multiple sclerosis patients had significantly lower QLI scores than healthy controls. EDSS and SDS scores were found to be predictors of global QLI score. Regarding the different QLI domains, mean SDS scores remained predictive for all QLI items, while mean EDSS, PSQI and FSS scores were only predictive for physical domains. CONCLUSION: Our study clearly demonstrates that depressive mood is the main factor influencing QOL. The disability status, fatigue and reduced sleep quality have an impact mainly on physical domains of life quality.     

Fatigue and processing speed are related in multiple sclerosis

Background: Fatigue is common in multiple sclerosis (MS) and could be related to impaired processing speed caused by MS specific brain alterations. The objective of this study was to examine the relationship between processing speed and fatigue in patients with relapsing remitting MS. Methods: Patients with EDSS score ≤3.5 were grouped as fatigued [Fatigue Severity Scale (FSS) score ≥5.0] or non‐fatigued (FSS score ≤4.0). Patients with FSS scores ≥5 were categorized as primary or secondary fatigued according to various indices. A cognitive test battery obtained from Wechsler’s Adult Intelligence Scale‐III/Wechsler’s Memory Scale‐III was applied. Results: Processing speed (Digit Symbol Coding) was lower amongst all MS patients being 9.4(2.9) in primary fatigued, 8.3(2.8) in secondary fatigued and 10.3(2.7) in non‐fatigued versus 12.3(3.0) in healthy controls. In the combined group of primary and secondary fatigued MS patients, processing speed was slower than that in non‐fatigued MS patients and inversely related to fatigue (r = ?0.35; P < 0.05). No such relationship could be established in non‐fatigued MS patients or in healthy controls. Conclusion: The degree of fatigue in MS is related to processing speed impairment and longitudinal studies should clarify their mutual dependency.     

Fatigue, depression and disability accumulation in multiple sclerosis: a cross-sectional study

Objective:  To investigate the influence of disability and the speed of disability accumulation on fatigue and depression in a large cohort of patients with multiple sclerosis (MS).
Methods:  A total of 412 patients completed the Fatigue Severity Scale (FSS) and Center for Epidemiological Studies Depression Scale (CESD). The patients were registered at our outpatient department and demographic and disease specific data were compared between patients with and without severe fatigue (FSS ≥ 5.0) and clinically significant depressive symptoms (CESD ≥ 16). We investigated the association of Expanded Disability Status Scale (EDSS) scores, multiple sclerosis severity scores (MSSS) and either CESD scores or FSS-scores with severe fatigue and clinically significant depressive symptoms in a multivariable logistic regression model, with adjustment for possible confounders.
Results:  Only CESD scores were independently associated with severe fatigue. FSS scores and female gender were independently associated with clinically significant depressive symptoms. Neither EDSS nor MSSS scores were independently associated with fatigue or depression.
Conclusion:  In patients with MS, fatigue and depression are strongly associated with each other but not with the degree of disability or the speed of disability accumulation.     

Reliability and validity of the Swedish Fatigue Assessment Scale when self-administrered by persons with mild to moderate stroke

Objective: To examine internal consistency, test-retest reliability, floor/ceiling effects and construct validity of the Fatigue Assessment Scale (FAS), when self-administrated by persons with mild to moderate stroke.

Method: The FAS was translated into Swedish and tested for psychometric properties when self-administrated by persons with mild to moderate stroke. Participants, consequently selected from the stroke unit admission register received a letter with three questionnaires: the FAS, Short Form Health Survey (SF-36) subscale for vitality and Geriatric Depression Scale, GDS-15. Within two weeks, a second letter with FAS was sent for re-test.

Result: Seventy-tree persons with mild to moderate stroke participated in the study. Internal consistency was good (Cronbach’s alpha 0.82). The test and retest reliability of individual items showed that five items out of 10 items were good (weighted kappa > 0.60), four were moderate (0.40-0.60), and one was fair (0.22). The relative reliability between total scores was good (ICC _3.1 = 0.73) and the absolute reliability was nine points, meaning that a change of at least nine points in total score implies a real change of fatigue level. Correlation analysis showed that the Swedish FAS correlated with the SF-36 subscale for vitality (r_s = - 0.73) and GDS-15 (r_s = 0.62), suggesting convergent construct validity. There were no floor or ceiling effects.

Conclusion: The Swedish translation of the FAS used as a self-administrated questionnaire is reliable and valid for measuring fatigue in persons with mild to moderate stroke.     

Adjunct modafinil for the short-term treatment of fatigue and sleepiness in patients with major depressive disorder: a preliminary double-blind, placebo-controlled study

BACKGROUND: Fatigue and sleepiness are primary symptoms of depression that may not resolve with antidepressant therapy. Modafinil is a novel agent that has been shown to improve wakefulness and lessen fatigue in a variety of conditions. In this study, we examined the utility of modafinil as an adjunct therapy to treat fatigue and sleepiness in patients with major depression who are partial responders to antidepressants. METHOD: Patients with partial response to anti-depressant therapy given for at least a 6-week period for a current major depressive episode (DSM-IV criteria) were enrolled in this 6-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Patients received once-daily doses (100-400 mg) of modafinil or matching placebo as adjunct treatment to ongoing antidepressant therapy. The effects of modafinil were evaluated using the Hamilton Rating Scale for Depression (HAM-D), the Fatigue Severity Scale (FSS), the Epworth Sleepiness Scale (ESS), the Clinical Global Impression of Change (CGI-C), and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Adverse events were monitored throughout the study. RESULTS: One hundred thirty-six patients were randomized to treatment, with 118 patients (87%) completing the study. Most patients (82%) were fatigued, and one half of patients (51%) were sleepy. Modafinil rapidly improved fatigue and daytime wakefulness, with significantly greater mean improvements from baseline than placebo in fatigue (FSS) scores at week 2 (p < .05) and sleepiness (ESS) scores at week 1 (p < .01); the differences between modafinil and placebo at week 6 were not statistically significant. Assessment of the augmentation effects of modafinil (HAM-D, CGI-C, and SF-36) did not significantly distinguish modafinil from placebo. Modafinil was well tolerated in combination with a variety of antidepressants. CONCLUSION: Modafinil may be a useful adjunct therapy for the short-term management of residual fatigue and sleepiness in patients who are partial responders to antidepressant therapy.