Differences In Fatigue Scores Research Articles

Prevalence of Restless Leg Syndrome in School Going Students and Assessment of Fatigue

Background: Restless Legs Syndrome (RLS), also known as Willis-Ekbom Disease (WED), is a common condition where you feel an uncontrollable urge to move your legs because they feel uncomfortable, occasionally as painful sensations in the legs. This study investigates the prevalence of Restless Legs Syndrome (RLS) among school-going students and examines the variation in fatigue scores between restless leg syndrome-positive and restless leg syndrome-negative individuals. Materials and methods: A sample of 142 students from Pune, India participated in this cross-sectional study. RLS prevalence was determined using standardized diagnostic criteria, while fatigue scores were assessed using the Multidimensional Fatigue Inventory (MFI) scale. Data was analysed using descriptive statistics. Result: Results revealed a 51.40% prevalence of restless leg syndrome among the sampled population. 47.37% students exhibit mild RLS, 35.53% students have moderate out of total diagnosed cases. Statistical analysis demonstrated slight differences in fatigue scores between restless leg syndrome -positive and restless leg syndrome-negative students, with mean fatigue score of 54.12 in restless leg syndrome positive students, highlighting the impact of RLS on fatigue levels. These findings underscore the importance of early detection and intervention strategies for RLS in school-aged individuals to mitigate its effects on daily functioning and well-being. Conclusion: A considerably higher prevalence of restless leg syndrome was found in school going students with female predominance. A slight increase in fatigue score was seen on fatigue score analysis in restless leg syndrome positive students compared to their nonaffected counterparts.

Older Adults with Acute Myeloid Leukemia (AML) Experience Improvement in Health-Related Quality of Life (HRQoL) Scores with Intensive Therapy: Prospective Study from ECOG-ACRIN (EA) E2906 Phase 3 Trial

Background There is limited prospective or comparative data evaluating the HRQoL impact of intensive chemotherapy (IC) in older adults (age ≥60 years) with AML. In the recent EA E2906 phase 3 study of '7&3' (daunorubicin & cytarabine) vs. clofarabine (CLO), a putative lower intensity therapy, we incorporated a prospective patient-reported outcomes (PRO) assessment of HRQoL and fatigue to understand treatment impact from the patients' (pts) perspective. Methods E2906 study design and results have been presented previously [n=727, med. age 68 years (range 60-86), randomized 1:1 to ‘standard’ ‘7&3‘ & high dose cytarabine (Arm A) vs. single agent CLO (Arm B), as remission induction (Step 1) and consolidation (Step 2), respectively]. There was no difference in composite complete remission (CCR, 50%) or 30-day mortality rates (8.5%), and in primary analysis CLO was inferior for Overall Survival. HRQoL was a key secondary protocol endpoint. PROs assessed HRQoL and leukemia-specific symptoms and concerns using Functional Assessment of Cancer Therapy-Leukemia scale (FACT-Leu), & Fatigue using FACT-Fatigue subscale. PROs were administered at prespecified time points: (1) Baseline; (2) Cycle 1 at nadir (approx. Day 15); (3) End of Step 1 restaging (approx. D 40); (4) Beginning of Step 2 (1 st consolidation, approx. D 45); and (5) 2 nd cycle consolidation/End Step 2 (approx. D 60). The FACT-Leu Trial Outcome Index ( TOI) was calculated by summing physical well-being, functional well-being, and leukemia-specific concerns subscales to create a single composite score. Higher TOI scores correspond to better HRQoL. The primary endpoint was to evaluate TOI difference from randomization to day 30 after induction therapy between arms, evaluated using Wilcoxon rank sum test. We also compared Clinically Meaningful differences (CMiD) in TOI (defined as patient change ≥½ standard deviation from baseline TOI) between arms, using the X2 test. Pts not completing at least 2 assessment forms (including baseline) were excluded. Testing of constructs of Physical Well-being (PWB), Functional, Leukemia & Fatigue scales demonstrated high Cronbach's a values (a >0.7) except for PWB (a=0.672) at a single time point (End of Step 2). Results Baseline TOI was available for n=489, and 364 pts (n=182 each Arm) were evaluable in this planned analysis. Evaluating CMiD during Cycle 1 induction, pts in Arm B were less likely to experience ‘Worse’ TOI score (32% vs. 40.7%, Arm A), more likely to maintain stable TOI scores (49.1% vs. 39%, Arm A), and had a similar proportion of ‘Better’ TOI scores (20.3%, A vs. 18.9%, B) although differences were not significant (p=0.1389). Conversely in cycle 1 consolidation, more patients in Arm A experienced Better TOI (45.1% vs. 29.2%, Arm B), fewer had stable TOI (45.1% vs. 58.3%, Arm B), and rates of ‘Worse’ TOI were similar (9.8%, A vs 12.5%, Arm B), again differences were not significant (p=0.2616). There was no difference in Fatigue scores between Arms (p=0.49). We evaluated whether TOI and Fatigue scores could predict the ability to complete protocol therapy. In univariate analysis baseline TOI (p=0.0059) and Fatigue (p=0.0057) were associated with Step 1 completion, however on multivariate analysis (adjusting for age, sex, and Arm) were no longer significant [TOI, Odds Ratio (OR) 1.03 (0.98-1.08, p=0.27); Fatigue, OR 1.03 (0.96-1.11, p=0.42)]. There was a borderline association of TOI with Step 2 completion [TOI OR 1.10 (1.00-1.23, p=0.06)]. Using a multivariable linear mixed effects model, we observed similar and significant changes in TOI scores in both Arms, demonstrating the effect of IC & CLO on HRQoL (Figure). Comparing to baseline, TOI scores decreased significantly at C1 induction nadir (-4.0873, p<0.0001), and increased by 5.0762 (p=0.0004) at end Step 1, by 6.9047 at cycle 1 consolidation (p<0.0001), and by 11.4601 (p<0.0001) at end Step 2. Differences were mainly apparent in those who achieved CCR, and there was significant attrition in PRO responses in non-CCR pts. Conclusions Older adults experienced significant improvement in HRQoL after nadir regardless of therapy, and those achieving CCR report significantly higher scores. We did not observe differences in leukemia specific HRQoL or fatigue between treatment Arms (7&3 vs. CLO). Patient-reported HRQoL & Fatigue was not predictive of completion of protocol therapy. These results serve as a benchmark for expectations with IC in older adults.

Achievements in Hypothyroidism Treatment with Herbal Medicine: A Systematic Review of Randomized Controlled Trials.

Background Hypothyroidism is a common endocrine disease in the world that causes morbidity and mortality due to its association with metabolic diseases, especially in old age, and long-term treatment with levothyroxine causes many side effects for patients. Treatment with herbal medicine can regulate thyroid hormones and prevent side effects. Objective The purpose of this systematic review is the evaluation of the effect of herbal medicine on the signs and symptoms of primary hypothyroidism. Method PubMed, Embase, Google Scholar, Scopus, and Cochrane Central Register of Controlled Trials were searched until 4 May, 2021. We selected randomized clinical trials (RCTs) that have assessed the effect of herbal medicine on hypothyroidism. Result Out of 771 articles, 4 trials with 186 participants were included. In one study, Nigella sativa L. caused a significant decrease in weight (P=0.004) and body mass index (BMI) (P=0.002). TSH levels were reported to be decreased and T3 increased in the treatment group (P =0.03) (P=0.008), respectively. In another study on Nigella sativa L., results did not show a significant difference between the two groups (p=0.02). A significant decrease in total cholesterol (CHL) and fasting blood sugar (FBS) was reported in participants with negative anti-thyroid peroxidase (anti-TPO) antibodies. In patients with positive anti-TPO antibodies, a significant increase in total cholesterol and FBS was observed in the intervention group (p=0.02). In the third RCT, T3 in the ashwagandha group at 4 and 8 weeks significantly increased by 18.6% (p=0.012) and 41.5% (p < 0.001), respectively. A noticeable increase was found in the T4 level from baseline by 9.3% (p= 0.002) and 19.6% (p < 0.001) at 4 and 8 weeks, respectively. TSH levels fell remarkably in the intervention group compared to placebo at 4 weeks (p <0.001) and 8 weeks (p <0.001), respectively. In the last article selected, Mentha x Piperita L. showed no significant difference in fatigue scores between intervention and control groups at the midpoint (day 7), while fatigue scores improved in the intervention group in all subscales compared to the control group on day 14. Conclusion Some herbal remedies, including Nigella sativa L., ashwagandha, and Mentha x Piperita L., can improve the signs and symptoms of primary hypothyroidism, but using a more extensive and advanced methodology will provide us with more complete results.

The effect of MARIKERJA, a fatigue management programme, on the management of fatigue among manufacturing shift workers in Indonesia

To evaluate the effects of a workplace fatigue management programme called MARIKERJA on reducing fatigue among manufacturing shift workers in Indonesia. A quasi-experimental pre- and post-test study was conducted among 116 shift workers (58 in the intervention group and 58 in the control group). The MARIKERJA programme was delivered to the intervention group for 12weeks. Meanwhile, the control groups received the MARIKERJA intervention only at the end of the study period. Fatigue levels were measured using the Fatigue Severity Scale (FSS) in weeks 6 and 12 of the intervention. Data were analysed using a t test and a general linear model repeated measures procedure. There were significant differences in fatigue scores between the control and intervention groups after the MARIKERJA intervention in week 6 (40.07 ± 8.89 vs. 27.12 ± 11.67; p < 0.001) and week 12 (38.22 ± 9.28 vs. 17.53 ± 6.54; p < 0.001). The MARIKERJA intervention effectively reduced fatigue levels by up to 37.3% (R2 = .373; p = 0.001; 95% CI = 15.82-19.25). The MARIKERJA intervention effectively reduces fatigue among manufacturing shift workers.

P277 Assessment of fatigue as a patient-reported outcome: Correlation with baseline disease activity and therapy response in Inflammatory Bowel Disease

Abstract Background Currently available disease activity indices for IBD (e.g., CDAI and Mayo score) focus on symptoms directly related to intestinal function, while other relevant health consequences of disease activity including quality of life, neuropsychiatric symptoms like depression, and social functionality, are not captured. With better therapies more stringent definitions of patient health have come into focus. One of the most common patient reported outcomes (PROs) in IBD is fatigue, which can be unrelated to endoscopic disease activity. We have shown earlier a strong degradation of tryptophan in active IBD (Nikolaus et al, 2017, Gastroenterology) and low tryptophan levels have been linked in various chronic disease to high fatigue levels. Here, we aim to study the relationship of fatigue with disease activity in the context of therapy response to a biological treatment. Methods Patients with Crohn’s disease and ulcerative colitis with high disease activity (Mayo score ≥ 6, CDAI ≥ 220) and planned new therapy with a biologic agent were included into a prospective observational protocol. After informed consent, clinical disease activity, inflammatory biomarkers, tryptophan levels in serum and fatigue levels were assessed longitudinally at week 0, 2, 6 and 14 after start of induction therapy. Complete assessments including week 14 were available for 38 patients for this interim analysis of the ingoing study. For fatigue assessment we used the validated German version of the fatigue subscale of the FACIT-F questionnaire. Patients were stratified into therapy responder (clinical remission (CR), reduction of partal Mayo score (pMayo) &amp;gt; 50%, CDAI &amp;lt; 150), non-responders (reduction of Mayo &amp;lt;30%, CDAI reduction &amp;lt;70) and partial responders at week 14. Results In the cross-sectional analysis of all patients (n = 76), the fatigue score strongly (inversely) correlated with pMayo and CDAI and correlated positively with tryptophan levels in serum. In receiver operating characteristic (ROC) analysis, FACIT-F score were able distinguish active vs. non-active disease (p &amp;lt; 0.0001, AUC = 0.7619) with specificity of 0.7103 and sensitivity of 0.7160. We did not observe significant differences in fatigue scores between males and females. In the longitudinal analysis, fatigue score only improved in the CR group (n = 25, median FACIT score 30 at baseline vs. 44 at week 14, p = 0.0221), and was significantly higher in CR vs. non-responder (n = 16, median FACIT score 44 vs. 31.5, p = 0.007). Conclusion Fatigue is strongly related but not completely overlapping with disease activity. Fatigue will be evaluated as a a patient-oriented indicator for therapeutic response. This observation will be extended by increasing the cohort size and independent validation.

The physical and mental health of the medical staff in Wuhan Huoshenshan Hospital during COVID-19 epidemic: A Structural Equation Modeling approach

IntroductionEarly in the epidemic of coronavirus disease 2019, the Chinese government recruited a proportion of healthcare workers to support the designated hospital (Huoshenshan Hospital) in Wuhan, China. The majority of front-line medical staff suffered from adverse effects, but their real health status during COVID-19 epidemic was still unknown. The aim of the study was to explore the latent relationship of the physical and mental health of front-line medical staff during this special period. MethodsA total of 115 military medical staff were recruited between February 17th and February 29th, 2020 and asked to complete questionnaires assessing socio-demographic and clinical characteristics, self-reported sleep status, fatigue, resilience and anxiety. Results55 medical staff worked within Intensive Care and 60 worked in Non-intensive Care, the two groups were significantly different in reported general fatigue, physical fatigue and tenacity (P<0.05). Gender, duration working in Wuhan, current perceived stress level and health status were associated with significant differences in fatigue scores (P<0.05), the current perceived health status (P<0.05) and impacted on the resilience and anxiety of participants. The structural equation modeling analysis revealed resilience was negatively associated with fatigue (β=-0.52, P<0.01) and anxiety (β=-0.24, P<0.01), and fatigue had a direct association with the physical burden (β=0.65, P<0.01); Fatigue mediated the relationship between resilience and anxiety (β=-0.305, P=0.039) as well as resilience and physical burden (β=-0.276, P=0.02). ConclusionDuring an explosive pandemic situation, motivating the effect of protective resilience and taking tailored interventions against fatigue are promising ways to protect the physical and mental health of the front-line medical staff.

A correlation study of emergency department nurses’ fatigue, perceived stress, social support and self-efficacy in grade III A hospitals of Xi’an

Fatigue is a universal and challenging problem in a nurse's career, particularly for those working in the emergency department. Through analyzing the current status of emergency department nurses’ fatigue, the purpose of this study is to provide guidance for occupational health promotion strategies making and fatigue relief.Cross-sectional study was conducted among nurses working in emergency department in 6 grade III A hospitals in Xi’an, China. Convenience sample of 346 nurses agreed to participate in this study. Data collection was based on the questionnaires. Descriptive statistics, hypothesis tests and correlation analysis were used to describe the samples’ characteristics and identify associations amongst participants’ characteristics.The fatigue score of those emergency nurses from grade III A hospitals in Xian was 8.71 ± 3.01, a high fatigue level. Moreover, there were significant differences in fatigue scores of different age groups, sleep qualities, work stress levels and physical states (P < .01). Further, the dimension of physical fatigue in various age groups, job title, marital status, sleep qualities, work stress levels and physical states was significantly different (P < .05) and the dimension of mental fatigue with different sleep qualities, work stress levels and physical states was significantly different (P < .01). The results of correlation analysis showed that fatigue was positively correlated with perceived stress while negatively correlated with social support and self-efficacy (P < .01). The multiple stepwise linear regression analysis indicated that the independent variables in the fatigue regression equation were perceived stress, physical condition and work stress in turn (P < .01), and the independent variables in the the dimensions of physical fatigue regression equation were perceived stress, physical condition,work stress and job title in turn (P < .05); the independent variables in the the dimensions of mental fatigue regression equation were perceived stress,subjective support and physical condition in turn (P < .05).The current status of high fatigue level of emergency nurses should be taken seriously. It is imperative to take effective measures to help emergency nurses reduce stress, improve social support, promote the self-efficacy, and thus relieve fatigue.

PROGRESSIVE MUSCLE RELAXATION REDUCE FATIGUE SCORES IN PREGNANT MOTHERS

Fatigue is a symptom that is often complained of by pregnant women in early pregnancy. The prevalence is quite high which causes pregnant women to experience several consequences, including feelings of depression, lack of energy, cognitive impairment, memory disorders, irritability, psychomotor dysfunction and decreased quality of life. This study aims to determine the effect of progressive muscle relaxation on fatigue in pregnant women in the Community Health Centres (Puskesmas) Kahuripan City of Tasikmalaya. The research design uses a method quasi-experiment, with one group approaches pretest and a post-test group without a control group. Sampling with consecutive sampling technique, as many as 26 pregnant women. The statistical analysis used was univariate, bivariate using paired t-test to test differences in fatigue scores before and after progressive muscle relaxation exercises. Pregnant women are given progressive muscle relaxation exercises for at least four days for two weeks. The results showed that there was an effect of providing progressive muscle relaxation exercises to the fatigue score, p-value 0.016 (p

Effectiveness of progressive muscle relaxation and aromatherapy on fatigue in pregnant mothers

Background: Fatigue in pregnant women can lead to cesarean delivery, also triggering problems during pregnancy, childbirth, and the puerperium. Therefore, there is a need for non-pharmacological interventions to reduce the level of fatigueObjective: This study aims to determine the effectiveness of giving progressive muscle relaxation (PMR) and aromatherapy to complaints of fatigue in pregnant womenMethods: This is a quasi-experiment with pretest and post-test with control group design. The sampling technique was simple random sampling, consisted of 52 respondents who were divided into two groups. The statistical using a paired t-test and independent t-testResults: After the administration of PMR and aromatherapy interventions, the fatigue score decreased significantly from 5.15 to 3.15; p&lt;0.001. In the control group, the fatigue score was reduced from 5.04 to 4.00; p&lt;0.0001. There was a significant difference in fatigue scores in the intervention and control groups (3.15 ± 1.592 vs. 4.00 ± 0.980; p&lt;0.05).Conclusion: Combination progressive muscle relaxation exercises and aromatherapy are effective in reducing fatigue scores in pregnant women

Effects of the ACTIVity And TEchnology (ACTIVATE) intervention on health-related quality of life and fatigue outcomes in breast cancer survivors.

The ACTIVATE Trial examined the efficacy of a wearable-based intervention to increase physical activity and reduce sedentary behavior in breast cancer survivors. This paper examines the effects of the intervention on health-related quality of life (HRQoL) and fatigue at 12 weeks (T2; end of intervention) and 24 weeks (T3; follow-up). Inactive and postmenopausal women who had completed primary treatment for stage I-III breast cancer were randomized to intervention or waitlist control. Physical activity and sedentary behavior were measured by Actigraph and activPAL accelerometers at baseline (T1), end of the intervention (T2), and 12 weeks follow-up (T3). HRQoL and fatigue were measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Primary intervention effects were evaluated comparing intervention and waitlist group at T2 using repeated measures mixed effects models. Overall, 83 women were randomized and trial retention was high (94%). A 4.6-point difference in fatigue score was observed between groups at T2 (95% CI: 1.3, 7.8) indicating improvement in fatigue profiles in the intervention group. In within groups analyses, the intervention group reported a 5.1-point increase in fatigue from baseline to T2 (95% CI: 2.0, 8.2) and a 3.3-point increase from baseline to T3 (95% CI: 0.1, 6.41). Despite small improvements in fatigue profiles, no effects on HRQoL were observed. While the ACTIVATE Trial was associated with improvements in physical activity and sedentary behavior, more intensive or longer duration interventions may be needed to facilitate changes in HRQoL.

Patterns and predictors of fatigue following living donor nephrectomy: Findings from the KDOC Study.

This study sought to identify the prevalence, pattern, and predictors of clinical fatigue in 193 living kidney donors (LKDs) and 20 healthy controls (HCs) assessed at predonation and 1, 6, 12, and 24monthspostdonation. Relative to HCs, LKDs had significantly higher fatigue severity (P=.01), interference (P=.03), frequency (P=.002), and intensity (P=.01), and lower vitality (P<.001), at 1-month postdonation. Using published criteria, significantly more LKDs experienced clinical fatigue at 1 monthpostdonation, compared to HCs, on both the Fatigue Symptom Inventory (60% vs. 37%, P<.001) and SF-36 Vitality scale (67% vs. 16%, P<.001). No differences in fatigue scores or clinical prevalence were observed at other time points. Nearly half (47%) reported persistent clinical fatigue from 1 to 6months postdonation. Multivariable analyses demonstrated that LKDs presenting for evaluation with a history of affective disorder and low vitality, those with clinical mood disturbance and anxiety about future kidney failure after donation, and those with less physical activity engagement were at highest risk for persistent clinical fatigue 6monthspostdonation. Findings confirm inclusion of fatigue risk in existing OPTN informed consent requirements, have important clinical implications in the care of LKDs, and underscore the need for further scientific examination in this population.

Is dietary supplement use longitudinally associated with fatigue in stage I-III colorectal cancer survivors?

Supplement use among colorectal cancer (CRC) survivors is common, yet evidence supporting its beneficial health effects is mostly lacking and cancer-specific lifestyle guidelines advise against the use of supplements. We aimed to describe the use of supplements by CRC survivors from diagnosis to 2 years post-treatment and investigate how overall supplement use is longitudinally associated with fatigue. In a prospective cohort study of stage I-III CRC survivors (n=325), information on supplement use was collected during repeated home visits at diagnosis and at 6 weeks, 6, 12, and 24 months post-treatment. Fatigue was assessed using the Checklist Individual Strength (score range 20-140) at all post-treatment time points. Linear mixed-models were applied to analyze longitudinal associations of overall supplement use with fatigue, adjusted for sex, age, comorbidities, chemotherapy, and physical activity. At all time points, about 40% of participants used supplements. Multivitamins/multiminerals were the most frequently used supplements at all time points. Of participants with at least two available measurements, 28% were consistent users, 45% consistent nonusers, and 27% inconsistent users (i.e.reported both use and nonuse). Reported fatigue levels declined significantly after treatment. Overall, no statistically significant differences in fatigue score over time were observed between supplement users and nonusers. Likewise, no intra-individual associations of supplement use and fatigue were found. However, in inter-individual analyses, supplement users reported to experience more fatigue compared to nonusers (β 7.0, 95% CI 0.3; 13.7). No overall association between supplement use and fatigue was found. Results of the current study do therefore not imply that supplement use alleviates complaints of fatigue among CRC survivors. However, increased levels of fatigue may be a reason for supplement use among CRC survivors.

Associations between clinical symptoms, plasma norepinephrine and deregulated immune gene networks in subgroups of adolescent with Chronic Fatigue Syndrome

BackgroundChronic Fatigue Syndrome (CFS) is one of the most important causes of disability among adolescents while limited knowledge exists on genetic determinants underlying disease pathophysiology. MethodsWe analyzed deregulated immune-gene modules using Pathifier software on whole blood gene expression data (29 CFS patients, 18 controls). Deconvolution of immune cell subtypes based on gene expression profile was performed using CIBERSORT. Supervised consensus clustering on pathway deregulation score (PDS) was used to define CFS subgroups. Associations between PDS and immune, neuroendocrine/autonomic and clinical markers were examined. The impact of plasma norepinephrine level on clinical markers over time was assessed in a larger cohort (91 patients). ResultsA group of 29 immune-gene sets was shown to differ patients from controls and detect subgroups within CFS. Group 1P (high PDS, low norepinephrine, low naïve CD4+ composition) had strong association with levels of serum C-reactive protein and Transforming Growth Factor-beta. Group 2P (low PDS, high norepinephrine, high naïve CD4+ composition) had strong associations with neuroendocrine/autonomic markers. The corresponding plasma norepinephrine level delineated 91 patients into two subgroups with significant differences in fatigue score. ConclusionWe identified 29 immune-gene sets linked to plasma norepinephrine level that could delineate CFS subgroups. Plasma norepinephrine stratification revealed that lower levels of norepinephrine were associated with higher fatigue. Our data suggests potential involvement of neuro-immune dysregulation and genetic stratification in CFS.

PND139 - IMPACT OF PROLONGED-RELEASE FAMPRIDINE ON FATIGUE AMONG PEOPLE WITH MULTIPLE SCLEROSIS IN A MULTI-COUNTRY STUDY

Prolonged-release (PR) fampridine (dalfampridine extended release in the United States) is approved for the improvement of walking in adult patients with multiple sclerosis (MS). It has been suggested that PR-fampridine could be associated with beneficial effects beyond walking. We investigated if an improvement in fatigue could be detected in patients who received PR-fampridine, among participants in a cross-sectional study of people with MS (PwMS) from 16 countries in Europe. Fatigue scores on a 10 point visual analogue scale (VAS) in PwMS and Expanded Disability Status Scale (EDSS) 4-7 from the study were analysed. A multiple regression analysis assessed the impact of PR-fampridine on fatigue improvement, with adjustment for categorical variables (gender, current treatment, relapse during last month, physical therapy use, and country) and continuously distributed variables such as disease duration, age, and EDSS. Two-tailed Student’s t-tests were used to test for differences in fatigue scores. In total, 934 patients on PR-fampridine and 4,171 who were not receiving PR-fampridine were analysed. The on-PR-fampridine group was slightly younger than the off-PR-fampridine group (mean age 53.3 vs 54.5 years; p=0.0024), had more male patients (20% vs 17%; p=0.0103), higher EDSS score (median EDSS 6 vs 5), and used more physical therapy (24% vs 14%; p<0.0001). The on-PR-fampridine group had lower fatigue score compared with the off-PR-fampridine group (mean value 5.54 vs 5.96; p<0.001). Adjusted multiple regression analysis demonstrated that PR-fampridine treatment was associated with significant fatigue score improvement – lowering fatigue score by 0.38 points on the VAS (p<0.0001). The effects of DMTs and age on fatigue score were not statistically significant. PwMS treated with PR-fampridine demonstrated a significantly lower fatigue score when compared to non-PR-fampridine patients in this cohort. Results from this study should be integrated with findings from other sources.

Developing a fatigue questionnaire for Chinese civil aviation pilots

Objective. To assess the fatigue risk is an important challenge in improving flight safety in the aviation industry. The aim of this study was to develop a comprehensive fatigue risk management indicators system and a fatigue questionnaire for Chinese civil aviation pilots. Methods. Participants included 74 civil aviation pilots (all males). They finished the questionnaire in 20 min before a flight mission. Estimation of internal consistency with Cronbach's α and Student's t test as well as Pearson's correlation analysis were the main statistical methods. Results. The results revealed that the fatigue questionnaire had acceptable internal consistency reliability and construct validity; there were significant differences in fatigue scores between international and domestic flight pilots. Also, some international flight pilots, who had taken medications as a sleep aid, had worse sleep quality than those who had not. Long-endurance flights across time zones caused significant differences in circadian rhythm. Conclusions. The fatigue questionnaire can be used to measure Chinese civil aviation pilots’ fatigue, which provides a reference for a fatigue risk management system for civil aviation pilots.

Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial

Background Primary biliary cirrhosis (PBC) is an autoimmune liver disease, and 50% of patients with this disease experience fatigue. This is a debilitating symptom affecting quality of life and resulting in social isolation, which is highlighted by patients as a research priority. PBC is characterised immunologically by the presence of high-titre autoantibodies that are directed at the pyruvate dehydrogenase complex (PDC) and are highly effective at blocking its energy generation function. We hypothesised that if anti-PDC antibodies were a driver of fatigue through bioenergetic dysfunction, then the B-cell-targeting biological agent rituximab (MabThera®, Roche Products Ltd, Welwyn Garden City, UK) might be a therapeutic option. Objective To assess whether or not rituximab safely improved moderate or severe fatigue in PBC patients. Design A Phase II, double-blind, randomised controlled trial comparing rituximab with placebo in fatigued PBC patients. Randomisation was conducted using a web-based system. Participants received two infusions on days 1 and 15 and were followed up at 3, 6, 9 and 12 months. Setting A single-centre UK study in Newcastle upon Tyne Hospitals NHS Foundation Trust. Participants Seventy-one participants aged ≥ 18 years with PBC and moderate or severe fatigue (score of &gt; 33 on the PBC-40 fatigue domain) were screened. The PBC-40 questionnaire is a fully validated disease-specific health-related quality-of-life measure for use in patients with PBC. Fatigue, with a maximum score of 55, is one of its six domains. Fifty-seven participants were randomised to the trial, 55 of whom reached the primary end-point assessment. Intervention Participants were randomised in a 1 : 1 ratio to receive either rituximab (1000 mg) or a saline intravenous infusion (placebo) on days 1 and 15. The infusions were delivered in a double-blind manner using the same protocol. Main outcome measures The primary outcome measure was the PBC-40 fatigue domain at 3 months, assessed on an intention-to-treat basis. Secondary outcome measures included markers of bioenergetics function (anaerobic threshold and post-exercise muscle pH assessed using magnetic resonance imaging) and physical activity levels. Impact on biochemical markers of liver disease severity was assessed as an experimental outcome. Results Rituximab therapy was safe, with no serious adverse events linked to the drug. There was no statistically significant difference in fatigue score at 3 months between the rituximab and placebo arms [adjusted mean difference –0.9, 95% confidence interval (CI) –4.6 to 3.1]. However, improvement in fatigue was observed in both arms {mean score decreasing from 41.2 [standard deviation (SD) 5.5] to 36.2 (SD 8.4) in the rituximab arm and from 43.0 (SD 5.9) to 38.1 (SD 8.7) in the placebo arm}. There was little difference in any of the secondary outcomes between arms. However, anaerobic threshold improved significantly in the rituximab arm (adjusted mean difference at 3 months 1.41, 95% CI 0.03 to 2.80). No change in muscle bioenergetics characteristics was seen. A suggestive improvement in liver biochemistry was observed. Limitations Recruitment was lower than the original target, leading to a reduction in study power. A clinically significant placebo effect on PBC-40 fatigue scores was seen. Conclusions Rituximab is ineffective for the treatment of fatigue in unselected PBC patients despite metabolic modulation through improvement of anaerobic threshold. Future work Results from the trial demonstrate that metabolic effect of rituximab is not translated into clinical benefit. This will help to guide us to design future trials and when looking at completely different targets. Trial registration Current Controlled Trials ISRCTN03978701, ClinicalTrials.gov identifier NCT02376335 and EudraCT number 2012-000145-12. Funding This project was funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation programme and will be published in full in Efficacy and Mechanism Evaluation; Vol. 5, No. 2. See the NIHR Journals Library website for further project information. Additional funding was received from the Medical Research Council and a Department of Health and Social Care subvention.

Altered Cd8+ T lymphocyte Response Triggered by Arginase 1: Implication for Fatigue Intensification during Localized Radiation Therapy in Prostate Cancer Patients.

Fatigue, the most common side effect of cancer treatments, is observed to intensify during external-beam radiation therapy (EBRT). The underlying molecular mechanisms remain unclear. This study investigated the differentially expressed genes/proteins and their association with fatigue intensification during EBRT. Fatigue scores measured by FACT-F and peripheral blood were collected prior to treatment (baseline D0), at midpoint (days 19-21, D21) and endpoint (days 38-42, D42) from men (n=30) with non-metastatic prostate cancer undergoing EBRT. RNA extracted from peripheral blood was used for gene expression analysis. Plasma arginase I and arginine were examined using ELISA and liquid chromatography-tandem mass spectrometry. Differences in fatigue scores, gene and protein expression between times points following EBRT were analyzed by one way ANOVA followed by Post Hoc t-test. Fatigue scores decreased significantly from baseline (44.6 ± 8.1) to midpoint (37.3 ± 10.6, p=0.000, low scores indicating high fatigue) and to endpoint (37.4 ± 10.1, p=0.001) during EBRT. ARG1 (encoding arginase type 1) was significantly up regulated from baseline to midpoint of EBRT (fold change =2.41, p<0.05) whereas genes associated with the adaptive immune functional pathway (CD28, CD27, CCR7, CD3D, CD8A and HLA-DOB) were significantly downregulated >2-fold between the study time points. The changes in gene expression were associated with patient reported fatigue intensity. Moreover, the upregulation of ARG1 was negatively correlated with the absolute lymphocyte count (R2=0.561, p=0.01) only in the high level of fatigue group (n=17) during EBRT. Increased ARG1 expression is known to result in arginine deficiency, which leads to immunosuppression by impairing lymphocyte proliferation and activation. EBRT-induced ARG1 upregulation may play an essential role in fatigue intensification via the arginine deficiency and suppression of T-cell proliferation pathways. These findings may provide novel insights into the molecular-genetic mechanisms underlying the development and intensification of cancer treatment-related fatigue.

Differences in fatigue severity in a sample of adult cancer patients.

To describe differences in fatigue severity in a sample of adult Puerto Rican patients during and postcancer treatments. Hispanics, including Puerto Ricans, are an understudied population who are under-represented in clinical trials, especially in symptom research. Although symptom management is a clinical priority in oncology care, treatment-related differences in Puerto Rican cancer patients' report of fatigue severity have not been well described. A cross-sectional survey was conducted from data of self-report of 138 Puerto Rican patients during and postcancer treatments at two ambulatory facilities located in San Juan, Puerto Rico. Fatigue severity was assessed using the Fatigue subscale from the Functional Assessment of Cancer Therapy-Fatigue quality of life questionnaire Spanish version. Differences in fatigue severity across type of treatment (radiation therapy, chemotherapy, combined radiation chemotherapy and post-treatment) were evaluated using nonparametric (Kruskal-Wallis and Mann-Whitney test) statistical tests. The majority of the participants had prostate (33%) and breast (32%) cancers and were receiving radiation therapy (43%) or chemotherapy (28%). The Kruskal-Wallis test showed that there was a statistically significant difference in fatigue scores between the different four treatment conditions, χ2 (3)=39.1, p=.001 with patients on combined radiation chemotherapy or chemotherapy alone experiencing more severe fatigue. Findings from the current study suggest that type of treatment is a key component of the symptom burden of fatigue among the Puerto Rican oncology population. Specially, patients receiving combined therapy or chemotherapy alone were at increased risk for experiencing severe fatigue, compared to radiation therapy and post-treatment patients. With the worldwide increase in migration of Puerto Rican families, nurses need to recognise that type of treatment is a key component of the symptom burden of fatigue among the Puerto Rican population. The results of this study will improve understanding of treatment-related fatigue to identify therapeutic targets and improve quality of life of patients.

Work, eat and sleep: towards a healthy ageing at work program offshore

BackgroundHealth management tools need to be developed to foster healthy ageing at work and sustain employability of ageing work-forces. The objectives of this study were to 1) perform a needs assessment to identify the needs of offshore workers in the Dutch Continental Shelf with regard to healthy ageing at work and 2) to define suitable program objectives for a future healthy ageing at work program in the offshore working population.MethodsA mixed methods design was used applying an intervention mapping procedure. Qualitative data were gathered in N = 19 semi-structured interviews and six focus-group sessions (N = 49). Qualitative data were used to develop a questionnaire, which was administered among N = 450 offshore workers. Subgroup analyses were performed to investigate age-related differences relating to health status and work-related factors.ResultsThe importance of good working environments, food, as well as sleep/fatigue management was identified by the qualitative data analysis. A total of 260 offshore workers completed the questionnaire. Significant differences in work ability were found between offshore workers aged <45 and 45–54 years (mean 8.63 vs. 8.19; p = 0.005) and offshore workers aged <45 and >55 years (mean 8.63 vs. 8.22; p = 0.028). Offshore workers had a high BMI (M = 27.06, SD = 3.67), with 46 % classified as overweight (BMI 25–30) and 21 % classified as obese (BMI >30). A significant difference in BMI was found between offshore workers aged <45 and ≥55 years (mean 26.3 vs. 28.6; p <0.001). In total, 73 % of offshore workers reported prolonged fatigue. A significant difference in fatigue scores was found between offshore workers aged <45 and ≥55 years (mean 36.0 vs. 37.6; p = 0.024). Further, a “dip” was reported by 41 % of offshore workers. Dips were mainly experienced at day 10 or 11 (60 %), with 45 % experiencing the dip both as physical and mental fatigue, whereas 39 % experienced the dip as only mental fatigue.ConclusionsBoth qualitative and quantitative analyses identified work, food and sleep/fatigue management as most important program objectives for a healthy ageing at work and sustainable employability program offshore. Future studies should investigate possible causes of dip occurrences and high fatigue scores to identify suitable interventions.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-2807-5) contains supplementary material, which is available to authorized users.

Fatigue and sleep under large summer temperature differences

BackgroundIt has been recognized that an increase in outdoor ambient temperatures has a negative impact on health, particularly fatigue and sleep quality; however, the relationship among fatigue, sleep quality, and air temperature has yet to be sufficiently elucidated. ObjectivesTo examine whether fatigue and sleep quality in a healthy Japanese population were affected by rising air temperature at three time points in summer and to investigate the confounding factors for fatigue. MethodsA total of 602 healthy volunteers in Osaka, Japan, participated in a survey that was conducted at the end of July, August, and September in 2010. The questionnaire consisted of four sections; demographic variables, accommodation status, fatigue, and sleep quality. We used the Chalder fatigue scale for assessment of fatigue, and the Japanese version of the Pittsburgh Sleep Quality Index (PSQI) for assessment of sleep quality. ResultsThe fatigue score was positively correlated with the sleep quality score in the total cohort. All the questionnaires at the three time points were completed by 162 participants. There were significant differences in fatigue scores among the surveys. We stratified the subjects into two groups of good and poor sleepers using a cutoff value of the PSQI. The good sleepers did not show differences in fatigue score regardless of the change in air temperature. However, the fatigue score of poor sleepers was greater at higher air temperatures. The use of air conditioners, accommodation type, and subject’s age were confounding factors for fatigue. ConclusionsHigh air temperatures in summer increased fatigue in healthy volunteers, especially those with poor sleep patterns, depending on the use of air conditioners, accommodation status, and subject’s age.