Protocol of the Healthy Brain Study: An accessible resource for understanding the human brain and how it dynamically and individually operates in its bio-social context.

The endeavor to understand the human brain has seen more progress in the last few decades than in the previous two millennia. Still, our understanding of how the human brain relates to behavior in the real world and how this link is modulated by biological, social, and environmental factors is limited. To address this, we designed the Healthy Brain Study (HBS), an interdisciplinary, longitudinal, cohort study based on multidimensional, dynamic assessments in both the laboratory and the real world. Here, we describe the rationale and design of the currently ongoing HBS. The HBS is examining a population-based sample of 1,000 healthy participants (age 30-39) who are thoroughly studied across an entire year. Data are collected through cognitive, affective, behavioral, and physiological testing, neuroimaging, bio-sampling, questionnaires, ecological momentary assessment, and real-world assessments using wearable devices. These data will become an accessible resource for the scientific community enabling the next step in understanding the human brain and how it dynamically and individually operates in its bio-social context. An access procedure to the collected data and bio-samples is in place and published on https://www.healthybrainstudy.nl/en/data-and-methods/access. Trail registration: https://www.trialregister.nl/trial/7955.

Everyday cognitive failure and depressive symptoms predict fatigue in sarcoidosis: A prospective follow-up study.

BACKGROUND: Fatigue is a major and disabling problem in sarcoidosis. Knowledge concerning correlates of the development of fatigue and possible interrelationships is lacking. OBJECTIVE: A conceptual model of fatigue was developed and tested. METHODS: Sarcoidosis outpatients (n = 292) of Maastricht University Medical Center completed questionnaires regarding trait anxiety, depressive symptoms, cognitive failure, dyspnea, social support, and small fiber neuropathy (SFN) at baseline. Fatigue was assessed at 6 and 12 months. Sex, age, and time since diagnosis were taken from medical records. Pathways were estimated by means of path analyses in AMOS. RESULTS: Everyday cognitive failure, depressive symptoms, symptoms suggestive of SFN, and dyspnea were positive predictors of fatigue. Fit indices of the model were good. CONCLUSIONS: The model validly explains variation in fatigue. Everyday cognitive failure and depressive symptoms were the most important predictors of fatigue. In addition to physical functioning, cognitive and psychological aspects should be included in the management of sarcoidosis patients.

Nature of fatigue moderates depressive symptoms and anxiety in sarcoidosis.

OBJECTIVES: Fatigue, depressive symptoms, and anxiety are frequently reported in sarcoidosis. However, the relationship between these debilitating symptoms is unclear. Therefore, the purpose of this prospective follow-up study was to identify the prevalence of depressive symptoms and anxiety in sarcoidosis patients, stratified for the nature of fatigue. In addition, we examined whether depressive symptoms and anxiety predicted fatigue. DESIGN: This is a prospective follow-up study. METHODS: Sarcoidosis outpatients (n = 274) were included. Clinical data were obtained from medical records. At baseline, patients completed the Fatigue Assessment Scale (FAS), the Center for Epidemiological Studies-Depression Scale (CES-D), and the State and Trait Anxiety Inventory (STAI). After 6, 12, and 18 months patients completed the FAS again. RESULTS: Concomitant fatigue (FAS > 21) and high-trait anxiety (STAI > 40) was frequently reported (35-36%). The combination of fatigue and high levels of depressive symptoms (CES-D > 16) was reported in 43-46%. Combined high-trait anxiety and high levels of depressive symptoms were reported in 31% of the patients. These percentages were higher in patients with all day fatigue, compared with patients with intermittent, or mild fatigue. Both anxiety and depressive symptoms were significant predictors of high fatigue scores. CONCLUSIONS: Nature of fatigue moderates the relationships between fatigue and anxiety and fatigue and depressive symptoms in sarcoidosis. Hence, beside fatigue, depressive symptoms and anxiety should be an integral part of the multidisciplinary management of sarcoidosis patients. STATEMENT OF CONTRIBUTION: What is already known on this subject? Fatigue is a frequently reported symptom in sarcoidosis. Symptoms such as depressive symptoms and anxiety are also prevalent in sarcoidosis. However, the relationships between these symptoms are still unclear and require more research. What does this study add? This paper shows that fatigue is often accompanied by depressive symptoms and anxiety, although these symptoms are not fully overlapping. In addition, depressive symptoms and anxiety predict fatigue after follow-up. Fatigue, depressive symptoms and anxiety are most strongly correlated in patients with All Day Fatigue, which indicate that these patients may benefit from psychological interventions in the management of fatigue.

Types of fatigue in sarcoidosis patients.

OBJECTIVE: Fatigue is frequently reported in sarcoidosis and appears to differ between patients. Three types of fatigue (Early Morning Fatigue, Intermittent Fatigue, and Afternoon Fatigue) are described in the literature for sarcoidosis, but have not been validated. Therefore, the aim of this study was to examine whether these types of fatigue can be identified in sarcoidosis. METHODS: Outpatients (n=434) from Maastricht University Medical Centre participated in this study. Data were obtained from medical records. Patients also completed questionnaires regarding depressive symptoms, fatigue, quality of life, restless legs, dyspnea, depressive symptoms, anxiety, sleeping problems, symptoms indicative for small fiber neuropathy, and employment. RESULTS: Latent Cluster Analysis revealed three clusters: 1) Mild Fatigue: patients with mild or no complaints of fatigue, 2) Intermittent Fatigue: patients with complaints of fatigue that varied during the day, and 3) All Day Fatigue: patients who felt tired the whole day. The three patient clusters differed regarding clinical, psychological, and demographical characteristics, with All Day Fatigue patients reporting the most complaints. CONCLUSION: Intermittent fatigue was validated and two other types were found. Careful consideration to categorize patients with sarcoidosis in the three types of fatigue will help healthcare providers to understand the challenges these patients encounter. The usefulness of psychological counseling should be evaluated in future research in order to improve the wellbeing of the patients, especially for those with All Day Fatigue.

Minimal (clinically) important differences for the Fatigue Assessment Scale in sarcoidosis.

OBJECTIVE: The usefulness of any questionnaire in clinical management and research trials depends on its ability to indicate a likelihood of treatment success during follow-up. The Minimal Clinically Important Difference (MCID) reflects a clinically relevant change score. The aim of this study was to estimate the MCID for the Fatigue Assessment Scale (FAS) in patients with sarcoidosis. METHODS: Outpatients (n = 321) of the ild care team of the Department of Respiratory Medicine of the Maastricht University Medical Centre, The Netherlands, participated in this prospective follow-up study. Anchor-based and distribution-based methods were used to estimate the MCID. Based on the anchor Physical Quality of Life, a Receiver Operating Characteristic (ROC) was obtained. The distribution-based methods consisted of the Effect Size and Standard Error Measurement (SEM). RESULTS: The anchor-based MCID found with ROC was 3.5. The distribution-based methods showed that the corresponding change scores in the FAS for a small effect was 4.2. The SEM criterion was 3.6 points change in the FAS. CONCLUSIONS: Based on the anchor-based and distribution-based methods, the MCID is a 4-point difference on the FAS. This MCID can be used in the follow-up of fatigue (FAS) in clinical trials and in the management of individual sarcoidosis cases.

Fatigue in sarcoidosis: a systematic review.

PURPOSE OF REVIEW: Several studies have investigated fatigue among sarcoidosis patients. The purpose of this review is to analyze published data on the assessment, prevalence, etiology, and treatment of sarcoidosis-associated fatigue. RECENT FINDINGS: Fatigue was identified as a prominent problem in sarcoidosis, and its presence was frequently associated with impaired quality of life, compared with patients without fatigue. Although the studies with good methodological fatigue assessment found no relationship between clinical parameters and fatigue in sarcoidosis patients, the remaining studies reported associations between fatigue and clinical and psychological parameters. No studies were designed to analyze the etiology of fatigue, but some studies showed that prednisone-treated patients reported more fatigue compared with untreated patients. In addition, only one study focused on a treatment for fatigue, dexmethylphenidate hydrochloride. Several instruments to measure fatigue were used, with the Fatigue Assessment Scale most frequently utilized. SUMMARY: This review illustrates the importance of fatigue as an under-recognized complication of sarcoidosis. It further emphasizes the need for longitudinal prospective studies to better define sarcoidosis fatigue, explore its impact on quality of life, define aggravating or alleviating factors and evaluate new potential treatment strategies.