Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study.

BACKGROUND: Janus kinase 1 inhibition may alleviate hidradenitis suppurativa (HS)-associated inflammation and improve symptoms. OBJECTIVE: To assess efficacy and safety of povorcitinib (selective oral Janus kinase 1 inhibitor) in HS. METHODS: This placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks. Primary and key secondary end points were mean change from baseline in abscess and inflammatory nodule count and percentage of patients achieving HS Clinical Response at week 16. RESULTS: Of 209 patients randomized (15 mg, n = 52; 45 mg, n = 52; 75 mg, n = 53; placebo, n = 52), 83.3% completed the 16-week treatment. At week 16, povorcitinib significantly reduced abscess and inflammatory nodule count from baseline (least squares mean [SE] change: 15 mg, -5.2 [0.9], P = .0277; 45 mg, -6.9 [0.9], P = .0006; 75 mg, -6.3 [0.9], P = .0021) versus placebo (-2.5 [0.9]). More povorcitinib-treated patients achieved HS Clinical Response at week 16 (15 mg, 48.1%, P = .0445; 45 mg, 44.2%, P = .0998; 75 mg, 45.3%, P = .0829) versus placebo (28.8%). A total of 60.0% and 65.4% of povorcitinib- and placebo-treated patients had adverse events. LIMITATIONS: Baseline lesion counts were mildly imbalanced between groups. CONCLUSION: Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.

The effects of vitamin D supplementation on disease activity and fatigue in Libyan rheumatoid arthritis patients.

Introduction: This study aimed to investigate the effect of vitamin D supplementation therapy on disease activity and fatigue in rheumatoid arthritis (RA) patients. Material and methods: A prospective randomized clinical trial was conducted at rheumatology clinics in Tripoli Central Hospital, Libya. The eligible patients received disease-modifying antirheumatic drugs (DMARDs) and were divided into two groups: group A received 50,000 IU of vitamin D once a week; while group B received conventional DMARDs without vitamin D supplementation. The groups were monitored for 12 weeks. Results: The study included 68 RA patients, with the majority being female (75%). There were no significant differences in parameters such as age, sex, duration of illness, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), calcium, and vitamin D levels, as well as DAS28 (Disease Activity Score with 28-joint count) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) levels between these two groups at baseline. After 12 weeks, group A showed a significant improvement in mean vitamin D levels and FACIT-F scores compared to group B. The increase in vitamin D levels in group A (24.21 ±4.81 nmol/l) was higher than that in group B (5.76 ±3.36 nmol/l). Furthermore, the FACIT-F score in group A was in the normal range (mean: 39.36 ±6.15), whereas group B still exhibited "abnormal" FACIT-F < 27.75 ±4.41. Correlation analysis indicated a positive correlation between FACIT-F and vitamin D levels, suggesting that higher vitamin D levels were associated with improved fatigue. Additionally, a weak inverse correlation was observed between DAS28 and vitamin D levels though the difference was not statistically significant (p > 0.05). Finally, the correlation between DAS28 and FACIT-F was positive (R = 0.557, p = 0.000). Conclusions: The results of the recent study indicated that vitamin D3 (50,000 IU of cholecalciferol) supplementation had a positive impact in RA patients compared to conventional DMARDs drugs, as was clear from the significant FACIT-F.

Changes in hemoglobin and clinical outcomes drive improvements in fatigue, quality of life, and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, acquired, hematologic, life-threatening disease characterized by thrombosis, impaired bone marrow function, and complement-mediated hemolysis. The PEGASUS phase III clinical trial demonstrated superiority of pegcetacoplan over eculizumab regarding improvements in hemoglobin levels in patients with suboptimal response to prior eculizumab treatment. The objective of this post hoc analysis was to compare the patient-reported outcome (PRO) response rates observed among PEGASUS participants and the relationships between their PRO scores with clinical and hematological parameters. Data from the 16-week randomized, controlled (1:1 to pegcetacoplan or eculizumab) period of the PEGASUS trial included comparisons of weekly PRO measurements taken using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) scales. A clinically meaningful FACIT-F response was defined as an increase from baseline of ≥5 points. Convergent validity was assessed using conventional threshold correlations between FACIT-F, EORTC QLQ-C30, and laboratory parameters. A clinically meaningful improvement in FACIT-F score was seen in 72.2% of pegcetacoplan-treated patients compared to 22.9% of eculizumab-treated patients. At week 16, the FACIT-F total score correlated with hemoglobin levels (r=0.47, p< 0.0001), absolute reticulocyte count (r=-0.37, p<0.01), and indirect bilirubin levels (r=-0.25, p<0.05). Clinically meaningful improvements in pegcetacoplan-treated patients were also observed for multiple EORTC scales. Fatigue and other self-reported outcomes were correlated with clinically meaningful improvements in clinical and hematological parameters. Clinical trial registration: NCT03500549.

Alterations in Fecal Microbiomes and Serum Metabolomes of Fatigued Patients With Quiescent Inflammatory Bowel Diseases.

BACKGROUND & AIMS: Fatigue is frequent and disabling in patients with inflammatory bowel diseases (IBD) but its mechanisms are poorly understood. We investigated alterations in fecal microbiomes and serum metabolomes and proteomes in patients with quiescent IBD, with vs without fatigue. METHODS: We performed a prospective observational study of patients (44% women; mean age, 39.8 y) with clinically and endoscopically quiescent Crohn's disease (n = 106) or ulcerative colitis (n = 60) at a tertiary hospital, from March 2016 through December 2018. Fatigue was assessed using the functional assessment of chronic illness therapy-fatigue scoring system and defined as a score of 43 or less. We performed metabolomic analysis of serum samples using liquid chromatography-mass spectrometry methods and proteomic analysis using multiplex proximity extension assay (PEA) technology. Stool samples were obtained from 50 patients and analyzed by shotgun metagenomic sequencing on Illumina HiSeq platform. RESULTS: Of the 166 study participants, 91 (55%) were fatigued. Serum samples from patients with fatigue (n = 59) did not have significant increases in levels of inflammatory cytokines compared with serum samples from nonfatigued patients (n = 72). We found a statistically significant difference in a cluster of 18 serum metabolites between patients with fatigue (n = 84) vs without fatigue (n = 72) (P = .033); serum samples from patients with fatigue had significant reductions in levels of methionine (P = .020), tryptophan (P = .042), proline (P = .017), and sarcosine (P = .047). Fecal samples from patients with fatigue had a less diverse gut microbiome, with significant reductions in butyrate-producing bacteria, including Faecalibacterium prausnitzii (P = .0002, q =.007) and Roseburia hominis (P = .0079, q = 0.105). This fatigue-like microbiome was associated with fatigue scales and correlated with progressive depletion of metabolites from serum samples. CONCLUSIONS: In an analysis of fecal and serum samples from 166 patients with IBD, we found alterations in serum metabolites and fecal microbes that were associated with fatigue.

Fatigue assessment by FACIT-F scale in Pakistani cohort with Rheumatoid Arthritis (FAF-RA) study.

OBJECTIVE: To fine out fatigue frequency and severity by FACIT-F scale in Pakistani cohort with rheumatoid arthritis. METHODS: This study was conducted at department of Medicine division of rheumatology CPMC Lahore. After the approval of IRB, 192 patients of RA were recruited. Written, informed consent was taken, demographic details were noted, patients filled the URDU version of FACIT-F (fatigue severity scale). 5-ml of blood was taken for fasting blood sugar, viral markers and ESR by a trained phlebotomist. Each individual's disease activity was assessed by DAS-28 and FACIT-F score was calculated. RESULTS: The Mean age (39.9±10.5) years, (71.9%) were females. Fatigue frequency was 62% (n=126), age, education, hypertension, DAS-28, exercise levels and HCV gives significant association with fatigue score. Linear regression analysis, results showed one unit increase in DAS-28 will gives 2.71 unit increases in fatigue scores(P <0.05). CONCLUSIONS: We have very high frequency of fatigue in RA, increases with disease activity & associated conditions.

Fatigue in systemic lupus: the role of disease activity and its correlates.

OBJECTIVES: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that leads to a variety of negative health outcomes resulting from inflammation in various organ systems. Although treatment continues to advance, fatigue remains one of the most salient, poorly understood and addressed patient complaints. Understanding the mechanisms of fatigue can help guide the development of interventions to improve health outcomes. The aim of this research was to evaluate the contribution of six variables (disease activity, insomnia, depression, stress, pain and physical health) to fatigue in SLE without concomitant fibromyalgia (FM). METHODS: A total of 116 ethnically diverse, primarily female participants (91%) with SLE, receiving care at university medical centers, completed assessments of disease activity and quality of life outcomes (FACIT-FT, Insomnia Severity Index, Perceived Stress Scale (PSS-4), Pain Inventory, Depression-PHQ-9, and LupusPRO-physical function). All patients met the American College of Rheumatology classification criteria for SLE and did not have a known diagnosis of FM. Multivariate linear and stepwise regression analyses were conducted with fatigue (FACIT-FT) as the dependent variable, and the above six variables as independent variables. RESULTS: Mean (SD) age was 39.80 (13.87) years; 50% were African American, 21% Caucasian, 13% Hispanic, 9% Asian and 8% other. Mean (SD) FACIT-FT was 20.09 (12.76). Collectively, these six variables explained 57% of the variance in fatigue. In the multivariate model, depression, stress and pain were significantly and independently associated with fatigue, but not disease activity, sleep or physical health. Stress had the largest effect on fatigue (ß 0.77, 95% CI 0.17-1.38, p = 0.01), followed by depression (ß 0.66, 95% CI 0.21-1.10, p = 0.005). On stepwise regression analysis, only stress, depression and pain were retained in the model, and collectively explained 56% of the variance in fatigue. All three remained independent correlates of fatigue, with the largest contribution being stress (ß 0.84, 95% CI 0.27-1.42, p = 0.005), followed by depression (ß 0.79, 95% CI 0.44-1.14, p < 0.001) with fatigue. CONCLUSION: Stress, depression and pain are the largest independent contributors to fatigue among patients with SLE, without concurrent FM. Disease activity, sleep and physical health were not associated with fatigue. The evaluation of stress, depression and pain needs to be incorporated during assessments and clinical trials of individuals with SLE, especially within fatigue. This stress-depression-fatigue model requires further validation in longitudinal studies and clinical trials. Significance and innovation: • Disease activity, sleep, pain, stress, depression, and physical health have been reported individually to be associated with fatigue in lupus. This analysis evaluated the role of each and all of these six variables collectively in fatigue among patients with SLE without a known diagnosis of FM. • Disease activity, sleep and physical health were not significantly related to fatigue, but depression, stress and pain were. • The results emphasize the need to evaluate and treat fatigue in individuals with SLE utilizing a biopsychosocial approach, particularly in the realm of clinical trials. Behavioral medicine interventions are shown to be most effective for the treatment of depression, stress and pain.

Fatigue in intensive care survivors one year after discharge.

BACKGROUND: Fatigue has not been investigated in long-term Intensive Care Unit (ICU) survivors. This study aimed to assess fatigue through a specific instrument, namely the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale, in ICU survivors one year after hospital discharge. A secondary aim was to compare the findings of FACIT-F with those of the Vitality domain (VT) of the 36-item Short-Form Health Survey (SF-36). METHODS: This prospective cohort study was performed on 56 adult patients with a Length Of Stay (LOS) in ICU longer than 72 h. At one year after hospital discharge, FACIT-F and SF-36 questionnaires were administered to consenting patients by direct interview. FACIT-F was measured as raw (range 0-52), and FACIT-F-trans value (range 0-100). Past medical history, and demographic and clinical ICU-related variables were collected. RESULTS: The patients' median age was 67.5, Simplified Acute Physiology Score II 31, and LOS in ICU 5 days. The median raw FACIT-F of the patients was 41, and Cronbach's α was 0.937. The correlation coefficient between FACIT-F-trans and VT of SF-36 was 0.660 (p < 0.001). Both FACIT-F and VT were related to dyspnoea scale (p = 0.01). A Bland-Altman plot of VT vs FACIT-F-trans showed a bias of -0.8 with 95 % limits of agreement from 35.7 to -34.1. The linear regression between differences and means was 0.639, suggesting a significant proportional bias. CONCLUSIONS: The 13-item FACIT-F questionnaire is valid to assess fatigue of long-term ICU survivors. VT of SF-36 relates to FACIT-F, but consists of only four items assessing two positive and two negative aspects. FACIT-F grasps the negative aspects of fatigue better than VT. Specific tools assess specific conditions better that general tools. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02684877 .

Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study.

BACKGROUND & AIM: Interferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF)+ribavirin (RBV)]. METHODS: Four PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] were administered at baseline, end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients (naïve or treatment-experienced) enrolled in the VALENCE study. Of these, 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment. RESULTS: Baseline PRO scores were similar between the two arms of the study. Throughout and after treatment, patients receiving 12 or 24 weeks had similar FACIT-F, CLDQ-HCV, SF-36 and WPAI:SHP scores (all p>0.05). Compared to their own baseline scores, patients receiving SOF+RBV experienced modest declines in some aspects of SF-36, CLDQ-HCV, fatigue and WPAI:SHP scores (p = 0.04 to <0.0001). By follow-up week 12, all PRO scores returned to the pre-treatment levels (p>0.05). In patients achieving SVR-12 (regardless of the regimen), significant improvements were noted in general health (p = 0.0004), CLDQ-HCV (p<0.0001), fatigue (p = 0.005), emotional well-being (p<0.0001) and physical component summary score of SF-36 (p = 0.0022). In multivariate analysis, baseline depression, fatigue, insomnia, cirrhosis, and treatment-related adverse events were the most consistent predictors of PRO impairment (all p<0.05). CONCLUSIONS: PROs are minimally impacted by SOF+RBV regimens. An additional 12 weeks of treatment does not substantially add to the PRO burden.

Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C.

BACKGROUND & AIMS: Interferon-based treatment of chronic hepatitis C virus (HCV) infection can negatively affect patient-reported outcomes (PROs) and work productivity (WP). We assessed these factors in patients with chronic hepatitis C treated with sofosbuvir and ribavirin, with or without pegylated interferon. METHODS: The HCV-specific Quality of Life (Chronic Liver Disease Questionnaire-HCV version [CLDQ-HCV]), Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem questionnaires were completed before, during, and after treatment of patients infected with HCV genotypes 2 or 3 who received sofosbuvir and ribavirin for 16 or 12 weeks (the FUSION study, n = 201) or patients infected with HCV genotype 1 who received pegylated interferon, sofosbuvir, and ribavirin for 12 weeks (the NEUTRINO study, n = 327). RESULTS: Patients in each group of the FUSION study had similar PRO and WP scores at each time point (all comparisons, P > .05). Compared with baseline, patients had modest reductions in fatigue, HCV-specific quality of life, and WP and Activity Index scores during treatment (P = .02 to <.0001). However, by 4 weeks after treatment, all scores returned to baseline levels or higher. Subjects in the NEUTRINO study had greater reductions in these scores during treatment; most remained significant through 4 weeks after treatment (P < .05). Significant improvements in PROs were observed among patients with sustained virologic responses 12 weeks after treatment in the FUSION and NEUTRINO studies (all P < .05). In multivariate analyses after adjustment for confounders, interferon therapy was independently associated with worse PROs after 12 weeks of treatment. CONCLUSIONS: On the basis of an analysis of 2 large clinical trials (FUSION and NEUTRINO), patient outcome and productivity are more negatively affected by the inclusion of pegylated interferon in treatment than by interferon-free regimens. Patients with sustained virologic responses 12 weeks after treatment had significant improvements in PROs in both studies.

Assessing fatigue in women over 50 years with rheumatoid arthritis: a comprehensive case-control study using the FACIT-F scale.

Introduction: Data on prevalence of fatigue in rheumatoid arthritis (RA) patients in the era of biological treatments remains scarce, with a lack of case-control studies. This study evaluates the prevalence of fatigue in Spanish women over 50 years with RA using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, explores its association with RA-related variables, and seeks to identify the primary factors influencing fatigue. Ultimately, our objective is to underscore the clinical significance of fatigue as a comorbidity and to advocate for its systematic evaluation in routine clinical practice. Methods: In a case-control study at a tertiary university hospital, 191 women over 50 years (mean age: 67.5 ± 8.8 years) meeting ACR 2010 criteria for RA and age-matched controls were assessed using the FACIT-F scale, SF-12 questionnaire, and RA-related clinical measures. Results: Fatigue was significantly more prevalent in the RA group (61%) compared to controls (37%, p < 0.001), with RA patients showing lower mean FACIT-F scores (36.0 ± 10.6 vs. 40.0 ± 0.6, p < 0.001). Correlations were noted between FACIT-F scores and C-reactive protein, DAS28, RAPID3, HAQ, and SF-12 scores. A multivariate analysis was performed and four models generated. The final model, with an R2 of 0.817, indicates that fatigue is significantly influenced by disease activity (RAPID 3) and mental and physical health (SF12) and age, explaining 81.7% of the variance in fatigue. Conclusion: Fatigue remains significantly prevalent and severe in women over 50 years with RA, strongly linked to disease activity, disability, and diminished quality of life. Systematic fatigue assessment and targeted strategies in clinical settings are essential to address this widespread issue. Future research should explore targeted interventions tailored to this demographic to enhance quality of care.

Fatigue and health-related quality of life in patients with immune thrombocytopenia: a longitudinal assessment in China.

BACKGROUND: There is lacking studies of longitudinally assessment of fatigue and health-related quality of life (HRQoL) among Chinese immune thrombocytopenia (ITP) adults. We aimed to evaluate changes in fatigue and HRQoL and identify the associated factors. METHODS: Patients' characteristics, Functional Assessment of Chronic Illness Therapy (FACIT-F) and the ITP-specific Patient Assessment Questionnaire (ITP-PAQ) scores at admission (T0), at discharge (T1), and three months after discharge (T2) were collected. Linear mixed effects models were used to examine changes over time. RESULTS: We included 175 patients. The mean score of FACIT-F at T0 was 37.2 and increased at T1 (39.0), while then decreased at T2 (34.7). Patients who were single, retired, had persistent ITP, splenomegaly had more severe fatigue, whereas those who had not received any prior treatment and had a bleeding score of 0 at admission had milder fatigue. The mean score of ITP-PAQ was 57.7 at T0, then gradually increased to 60.3 at T1 and 62.8 at T2. Patients with persistent ITP and those who have never received treatment for ITP have better HRQoL. CONCLUSION: ITP adults' fatigue and HRQoL were impaired. Patients' fatigue improved at discharge but worsened at three months after discharge, while HRQoL gradually improved over time.

Severe, Persistent, Disruptive Fatigue Post-SARS-CoV-2 Disproportionately Affects Young Women.

Introduction: Post-acute SARS-CoV-2 (PASC) symptoms are often persistent, disruptive, and difficult to treat effectively. Fatigue is often among the most frequently reported symptoms and may indicate a more challenging road to recovery. Purpose: To describe the natural history, symptomology, and risk profile of long-term post-acute SARS-CoV-2. Patients and Methods: Participants treated for SARS-CoV-2 within a large, community health system in the US were enrolled prospectively in a longitudinal, observational PASC study examining participants at enrollment and 6 months. Medical history, symptom reporting, validated measures of cognition, and patient-reported outcomes (PROs), were performed for all participants and repeated during study follow-up visits. Results: A total of 323 participants completed baseline evaluations. Sixty one participants indicated clinically significant fatigue (23.1% at baseline); a representative sample of 141 enrollees also completed a baseline Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) in-depth fatigue reporting questionnaire, 37 had severe fatigue. The severely fatigued (FACIT-F ≤29.7) were significantly younger, female, had more anxiety and depression, had a higher resting heart rate, reported more sick days, and were less physically active post-COVID. They were more likely to have a diagnosis of chronic kidney disease (13.5% vs 2.9%) but less likely to have a history of cancer (8.1% vs 23.1). Participants who were severely fatigued reported health, diet, weight, and sleep were worse than those not severely fatigued post-COVID (p = 0.02 to 0.0002). Fatigue was significantly correlated with impairment of all PROs administered after COVID-19 infection. Conclusion: Fatigue is a common symptom post-COVID-19 infection and is associated with lower reported well-being and function. Those with severe fatigue tended to be younger and female and have a past medical history of anxiety, depression, kidney disease, and more sedentary lifestyles.

Identification of an Unmet Medical Need: Height of Depression, Hypersomnia, and Sleep Apnea Positively Correlate With the Level of Fatigue in Patients With Immune Thrombocytopenia.

INTRODUCTION: Immune thrombocytopenia (ITP) is a rare chronic disease, frequently accompanied by fatigue, which is an important comorbidity associated with this disease. Patients experience difficulties in managing their daily activities and a reduction in their overall quality of life (QoL). The causes of fatigue in ITP are not clarified yet, and underlying causes seem to be multifactorial. The development of fatigue may not solely be influenced by a decrease in platelet count but also by unknown factors as well as psychological reasons. METHODS: This prospective, multicenter, exploratory, pilot study aimed to investigate which parameters contribute to the occurrence of fatigue in patients with ITP. Adult patients with ITP and with or without fatigue who visited the study center for their regular appointments were asked to complete questionnaires pertaining to patient-reported outcome measures regarding bleeding symptoms, depression, sleep apnea, and hypersomnia. Blood tests included platelet count as well as different parameters like vitamin D. RESULTS: A total of 36 patients (100%; 27 females (75%) and nine males (25%)) with primary ITP, with a median age of 46.5 years (range 19­83 years) were analyzed. The median duration of ITP was 4.5 years (min­max 0-21). Approximately one-third of patients (29.4%; 10/34 patients) had no comorbidities. The two most frequently used current treatment options were "watch-and-wait" (38.9%; 14/36 patients) and "avatrombopag" (30.6%; 11/36 patients); eight patients (22.2%; 8/36 patients) needed rescue therapy with corticosteroids. There was a statistically negative correlation between fatigue and year of diagnosis (r=-0.41, p=0.014). Results indicated no statistically significant relationship between fatigue and age or differences in fatigue between the genders. Ferritin predicted fatigue with statistical significance. Platelet count was not correlated with the level of fatigue. A significant correlation was obvious between fatigue, depression, and obstructive sleep apnea syndrome (OSAS) as well as sleep-related problems (p<0.01). DISCUSSION: Patient characteristics were comparable to that of other studies. The level of fatigue negatively impacts the lives of patients with ITP. Age and gender were not correlated with fatigue in ITP, which is in line with other reports. Interestingly, the fatigue level was higher in patients presenting with additional depression and poor sleeping quality due to, e.g., hypersomnia, which seems common. Fatigue levels seem independent from thrombocyte levels, which were reported elsewhere. CONCLUSION: Patients diagnosed with ITP several years ago cope with their condition better than patients with a more recent diagnosis, who have higher levels of fatigue. Concurrent depression, hypersomnia, and sleep apnea are important underestimated factors, which do have a negative effect on the QoL of patients with ITP. We were able to show that patients with ITP might face an unmet medical need in terms of delayed diagnosis and supportive therapy. To our knowledge, this is the first report on combined findings of depression, hypersomnia, and sleep apnea in patients with ITP.

Long-Term Effect on Health-Related Quality of Life in Patients With COVID-19 Requiring Hospitalization Compared to Non-hospitalized COVID-19 Patients and Healthy Controls.

Background In this study, we aimed to evaluate the health-related quality of life (HRQL) in patients with severe coronavirus disease 2019 (COVID-19) six months after their hospitalization and compare it to that of non-hospitalized patients with mild COVID-19 and healthy controls. Methodology Participants were enrolled between September 2021 and April 2022 and included hospitalized COVID-19 patients at General Hospital of Athens "Hippocration" who had been discharged at least six months prior to enrollment, non-hospitalized patients with COVID-19, and healthy controls. Collected data included demographics, disease severity, medication history, and comorbidities. Participants completed a EuroQol 5 Dimensions 5Levels (EQ5D5L), a Short Form 36 version 2 (SF36v2), a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and a Post-COVID-19 Functional Status Scale (PCFSS) regarding HRQL before and six months after infection with severe acute respiratory syndrome coronavirus 2. In the case of healthy controls, two sets of questionnaires were completed at least six months apart. Statistical analysis was performed using the SPSS version 25 software (IBM Corp., Armonk, NY, USA). Results A total of 151 participants were enrolled. Hospitalized patients with COVID-19 demonstrated a statistically significant deterioration in most parameters of SF36v2 as well as both parameters of the EQ5D5L and FACIT-F questionnaires. Hospitalized patients exhibited worse results in SF36v2 and EQ5D5L when compared to both healthy controls as well as those with mild COVID-19 (p < 0.05). Hospitalized women, in particular, were shown to fare worse than other women in parameters associated with both mental/psychological and physical health (p < 0.05). Hospitalized patients between 41 and 60 years old demonstrated a statistically significant drop in the scores of all three main questionnaires compared to their previous health status (p < 0.05). Hospitalized patients between 61 and 80 years old exhibited a similar trend, but statistical significance was achieved in fewer parameters. HRQL decline was greater in both age groups compared to that of healthy and milder disease counterparts. There was a significant correlation between the results from the three main questionnaires. Similarly, PCFS scale values were shown to correlate with disease severity (hospitalization or not) and age. Conclusions HRQL remained noticeably impacted six months after hospitalization due to COVID-19. The physical and mental/psychological stress of severe COVID-19 translated into lasting health deterioration, especially for women and those aged 41-60 years old. The use of questionnaires, such as those implemented in this study, might help in the early detection of patients who could benefit from rehabilitation programs. Psychological, as well as physical and social, support is crucial to alleviate the burden of post-COVID-19 symptomatology and expedite the recovery of this group of patients.

Content Validity of Sjögren's Syndrome Symptom Diary and Functional Assessment of Chronic Illness Therapy-Fatigue in Patients with Sjögren's.

INTRODUCTION: Sjögren's Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are patient-reported outcome (PRO) instruments assessing Sjögren's symptoms. Original SSSD items have demonstrated content validity, however qualitative evidence supporting the updated 'tiredness' item and two new supplementary items is lacking. Although well established and validated in other rheumatic diseases, there is no qualitative evidence supporting content validity of FACIT-F in Sjögren's. This study addressed these evidence gaps to support use of SSSD and FACIT-F as clinical trial endpoints, in clinical practice and in other research settings. METHODS: Qualitative, semi-structured telephone interviews were conducted with patients with Sjögren's (n = 12) and expert Sjögren's physicians (n = 10). Patient interviews explored content validity (e.g., understanding and relevance) of the new and updated SSSD items, perceptions of item and total score meaningful change on SSSD, and understanding and relevance of FACIT-F items. Physician interviews explored opinions on various SSSD scoring approaches. RESULTS: The new and updated SSSD items and FACIT-F demonstrated good content validity. Most patients considered a two-point improvement on most SSSD items meaningful, as well as a one- or two-point total score improvement. Most physicians reported tracking changes in patient responses to individual items as the most appropriate SSSD scoring approach. CONCLUSIONS: SSSD and FACIT-F are content valid in a Sjögren's population, meeting an important criterion to support their use as clinical trial endpoints, but also their use in clinical practice and other research settings. Qualitative data exploring meaningful change will be valuable in supporting psychometrically derived responder definitions.

Sjögren's Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are questionnaires completed by individuals with Sjögren's to assess the severity of their symptoms. It is important to show that these questionnaires are well understood and relevant to the individuals who complete them. Therefore, interviews were conducted with individuals with Sjögren's to explore their understanding and relevance of new and updated SSSD questions. Similarly, the interviews explored whether the FACIT-F questionnaire was well understood and relevant to individuals with Sjögren's, as this has not been explored before. Interviews were also conducted with expert Sjögren's physicians to explore the best approach to scoring SSSD (e.g., calculating a total score or looking at scores on individual items). The new and updated SSSD questions and the FACIT-F questionnaire were well understood and considered relevant by most individuals with Sjögren's. This suggests these questionnaires are appropriate for use in Sjögren's clinical trials, clinical practice, and other research settings. Most individuals with Sjögren's considered an improvement of two points on individual SSSD questions to be important, as well as a one- or two-point improvement in their total SSSD score. Most physicians agreed on the best approach to scoring SSSD.

ACE-Neuro: A tailored exercise oncology program for neuro-oncology patients - Study protocol.

Background: Patients with primary brain tumours (i.e., neuro-oncology patients) lack access to exercise oncology and wellness resources. The purpose of the Alberta Cancer Exercise - Neuro-Oncology (ACE-Neuro) study is to assess the feasibility of a tailored neuro-oncology exercise program for patients across Alberta, Canada. The primary outcome is to assess the feasibility of ACE-Neuro. The secondary outcome is to examine preliminary effectiveness of ACE-Neuro on patient-reported outcomes and functional fitness. Methods: Neuro-oncology patients with a malignant or benign primary brain tumour that are pre, on, or completed treatment, are >18 years, and able to consent in English are eligible to participate in the study. Following referral from the clinical team to cancer rehabilitation and the study team, participants are triaged to determine their appropriateness for ACE-Neuro and other cancer rehabilitation services (including physiatry, physiotherapy, occupational therapy, and exercise physiology). In ACE-Neuro, participants complete a tailored 12-week exercise program with pre-post assessments of patient-reported outcomes and functional fitness, and objective physical activity tracked across the 12-week program. ACE-Neuro includes individual and group-based exercise sessions, as well as health coaching. Conclusion: We are supporting ACE-Neuro implementation into clinical cancer care, with assessment of needs enabling a tailored exercise prescription.

Assessment of Functional Status and Quality of Life of Elderly Patients Undergoing Radiotherapy and Radiotherapy Combined with Chemotherapy - A Cross-Sectional Study.

BACKGROUND: Aging is associated with various diseases, a plethora of which are oncological. Selected treatment methods influence the performance status and the adaptability to changing circumstances. OBJECTIVE: The aim of the study was to assess the functional status, quality of life, and adaptation to disease of elderly patients who underwent only radiotherapy or chemotherapy combined with radiotherapy. PATIENTS AND METHODS: The cross-sectional study was conducted in a sample of 76 patients diagnosed with cancer, over 60 years of age (mean 69.3/SD 6.8) who were hospitalized in the Radiotherapy Department at the Ludwik Rydygier Hospital in Krakow. Standardized research tools were: Functional Assessment of Chronic Illness Therapy (FACIT-F), Mental Adjustment to Cancer Scale (Mini-MAC), Lawton Instrumental Activity of Daily Living (IADL), Yesavage Geriatric Depression Scale (GDS), an assessment scale of the post radiation reaction devised by Eastern Cooperative Oncology Group (ECOG). RESULTS: Most (n=37) patients were treated with a combination of radiotherapy and chemotherapy (48.6%), whereas 21 patients underwent only radiotherapy (27.6%). More than half of the respondents were male (68.4%, n = 52), whereas 24 (31.6%) were female. The assessment of the participants' performance status yielded results indicating an average level of all domains. Men performed better in terms of physical condition compared to a group of women (p=0.010). Women experienced fatigue more frequently than men (p=0.012). Patients who had received radiation therapy combined with chemotherapy achieved on average better results in functional well-being (FWB) than the patients who had undergone radiotherapy only (p=0.046). Depression had a significant impact on all spheres of functioning (p<0.001) except social/family well-being. CONCLUSION: The results pointed to the essential elements that should be taken into consideration in relation to treatment planning and providing care. Particular attention should be paid to women who suffered from depression and negative adaptation strategies that directly affect their functioning.

Chronic hepatitis D associated with worse patient-reported outcomes than chronic hepatitis B.

BACKGROUND & AIMS: Health-related quality of life (HRQoL) determined by patient-reported outcomes (PROs) is impaired in chronic hepatitis B (CHB) and C patients, but there are no data regarding patients with chronic hepatitis D (CHD). The aim of this study was to assess PRO scores in untreated patients with CHD and compare them with those obtained for patients with CHB. METHODS: Patients with CHD completed 3 PRO instruments (Chronic Liver Disease Questionnaire [CLDQ], Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], and Work Productivity and Activity Impairment [WPAI]), and the results were compared with those of patients mono-infected with CHB. RESULTS: In total, 125 patients were included: 43 with CHD and 82 with CHB. Overall, baseline PROs showed differences between both groups. Several assessments, such as the worry score from CLDQ (p = 0.0118), functional well-being from FACIT-F (p = 0.0281), and activity impairment from WPAI (p = 0.0029) showed a significant trend to worse scores in patients with CHD than with CHB. In addition, the linear regression model supports the finding that having CHD as opposed to having CHB was a predictor of a higher worry score (CLDQ) and a higher activity impairment (WPAI). CONCLUSIONS: In this first assessment in CHD, PROs recorded in patients with CHD showed a significant impairment in some domains of HRQoL questionnaires in comparison with those with CHB. Studies in larger cohorts with lengthier follow-up are needed to fully assess patient-reported quality of life over the course of CHD. LAY SUMMARY: Chronic hepatitis D (CHD) is a viral disease that causes rapid evolution to liver cirrhosis, amongst other severe complications, when compared to patients with chronic hepatitis B (CHB). Health-related quality of life in chronic hepatitis C and CHB has been reported widely, but no studies have been performed on patient-reported outcomes in patients with CHD. Results showed that CHD patients reported worse outcomes in psychological domains such as worry and emotional well-being, as well as in physical domains such as abdominal symptoms, physical well-being, and activity impairment in comparison with patients with CHB.

Psychometric Properties of the Arabic Version of the Functional Assessment of Chronic Illnesses Therapy-Fatigue in Arabic Cancer Patients.

BACKGROUND: The Functional Assessment of Chronic Illness Therapy (FACIT) is a measurement system that was developed to assess the health-related quality of life among patients with cancer and other chronic illnesses. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 40-item questionnaire, and it is one of the most frequently used instruments to assess fatigue in cancer populations. The aim of this study was to evaluate the psychometric properties of the Arabic FACIT-F among patients diagnosed with cancer. METHODS: Following a translated and cross-cultural evaluation procedure of the FACIT-F Arabic version, a cross-sectional and descriptive correlational design was conducted. A total of 369 patients with cancer completed the FACIT-F, which consists of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) and the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). The scale was assessed in terms of acceptability, internal consistency, and validity. Construct validity was explored through confirmatory factor analysis. RESULTS: The FACT-G had acceptable fit in the four-factor model, whereas the FACIT-Fatigue was found to be acceptable for the one-factor model in Arabic patients diagnosed with cancer. The Cronbach's alpha coefficient for the Arabic FACIT-Fatigue was 0.92, whereas the total score for FACT-G was 0.92, which showed good reliability. There was evidence that discriminated validity analysis was generally very good for the FACIT-Fatigue and FACT-G Arabic versions. CONCLUSION: The Arabic versions of the FACIT-Fatigue and FACT-G demonstrated good reliability and validity for assessing fatigue and quality of life in patients diagnosed with cancer.

Mapping health-related quality of life scores from FACT-G, FAACT, and FACIT-F onto preference-based EQ-5D-5L utilities in non-small cell lung cancer cachexia.

BACKGROUND: Health-related quality of life (HRQoL) measurements from disease-specific tools cannot be directly used in economic evaluations. This study aimed to develop and validate mapping algorithms that predicted EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) utilities from Functional Assessment of Anorexia-Cachexia Therapy (FAACT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and their common component (Functional Assessment of Cancer Therapy-General-FACT-G) in patients with non-small cell lung cancer cachexia. METHODS: Data were collected on five occasions over a 12-week period in two multicenter placebo-controlled trials. EQ-5D-5L utilities were calculated using both English and Dutch value sets. The study sample was divided into development and validation datasets according to patients' geographical residence. Generalized estimating equations were applied to five different sets of independent variables including overall, Trial Outcome Index (TOI), and individual subscales results. The best performing models were selected based on mean absolute error (MAE) and root-mean square error (RMSE). RESULTS: EQ-5D-5L and FAACT/FACIT-F results were available for 96 patients. The developed algorithms showed a good predictive performance, with acceptable MAE/RMSE and small differences between mean observed and predicted EQ-5D-5L utilities. In FACT-G models, Physical Well-Being had the highest explanatory value, while Emotional Well-Being did not significantly affect the EQ-5D-5L score; Anorexia-Cachexia and Fatigue subscales were highly statistically significant in FAACT and FACIT-F models, respectively, as well as the TOI scores. The Eastern Cooperative Oncology Group status was included as covariate in all models. CONCLUSION: The developed algorithms enable the estimation of EQ-5D-5L utilities from three cancer-specific instruments when preference-based HRQoL data are missing.