Functional Assessment Of Chronic Illness Therapy-Fatigue Research Articles

Psychometric evaluation of the NTDT-PRO questionnaire for assessing symptoms in patients with non-transfusion-dependent beta-thalassaemia

ObjectivesThe non-transfusion-dependent beta-thalassaemia-patient-reported outcome (NTDT-PRO) questionnaire was developed for assessing anaemia-related tiredness/weakness (T/W) and shortness of breath (SoB) among patients with NTDT. Psychometric properties were evaluated using blinded data from...

Instrumen Pengukuran Kelelahan pada Systemic Lupus Erythematosus

This study aims to identify instruments for measuring fatigue in SLE to manage this problem to improve quality of life. The method used is a narrative review by searching the EBSCO CINAHL and Pubmed databases with the keyword measurement instrument for fatigue, systemic lupus erythematosus. The results showed that there were 58 articles (CINAHL) and 27 articles from Pubmed, but only five pieces fit the focus of the study, which measured fatigue in SLE patients. In conclusion, Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F), Fatigue Severity Scale (FSS), and fatigue pro are fatigue measurement instruments that can be used in SLE patients.
 
 Keywords: Fatigue Measurement Instrument, Systemic Lupus Erythematosus

Patient-reported outcomes measures of X-linked hypophosphataemia participants: findings from a prospective cohort study in the UK

BackgroundX-linked hypophosphataemia (XLH) is a rare genetic condition passed on through the X chromosome which causes multiple symptoms including weakened teeth, bones, and muscles. Due to the rarity of the condition, little is known about the health outcomes as reported by people with the disease. The objectives of this study were threefold: to characterise key patient reported outcome measures (PROMs) in adults with XLH, to identify clusters of symptom-severity groups based on PROMs, and to analyse the longitudinal progression of available PROMs.MethodsData from 48 participants from the Rare and Undiagnosed Diseases cohort Study (RUDY) was used to analyse both cross-sectional and longitudinal patient-reported outcomes. We analysed data for health-related quality of life (HRQL): EuroQol 5 dimensions-5 levels (EQ-5D-5L), Short-form 36 (SF-36) Physical Component Score (PCS), and SF-36 Mental Component Score (MCS), sleep: Pittsburgh sleep quality index (PSQI) and Epworth Sleepiness scale (ESS), fatigue: Fatigue Severity Scale (FSS) and Functional assessment of chronic illness therapy-fatigue (FACIT-F), pain: Short form McGill pain questionnaire version 2 (SF-MPQ-2) and PainDETECT, and mental well-being: Hospital anxiety and depression scale (HADS) anxiety and depression. Summary statistics, tests of mean differences, mixed-effects models, and cluster analysis were used to describe and examine the various health dimensions of individuals with XLH.ResultsOverall mean scores were EQ-5D-5L = 0.65, SF-36-PCS = 32.7, and SF-36-MCS = 48.4 for HRQL, ESS = 5.9 and PSQI = 8.9 for sleep, FSS = 32.8 and FACIT-F = 104.4 for fatigue, SF-MPQ-2 = 1.9 for pain, and HADS-depression = 4.7 and HADS-anxiety = 6.2 for mental well-being. 7% reported neuropathic pain (PainDETECT). Whilst many adults with XLH reported good outcomes, extreme or severe problems were reported across all outcomes. Cluster analysis identified that adults with XLH could be divided into two distinct groups, one reporting worse (35.3%) and the other better outcomes (64.7%) (less pain, fatigue, depression, and higher levels of sleep). Longitudinal analysis showed that FACIT-F and HADS-anxiety scores worsened slightly over two years with statistically significant (p < 0.05) time coefficients (b = − 2.135 and b = 0.314, respectively).ConclusionAlthough about two thirds of adult participants of the RUDY cohort with XLH report good health outcomes, for a considerable third much worse outcomes are reported. More research is needed to examine why some experience good and others poor health outcomes and the characteristics which identify them.

P434 Upadacitinib improved fatigue and health-related quality of life in patients with moderately to severely active Crohn’s disease: Results from induction and maintenance phase 3 trials

Abstract Background Upadacitinib (UPA) demonstrated efficacy and safety in the phase 3 U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849) induction, and U-ENDURE (NCT03345823) maintenance trials in patients (pts) with moderately to severely active Crohn’s disease (CD). We evaluated the impact of UPA on health-related quality of life (QoL) in pts with CD. Methods Clinical responders to UPA 45 mg (UPA45) in U-EXCEED and U-EXCEL induction trials were re-randomised at Week 12 (1:1:1) to UPA 15 mg (UPA15), UPA 30 mg (UPA30), or placebo (PBO) for 52 weeks of maintenance treatment in U-ENDURE; data from these induction and maintenance trials were included in this analysis. Endpoints included the percentage of pts who achieved an Inflammatory Bowel Disease Questionnaire (IBDQ) response (≥16 points), IBDQ remission (≥170 points), a meaningful within-person change (MWPC) from baseline of ≥9 points on the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), and of ≥4.1 and ≥3.9 points on the 36-item Short-Form Health Survey (SF-36) physical (PCS) and mental (MCS) component summary scores, respectively, at Weeks 4/12 of induction and Week 52 of maintenance. Adjusted risk differences compared to PBO, 95% confidence intervals, and p-values were calculated based on the Cochran-Mantel-Haenszel test. Results In U-EXCEED (n=324 UPA; 171 PBO) and U-EXCEL (n=350 UPA; 176 PBO), a greater proportion of UPA45- vs PBO-treated pts had an IBDQ response at Weeks 4 (U-EXCEED: 71.6% vs 47.6%; U-EXCEL: 71.0% vs 50.2%; p≤0.001) and 12 (U-EXCEED: 63.9% vs 44.4%; U-EXCEL: 68.4% vs 46.5%; p≤0.001; Figure 1). In UPA- vs PBO-treated pts, a greater proportion achieved IBDQ remission at Weeks 4 (U-EXCEED: 41.4% vs 22.4%; U-EXCEL: 44.2% vs 23.7%; p≤0.001) and 12 (all p≤0.001; Figure 1). At Week 12, a significantly greater proportion of UPA-treated pts vs PBO demonstrated a MWPC in FACIT-F, and SF-36 PCS and MCS from baseline (p≤0.001; Figure 1). Similar results for UPA45 vs PBO were achieved as early as Week 4 in FACIT-F (U-EXCEED: 42.3% vs 20.0%; U-EXCEL: 42.0% vs 27.0%), SF-36 PCS (U-EXCEED: 56.6% vs 37.2%; U-EXCEL: 53.0% vs 37.5%; p≤0.001) and MCS (p≤0.05). In the maintenance study U-ENDURE (n=168 UPA30; 169 UPA15; 165 PBO), a greater proportion of pts receiving UPA15 and UPA30 vs PBO achieved an IBDQ response (39.1%, 53.5% vs 20.4%), IBDQ remission (36.1%, 45.2% vs 13.5%), and a meaningful improvement from baseline in FACIT-F, SF-36 PCS and MCS through 52 weeks (p≤0.01; Figure 2). Conclusion In pts with moderately to severely active CD, UPA treatment significantly improved fatigue, disease-specific and generic QoL, compared with PBO, as early as Week 4 of induction. The effects were sustained through 52 weeks of maintenance treatment.

P573 Change in fatigue in patients with Ulcerative Colitis or Crohn’s disease initiating vedolizumab or other biologic therapy: Data from Belgian registry patients

Abstract Background Fatigue in patients (pts) with ulcerative colitis (UC) and Crohn’s disease (CD) is associated with decreased quality of life. This analysis aimed to describe fatigue evolution and identify factors associated with time to fatigue disappearance or fatigue persistence at 1 year among pts initiating vedolizumab (VDZ) or other biologic treatment (tx). Methods Post-hoc analysis of fatigue registry data of Belgian pts being followed in a prospective real-world safety study (PASS; NCT02674308). Pts ≥18 years with UC or CD initiating VDZ or other biologics with no prior VDZ exposure were included. Pts completed the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and physicians collected disease characteristics at baseline and 6-month intervals (4.5-year follow-up). Fatigue persistence was defined by 2 consecutive FACIT-F scores of &amp;lt;40, and fatigue disappearance (in pts with baseline fatigue) by a FACIT-F score of &amp;gt;40. Factors associated with time to fatigue disappearance and fatigue persistence at 1 year were assessed using multivariate regression. Results This analysis included 465 pts with UC (n=174) or CD (n=291) who initiated VDZ (n=259) or other biologic tx (n=206) at registry enrolment (Table 1 for baseline characteristics). Change in FACIT-F scores among all pts (Figure 1) showed an improvement in fatigue in the first 6-months following tx initiation before stabilising for the remainder of the study. The Kaplan-Meier estimate for time to fatigue disappearance (Figure 2) indicated fatigue disappearance occurred in 2.1%, 6.2% and 14.2% of pts with baseline fatigue at 6, 12 and 24-months respectively. In pts with baseline fatigue, lower likelihood of fatigue persistence was associated with achieving clinical remission (OR 0.31 [0.16, 0.60]). Probability of fatigue disappearance per unit of time was estimated to be higher in pts with UC vs CD (HR 1.53 [1.07, 2.21]) and in pts achieving vs not achieving clinical remission (HR 2.02 [1.18, 3.48]) and lower in pts with vs without extra-intestinal manifestations at baseline (HR 0.62 [0.39, 0.99]). No associations were observed between fatigue persistence/disappearance and tx group, demographics, disease duration, tx history, use of other medication, history of or active fistula, IBD surgery or clinical response. Conclusion These real-world findings suggest fatigue in pts initiating VDZ or other biologic therapy for UC or CD improves in the first 6 months of treatment before stabilising over time. Clinical remission was associated with a lower likelihood of fatigue persistence and shorter time to fatigue disappearance.

A novel electronic patient-reported outcome delivery system to implement health-related quality of life measures in routine clinical care: An analysis of 5 years of experience.

To develop a simple and secure technological solution to incorporate electronic patient-reported outcomes (ePROs) into routine clinical care. A novel ePRO questionnaire delivery system was developed by Software for Specialists (S4S) in partnership with OPAL Rheumatology Australia. Validated questionnaires were sent from the electronic medical record (EMR) (Audit4) of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), lupus or giant cell arteritis (GCA) and delivered to the patient's email address or completed in the clinic waiting room using a smart device (in-practice). Completed questionnaires were encrypted and returned to the patient's Audit4. Deidentified clinical data was extracted and aggregated across all sites. Data collected between April 2016-Dec 2020 were analysed descriptively. Between April 2016 to Dec 2020, 221,352 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), Patient Health Questionnaire-2 (PHQ-2) and/or HealthCare Resource Utilization (HCRU) questionnaires were sent from 39 of 42 contributing clinics (93%). 85% of questionnaires were delivered via email and 15% in-practice. Overall, 85% of patients completed at least one questionnaire, and of all questionnaires sent, 73% were completed. Females were more likely to engage with the questionnaires than males (87% vs. 81%), and older patients were slightly more likely to complete all questionnaires delivered. The novel Audit4 ePRO delivery system is an effective tool for incorporating PROs into routine clinical care. The data generated provides a unique opportunity to understand the full burden of disease for patients in the real-world setting and the impact of interventions.

Ultrasonographic findings in long COVID: A cross-sectional study of 312 patients.

Fatigue and muscle weakness are common complaints in COVID-19 survivors. However, little is still known about the skeletal muscle qualitative and quantitative characteristics after hospitalization due to moderate and severe COVID-19. To assess rectus femoris and vastus intermedius muscle thickness (MT) and rectus femoris echo intensity (EI) and to establish its association with demographic, clinical, functional, and inflammatory parameters in long COVID patients after hospital discharge. Cross-sectional study with 312 COVID-19 patients (53.53% male; age: 54.59 ± 13.50 years), with a laboratory-confirmed diagnosis of COVID-19. Patients were assessed 3-11 months after hospital discharge. We evaluated MT of the right rectus femoris and vastus intermedius and EI of the right rectus femoris using a portable ultrasound system, 6-13 MHz, broadband linear transducer. We corrected EI using the subcutaneous fat thickness. Ultrasonographic parameters were tested in association with demographic (sex and age); functional (Handgrip strength measurement, Timed Up and Go, 1 min Sit-to-Stand test, EuroQoL-5 Dimensions-5 Levels, World Health Organization Disability Assessment Schedule (WHODAS 2.0), Post-COVID-19 Functional Status, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT), Medical Research Council (MRC) sum score, Borg Dyspnea Scale, MRC Dyspnea score, Visual Analogue Scale (VAS), Epworth Sleepiness Scale, Insomnia Severity Index, Functional Independence Measurement (FIM), and Functional Oral Intake Scale); clinical (length of hospital stay, intubation, and presence of comorbidities such as systemic hypertension, diabetes, obesity, chronic obstructive pulmonary disease, asthma), and inflammatory data assessed by the C-reactive protein and D-dimer serum concentrations. Rectus femoris MT was associated with age, handgrip strength, Epworth Sleepiness Scale, and subcutaneous fat thickness (r2 = 27.51%; p < 0.0001). Vastus intermedius MT was associated with age, pain intensity, handgrip strength, Epworth Sleepiness scale, FIM, and time since hospital discharge (r2 = 21.12%; p < 0.0001). Rectus femoris EI was significantly associated with the male sex, TUG, Epworth Sleepiness Scale, and C-Reactive Protein levels (r2 = 44.39%; p < 0.0001). Mean MT of rectus femoris and vastus intermedius are significantly different (p < 0.001). After hospital discharge, long COVID patients present qualitative and quantitative skeletal muscle characteristics associated with a combination of demographic, clinical, and functional parameters.

Efficacy of complement inhibitors for patients with paroxysmal nocturnal hemoglobinuria: a systematic review and meta-analysis.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired hematological disease. The development of complement inhibitors such as eculizumab, ravulizumab, and pegcetacoplan has revolutionized the management of PNH, leading to improvements in overall survival and quality of life for patients. This systematic review aims to provide comprehensive evidence of the efficacy of complement inhibitors in relation to treatment duration. This is a systematic review and meta-analysis. A thorough literature search was conducted in MEDLINE, EMBASE, and the Cochrane Library up to 3 May 2022. We included all prospective interventional studies including single-arm trials. The primary outcomes of interest were lactate dehydrogenase (LDH) levels, hemoglobin (Hb) concentrations, transfusion avoidance, and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores. Our study included a total of 27 studies, comprising 5 randomized controlled trials and 11 single-arm trials, with a total of 912 patients with PNH. We stratified the studies according to treatment duration, based on the most frequently reported period of 26 weeks. Our analysis showed that treatment-naïve patients who received complement inhibitors had a pooled estimate of a decrease in LDH levels from baseline by -1462.0 U/L (95% CI: -1735.6 to -1188.5) for treatment ⩽26 weeks and -1696.5 U/L (95% CI: -2122.7 to -1270.2) for treatment >26 weeks. The mean Hb levels were increased by 1.4 g/dL (95% CI: 0.5-2.3) and 1.9 g/dL (95% CI: 0.7-3.1) in each group. Treatment with any complement inhibitor prevented the need for transfusion in at least 50% of patients with PNH in all treatment periods. Clinically meaningful improvements in FACIT-F were observed both before and after 26 weeks, with a pooled estimate of 6.8 (95% CI: 6.0-7.6) and 9.5 (95% CI: 7.0-12.0), respectively. Our findings suggest that complement inhibitors can result in positive treatment outcomes and sustained benefits for patients with PNH.

Depression is the most significant independent predictor of fatigue in patients with primary Sjögren's syndrome.

The study aimed to evaluate the level of fatigue and the relationship between mood, pain, fibromyalgia, insomnia, disease activity, and dryness with fatigue in primary Sjögren's syndrome (PSS) patients. In this case-control study, the participants were recruited between January 2021 and July 2021. Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F), pain DETECT questionnaire, Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Insomnia Severity Index (ISI) were administered to 50 PSS patients (48 females, 2 males; mean age: 48.9±10.8 years; median age: 47 years; range, 29 to 71 years) and 60 healthy controls (HCs; 57 females, 3 males; mean age: 49.8±8.4 years, median age: 52 years; range, 32 to 72 years). In addition, EULAR Sjögren's syndrome disease activity index (ESSPRI), EULAR Sjögren's Syndrome Patient Reported Index (ESSDAI), pain thresholds, Schirmer tests, and whole unstimulated salivary flow rate measurements were determined in PSS patients. Independent predictors of fatigue (fatigue subscale scores <30.5) were investigated by logistic regression analysis. The frequency of fatigue in PSS patients and HCs was 54.0% and 8.3%, respectively. The rates of mood disturbance (BDI ≥11) in PSS patients with and without fatigue were 70.4% and 13.1%, respectively. BDI (Rho=-0.804), BAI (Rho=-0.586), ISI (Rho=-0.483), and ESSDAI (Rho=-0.345) were negatively correlated with the fatigue subscale score. Depression [Odds ratio (OR): 1.214, confidence interval (CI): 1.007-1.463], fibromyalgia (OR: 21.674, CI: 1.470-319.469), disease activity (OR: 1.440; CI: 1.005-2.065), and insomnia (OR: 1.223, CI: 1.003-1.4922) were identified as independent predictors of fatigue in PSS patients. It was determined that BD alone could predict fatigue by 84% in PSS patients. Depression can be a prominent predictor of fatigue in PSS patients. There is a need for studies evaluating the effect of antidepressant treatment approaches on fatigue accompanied by mood disturbance in PSS patients.

Association of baseline self-reported fatigue with overall survival after stereotactic body radiation therapy for localized prostate cancer.

Stereotactic Body Radiation Therapy (SBRT) has emerged as a definitive therapy for localized prostate cancer (PCa). However, more data is needed to predict patient prognosis to help guide which patients will benefit most from treatment. The FACIT-Fatigue (FACIT-F) is a well validated, widely used survey for assessing fatigue. However, the role of fatigue in predicting PCa survival has yet to be studied. Herein, we investigate the role of FACIT-F as a baseline predictor for overall survival (OS) in patients undergoing SBRT for localized PCa. A retrospective review was conducted of 1358 patients who received SBRT monotherapy between January 2008 to April 2021 at an academic, tertiary referral center. FACIT-F scores (range 0 to 52) were summed for patients who answered all 13-items on the survey. FACIT-F total scores of ≥35 represented severe fatigue. Patients receiving androgen deprivation therapy were excluded. Differences in fatigue groups were evaluated using chi-squared tests. OS rates were determined using the Kaplan-Meier method and predictors of OS were evaluated using Cox proportional hazard method. Baseline full FACIT-F scores and survival data was available for 891 patients. 5-year OS was 87.6% and 95.2%, respectively, for the severely fatigued and non-fatigued groups. Chi-squared analysis of fatigue groups showed no significant difference in the following categories: D'Amico risk group, age, ethnicity, grade group, T-stage, or PSA density. Severe fatigue was associated with a significant decrease in OS (hazard ratio 2.76; 95%CI 1.55 - 4.89). The Cox proportional hazard model revealed that age and FACIT-F were both statistically significant (p <0.05). Baseline FACIT-F scores are significantly associated with OS. Higher FACIT-F scores, representing less fatigued patients, are associated with an overall survival benefit. These results indicate that the FACIT-F survey could serve as an additional metric for clinicians in determining prognostic factors for patients undergoing SBRT.

S96 An Exploration of the Experience and Measurement of Fatigue in Adults With Crohn’s Disease

Background: Fatigue has a detrimental impact on health-related quality of life and functioning in patients with Crohn’s disease (CD). We aimed to confirm the relevance and importance of fatigue, establish the content validity of the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), qualitatively explore meaningful change in fatigue experience, and assess the measurement properties of the FACIT-F in patients with moderate-to-severe CD. Methods: This was a mixed-methods observational study consisting of a cross-sectional qualitative interview (Part A) and a longitudinal 2-week daily diary pilot study (Part B) in participants aged ≥18 years with a clinical diagnosis of moderate-to-severe CD. Part A included open-ended questions related to the participant’s overall experiences with CD, fatigue, and impact on daily activities and a cognitive debriefing of several patient-reported outcomes (PROs), including the FACIT-F. Part B consisted of participants completing an electronic daily diary that included the FACIT-F and other PROs for 14 days. Item performance, test-retest reliability, and construct validity were assessed at baseline (Day 1), Day 7, and Day 14. Results: In Part A, thirty-five participants (mean age 45.1 years; 65.7% female) completed an interview. Ninety-one percent of the interview participants reported fatigue as a symptom attributed to CD. Participants indicated that fatigue had a major impact on their daily activities (e.g., recreation/ hobbies, work/school, yard work and housework), social activities, and emotional health. The FACIT-F was well understood by the interview participants. In Part B, seventy-6 participants (mean age 41.9 years; 66% female) completed at least the Day 1 diary entry. Potential floor and ceiling effects were observed for several FACIT-F items, but test-retest reliability and construct validity were all strong and within the ranges hypothesized a priori. Conclusion(s): The interviews indicate that fatigue is a frequent and bothersome symptom experienced by most patients with moderate-to-severe CD and support the content validity of the FACIT-F in this population. Daily diary study results indicate that the FACIT-F scale demonstrates adequate reliability and validity among patients with CD. These study findings suggest that the FACIT-F would be a reliable, valid, and useful measure of fatigue in patients with moderate-to-severe CD.

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 usingthe 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.

Psychological Characteristics Associated with Post-Treatment Physical Status and Quality of Life in Patients with Brain Tumor Undergoing Radiotherapy

Radiotherapy (RT) is a mainstay of treatment for brain tumors. To minimize the risk of side effects while maximizing the therapeutic effects, personalized treatment plans, consisting mainly of genomics, radiomics, and mathematical modeling, are increasingly being used. We hypothesize that personality characteristics could influence treatment outcomes and thus could be used to help personalize RT. Therefore, the aim of this study was to identify the psychological characteristics associated with post-treatment physical status and quality of life (QoL) in patients with brain tumors undergoing RT. Two psychological tests-the Eysenck Personality Questionnaire and the State-Trait Anxiety Inventory-were administered prior to RT. Physical parameters before and after RT were also assessed through the following tests: hand grip strength, Timed Up and Go test, 6 Min Walk Test, and Functional Independence Measure. The Functional Assessment of Cancer Therapy-General (FACT-G) was used to assess QoL. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) was administered to assess fatigue. Neuroticism was significantly associated with low FACT-G Physical Well-Being scores. Psychoticism was associated with an improvement in physical fitness scores after RT. These findings suggest that personality traits should be considered when designing a personalized radiotherapy plan.

Effect of risankizumab on health-related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials.

Crohn's disease has a substantial negative impact on health-related quality of life (HRQoL). To examine the effects of risankizumab on HRQoL in Crohn's disease METHODS: We analysed data from patients with Crohn's disease from 12-week induction trials ADVANCE (N=850) and MOTIVATE (N=569) with risankizumab 600 mg or 1200 mg intravenous (IV) versus placebo IV and a 52-week maintenance trial FORTIFY (N=462) with risankizumab 180 or 360 mg subcutaneous (SC) versus placebo SC. Outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-item Short Form Health Survey (SF-36), EuroQol 5-Dimension-5-Level (EQ-5D-5L) and work productivity. The mean change and percentages of patients achieving clinically meaningful improvement in all outcomes were determined at weeks 12 and 52. At week 12, more patients in the risankizumab 600 or 1200 mg groups achieved IBDQ response than with placebo (ADVANCE: 70.2%, 75.5% vs. 47.8%, p ≤ 0.001; MOTIVATE: 61.7%, 68.5% vs. 48.2%, p ≤ 0.01) and FACIT-F response (ADVANCE: 51.3%, 48.0% vs. 35.7%, p ≤ 0.01; MOTIVATE: 44.2%, 49.1% vs. 33.7%, p < 0.05). These improvements persisted at week 52 with risankizumab maintenance treatment. Similar trends were observed for SF-36 physical and mental component summary scores, EQ-5D-5L and activity impairment within work productivity measures. Risankizumab induction therapy (600 or 1200 mg IV) led to clinically meaningful improvements in disease-specific and general patient-reported outcomes, including fatigue, in patients with moderate to severe Crohn's disease. These improvements were sustained after 52 weeks of risankizumab (180 or 360 mg SC) maintenance therapy.

S834 Improvement in Fatigue With Mirikizumab Therapy Is Associated With Clinical Remission and Pain Improvements but Not With Endoscopic Response in Patients With Moderately-to-Severely Active Crohn’s Disease

Introduction: Fatigue is common in patients (pts) with Crohn’s disease (CD) and negatively impacts quality of life. We previously reported that fatigue improved in pts with CD receiving mirikizumab (miri) in the AMAG study in all treatment arms. The association between changes in clinical and inflammatory markers and changes in fatigue might reveal the mechanism of fatigue relief. Methods: 191 moderately-to-severely active CD pts were randomized 2:1:1:2 into 4 treatment arms (placebo [PBO], 200mg, 600mg, 1000mg miri), administered intravenously every 4 weeks at Weeks (W) 0, 4, 8. At W12 pts were switched from PBO to miri and rerandomized between miri doses based on response. Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. Endoscopic response was defined as ≥50% reduction from baseline in total Simplified Endoscopic Activity Score for Crohn’s Disease. For continuous variables, Pearson’s correlation coefficients, 95% confidence intervals, and p-values were calculated. Cohen’s conventions were used to assess strength of correlations. Analysis of covariance was used to assess relationship between change in FACIT-F and endoscopic response at the same timepoint adjusting for baseline FACIT-F values. Data were pooled for all treatment arms including PBO. Results: Mean change in FACIT-F scores for pts with and without endoscopic response at W12 were 8.1 and 7.2, respectively (p=0.33) and at W52 were 13.9 and 13.7, respectively (p=0.54). At W12, change in FACIT-F showed moderate but statistically significant correlation with change at the same timepoint in Crohn’s Disease Activity Index (CDAI) total score, abdominal pain, and stool frequency. Weak but statistically significant correlations were observed with calprotectin, and C-reactive protein (Table). At W52, change in FACIT-F was moderately but significantly correlated with change in CDAI total score, abdominal pain, and stool frequency (Table). Conclusion: Considering the limitation of the posthoc analysis and design of this Phase 2 trial, improvements in fatigue were significantly associated with improvement in CDAI score, abdominal pain, and stool frequency in patients with CD. Although fatigue has been hypothesized to be mediated in part by inflammatory cytokines, our data showed no consistent relationship of improvement in fatigue with changes in objective markers of disease activity, suggesting the possibility of alternative or additional mechanistic processes for fatigue in CD. Table 1. - Correlation of change in FACIT-F with change in clinical measures Week 12 (N=191) Week 52 (N=176) Clinical measure Pearson corr 95% CI p-value Pearson corr 95% CI p-value CDAI total score -0.404 (-0.530, -0.259) < 0.0001 -0.492 (-0.614, -0.346) < 0.0001 SES-CD total score -0.146 (-0.290, 0.004) 0.0572 -0.076 (-0.238, 0.090) 0.3702 Hematocrit (%) -0.039 (-0.194, 0.119) 0.6319 0.152 (-0.016, 0.312) 0.0756 Hemoglobin -0.011 (-0.167, 0.145) 0.8916 0.120 (-0.049, 0.282) 0.1638 Fecal calprotectin (log) -0.269 (-0.419, -0.105) 0.0015 -0.175 (-0.342, 0.003) 0.0544 C-reactive protein (log) -0.165 (-0.310, -0.013) 0.0331 -0.151 (-0.310, 0.016) 0.0756 Abdominal pain average score -0.380 (-0.504, -0.240) < 0.0001 -0.438 (-0.565, -0.292) < 0.0001 Stool frequency average score -0.354 (-0.481, -0.212) < 0.0001 -0.290 (-0.437, -0.128) 0.0006 Abbreviations: CDAI=Crohn’s Disease Activity Index; corr=correlation; N=number of patients in the analysis (including patients with non-missing change scores); FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; SES-CD=Simplified Endoscopic Activity Score for Crohn’s Disease.

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

IntroductionSjögren’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.MethodsQualitative, 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.ResultsThe 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.ConclusionsSSSD 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.

Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis

BackgroundThe Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale has demonstrated good internal consistency and responsiveness to changes in clinical status among patients with ankylosing spondylitis (AS). We aimed to further evaluate the psychometric properties of the FACIT-F scale in adult patients with AS.MethodsMeasurement properties of the FACIT-F scale were evaluated using data from tofacitinib phase 2/3 (NCT01786668/NCT03502616) studies in adult patients with active AS.ResultsSecond-order confirmatory factor modeling supported the measurement structure of the FACIT-F scale (Bentler’s comparative fit index ≥ 0.91), and FACIT-F demonstrated excellent internal consistency (Cronbach’s coefficient α ≥ 0.88) and test–retest reliability (Intraclass Correlation Coefficient ≥ 0.75). Correlation coefficients between FACIT-F and other patient-reported outcomes generally exceeded 0.40, supporting convergent validity. Meaningful within-patient change was estimated as 3.1–6.3 for FACIT-F total score, and 1.4–2.8 and 1.7–3.6 for FACIT-F Experience and Impact domain scores, respectively. Large (effect size ≥ 1.17 standard deviation units), statistically significant differences in FACIT-F domain/total scores between ‘no disease activity’ (Patient Global Assessment of Disease Activity [PtGA] = 0) and ‘very active disease’ (PtGA = 10) patient groups supported known-groups validity. Ability to detect change was evidenced by an approximately linear relationship between changes in FACIT-F and PtGA scores.ConclusionsFACIT-F is a reliable and valid measure for evaluating fatigue in adult patients with active AS.Trial registration: ClinicalTrials.gov; NCT01786668 (registered 6 February 2013, https://clinicaltrials.gov/ct2/show/NCT01786668) and NCT03502616 (registered 11 April 2018, https://clinicaltrials.gov/ct2/show/NCT03502616).

Dynamics of patient reported outcomes during the use various biological disease-modifying antirheumatic drugs for rheumatoid arthritis

One of the main tasks of modern complex therapy of rheumatoid arthritis (RA) is to improve the quality of life of patients. To do this, it is necessary not only to achieve remission or low activity, but also to successfully control the main, most painful, manifestations of the disease. Therefore, when evaluating the results of RA treatment, the dynamics of not only standard indices (DAS28 (Disease Activity Score 28), CDAI (Clinical Disease Activity Index), SDAI (Simplified Disease Activity Index)), but also the so-called “patient reported outcomes” (PRO) – a patient’s global assessment of disease activity (PGA), pain, functional disorders and fatigue.This review examines the effect of one of the main classes of anti–rheumatic drugs - biological disease-modifying antirheumatic drugs (bDMARDs) on the PROs. The results of a series of randomized controlled trials are presented, in which changes in PROs were studied using various tumor necrosis factor α (TNF-α) inhibitors, abatacept T-lymphocyte co-stimulation inhibitor, rituximab CD20 inhibitor and interleukin (IL) 6 inhibitors.The use of bDMARDs in combination with methotrexate (MTX) provides a reduction in PGA and pain by 50-60%, functional disorders according to HAQ (Health Assessment Questionnaire) and fatigue according to FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) – by 15-30%. B DMARDs monotherapy (with the exception of the effect of tocilizumab on HAQ) does not exceed MTX monotherapy in its effect on PROs. Monotherapy with tocilizumab provides more favorable dynamics of PGA and pain than monotherapy with TNF-α inhibitors. An important advantage of IL-6 inhibitors is the rapid achievement of a clinical effect, which is noted already in the first 2 weeks after the first administration of the drug.

Fatigue and Sleep Disturbance among Breast Cancer Patients during Treatment in Saudi Arabia.

Background Fatigue and sleep disturbances are highly prevalent side effects encountered during treatment by patients with breast cancer, and they affect women's quality of life. Most studies investigating sleep and exhaustion in cancer patients provide evidence that supports a strong connection between different sleep parameters and fatigue associated with cancer. Objective This study was to assess the level of fatigue and sleep disturbance in breast cancer patients during treatment in Saudi Arabia. Method A descriptive cross-sectional study design was conducted on breast cancer patients undergoing treatment in Saudi Arabia. The data were collected through convenience sampling of patients. The study involved self-administered questionnaires comprising three categories: demographic data, perceived Pittsburgh Sleep Quality Index (PSQI), and Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F). A total of 101 participants took part in this study. The significant statistical test was determined at a 95% confidence interval and at p < 0.05. Results Half of the study participants were aged between 30 and 50 years. Significant differences were found in fatigue and sleep disturbance among BC patients during treatment in Saudi Arabia. A high prevalence of fatigue was found at 21.8%, and 5% of participants experienced sleep disturbance. Conclusions Breast cancer patients in Saudi Arabia have a low overall global quality of life. The patients experience poor sleep quality and fatigue, which suggests that during treatment, patients need to be assessed routinely for these symptoms to prevent or reduce fatigue and sleep disturbance. Sleep disturbance might be correlated with fatigue.

Impact Of Covid-19 Infection On Activity Levels, Perceived Fatigue, And Mental Health

Physical activity patterns have changed dramatically during the COVID-19 pandemic. Whether perceived fatigue and mental health, which are known to be altered after surviving COVID-19 infection, impacts physical activity is not understood. PURPOSE: To determine associations between indices of mental health, perceptions of fatigue, and physical activity in COVID-19 survivors. METHODS: 24 COVID-19 survivor-control pairs (n = 48, males 14, females 34) matched for age, sex, and BMI and 2-13 months post infection (8.04 ± 0.71 months), aged 19-69 yr (38.6 ± 17.8 yr, 46 White, 2 Asian) completed 1) Past Medical History, 2) Depression, Anxiety, and Stress Scale (DASS), 3) Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), and 4) wore an accelerometer to track activity for up to 7 days. RESULTS: There were no differences between controls (CON) and COVID-19 survivors (COV) for sedentary time/day (p = 0.14), sedentary bouts/day (p = 0.29), and steps/day (p = 0.31). COV scored higher than CON on the depression subsection of the DASS (6.17 ± 6.54 vs. 2.88 ± 3.99, p = 0.021). COV also scored higher than CON on the anxiety sub-section of the DASS (5.17 ± 4.57 vs. 2.83 ± 3.58, p = 0.028). However, COV were similar to CON on the stress sub-section of the DASS (6.83 ± 4.97 vs. 8.92 ± 7.25, p = 0.13). Additionally, COV reported greater feelings of fatigue, scoring lower than CON on the FACIT-F by 6.08 points (p = 0.004). There were no correlations between anxiety and depression with steps/day (R2 = 0.005-0.09), nor between time since infection with perceived fatigue, anxiety, and depression (R2 = 0.0007-0.2). CONCLUSION: Despite being 8 months post COVID infection on average, COVID survivors reported greater anxiety, depression, and feelings of fatigue than healthy matched controls during the pandemic. Physical activity (steps/day), thought to accelerate recovery from COVID-19, did not appear to mediate an individual’s perceived fatigue and mental health in these mild-to-moderate cases of COVID-19 infection. Funded by Institute for Women’s Leadership (Marquette University)