Fatigue Domains Research Articles

Fast score is associated with patient-reported outcomes in patients with metabolic dysfunction-associated steatotic liver disease

Backgrounds People with metabolic dysfunction-associated steatotic liver disease (MASLD) frequently report fatigue. This symptom is associated with hepatic inflammation and fibrosis. FibroScan-aspartate aminotransferase (FAST) score is a noninvasive measurement tool that can be used to assess the severity of MASLD. We aimed to investigate the independent factors associated with patient-reported outcomes (PROs) including fatigue, and their FAST scores. Methods We enrolled 116 patients with MASLD. PROs were assessed by the Chronic Liver Disease Questionnaire for nonalcoholic fatty liver disease (CLDQ-NAFLD), which consists of six domains including fatigue. Each domain score that was less than 6 was classified into the impairment group. A cutoff value of 0.67 in the FAST score was used to categorize a high or low FAST score. Independent factors associated with impaired PROs and fatigue were analyzed using logistic regression analysis and a graphical model. Results For factor total, in the logistic regression analysis, the high FAST score was only identified as a negative independent factor for impaired total CLDQ-NAFLD (odds ratio: 5.9, 95% confidence interval: 1.11–31.20, P = 0.034). The graphical model revealed that FAST score, BMI, and age directly interact with impaired total CLDQ-NAFLD. For fatigue, there was no statistically significant factor in the logistic regression analysis. The graphical model revealed that the FAST score, BMI, estimated glomerular filtration rate, and age directly interact with fatigue. Conclusion We found that the FAST score directly interacted with total CLDQ-NAFLD and the domain of fatigue. The FAST score may be a useful tool to assess impaired CLDQ-NAFLD.

Describing Zoom exhaustion and fatigue in nursing students at a university in South Africa.

Online platforms have gained considerable support from students and lecturers post COVID-19, however they are associated with student exhaustion and fatigue. To determine Zoom exhaustion and fatigue in nursing students at a selected university in South Africa. A quantitative cross - sectional study was conducted in KwaZulu-Natal to collect data from 146 nursing students registered at the selected university for the 4-year Bachelor of Nursing programme. The Zoom Exhaustion and Fatigue Scale collected data on responses to domains of general fatigue, visual fatigue, social fatigue, motivational fatigue, and emotional fatigue. The data were analysed using the International Business Machines, Statistical Package for Social Sciences, version 26.0. Descriptive statistics were calculated for demographics, a total score was calculated and mean scores and 95% confidence intervals for the different domains were calculated. Mann Whitney U and Kruskal Wallis Independent Tests were calculated to determine associations between demographics and Zoom usage. The overall Zoom exhaustion and fatigue score was 46.71 (s.d. = 10.50). The motivational fatigue construct had the highest mean score of 3.29 (s.d. = 0.83), followed by general (3.18 s.d. = 0.81), social (3.11, s.d. = 0.88), emotional (3.06, s.d. = 0.99) and visual fatigue (2.92, s.d. = 0.94). The study concluded that while the overall mean score indicated moderate levels of Zoom exhaustion and fatigue among respondents, majority of the respondents scored high levels (> 48) of Zoom fatigue. Students reported higher levels of motivational fatigue compared to the other 4 constructs.

Comparison of clinically meaningful improvements following center-based and home-based tele rehabilitation in people with COPD.

Response to pulmonary rehabilitation is not equal for all participants, and may vary across health outcomes for any one individual. Alternative modes of pulmonary rehabilitation delivery, e.g. telerehabilitation, may improve program access but could also affect response to rehabilitation. What is the rate of clinical response to home-based telerehabilitation compared to center-based pulmonary rehabilitation? And, are there participant baseline characteristics associated with pulmonary rehabilitation response relative to model of delivery? Secondary analysis of two randomized controlled trials. Participants were categorized as 'responders' or 'non-responders' according to achievement of the minimal important difference (MID) for each outcome of interest at end rehabilitation and after 12-month follow-up (change from baseline). Outcomes of interest were: functional exercise capacity (six-minute walk distance [6MWD], MID 30m); health-related quality of life (chronic respiratory questionnaire [CRQ], MID 2.5, 2, 3.5 and 2 points for the dyspnea, fatigue, emotion and mastery domains, respectively; CRQ total score MID 10 points); and symptoms (modified Medical Research Council [mMRC], MID -1 point). 266 individuals with COPD were included in the analysis. The proportion of responders was not different between center-based pulmonary rehabilitation and home-based telerehabilitation at either end rehabilitation or 12-month follow-up for any outcome (range 39% to 62%). In a binary logistic regression analysis, baseline outcome values, but not participant demographic characteristics, were most commonly associated with responder status. The relative risk of program non-completion in the center-based group was nearly four times greater than for telerehabilitation (PR completion: center-based PR n=79 (58%) versus home-based telerehabilitation n=116 (90%); RR 3.89, 95%CI 2.28 to 6.63). Responder status to pulmonary rehabilitation was not different between center-based and home-based telerehabilitation. The ability to identify patient characteristics that confer greater potential for rehabilitation response, or better suitability for a particular model of rehabilitation, remains a challenge. Take home points: STUDY QUESTION: What is the rate of clinical response to home-based telerehabilitation compared to center-based pulmonary rehabilitation? And, are participant baseline characteristics, program completion or program location associated with rehabilitation response? The proportion of responders to rehabilitation is not different between center-based and home-based telerehabilitation programs; however the risk of program non-completion is 4 times higher for center-based rehabilitation. Responder status to pulmonary rehabilitation was not different between center-based and home-based telerehabilitation, although rehabilitation completion was higher for home-based telerehabilitation. Identifying participant features that confer greater potential for rehabilitation response, or better suitability for a particular model of rehabilitation, remains a challenge.

Increased lengthening frequency does not adversely affect the EOSQ scores in magnetically controlled growing rod surgeries in 133 subjects followed to final fusion.

Magnetically Controlled Growing Rod (MCGR) allows frequent outpatient rod lengthening when treating Early Onset Scoliosis (EOS) patients. But there is lack of expert consensus on the optimal MCGR lengthening interval. EOS 24-Item Questionnaire (EOSQ) is validated for assessing health-related quality of life (HrQOL), family burden, and satisfaction. This is the first study assessing how MCGR lengthening intervals affects patient-perceived outcomes. This is a multicentred cohort study with subjects recruited from 2012 to 2018 and followed till fusion. EOS subjects who underwent MCGR surgeries were grouped into high, mediumor low lengthening interval subgroups based on 16 and 20week cut-offs. Repeated measure analysis was performed on EOSQ's specified 12 domains. EOSQ results were taken: before index surgery, after index surgery, and prior to definitive treatment. Demographic, clinical and radiographic data were included in model adjustment. 133 subjects with mean follow-up of 3.5 (± 1.3)years were included, with 60 males and 73 females; 45 idiopathic, 23 congenital, 38 neuromuscular, and 27 syndromic patients. Mean Cobb angle at surgery was 67° (± 22°) with mean age of 8.3 (± 2.5)years. Between groups, clinical and radiographic parameters were comparable. Higher EOSQ scores in mediumlengthening interval subgroup was present in fatigue (p = 0.019), emotion (p = 0.001), and parental impact (p = 0.049) domains, and overall score (p = 0.046). Trendline contrast between subgroups were present in general health (p = 0.006) and physical function (p = 0.025) domains. Patient-perceived outcome improvements appear similar between lengthening interval subgroups. All MCGR lengthening intervals were tolerated by patients and family, with no negative impact observed. Prognostic Level III.

Patient-reported outcomes of chimeric antigen receptor T-cell therapy in hematologic malignancies: a systematic review and meta-analysis

Few studies evaluated patient-reported outcomes (PROs) for patients with hematologic malignancies receiving with Chimeric Antigen Receptor T (CAR-T) cell therapy. We performed a systematic review and meta-analysis to evaluate the benefits of CAR-T cell therapies focused on PROs. A systematic literature searched from PubMed, Cochrane, and the Web of Science from inception to September 2023. Study selection and data extraction were conducted independently by two reviewers based on pre-specified criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist was used to evaluate the methodological quality of the included studies. The random-effects model was employed to calculate the combined effect and 95% Confidence intervals. This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and the protocol was registered with PROSPERO (CRD42024586706). We identified 20,110 studies. Of those, 15 studies with 16 different PRO measures (PROMs) were included in the meta-analysis. CAR-T cell therapy improved PROs in the six domains of general health status, pain, fatigue, depression, social function, and cognitive function: from the general health status (SMD: 0.57, 95% CI: 0.34 to 0.81) to cognitive function (SMD: 0.25, 95% CI: 0.14 to 0.37). The current meta-analysis shows that CAR-T cell therapy produces clinically meaningful differences in PROs. These results suggest that the professional perspective and patient values and preferences should be weighed equally when considering CAR-T cell therapy for hematologic malignancies.

Fatigue levels and associated factors in systemic sclerosis: a cross-sectional study of 2,385 SPIN Cohort participants.

To compare fatigue in a large multinational systemic sclerosis (SSc) cohort to general population data and identify associated sociodemographic, lifestyle and SSc disease factors. Scleroderma Patient-centered Intervention Network Cohort participants completed the Patient-Reported Outcomes Measurement Information System-29 v2.0 fatigue domain. T-scores were compared with the USA general population (mean = 50; SD = 10). Multivariable linear regression was used to assess associations with sociodemographic, lifestyle, and disease-related variables. Among 2,385 participants (mean age 54.9 (SD = 12.6) years, 87% female, 38% diffuse SSc), mean fatigue T-score was 54.6 (SD = 11.0); 438 (18%) reported mild fatigue, 641 (27%) moderate, and 180 (8%) severe fatigue. Fatigue was independently associated with sociodemographic factors age (-0.10 points per year, [95% CI -0.14;-0.07]), male sex (-1.67 points, [-2.96;-0.37]), non-married status (0.97 points [0.04; 1.89]), and country (reference USA; France -2.35 points [-3.48;-1.21] and UK 2.38 points [0.80; 3.97]), and lifestyle factors smoking (4.16 points [2.52; 5.80]), alcohol consumption (-0.18 points per drink per week [-0.28;-0.07]), and body-mass index (0.34 points per unit [0.27; 0.42]). Fatigue was associated with disease-related factors gastrointestinal involvement (4.21 points [2.99; 5.43]), digital ulcers (1.51 points, [0.25; 2.77]), moderate small joints contractures (1.41 points [0.13; 2.69]), rheumatoid arthritis (4.34 points [2.37-6.31]) and Sjögren's syndrome (1.89 points [0.23; 3.55]). When pain was included in the model, its association was large (2.19 points [2.03; 2.34]) and interstitial lung disease was also associated (1.21 points [0.42; 2.00]). In people with SSc, fatigue scores were substantially higher than the general population and associated with multiple disease factors including gastrointestinal involvement, several painful disease manifestations, and lung involvement.

Development of the small punch fatigue test method based on the finite element method

The Small Punch Test (SPT) is a method of evaluating the mechanical properties of metallic materials that overcomes the limitations of the Uniaxial Test (UT), a traditional method of testing. Unlike UT, which provides strain data for each stress, SPT provides displacement data for each load. Therefore, SPT must be converted to UT to evaluate the mechanical properties of materials. However, SPT and UT employ disparate loading mechanisms. The difficulty in converting SPT to UT, which stems from the disparate loading mechanisms, has thus far limited SPT to mechanical property evaluation areas such as tensile and creep. This paper, therefore, aims to extend SPT to the fatigue domain, which is currently limited to the tensile and creep domains. The fatigue properties of metallic materials were evaluated based on the Finite Element Method (FEM) for the Small Punch Fatigue Test (SPFT). Moreover, the fatigue properties derived from the FEM for SPFT were converted to Uniaxial Fatigue Test (UFT) by employing the equivalent equation. Finally, an S-N curve was constructed based on SPFT and was validated by comparison with the same curve constructed based on UFT.

Early Changes in Health-Related Quality of Life as a Biomarker of Survival in African Patients with HIV-Associated Kaposi Sarcoma.

Sub-Saharan Africa bears the largest public health burden of Kaposi sarcoma (KS), a leading cause of cancer mortality. Quality of life (QOL) assessments in cancer patients can provide information on prognosis beyond traditional biomarkers or biological measures. The prognostic value of QOL measures in patients with HIV-KS was evaluated. Prognostic associations of baseline QOL scores (by quartiles or thresholds for clinical importance) and changes in QOL scores (using minimum important difference) over the first 3 months of therapy were evaluated in 112 participants with HIV-KS randomised to receive ART, with or without chemotherapy. Cox's regression analysis assessed the prognostic contribution of QOL scores from the EORTC QLQ-C30 questionnaire. Survival curves were generated using the Kaplan-Meier method. Baseline QOL scores did not predict overall survival. The change in the 3-month QOL scores for the global health scale, fatigue, and pain domains was prognostic; the hazard ratios were 3.88 (95% CI 1.32-11.38, p = 0.01), 3.72 (95% CI 1.61-8.62, p = 0.00) and 5.96 (95% CI 2.46-14.43, p = 0.00), respectively. QOL assessments can provide useful prognostic information in patients with HIV-KS. Patients lacking meaningful improvement early into treatment represent a population at high risk of death.

Using network analysis to provide evidence for brain health as a unified construct relevant to aging with HIV.

Brain health is a dynamic state involving cognitive, emotional, and motor domains. Measuring brain health is a challenge owing to the uncertainty as to whether it is one or many constructs. This study aimed to contribute evidence for brain health as a unified construct by estimating the strength of relationships between and among patient-reported items related to the brain health construct in a population with brain vulnerability owing to HIV. Data for this cross-sectional analysis came from a Canadian cohort of people aging with HIV. The sample included 710 men recruited between 2014 and 2016 from five Canadian cities. A network analysis was conducted with 30 items selected from the brain-related domains of fatigue, cognition, depression, sleep, anxiety, and motivation. Node centrality measures were used to determine the most critical items in the network. The network showed small-world properties, that is, most nodes can be reached from other nodes with few hops," indicating strong connectivity. The most central symptoms were "How much do you enjoy life?" and "How often do you have negative feelings?". The small-world properties of the network structure indicate that brain health items are interconnected and may be influenced by shared underlying factors. The centrality indices suggest that items related to enjoyment of life and negative feelings may be particularly important for understanding brain health in this population. Future research should aim to replicate these findings in larger and more diverse samples to confirm their robustness and generalizability.

Effect of chemical etching time on the fatigue behavior of Ti‐6Al‐4V produced by laser powder bed fusion

AbstractThis study focuses on the evolution of the fatigue strength of Laser Powder Bed Fusion (L‐PBF) produced Ti‐6Al‐4V as a function of the chemical etching finishing process. The aim is to identify the critical fatigue crack initiation mechanisms and the transitions between them in terms of the evolution of the surface micro‐geometry. This is done using three different geometries and six different surface states. The evolution of the crack initiation mechanisms is then used to explain the evolutions of the fatigue strength and the fatigue scatter. Chemical etching affects the fatigue life via a polishing effect, which directly influences both the finite and the high cycle fatigue domains. It is shown that chemical etching makes it possible to obtain fatigue strengths that are almost similar to those of the machined surface. However, it is also observed that etching cannot fully counteract the effects of large surface cavities caused by surface connected porosities.

Differences in Patient-Reported Outcome Measures in Patients With Cancer Six Months Before Death.

Patient-reported outcome measures (PROMs) provide a direct report of the patient's perspective, complementary to clinician assessment. Currently, understanding the real-time changes in PROM scores near the end of life remains limited. This study evaluated differences in mean PROM scores between patients with cancer within 6 months before death compared with surviving patients with cancer. This retrospective case-control study uses the National Institutes of Health's Patient-Reported Outcomes Measurement Information System computer adaptive testing instruments to assess pain interference, physical function, fatigue, and depression. Patients dying within 6 months of PROM completion were selected as cases and matched to controls 1:3 by age at PROM completion, sex, cancer disease site, and cancer stage at diagnosis. Generalized estimating equation models assessed the difference in mean PROM score in cases compared with controls. A total of 461 cases and 1,270 controls from September 2020 to January 2023 were included. After adjustment for ethnicity, Charlson Comorbidity Index, and census tract median household income, significant differences in mean scores were demonstrated. Physical function domain showed the largest difference, with cases averaging 6.52 points lower than controls (95% CI, -8.25 to -4.80). Fatigue and pain interference domains showed a rise in PROMs scores by 4.83 points (95% CI, 2.94 to 6.72) and 4.33 points (95% CI, 2.53 to 6.12), respectively. Compared with controls, patients dying within 6 months of PROM completion demonstrated worse PROM scores in the four domains assessed. These findings suggest the utility of routinely collected PROMs as a real-time indicator of the terminal stage of life among patients with cancer to allow for earlier intervention with supportive oncology services.

Patient-perceived factors on treatment satisfaction in early onset scoliosis treated surgically with a minimum of ten years

BackgroundThe prognosis of surgically treated subjects with early onset scoliosis (EOS) into adulthood has been lacking. We aimed to investigate the patients’ perspectives on satisfaction with surgical treatment.MethodologyWe included all surgical candidates with EOS who had undergone index spinal surgery for scoliosis correction between 2009 and 2013. The minimum duration of postoperative follow-up was 10 years at the time of survey completion. Three questionnaires were used in this study, comprising the revised Scoliosis Research Society questionnaire (SRS-22r), the Patient-Reported Outcomes Measurement Information System (PROMIS-29), and the World Health Organization Quality of Life (WHOQOL-BREF). Measures of treatment satisfaction were retrieved from SRS-22r.ResultsThere were 29 participants who completed the survey, and thereby included in the study (i.e., a response rate of 43% and a dropout rate of 6%). Amongst them, 14, 11, and 4 individuals received posterior spinal fusion (PSF), magnetically controlled growing rods (MCGR), and traditional growing rods, respectively. The average duration after the index spinal surgery was 12.6 ± 2.2 years. Our findings revealed that self-image (across all treatment groups), sleep disruption (only in PSF), and social aspects (in both PSF and MCGR) were significantly worse when compared to the normative values. According to the multivariable linear regression model (R-square = 0.690, p < .001), an increase in SRS-22r mental health (p = .008) and PROMIS-29 social participation scores (p = .004) corresponded to 0.511 and 0.055 points increases in satisfaction. Every unit increase in PROMIS-29 fatigue (p = .043) and WHOQOL-BREF physical domain scores (p = .007) was in conjunction with 0.019 and 0.040 points decreases in satisfaction. SRS-22r self-image (p = .056) and WHOQOL-BREF environmental domain scores (p = .076) were included in the model but did not reach statistical significance.ConclusionsTo improve the long term quality of life in surgical candidates with EOS, we demonstrated that mental health, social participation, fatigue, and physical health were significant factors associated with treatment satisfaction. Interestingly, demographic and radiographic parameters did not have a significant effect in our cohort.

The analysis of quality of life of patients with glioblastoma after adjuvant radiation therapy

Background. Optimizing approaches to the treatment of patients with glioblastoma (GB) is an urgent task partly owing to the wider implementation of hypofractionated radiation therapy (HRT) regimens. At the same time, increasing survival without maintaining the patient’s quality of life (QoL) cannot be considered successful treatment. Purpose – to analyze QoL of patients with GB after adjuvant radiation treatment in the groups of standard and hypofractionated radiation regimens. Materials and methods. 159 patients with verified GB, who had undergone surgery in State Institution «Romodanov Neurosurgery Institute of the National Academy of Medical Sciences of Ukraine» over the period from 2014 to 2020, were divided into two groups according to the regimen of RT: SRT group (n = 49) – standard regimen (total dose 60.0 Gy in 30 fractions over 6 weeks); HRT group (n = 110) – hypofractionated regimen (total dose 52.5 Gy in 15 fractions over 3 weeks). The patients were surveyed about QoL three times during their follow-up (3, 6 and 12 months after RT) according to the Global Health Status Scale (GHSS), domains of insomnia and fatigue of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30 version 3.0). Statistical analysis was performed separately for each group (SRT and HRT; intragroup analysis), as well as between SRT and HRT groups as comparison of independent groups with a different number of follow-up examinations for each period of the follow-up (intergroup analysis). Results. The H0 hypothesis about the absence of statistically significant difference between the results of three subsequent surveys according to the GHSS, domains of insomnia and fatigue in both SRT (p = 0.00003; p = 0.00002; p = 0.00002, respectively) and HRT (p = 0.00000; p = 0.00001; p = 0.00001, respectively) groups in the intragroup analysis according to the Friedman test was rejected. The pairwise comparison of the results of the second and the first survey (6 vs. 3 months) according to the Wilcoxon test showed a statistically significant decrease in QoL in the domain of insomnia (р = 0.000733) in SRT group and in the domain of fatigue (р = 0.016813) in HRT group. When comparing the results of the third and the second survey (12 vs. 6 months), the H0 hypothesis for all the studied parameters of QoL (GHS, insomnia, and fatigue) was rejected in both SRT and HRT groups (p ≤ 0.017 with the Bonferroni correction). When comparing the results of the third and the first survey (12 vs. 3 months), a statistically significant decrease in QoL in all studied parameters of QoL was observed: GHSS (р = 0.000078); fatigue (р = 0.000294); insomnia (р = 0.000318). The comparison of the results of these surveys in SRT group showed a statistically significant decrease of QoL in GHSS (р = 0.004650) and fatigue (p = 0.017938), with the level of statistical significance getting closer to the set critical value considering the Bonferroni correction. The intergroup analysis according to the Mann-Whitney U test showed a statistically significant advantage of HRT over SRT in all studied parameters of QoL in three subsequent surveys (p &lt; 0.05). The ρ-test confirmed these data: HRT group patients had better parameters of QoL than SRT group patients over the whole period of the follow-up. Conclusions. The analysis of QoL according to the results of three subsequent surveys 3, 6, and 12 months after RT according to the GHSS, domains of insomnia and fatigue of the EORTC QLQ-C30 demonstrated a decrease in QoL of patients in both SRT and HRT groups. At the same time, a statistically significant advantage of HRT group over SRT group in all studied parameters of SRT was observed when the results of three subsequent surveys were compared. The proposed regimen of HRT for patients with primarily diagnosed GB may be considered an acceptable alternative to SRT in view of impact on QoL.

Fatigue in patients with hypothalamic syndrome – A cross-sectional analysis of the German childhood-onset craniopharyngioma cohort

ObjectivePatients with suprasellar tumors are at risk for hypothalamic syndrome (HS), including fatigue and excessive daytime sleepiness. The aim of this cross-sectional study was to determine the severity of fatigue in patients with and without HS. MethodsPatients diagnosed with CP or pilocytic astrocytoma were recruited from the KRANIOPHARYNGEOM studies. Eligibility criteria were availability of one completed Multidimensional Fatigue Inventory-20 (MFI-20) questionnaire and complete medical records on criteria for HS. The associations between HS and levels of fatigue symptoms (MFI-20 sum score) were assessed. MFI-20 scores were compared to sex- and age-matched reference values from a German normative population. ResultsData on 41 patients, with a median age of 22 years, were available for analyses of which 25 (61 %) patients presented with HS. After adjustment for age and sex, patients with HS reported higher scores in the physical (β= 3.39 [95 %-CI:1.18–5.60]) and sum MFI-20 (β=11.42 [95 %-CI:2.06–20.79]) domain than patients without HS. Compared to reference values, all patients reported higher mean scores in each fatigue domain. Abnormal self-reported daytime sleepiness was reported in 6 of 25 (24 %) patients with HS. Regardless of the level of daytime sleepiness in patients with HS, the reported fatigue scores were high. Daytime sleepiness did not correlate with fatigue. ConclusionsFatigue symptoms are present in patients with CP. However, patients with HS are more affected with physical and overall fatigue. It is crucial in clinical practice, to distinguish between daytime sleepiness and fatigue and to target patients with HS.

CP-01. FATIGUE IN PATIENTS WITH HYPOTHALAMIC SYNDROME – A CROSS-SECTIONAL ANALYSIS IN THE GERMAN CHILDHOOD-ONSET CRANIOPHARYNGIOMA COHORT

Abstract BACKGROUND Patients with tumors of the sellar region are at risk of developing hypothalamic syndrome. Survivors experience fatigue and excessive daytime sleepiness even years after tumor treatment. The aim of this cross-sectional study was to determine the severity of fatigue in patients with and without hypothalamic syndrome. METHODS Patients diagnosed with CP or pilocytic astrocytoma were recruited from the KRANIOPHARYNGEOM 2000/2007/Registry 2019 studies and included in this analysis. Eligibility criteria were regular participation in outpatient after-care, one completed Multidimensional Fatigue Inventory-20 (MFI-20) questionnaire and complete medical records on criteria for hypothalamic syndrome. With univariable and multivariable linear regression, the relation of hypothalamic syndrome and levels of fatigue symptoms (MFI-20 sum score) were assessed. MFI-20 scores were compared to sex- and age-matched reference values from a German normative population using paired t-test. RESULTS Data on 46 patients, with a median age of 20 years, was available for this analysis of which 28 (61%) patients presented with hypothalamic syndrome. After adjustment for age and sex, patients with hypothalamic syndrome reported higher scores in the physical (= 3.61 [95% CI: 1.38–5.85]), mental (= 2.80 [95% CI: 0.28–5.32]) and sum MFI-20 (= 12.02 [95% CI: 2.93–21.10]) domain than patients without hypothalamic syndrome. Compared to reference values from a general German population, all patients reported higher mean scores in each fatigue domain. Regardless of the level of daytime sleepiness in patients with hypothalamic syndrome, the reported fatigue scores were high. Daytime sleepiness did not correlate with fatigue. CONCLUSIONS Fatigue symptoms are present in patients with CP. However, patients with hypothalamic syndrome are more affected in mental, physical and overall fatigue. It is crucial in clinical practice, to distinguish between sleep disorders and fatigue and to target patients with hypothalamic syndrome.

Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: data from the phase 3 clinical trial in Europe and Russia

Purpose To describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms. Materials and Methods We used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 − 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ-t-scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain. Results Of 1,553 treated participants, 1,398(90.0%), including 531(38%) starters, completed both MDQs. Starters reported improvements for premenstrual Pain (−1.4), Water Retention (−3.3) and Negative Affect (−2.5); and for menstrual Pain (−3.5), Water Retention (−3.4), and Negative Affect (−2.7) (all p < 0.01). For switchers, no changes were significant except an increase in premenstrual (+1.0, p = 0.02) and menstrual (+1.5, p = 0.003) Water Retention. We observed a change in symptom intensity in >40% of participants for Cramps, Backache and Fatigue (domain Pain), Painful or Tender Breast and Swelling (domain Water Retention) and Mood Swings and Irritability (domain Negative Affect). Conclusion E4/DRSP starters experienced significant improvements in the domains Pain, Water Retention and Negative Affect particularly benefiting those with more severe baseline symptoms. Switchers showed minimal changes.

Systematic review of fatigue severity in ME/CFS patients: insights from randomized controlled trials

BackgroundMyalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating illness medically unexplained, affecting approximately 1% of the global population. Due to the subjective complaint, assessing the exact severity of fatigue is a clinical challenge, thus, this study aimed to produce comprehensive features of fatigue severity in ME/CFS patients.MethodsWe systematically extracted the data for fatigue levels of participants in randomized controlled trials (RCTs) targeting ME/CFS from PubMed, Cochrane Library, Web of Science, and CINAHL throughout January 31, 2024. We normalized each different measurement to a maximum 100-point scale and performed a meta-analysis to assess fatigue severity by subgroups of age, fatigue domain, intervention, case definition, and assessment tool, respectively.ResultsAmong the total of 497 relevant studies, 60 RCTs finally met our eligibility criteria, which included a total of 7088 ME/CFS patients (males 1815, females 4532, and no information 741). The fatigue severity of the whole 7,088 patients was 77.9 (95% CI 74.7–81.0), showing 77.7 (95% CI 74.3–81.0) from 54 RCTs in 6,706 adults and 79.6 (95% CI 69.8–89.3) from 6 RCTs in 382 adolescents. Regarding the domain of fatigue, ‘cognitive’ (74.2, 95% CI 65.4–83.0) and ‘physical’ fatigue (74.3, 95% CI 68.3–80.3) were a little higher than ‘mental’ fatigue (70.1, 95% CI 64.4–75.8). The ME/CFS participants for non-pharmacological intervention (79.1, 95% CI 75.2–83.0) showed a higher fatigue level than those for pharmacological intervention (75.5, 95% CI 70.0–81.0). The fatigue levels of ME/CFS patients varied according to diagnostic criteria and assessment tools adapted in RCTs, likely from 54.2 by ICC (International Consensus Criteria) to 83.6 by Canadian criteria and 54.2 by MFS (Mental Fatigue Scale) to 88.6 by CIS (Checklist Individual Strength), respectively.ConclusionsThis systematic review firstly produced comprehensive features of fatigue severity in patients with ME/CFS. Our data will provide insights for clinicians in diagnosis, therapeutic assessment, and patient management, as well as for researchers in fatigue-related investigations.

Age-normed patient-reported outcome measures among cancer survivors.

11122 Background: Patient-reported outcome measures (PROMs) are instruments used to collect health-related outcomes that are derived completely from the patient without interpretation from healthcare providers. Monitoring and subsequent intervention based on PROMs collection has demonstrated efficacy in clinical trial settings. This has resulted in implementation of PROMs in routine clinical cancer practices throughout the nation. PROMs have been normed to the general population, but establishing the norms among cancer patients is essential to understanding how PROMs can be evaluated on an individual basis in routine clinical cancer care. This study aims to characterize age-normed PROMs scores among survivors of cancer using the National Institute of Health’s Patient-Reported Outcome Measures Information System (PROMIS) depression, fatigue, pain interference, and physical function domains. Methods: Routine collection of PROMs using 4 domains (depression, fatigue, pain interference, and physical function) of PROMIS were offered to all patients with a diagnosis of cancer of any disease site at visits with an oncologic provider using computer adaptive testing. All patients ≥18 years old with a completed PROM at least 2 years since their diagnosis of cancer were eligible for inclusion in the analysis. Only completed PROMs were included in the final analysis. Generalized estimating equation models were used to assess the relationship between age and the estimated mean T-score for each PROMs domain, considering repeat measures within a single patient. Results: A total of 3,636 patients were included in this retrospective cohort study with a total of 26,173 completed PROMs among all 4 domains. Mean age at diagnosis was 61.2 years (SD=12.44), 64% (n=2324) were female, 68% (n=2,461) identified as White, and 25% (n=893) identified as Black. For fatigue, mean T-score ranged from 48.4 points (SD=9.6) among 18-29 years olds to 56.5 points (SD=10.1) among 90-99 years olds, with no significant change with age (p=0.27). For depression, mean T-score ranged from 48.9 points (SD=9.0) among 60-69 year olds to 51.1 points (SD=8.8) among 80-89 year olds with a 0.3 point/decade decrease in T-score (p=0.01). Pain interference T-scores ranged from 48.6 points (SD=10.5) among 18-29 year olds to 55.0 points (SD=9.4) among 80-89 year olds with a 0.4 point/decade average increase (p&lt;0.001). The largest differences were observed in physical function, where scores ranged from 53.5 points (SD=11.0) among 18-29 year olds to 34.3 points (SD=9.2) among 90-99 year olds. There was a 2.1 point/decade decrease in T-score (p&lt;0.001). Conclusions: Among survivors of cancer, mean PROMIS scores differed by age in the depression, pain interference, and physical function domains but not fatigue. These age-normed PROMIS T-scores, which are required to understand individualized assessments of PROMs, are essential as PROMs are integrated into routine cancer care.

A phase 2 study of regorafenib in metastatic/unresectable, refractory synovial sarcomas.

e23551 Background: Current therapeutic options for advanced synovial sarcomas remain limited. Adoptive T-cell therapies against NY-ESO-1 and MAGE-4 benefit a subset of patients, but is of limited value in Asian patients due to the absence of the HLA-A*02 genotype. Methods: The trial had a single arm, Simon two-stage design that included patients with advanced synovial sarcomas who had progressed on 2 lines of therapy, one of which could be an anti-VEGF therapy. Regorafenib was administered orally in a continuous regimen with 80mg and 120 mg doses on alternate days. The primary end point was 3-month progression-free rate (PFR). A 3-month PFR of greater than 40% was taken to be a marker of drug efficacy. Secondary end points included median PFS, OS and safety analysis. Quality of life assessment was carried out at baseline and at 3 months using the EORTC C-30 questionnaire. Radiological responses were assessed using RECIST 1.1 criteria after independent review by 2 radiologists. Results: A total of 22 patients were included in the study during the period from January 2022 to December 2023 with baseline characteristics as shown in Table 1. 18 patients were eligible for assessment of the primary outcome. The 3-month PFR with regorafenib was 57% with an ORR of 5%. At a median follow up of 9 months, the median PFS was 5.0 (2.9-7.0) months, and the median OS was 10.0 (7.8-11.2) months. In an exploratory analysis, the subset of patients previously exposed to pazopanib showed a 3-month PFR of 46% and a median PFS of 3 months. The grade ¾ toxicities seen included HFSR (52%), diarrhea (5%) and oral mucositis (5%). The quality-of-life analysis showed symptom burden to be highest in the fatigue, pain and financial difficulties domain at baseline. No worsening of symptom burden scores was seen over the study period. The global health status score showed a numerical improvement at 3 months. Conclusions: The study had a significant number of patients with poor PS. Regorafenib in the above-mentioned dosing regimen demonstrated meaningful clinical activity in a heavily pre-treated population of patients with synovial sarcoma, including those previously exposed to pazopanib, with a preserved quality of life. The treatment was associated with manageable toxicities and no new safety signals, albeit with higher HFSR rates. [Table: see text]

Effectiveness of Acupressure for Fatigue Alleviation in Patients Receiving Hemodialysis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Fatigue, a major health concern among patients receiving hemodialysis, is associated with poor quality of life, negative emotions, and cognitive dysfunction. Acupressure is a low-cost and noninvasive traditional Chinese therapy that has been widely used in community and clinic settings. However, the beneficial effects of acupressure on various aspects of fatigue among these patients have not been systematically investigated. This study was designed to determine the effects of acupressure on fatigue in patients receiving hemodialysis. The moderating influences of bio-sociodemographic characteristics and methodology on the association between acupressure and posthemodialysis fatigue were also examined. Four electronic databases were searched for qualified articles published between database inception and November 2, 2022. Only randomized controlled trials designed to investigate the effects of acupressure on fatigue in patients receiving hemodialysis were qualified for consideration. A random-effects model was used for data analysis. Eight randomized controlled trials with 11 effect sizes and 725 participants were included in this study. In these studies, acupressure was found to have a significantly higher alleviation effect on general fatigue (g = -0.78; 95% confidence interval [-1.09, -0.48]) and the behavioral, emotional, sensory, and cognitive domains of fatigue (g = -0.51, -0.51, -0.72, and -0.41, respectively) among patients receiving hemodialysis than those in the control groups. Furthermore, the stimulation of the Shenmen acupoint was found to increase the effects (p < .01) of acupressure on fatigue reduction significantly. Notably, the use of special equipment to perform the acupressure was not found to significantly improve outcomes (p = .99). Acupressure is effective in alleviating fatigue in patients receiving hemodialysis, particularly when the Shenmen acupoint is used together with other acupoints, and is effective without the application of special equipment. Acupressure may be adopted as a complementary therapy for fatigue alleviation in patients receiving hemodialysis. Based on the findings, healthcare providers should coach patients receiving hemodialysis with fatigue on how to use acupressure therapy appropriately to alleviate this health concern.