EQ-5D VAS Research Articles

Health-related quality of life is improved after coronary artery bypass graft surgery: a 1-year follow-up study

Objectives: The purpose of this study was to detect changes in QoL after coronary artery bypass grafting surgeries (CABG) in one year, and to identify the possible predictive factors associated with the change. Design: A single-center prospective study of 501 patients was conducted between 2013 and 2018 using the EQ-5D VAS questionnaire for estimating the QoL. The patients filled in a questionnaire preoperatively, at 6 and at 12 months postoperatively. Univariate and multivariable logistic regression analyses were used to find out if certain pre-selected factors or EQ5D dimensions had independent effects on the observed EQ VAS scores. Results: QoL improved in all EQ-5D dimensions and in EQ VAS scores at 6 and at 12 months: the greatest changes in the number of reported problems were in the dimensions “mobility” (–34.2%, p<.001), “self-care” (–36.7%, p=.001) and “pain or discomfort” (–31.0%, p<.001). With the multivariable regression model, we could show that normal left ventricle ejection fraction (LVEF) and improvement in mobility and pain/discomfort dimensions were in association with improvement of EQ VAS score at 6 months. At 12 months this association was no longer detectable. Conclusions: CABG procedure can improve patient’s QoL when judged with EQ5D dimensions and related overall self-rated health (VAS). This improvement was seen both at 6 and at 12 months postoperatively. Except for LVEF, the other patient-specific risk factors we examined did not seem to affect QoL in the long term.

Abstract 16553: Effects of Digital Yoga on Physical and Psychological Outcomes in Patients With Heart Failure: A Randomised Controlled Trial

Objectives: To determine effects of digitally delivered yoga on exercise capacity and patient-reported outcome measures. Methods: Two-arm randomised controlled study including participants with heart failure or conditions in need of intensive care from four hospitals in Sweden. Participants were randomised to a control group receiving individual exercise advice or to the intervention group (tele-yoga). The intervention lasted for 3 months and included live-streamed group-yoga via Zoom for 60 minutes twice/week and individual yoga for a minimum of 10 minutes/day using an app. The primary endpoint of the study was a combined endpoint consisting of change in functional capacity measured by 6 minute walk test (6MWT), health-related quality of life (EQ-5D index/VAS) and symptoms of anxiety and depression (hospital anxiety and depression scale - HADS). The primary end-point analysis after 3 months follow-up compared the change in the combined endpoint between the participants in the tele-yoga and control group. Secondary endpoints included separate analysis of functional capacity, health-related quality of life and symptoms of anxiety/depression. Results: 311 participants were randomized to tele-yoga (n=156) and control (n=155), mean age 66 years, 30% women, 80% diagnosed with heart failure. There was a significant improvement in favor of the tele-yoga group in the combined primary endpoint consisting of physical function, quality of life and anxiety and depression (p=.006). When analysing them separately, there was a significant improvement in 6MWT (p=.008) and quality of life in EQ-5D VAS (p=.014), but not in EQ-5D index (p=.12), and a significant difference between the groups in symptoms of anxiety and depression (p=.03). Median attendance to yoga-sessions was 20 sessions (maximum 24) and 69% of the study participants were adherent to &gt;18 tele-yoga sessions. There were no adverse events reported during yoga sessions or app usage. Conclusion: Digitally delivered mind-body training such as tele-yoga showed a significant improvement in the combined end-point consisting of physical function, health-related quality of life and mental health. Tele-yoga may be a promising new form of rehabilitation for patients with heart failure.

Effects of Idecabtagene Vicleucel (Ide-Cel) Versus Standard Regimens on Health-Related Quality of Life (HRQoL) in Patients with Triple-Class-Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM) Who Received at Least 3 Lines of Prior Antimyeloma Regimens in the KarMMa-3 Phase 3 Randomized Controlled Trial

Introduction: Patients with TCE RRMM have a high disease burden and often report worsening HRQoL with additional lines of therapy. The single-arm, phase 2 KarMMa study demonstrated that ide-cel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell therapy, improved HRQoL from baseline in patients with TCE RRMM who had received ≥ 3 prior regimens (Delforge M, et al. Blood Adv 2022;6:1309-1318). Furthermore, in the phase 3 KarMMa-3 clinical trial (NCT03651128), ide-cel significantly improved progression-free survival and response compared with standard regimens in patients with TCE RRMM who had received 2-4 prior regimens (Rodriguez-Otero P, et al. N Engl J Med 2023;388:1002-1014). Here we assessed the comparative effects of ide-cel versus standard regimens on HRQoL in patients with TCE RRMM who had received 3-4 prior regimens including an immunomodulatory agent, a proteasome inhibitor, and daratumumab (an anti-CD38 monoclonal antibody) using data from the KarMMa-3 study. Methods: Patient-reported outcomes (PROs) were assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20), and EQ-5D-5L. The pre-specified primary domains of interest included EORTC QLQ-C30 global health status/QoL, physical functioning, cognitive functioning, fatigue, and pain; EORTC QLQ-MY20 disease symptoms and side effects of treatment; and the EQ-5D-5L visual analog scale (EQ-5D VAS). PROs were collected at screening (baseline), the day of ide-cel infusion (ide-cel) or first treatment dose (standard regimens), monthly from 2 to 28 months, and thereafter every 3 months. Comparisons were performed on least squares (LS) mean changes from baseline through 28 months between arms using constrained longitudinal data analysis (cLDA). Effect size was estimated by Hedges' g. The comparative effects of ide-cel versus standard regimens on time to confirmed improvement and time to confirmed deterioration (defined by prespecified change thresholds) were assessed via stratified Cox proportional hazards regression analyses. All P values are nominal and not adjusted for multiple testing. Statistical significance was set at P &amp;lt; 0.05. Results: Baseline characteristics were well balanced among the patients in the ide-cel arm (n = 167) and the standard regimen arm (n = 93), with a median age of 63 years and a median time of 4.7 years from RRMM diagnosis to study screening. Completion rates of HRQoL assessments were high over time for most visits (&amp;gt; 75%). At baseline, mean HRQoL domain scores were similar between arms. Overall LS mean changes from baseline to 28 months showed significant differences in favor of ide-cel versus standard regimens (nominal P &amp;lt; 0.05) for 11 domains (effect sizes of 0.26-0.82), and 7 (4 primary: global health status/QoL, cognitive functioning, pain, EQ-5D VAS; 3 secondary: dyspnea, insomnia, constipation) of them exceeded the prespecified MID thresholds (Table). Time to confirmed improvement was significantly shorter (nominal P &amp;lt; 0.05) in the ide-cel arm than in the standard regimen arm for 10 domains, including all primary domains except pain. Time to confirmed deterioration was longer in the ide-cel arm than the standard regimen arm for most domains, with significant differences in emotional functioning, cognitive functioning, and dyspnea (EORTC QLQ-C30). Finally, side effects of treatment favored the ide-cel versus standard regimen arm (EORTC QLQ-MY20) (Table). Conclusions: These patient-reported findings demonstrate that compared with standard regimens, treatment with ide-cel improved MM-relevant disease symptoms, functioning, and overall health status/HRQoL of patients with TCE RRMM in the KarMMa-3 trial. These data further substantiate the superior treatment outcomes of ide-cel over standard regimens in this patient population. Overall, treatment with ide-cel may help alleviate detriments to HRQoL in these patients with complex disease.

Title: The Impact of Recent Vaso-Occlusive Crisis on Health-Related Quality of Life in Adults with Sickle Cell Disease

Introduction: Sickle cell disease (SCD) is characterized by vaso-occlusive crises (VOCs) and a progressive clinical course, often leading to end organ damage and mortality. Individuals living with SCD with recurrent VOCs experience daily life disruptions due to recurrent pain crises, debilitating chronic pain and fatigue, which substantially impair health-related quality of life (HRQoL). The impact of a recent VOC on HRQoL has not been quantified. We investigated HRQoL impacts in adults with SCD who experienced a recent VOC (&amp;lt; 1 week) in comparison to overall adults with SCD with recurrent VOCs. Methods: A mixed-methods study was conducted to quantify the HRQoL, work impacts, and perceived health inequalities of individuals with SCD with recurrent VOCs. The study consisted of qualitative interviews and an online longitudinal survey administered at 3 timepoints (month 0, 3, and 6) in the US, UK, France, Germany, and Italy. Patient advocacy groups used multi-channel outreach to invite participants, who were required to meet the eligibility criteria and provide consent. Key eligibility criteria included recurrent VOCs defined as ≥ 2 VOCs/year in each of the 2 years prior to enrollment requiring a medical facility interaction and administration of pain medication or red blood cell transfusion. The survey included multiple patient-reported outcome (PROs) measures: the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) inclusive of the FACT-General (FACT-G), EuroQol- 5 Dimension 5-Level (EQ-5D-5L), 11-point pain numerical rating scale (NRS), Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me), and the Work Productivity and Activity Impairment (WPAI) questionnaire. In this post-hoc analysis study participants with a current or recent VOC (&amp;lt; 1 week ago) were identified based on ASCQ-Me responses (herein referred to as recent VOC). The HRQoL impact of a recent VOC was assessed by descriptively comparing PRO scores between those with a recent VOC and the overall population of adults with SCD with recurrent VOCs (herein referred to as overall population). Results: The survey was completed by 142 participants with SCD (≥ 18 years) with 139 providing time since last VOC living in the US (n=82) and UK, Germany, France, and Italy (n=57). Fifty-six (40.3%) reported a recent VOC and had a similar mean age (35.7 vs. 35.3 years) and hydroxyurea use in the past month (58.9% vs. 61.9%) compared with the overall population. A higher proportion of those with a recent VOC were unemployed or unable to work due to SCD (76.8% vs. 64.7%). The mean EQ-5D VAS (0-100 scale, 100=best health) among those with a recent VOC was 49.2 (SD: 14.2), which was 16.2% and 38.8% lower relative to the overall study population (58.7 [SD: 19.4]) and the US general population (80.4 [SD: 15.6]), respectively. The overall mean EQ-5D health utility US index score (0.59 [SD: 0.27]) was much lower than the US general population (0.85 [SD: 0.21]) and further reduced among those with a recent VOC by 0.11 (0.48 [SD: 0.25]). The FACT-G total mean score was 53.6 (SD: 14.3) (0-108 scale, 108=best HRQoL) among those with a recent VOC representing a clinically meaningful reduction compared with the overall population (62.5 [SD:18.1]); with all FACT-G domain scores negatively impacted by a recent VOC. Based on the WPAI, those employed with a recent VOC (n=15) reported a mean of 35.4% (SD: 35.8%) absenteeism and 62.5% (SD: 21.8%) presenteeism, which were higher than the overall study population (24.7% [SD: 27.1%] and 42.0% [SD: 27.8%)], respectively). In the past 12 months, those with a recent VOC had a greater mean number of emergency room visits (9.6 [SD: 12.6] vs 6.2 [SD: 8.8]), hospitalizations with overnight stays (6.0 [SD: 5.7] vs. 4.0 [SD: 4.5]), and days overnight in the hospital (21.8 days [SD: 32.9] vs. 14.7 [SD: 24.7]) compared to the overall population. Conclusions: Despite current treatments, nearly 40% of adults with SCD in the surveyed population experienced a recent VOC (&amp;lt; 1 week), which has significant negative impacts on HRQoL and functional status, including the ability to work. These results demonstrate the substantial humanistic burden of those living with SCD with recurrent VOCs and the additional impairment of a recent VOC. Novel treatments that reduce or eliminate VOCs may provide an opportunity to improve health inequalities, HRQoL, and address unmet needs in this patient population.

Poorer patient-reported knee function and quality of life, but not activity level, after revision ACL reconstruction compared with primary ACL reconstruction: a matched-pair analysis with a minimum 5-year follow-up

BackgroundAn appropriate method for comparing knee function and activity level between patients with primary and revision anterior cruciate ligament reconstruction (ACLR) is to perform a matched-group analysis. The aim was to assess and compare knee function, knee-related quality of life and activity level between patients with revision ACLR and primary ACLR at a minimum of 5 years of follow-up.MethodsPatients aged ≤ 40 years old who underwent revision ACLR between 2010 and 2015 and a matched control group (primary ACLR) (1:1) with age ± 2 years, year of ACLR, sex, and pre-injury sport and Tegner Activity Scale (TAS) were retrospectively identified in our clinic database. The preoperative Knee injury and Osteoarthritis Outcome Score (KOOS) and surgical data were extracted and analyzed. Patients were mailed KOOS and EQ-5D questionnaires at a minimum of 5-years after revision ACLR. Study-specific questions about knee function, limitation in sport, satisfaction, and activity level according to the TAS (all scales of 1–10, 10 best) were also asked by telephone.ResultsSeventy-eight patients with a revision ACLR (mean age ± SD, 29.9 ± 6.0 years) matched with seventy-eight patients with a primary ACLR (30.2 ± 5.8 years) were included. The follow-up for the revision ACLR group was 7.0 ± 1.5 years and for the primary ACLR group 7.7 ± 1.6 years. The revision ACLR group reported poorer KOOS scores in all subscales (p < 0.05) except the Symptoms subscale, poorer EQ-5D VAS (mean 79.2 ± 20.1 vs 86.0 ± 20.1, p = 0.012), and less satisfaction with current knee function (median 7 (6–8) vs 8 (7–9), p < 0.001). Patients with revision ACLR also experienced greater limitation in sports (median 7 (4–8) vs 8 (6–9), p < 0.001). There were no significant differences in the EQ-5D (mean 0.86 ± 0.17 vs 0.89 ± 0.11, p = 0.427), activity level (median 2 (2–5) vs 4 (2–7), p = 0.229), or satisfaction with activity level (median 8 (5–9) vs 8 (6–10), p = 0.281) between the groups.ConclusionsAt a minimum 5-year follow-up, the revision ACLR group reported poorer knee function and quality of life, less satisfaction with knee function and a greater limitation in sports but no differences in activity level and satisfaction with activity level compared with the primary ACLR group.

Depression and health-related quality of life of patients with type 2 diabetes attending tertiary level hospitals in Dhaka, Bangladesh

IntroductionType 2 diabetes mellitus (T2DM) and depression are closely linked. People with T2DM are at increased risk of developing depression and vice versa. T2DM and depression comorbid conditions adversely affect Health-Related Quality of Life (HRQOL) and management of T2DM. In this study, we assessed depression and HRQOL among patients with T2DM in Dhaka, Bangladesh.MethodsA cross-sectional study was conducted in two tertiary-level hospitals in Dhaka, Bangladesh. Data were collected from 318 patients with T2DM. A set of standard tools, PHQ-9 (for assessing depression) and EuroQol-5D-5L (for assessing the HRQOL), were used. Statistical analyses, including Chi-square and Fisher's exact tests, Wilcoxon (Mann–Whitney), and Spearman's correlation coefficient tests, were performed using SPSS (v.20).ResultsThe majority of the patients (58%) were females, with a mean age (standard deviation) of 52 ± 10 years, and 74% of patients lived in urban areas. The prevalence of depression was 62% (PHQ-9 score ≥ 5). Over three-quarters (76%) reported problems in the anxiety/ depression dimension of EQ-5D, followed by pain/discomfort (74%), mobility (40%), self-care (36%), and usual activities (33%). The depression and T2DM comorbid condition were associated with all the five dimensions of EQ-5D (χ2 statistics with df = 1 was 52.33, 51.13, 52.67, 21.61, 7.92 for mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression dimensions respectively, p- < 0.01). The mean EQ-5D index (0.53 vs. 0.75) and the mean EQ-5D VAS (65 vs. 76) both showed lower values in T2DM patients with depression compared to T2DM patients without depression (Wilcoxon test, p- < 0.001).ConclusionsWe conclude that the majority of the patients with T2DM had comorbid conditions, and the HRQOL was negatively affected by comorbid depression in T2DM patients. This suggests the importance of timely screening, diagnosis, treatment, and follow-up of comorbid depression in T2DM patients to improve overall health and QOL.

The Effects of a 'New Generation' of Heat and Moisture Exchangers in Laryngectomized Patients with Previous Heat and Moisture Exchanger Experience.

Objectives: To evaluate the effects of a new generation of heat and moisture exchangers (NG-HMEs) on pulmonary rehabilitation, quality of life, patient satisfaction, and usage patterns. Methods: A prospective observational study on 23 laryngectomized patients with prior HME experience from June 1, 2021 to November 30, 2021. Patients were interviewed at inclusion, after 6 weeks and after 12 weeks after the introduction of NG-HMEs. Two validated questionnaires were used to report pulmonary complaints and quality of life: the Cough and Sputum Assessment Questionnaire (CASA-Q), the European Quality of Life 5 Dimensions Index Score (EQ-5D Index Score), and the European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D-VAS). Usage patterns and patient satisfaction were reported using study-specific questionnaires. Results: The patients had an average age of 65.7 ± 6.8 years, with 87% being male, on average 33.7 ± 35.3 months after total laryngectomy (TLE). NG-HMEs were used for a mean of 21.87 ± 4.63 hours/day (P = .034). After 12 weeks of use, patients reported the following changes in the CASA-Q domains: cough symptoms (+5; P = .663), cough impact (0; P = .958), sputum symptoms (+8; P = .13), and sputum impact (+3; P = .489). The EQ-5D index score increased (+0.024; P = .917) as well as the EQ-5D VAS (+0.8; P = .27). All patients rated their experience with NG-HMEs with ≥3 out of 5. The patients who used NG-HMEs as instructed (n = 13) reported more profound changes in the CASA-Q domains: cough symptom (+11; P = .129), cough impact (+7; P = .209), sputum symptom (+11; P = .123), and sputum impact (+10; P = .102). Conclusions: Our results show that NG-HMEs could have a positive clinical impact on pulmonary rehabilitation after TLE, even in HME-experienced patients. The use of NG-HMEs does not affect the quality of life. The possible effects of NG-HMEs require further evaluation in long-term studies to fully assess their efficacy.

The translated proximal humerus fracture: a comparison of operative and non-operative management.

To report on the long-term outcomes of the management of translated proximal humerus fractures. A prospective cohort study was conducted from January 2010 to December 2018. Academic Level 1 trauma centre.Participants/Patients: A total of 108 patients with a proximal humerus fracture with ≥100% translation, defined as no cortical bony contact between the shaft and humeral head fragments, were included. Patients were managed non-operatively with sling immobilisation or with operative management as determined by the treating surgeon. Outcome measures were the Oxford Shoulder Score (OSS), EQ-5D-5L, return to work, and radiological outcomes. Complications recorded included further surgery, loss of position/fixation, non-union/malunion, and avascular necrosis. Of the 108 patients, 76 underwent operative intervention and 32 were managed non-operatively. The mean (SD) age in the operative group was 54.3 (±20.2) and in the non-operative group was 73.3 (±15.3) (p<0.001). There was no association between OSS and management options (mean 38.5 (±9.5) operative vs mean 41.3 (±8.5) non-operative, p=0.48). Operative management was associated with improved health status outcomes; EQ-5D utility score adjusted mean difference 0.16 (95%CI 0.04-0.27, p=0.008); EQ-5D VAS adjusted mean difference 19.2 (95%CI 5.2-33.2, p=0.008). Operative management was associated with a lower odds of non-union (adjusted OR 0.30, 95%CI 0.09-0.97, p=0.04), malunion (adjusted OR 0.14, 95%CI 0.04-0.51, p=0.003) and complications (adjusted OR 0.07, 95%CI 0.02-0.32, p=0.001). Translated proximal humerus fractures with ≥100% displacement demonstrate improved health status and radiological outcomes following surgical fixation.

Two-Year Results of Injectable Matrix-Associated Autologous Chondrocyte Transplantation in the Hip Joint: Significant Improvement in Clinical and Radiological Assessment.

Articular cartilage defects are a prevalent consequence of femoroacetabular impingement (FAI) in young active patients. In accordance with current guidelines, large chondral lesions of the hip joint over 2 cm2 are recommended to be treated with matrix-associated, autologous chondrocyte transplantation (MACT); however, the conditions in the hip joint are challenging for membrane-based MACT options. Injectable MACT products can solve this problem. The purpose of the trial was to assess clinical and radiological outcomes 24 months after injectable MACT of focal chondral lesions caused by FAI. We present data of 21 patients with focal cartilage defects of the hip [3.0 ± 1.4 cm2 (mean ± SD)], ICRS Grade III and IV caused by CAM-type impingement, who underwent arthroscopic MACT (NOVOCART® Inject) and FAI correction. The outcome was evaluated with the patient-reported outcome instruments iHOT33 and EQ-5D-5L (index value and VAS), whilst graft morphology was assessed based on the MOCART score over a follow-up period of 24 months. The iHOT33 score increased significantly from 52.9 ± 21.1 (mean ± SD) preoperatively to 85.8 ± 14.8 (mean ± SD; p < 0.0001) 24 months postoperatively. The EQ-5D-5L index value (p = 0.0004) and EQ-5D VAS (p = 0.0006) showed a statistically significant improvement as well. MRI evaluation after 24 months showed successful integration of the implant in all patients with a complete defect filling in 11 of 14 patients. Injectable MACT for the treatment of full-thickness chondral lesions of the hip joint due to FAI in combination with FAI correction improved symptoms, function, and quality of life in the treated cohort. Alongside the treatment of the underlying pathology by the FAI correction, the developed cartilage defect can be successfully repaired by MACT, which is of considerable clinical relevance.

Is food insecurity contributing to malnutrition in older adults in Switzerland? - A cross-sectional study.

Food insecurity has been defined as "limited access to food, at the level of individuals or households, due to lack of money or other resources" and may increase the nutritional risk, which in turn leads to poor health, development of chronic diseases, poor psychological and cognitive functioning, and substandard academic achievements. There is limited data on the importance of food insecurity in a rich country such as Switzerland. This is a cross-sectional analysis of data from a structured survey in an elderly population of Switzerland. The data was assessed between June and August 2021 in the course of a 7-year phone call follow-up from the EFFORT trial, which included medical inpatients at nutritional risk from 2014 to 2018. A validated questionnaire (Six-Item Short Form 2012 of the U.S: Household Food Security Survey Module) was used to assess food security status. Of the 433 included patients, 30 (6.9%) were food insecure. A significant association between food insecurity and age, governmental financial support and self-reported loneliness was found. When compared with the food secure group, there was a significant lower quality of life measured by the EQ-5D VAS. In an older Swiss population of patients at nutritional risk, food insecurity was named as a contributing factor for malnutrition in about 7% of patients, particularly younger individuals with financial support, and self-reported loneliness. In the assessment of malnutrition, physician and dieticians should ask for food insecurity and if detect take appropriate actions.

Respiratory Rehabilitation Improves Quality of Life and Functionality of Covid 19 Patients

Abstract Respiratory rehabilitation leads to reduction of symptoms, strengthens extremity musculature and improves emotional state and management of daily activities in patients with respiratory diseases. Aim of our study was to determine quality of life and functionality of COVID 19 patients before and after respiratory rehabilitation program. The study was conducted at the Clinical Center, Kragujevac, from June to July 2020. The study was a prospective clinical trial and included 62 patients with the acutephase of COVID-19. Respiratory rehabilitation program started at hospital and continued at home for three months overall. Quality of life was measured by the EQ-5D-5L and patient’s functionality by The FIM score. All five dimension of EQ-5D-5L were higher after respiratory rehabilitation program as well as EQ-5D index score and VAS score (0.8516±0.202 and 53.31±17.129 before rehabilitation, 0.9147±0.074 and 64.53±8.368 after rehabilitation). Respiratory exercise showed significantly improvement in FIM total score from 104.48±12.880 to 106.21±9.791, as well as in FIM motor and cognitive subscores. Respiratory rehabilitation program improves quality of life and functionality of COVID 19 patients.

A Prospective Study of Patients with Persistent Symptoms after SARS-CoV-2 Infection Referred to Physical Medicine and Rehabilitation.

New evidence and extrapolated data from other coronaviruses suggest that symptoms and consequences of COVID-19 may persist beyond the cure. The aims of this study were to evaluate persistent symptoms after SARS-CoV-2 infection and its impact on physical condition, activities of daily living, and quality-of-life; establish whether symptom persistence is associated with higher disability; and document the evolution of the multiple domains after a home exercise program. Prospective study with patients referred to a Physical and Rehabilitation Medicine clinic, after SARS-CoV-2 infection. Patient evaluations, including a symptom questionnaire, the 1-Min Sit-to-stand test (1-MSTS), the EQ-5D questionnaire and the London Chest Activity Daily Living (LCA-DL) questionnaire, were performed before and after a home exercise program. Seventy-four patients were included. The majority (n = 71) had been hospitalized (mean stay 19.66 ± 13.35 days), 51% required intensive care. At first evaluation, 54 days after symptom onset, a mean of 18.6 repetitions in the 1-MSTS were performed. The percentage of LCA-DL was above 28% in 23% of the patients. Impairments on EQ-5D were present in 44% for mobility and 44% for anxiety/depression. Mean EQ-5D VAS was 66.5 out of 100. Fifty-one (70%) had at least one persistent symptom (Symptomatic Group), while 22 (30%) were asymptomatic (Asymptomatic Group). The Symptomatic Group had statistically significantly worse mean results on 1-MSTS (16.8 vs 22.9; p < 0.001), % LCA-DL score, EQ-D5 (7.8 vs 5.7; p < 0.001) and EQ-D5-VAS. No patient characteristic, clinical background, comorbidity, or hospitalization characteristics was significantly different between groups. Every patient was given a home exercise program; 47 patients joined an additional rehabilitation program or were clinically discharged and were therefore excluded from the second evaluation. Twenty-seven patients participated in a second evaluation. In the matched analysis, mean 1-MSTS improved by 3.4 repetitions. Mean LCA-DL, mean EQ-5D score (7.1 to 6.6) and EQ-VAS score changed favourably and significantly. Two months after infection by SARS-CoV-2, persistent symptoms were frequent in patients referred to a Physical Medicine and Rehabilitation clinic. Additionally, the SARS-CoV-2 infection, as well as the persistence of symptoms, had a negative impact in the physical condition and functionality in ADL and quality-of-life. With a home exercise program in place, a statistically significant improvement was observed. Referral of patients with persistent symptoms to Physical and Rehabilitation Medicine may be warranted.

Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: results from the PsABio real-world study

BackgroundTo evaluate the real-world effect of the IL-12/23 inhibitor ustekinumab or of a tumour necrosis factor inhibitor (TNFi) on patient-reported outcomes (PRO) and their association with effectiveness endpoints in psoriatic arthritis (PsA) patients over 3 years.MethodsIn PsABio (NCT02627768), a prospective, observational study, patients with PsA that were prescribed first- to third-line ustekinumab or a TNFi, and remained on that drug for 3 years, were analysed for change in baseline in PROs (EuroQol-5 dimensions health state VAS [EQ-5D VAS], 12-item Psoriatic Arthritis Impact of Disease questionnaire [PsAID-12; range 0–10], Work Productivity and Activity Impairment for Psoriatic Arthritis questionnaire [WPAI; results expressed as a percentage for each domain]), and the association between PROs and WPAI with effectiveness endpoints, clinical disease activity index for psoriatic arthritis (cDAPSA), low disease activity (LDA)/remission, minimal disease activity (MDA) and very low disease activity (VLDA).ResultsIn 437 patients (mean age 49.1 years, 47.8% female), at 3 years, ustekinumab and TNFi treatment led to comparable improvements in EQ-5D VAS; mean change from baseline (95% confidence intervals [CI]) was 11.0 (6.5; 15.4) and 18.9 (14.0; 23.9), respectively. Both groups improved PsAID-12 after 3 years; mean change from baseline (95% CI) was −2.9 (−3.2; −2.5) and −3.5 (−3.9; −3.2), respectively. At baseline, due to their PsA, TNFi-treated patients had lower work productivity compared to ustekinumab-treated patients; mean productivity reduction (95% CI) was 58.8 [52.4; 65.2] and 43.3 [35.6; 51.1]. Over 3 years, TNFi-treated patients had a greater improvement in work productivity compared to ustekinumab-treated patients, ultimately leaving work productivity to be comparable between groups; mean improvement (95% CI) was 44.5% (38.4; 50.6) and 24.9% (15.8; 34.0), respectively. A similar trend was observed in activity impairment. Patients in both treatment groups who achieved effectiveness endpoints, cDAPSA LDA/remission, MDA, and VLDA had greater improvement in PROs and WPAI than patients who did not achieve these endpoints.ConclusionsAt 3 years, improvements in PROs following ustekinumab or TNFi treatment were generally comparable; however, TNFi-treated patients achieved a greater improvement in work productivity, although this group started from a lower baseline. Achievement of effectiveness endpoints, independent of treatment group, also improved PROs.Trial registrationClinicalTrials.gov, NCT02627768. Registered on 11 December 2015

Use of latent class analysis and patient reported outcome measures to identify distinct long COVID phenotypes: A longitudinal cohort study.

We sought to 1) identify long COVID phenotypes based on patient reported outcome measures (PROMs) and 2) determine whether the phenotypes were associated with quality of life (QoL) and/or lung function. This was a longitudinal cohort study of hospitalized and non-hospitalized patients from March 2020 to January 2022 that was conducted across 4 Post-COVID Recovery Clinics in British Columbia, Canada. Latent class analysis was used to identify long COVID phenotypes using baseline PROMs (fatigue, dyspnea, cough, anxiety, depression, and post-traumatic stress disorder). We then explored the association between the phenotypes and QoL (using the EuroQoL 5 dimensions visual analogue scale [EQ5D VAS]) and lung function (using the diffusing capacity of the lung for carbon monoxide [DLCO]). There were 1,344 patients enrolled in the study (mean age 51 ±15 years; 780 [58%] were females; 769 (57%) were of a non-White race). Three distinct long COVID phenotypes were identified: Class 1) fatigue and dyspnea, Class 2) anxiety and depression, and Class 3) fatigue, dyspnea, anxiety, and depression. Class 3 had a significantly lower EQ5D VAS at 3 (50±19) and 6 months (54 ± 22) compared to Classes 1 and 2 (p<0.001). The EQ5D VAS significantly improved between 3 and 6 months for Class 1 (median difference of 6.0 [95% CI, 4.0 to 8.0]) and Class 3 (median difference of 5.0 [95% CI, 0 to 8.5]). There were no differences in DLCO between the classes. There were 3 distinct long COVID phenotypes with different outcomes in QoL between 3 and 6 months after symptom onset. These phenotypes suggest that long COVID is a heterogeneous condition with distinct subpopulations who may have different outcomes and warrant tailored therapeutic approaches.

Baseline symptom, health status, and health utilities in patients in early-phase clinical trials combining immune checkpoint blockade with other anticancer therapies.

12117 Background: The overall goal of our prospective and longitudinal study (NCI R01CA242565) is to examine the use of patient report to evaluate symptomatic adverse events associated with combination treatment including at least one immune checkpoint inhibitor in early-stage clinical trials. We present here the baseline symptom, health status and utilities in patients prior to trial start, and their association with clinical factors. Methods: Patients scheduled to start an early-phase trial of combination treatment with at least one immune checkpoint inhibitor and who had not received clinical trial-related treatment completed the validated MD Anderson Symptom Inventory - Immunotherapy (0-10, higher scores = worse severity) and the validated EuroQoL-5 dimensions questionnaire including a visual analog scale (EQ5D VAS) (0-100, higher scores = better health status) and health utility items (e.g., self-care, mobility). Clinical data were extracted from the EMR. Statistical tests included Spearman’s correlation coefficients. Results: At baseline prior to start of trial-related treatment, 38% of patients (N = 164; median age = 60 y; 52% male; 85% White; 17% ECOG PS 0, 89% ECOG PS 1, 3% ECOG PS 2) experienced at least 1 severe symptom (≥7 on 0-10 scale). The most frequent severe baseline symptoms were pain (21% of patients), fatigue (17%), disturbed sleep (15%), drowsiness (12%), lack of appetite (10%), distress (10%), and pain in the abdomen (10%). Less than 2% of pts experienced severe immunotherapy-specific symptoms of rash, fever/chills and swelling of the hands and feet at baseline. Moderate-severe symptom-related interference (≥4 on 0-10 scale) was worst for activity (40% of patients), work (38%), and enjoyment of life (30%). For the EQ5D health utility dimensions, patients reported the most problems with pain or discomfort (75%) and fewest problems with self-care (10%). Worse composite symptom severity (P = 0.013) and worse problems with activity (P = 0.001) and pain (P = 0.012) were associated with worse and higher ECOG PS. Worse symptom severity (-0.54, P &lt; 0.001), symptom interference with activity- (-0.57, P &lt; 0.001) and mood- (-0.42, P &lt; 0.001) related functioning were associated inversely with superior health status. Worse symptom interference with activity-related functioning was linked with lower concurrent lymphocyte counts (P = 0.01), hemoglobin (P = 0.01) and serum albumin (P = 0.004) levels and higher platelet (P = 0.02) counts. Conclusions: Patients in early-phase trials that combine immunotherapy with other anti-cancer therapies may experience severe symptom burden and symptom interference with functioning, even at baseline prior to treatment start. Thus, it is important to baseline symptoms to fully understand the impact of combination treatments including checkpoint inhibitors in early-stage clinical trials.

Muscle assessment in brachial plexus injury: A reliability study

PurposeMotor outcome following a brachial plexus injury is frequently measured to evaluate the success of surgical interventions. We aimed to identify whether the manual muscle testing using the Medical Research Council (MRC) method in adults with C5/6/7 motor weakness was reliable and whether its results correlated with functional recovery. MethodsTwo experienced clinicians examined 30 adults with C5/6/7 weakness following proximal nerve injury. The examination included using the modified MRC to assess motor outcome in the upper limb. Kappa statistics were calculated to evaluate inter-tester reliability. Correlation coefficients was calculated to explore the correlation between the MRC and the Disabilities of the Arm Shoulder and Hand (DASH) score and each EQ5D domain. ResultsWe found that grades 3–5 of the modified and unmodified MRC motor rating scales have poor inter-rater reliability when assessing C5/6/7 innervated muscles in adults with a proximal nerve injury. The Deltoid Posterior and the Extensor Carpi Radialis Longus were the only muscles (using the modified MRC) to achieve a Kappa over 0.6 indicating substantial reliability. Higher combined MRC scores correlated significantly with a lower DASH and vice versa. Similarly, higher combined scores of MRC correlated significantly with a higher rating of overall health on the EQ5D VAS. ConclusionsThis study demonstrates that the MRC motor rating scale has poor inter-rater reliability when assessing C5/C6/C7 innervated muscles in adults following proximal nerve injury. Other methods of assessing motor outcome following proximal nerve injury need to be considered.

Association of a ≥2 point decrease of MoCA 1 year after noncardiac surgery with patient-important outcomes: a secondary analysis of the NeuroVISION cohort study (P2-12.001)

<h3>Objective:</h3> To evaluate whether, among ≥65 years old people, a ≥2 point decline in the Montreal Cognitive Assessment (MoCA) 1 year after noncardiac surgery is associated with patient-important outcomes. <h3>Background:</h3> NeuroVISION was an international prospective cohort study of 1114 patients, ≥65 years old, undergoing elective noncardiac surgery. In NeuroVISION, 30.3% of patients had a ≥2 point decrease in MoCA from baseline to 1 year after surgery. A ≥2 point MoCA decrease has been associated with cognitive decline based on formal neuropsychological testing. However, there is paucity of data on its association with patient-important outcomes. <h3>Design/Methods:</h3> NeuroVISION participants had MoCA, Lawton iADL, and EQ-5D questionnaires administered at baseline and 1 year after surgery. The iADL score was defined as the number of instrumental activities in which patients were independent (range 0–8). At 1 year participants also reported whether they had had any fall in the previous year. We performed multivariable regression analyses adjusting for age, sex, and baseline scores. <h3>Results:</h3> At baseline, the median iADL score of NeuroVISION participants was 8 (interquartile range 7–8). At 1-year, patients with ≥2 point MoCA decline reported a greater decline in iADL (adjusted beta coefficient −0.20, 95% CI −0.36 to −0.05; p=0.010) and in EQ-5D VAS scores (adjusted beta-coefficient −2.90, 95% CI −5.08 to −0.73; p=0.009) than patients without. 22.2% of the patents with <i>versus</i> 12.1% of patients without a ≥2 point MoCA decline lost independence in ≥1 iADL (adjusted odds ratio 1.93, 95% CI 1.35–2.76, p&lt;0.001). At 1 year, patients with a ≥2 point MoCA decline reported more frequently ≥1 fall (14.9% versus 10.2%), and a higher number of falls (adjusted incident risk ratio 1.76, 95% CI 1.28 – 2.40). <h3>Conclusions:</h3> In the large NeuroVISION cohort, a ≥2 point MoCA decline 1 year after noncardiac surgery was not only frequent but also associated with functional decline. <b>Disclosure:</b> Dr. Marcucci has nothing to disclose. The institution of Dr. Thirumala has received research support from University of Pittsburgh. Dr. Mrkobrada has nothing to disclose. The institution of Dr. Devereaux has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Trimedic. The institution of Dr. Devereaux has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. The institution of Dr. Devereaux has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Quidel. The institution of Dr. Devereaux has received research support from Abbott Diagnostics. The institution of Dr. Devereaux has received research support from CloudDX. The institution of Dr. Devereaux has received research support from Philips Healthcare. The institution of Dr. Devereaux has received research support from Roche Diagnostics. The institution of Dr. Devereaux has received research support from Siemens.

Health-Related Quality of Life and Healthcare Resource Use: Comparison of Patients with Bipolar I Disorder and Potentially Misdiagnosed Depression

AbstractBackgroundBipolar I disorder (BP-I) is associated with a high humanistic and economic burden. Evidence suggests that BP-I is often misdiagnosed as major depressive disorder (MDD), but the unmet needs associated with BP-I misdiagnosis are unknown. This study compares socioeconomic, healthcare-related quality of life (HRQoL), and healthcare resource utilization (HRU) burdens of participants diagnosed with BP-I vs participants who screened as probable for BP-I but were diagnosed only with MDD.MethodsUsing responses to the 2020 National Health and Wellness Survey, respondents were categorized into cohorts of potentially misdiagnosed BP-I (i.e., self-reported physician diagnosis of MDD but screened as probable BP-I [mBP-I]) or BP-I (i.e., self-reported physician diagnosis of BP-I, stratified by BP-I severity). Baseline characteristics were evaluated using bivariate analyses. HRQoL (Short Form-36v2 Health Survey [SF36v2] mental and physical component scores, EuroQol Five-Dimension Visual Analogue Scale [EQ-5D VAS]), HRU, were evaluated using multivariable analyses adjusting for key baseline differences.ResultsThere were 302 respondents in the mBP-I cohort and 818 in the BP-I cohort (mild=336, moderate=285, severe=197). Adults with mBP-I were similar in age and level of depression and anxiety to those with moderate and severe BP-I. With respect to HRQoL, the mBP-I cohort had significantly worse SF36v2 mental component scores and EQ-5D VAS scores vs the mild BP-I cohort (31.3 vs 40.3 [P&lt;.001] and 60.6 vs 69.4 [P=.01], respectively) and statistically similar scores vs the moderate BP-I cohort. SF36v2 physical component scores were statistically similar to those of the mild BP-I cohort. Respondents with mBP-I reported similar rates of provider (5.5 vs 6.1 [P=.63]) and ER visits (.34 vs .40 [P=.59]) to patients with mild BP-I (but significantly fewer hospitalizations: .08 vs .19 [P=.03]).ConclusionsRespondents with mBP-I exhibited similar HRQoL scores to those with mild to moderate BP-I. As expected for patients without a formal BP-I diagnosis, HRU was lower for mBP-I patients than moderate or severe BP-I, but comparable with mild BP-I. These results suggest that patients with potentially misdiagnosed BP-I may experience considerable HRQoL and HRU burdens akin to those of patients with mild to moderate BP-I.FundingAbbVie

Association between Inflammation and Thrombotic Pathway Link with Pathogenesis of Depression and Anxiety in SLE Patients.

As a complication of systemic lupus erythematosus (SLE), the neuropsychiatric form may manifest with neurological and psychiatric symptoms. Diagnosing neuropsychiatric SLE can be challenging due to the heterogeneity of this disease manifestation and the possibilities of investigation. This research aims to identify the possible associations between inflammation and thrombotic biomarkers alongside anxiety and/or depression manifestations in SLE patients. A group of 65 outpatients were investigated regarding the levels of depression, anxiety, disability, quality of life and other specific serum biomarkers linked with inflammation or coagulopathies. The results showed severe depression in eight participants, moderate depression in 22 (33.85%), and 26 (40%) subjects with mild depression. Anxiety was more prevalent within 64 participants (98.46%), while a degree of disability was reported by 52 participants (80%). Quality of life evaluated by EQ5D revealed a medium value of 1.57, and EQ5D VAS health medium value was 57.95 and was correlated with anxiety. A strong positive correlation between depression, anxiety and antibodies associated with anti-cardiolipin and anti beta2 glycoprotein I antibodies, lupus anticoagulant, ICAM-1, low C4 a and anti-ribosomal P antibodies were identified. These data results suggest that autoimmune/inflammatory and ischemic/thrombotic pathways could contribute to depression and anxiety as neuropsychiatric SLE manifestations.

Long-term patient-related quality of life outcomes and ICD-10 symptom rating (ISR) of patients with pyogenic vertebral osteomyelitis: What is the psychological impact of this life-threatening disease?

PurposeWe aimed to evaluate the long-term impact of the treatment of pyogenic vertebral osteomyelitis (VO) on functional outcomes and patients' quality of life (QoL) with a special focus on psychological well-being.MethodsA total of 156 patients with VO with a minimum clinical follow-up of 12 months were retrospectively identified and asked to participate. Patient-reported outcome measures were evaluated with the EuroQol five-dimension questionnaire (EQ-5D) and German Short-Form 36 (SF-36) outcome instruments as well as with an ICD-10 based symptom rating (ISR) and compared to normative data. Spine-specific outcomes were assessed with the Core Outcome Measure Index and the Oswestry disability index (ODI) or the Neck disability index (NDI), respectively.ResultsFrom n = 156 eligible patients, n = 129 patients could be contacted and n = 40 returned questionnaires, yielding a response rate of 31.0%. The mean time from hospital discharge to follow-up was 83.0 ± 3.8 (13–193) months. Spine-specific outcomes showed mild to moderate disability. The mean physical health component score of the SF-36 (37.1 ± 16.7), the mean mental health component score (38.2 ± 14.0) and the mean EQ-5D VAS rating (57.1 ± 21.5) were significantly lower in comparison with the scores of an age-matched reference population (all p < 0.05). The mean total score of the ISR was 0.53 ± 0.23. On average, the cohort did not cross the threshold of clinically relevant symptom burden on any subscale.ConclusionEven almost seven years on average after completed treatment of VO, patients report impaired QoL. Assessment of psychological disorders should be implemented in clinical practice and future prospective studies.