EuroQol Visual Analogue Scale Research Articles

Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial

BackgroundNon-cardiac chest pain is common and associated with increased anxiety and reduced health-related quality of life. Randomized controlled trials on psychological interventions for patients with non-cardiac chest pain have reported mixed results. Patients with non-cardiac chest pain are a heterogeneous group. Identifying sub-groups that could potentially benefit more (or less) from an intervention would be valuable knowledge. We have conducted a randomized controlled trial where internet-based cognitive behavioural therapy (iCBT) had effect on reducing cardiac anxiety and increasing health-related quality of life at 12-month follow-up. The aim of the present study was to explore potential effect modifiers of iCBT in patients with non-cardiac chest pain on cardiac anxiety and/or health related quality of life at 12-month follow-up.MethodsWe analysed data from our randomized, controlled trial where 161 patients with non-cardiac chest pain were included and randomized to either iCBT or a treatment as usual (control). Cardiac anxiety measured by the Cardiac Anxiety Questionnaire and health-related quality of life measured by the EuroQol Visual Analog Scale at 12 month follow-up were the primary outcomes. Four potential baseline characteristics where identified as potential effect modifiers by a theory-based approach: (1) depression measured by the Patient Health Questionnaire; (2) anxiety measured by the Body Sensations Questionnaire; (3) prior healthcare contacts measured by a self-developed question; and (4) chest pain frequency measured by a self-developed question. Each potential effect modifier was analysed in a linear regression model where cardiac anxiety and EQ-VAS scores at 12-month follow-up, separately, were used as dependent variables. The potential differential treatment effect for each effect modifier was assessed by the interaction term: effect modifier x treatment group.ResultsDepression symptoms at baseline predicted a differential treatment effect at 12-month follow-up on health-related quality of life in favor of the iCBT group (regression coefficient of the interaction term: -1.85 (CI -3.28 to -0.41), p = 0.01), but not on cardiac anxiety at 12-month follow-up. Fear of bodily symptoms, chest pain frequency and prior health care contacts at baseline did not predict a treatment effect on either health-related quality of life or cardiac anxiety.ConclusionsDepression symptoms at baseline predicted a positive treatment effect of iCBT on health-related quality of life in patients suffering from non-cardiac chest pain. This indicates that it is important to identify patients with non-cardiac chest pain and co-occurring depression symptoms given that they are particularly likely to benefit from iCBT.Trial registrationClinicalTrials.gov NCT03096925.

Structural Equation Model for Social Support and Quality of Life Among Individuals With Mental Health Disorders During the COVID-19 Pandemic.

In light of the COVID-19 pandemic, the distribution of social support for mental health problems has likely become unequal. Family- and community-based social support has been recognized as a promising approach for mental disorders; however, limited global frameworks have been applied to developing countries such as Vietnam. The aim of this study was to evaluate the quality of life and social support among patients with mental health disorders in Vietnam and to investigate the factors associated with quality of life among these patients. A cross-sectional study was conducted on 222 psychiatric patients in Hanoi from 2020 to 2022. A structured questionnaire was developed based on four standardized scales: Mental Well-Being-5 scale, Multidimensional Scale of Perceived Social Support, EuroQoL-visual analog scale (EQ-VAS), and EuroQoL-5 dimensions-5 levels (EQ-5D-5L) scale. Tobit regression was used to identify factors associated with the EQ-5D-5L and EQ-VAS scores. Structural equation modeling was applied to verify the relationship between quality of life and social support. The results showed that perceived support from family scored the highest compared to support from friends and significant others. Patients with depression reported the lowest quality of life and perceived social support. Structural equation modeling showed a root mean square error of approximation of 0.055 (90% CI 0.006-0.090), comparative fit index of 0.954, Tucker-Lewis index of 0.892, and standardized root mean squared error of 0.036 (P<.001). The hypothetical model indicated statistically significant correlations between EQ-VAS score and social support (P=.004), EQ-5D-5L and mental well-being (P<.001), and social support and mental well-being (P<.001). Critical deterioration of quality of life and inconsistency in social support for patients with mental illness were also recorded. There is a need to enhance social support and service delivery in Vietnam, focusing on occupation and quality of life. The correlations between social support, quality of life, and mental health issues suggest the potential of a clinical-social integrated intervention model of care.

Quality of Life and Bidirectional Gut-Brain Interactions in Irritable Bowel Syndrome From Adolescence to Adulthood

Reports on cross-sectional and longitudinal associations between health-related quality of life (HRQoL), psychological distress, and irritable bowel syndrome (IBS) in the adolescent and young adult general population are few. We aimed to describe cross-sectional associations between HRQoL and IBS in adolescence and young adulthood, and examine bidirectional gut-brain interactions in the transition from childhood to adulthood. We included 3391 subjects from a prospective birth cohort study, with data on IBS at 16 years of age and 24 years of age. IBS was assessed using the pediatric Rome III (16 years of age) and the adult Rome IV (24 years of age) diagnostic questionnaires. HRQoL and psychological distress were assessed through EQ-5D. Sex-adjusted logistic regression models were used to examine associations between overall HRQoL/psychological distress at 16 years of age and new-onset IBS at 24 years of age (brain-gut) and between IBS at 16 years of age and new-onset psychological distress at 24 years of age (gut-brain). In subjects with vs without IBS at 16 and 24 years of age, overall HRQoL (EQ visual analog scale, EQ-5D index value) was lower, and it was more common reporting problems in 4 of 5 EQ-5D dimensions (all P < .05). EQ-5D index value at 16 years of age was inversely associated (odds ratio [OR], 0.1, 95% confidence interval [CI], 0.01-0.6), and psychological distress at 16 years of age was positively associated (OR, 1.6; 95% CI, 1.2-2.3), with new-onset IBS at 24 years of age. Having any abdominal pain-related disorder of gut-brain interaction at 16 years of age was associated with new-onset psychological distress at 24 years of age (OR, 1.7; 95% CI, 1.2-2.5). Adolescents and young adults with IBS in the general population have impaired HRQoL. Bidirectional gut-brain interactions are relevant for symptom generation in abdominal pain-related disorders of gut-brain interaction, and for HRQoL impairment and psychological distress in the transition from childhood to adulthood.

The effect of body mass index and preoperative weight loss in people with obesity on postoperative outcomes to 6 months following total hip or knee arthroplasty: a retrospective study

BackgroundFew studies have investigated the association between obesity, preoperative weight loss and postoperative outcomes beyond 30- and 90-days post-arthroplasty. This study investigated whether body mass index (BMI) and preoperative weight loss in people with obesity predict postoperative complications and patient-reported outcomes 6 months following total knee or hip arthroplasty.MethodsTwo independent, prospectively collected datasets of people undergoing primary total knee or hip arthroplasty for osteoarthritis between January 2013 and June 2018 at two public hospitals were merged. First, the sample was grouped into BMI categories, < 35 kg/m2 and ≥ 35 kg/m2. Subgroup analysis was completed separately for hips and knees. Second, a sample of people with BMI ≥ 30 kg/m2 was stratified into participants who did or did not lose ≥ 5% of their baseline weight preoperatively. The presence of postoperative complications, Oxford Hip Score, Oxford Knee Score, EuroQol Visual Analogue Scale and patient-rated improvement 6 months post-surgery were compared using unadjusted and adjusted techniques.ResultsFrom 3,552 and 9,562 patients identified from the datasets, 1,337 were included in the analysis after merging. After adjustment for covariates, there was no difference in postoperative complication rate to 6 months post-surgery according to BMI category (OR 1.0, 95%CI 0.8–1.4, P = 0.8) or preoperative weight loss (OR 1.1, 95%CI 0.7–1.8, P = 0.7). There was no between-group difference according to BMI or preoperative weight change for any patient-reported outcomes 6 months post-surgery.ConclusionPreoperative BMI or a 5% reduction in preoperative BMI in people with obesity was not associated with postoperative outcomes to 6 months following total knee or hip arthroplasty.

Electrochemotherapy in plastic surgery: New perspectives from the pandemic experience in the treatment of advanced skin cancers in elderly and frail patients

Background: During the COVID-19 pandemic, most of the surgical units involved in the treatment of skin cancers could continue their activities, but the reevaluation of cases and the adaptation of the surgical approach, to limit access and hospital stays, proved to be mandatory. The study aims to demonstrate how the electrochemotherapy (ECT) approach guarantees a chance to keep on delivering comprehensive oncologic surgical treatment in a difficult and high-risk cohort of patients. Methods: We collected 35 elderly and frail patients affected by advanced and metastatic skin cancer who were unsuitable for a standard surgical approach. They were submitted to an ECT protocol, while evaluating the impact of ECT on health-related quality of life, using the EuroQol–five dimensions–three levels (EQ-5D-3L) instrument at baseline and after treatment. Results: A general improvement in health status was reported from the preoperative (mean 56.9) to the postoperative period (mean 63.7), according to the EuroQol–visual analog scale measure. The EuroQol–five dimensions descriptive system showed a reduction of the “patients reporting problems” from the baseline, in the domains for self-care (−27%), usual activities (−24%), pain/discomfort (−43%), and anxiety/depression (−11%). Conclusions: Rapid intervention, minimum hospitalization, palliation in selected cases, and postoperative management with telemedicine may represent the only option in the hands of a surgeon to treat advanced oncologic lesions in fragile patients, especially in a pandemic scenario. ECT can be considered a safe and effective procedure, well tolerated by most elderly and “high-risk” patients.

Effects of anxiety, depression, social support, and physical health status on the health-related quality of life of pregnant women in post-pandemic Korea: a cross-sectional study.

This study aimed to examine the effects of anxiety, depression, social support, and physical health status on the health-related quality of life of Korean pregnant women using Spilker's quality of life model. This was a cross-sectional study with a correlational design. The participants included 166 pregnant women who were recruited via convenience sampling at two healthcare centers in South Korea. Questionnaires were collected from April 22 to May 29, 2023, in two cities in South Korea. The EuroQol-5D-3L, General Anxiety Disorder-7, Patient Health Questionnaire-2, Perceived Social Support through Others Scale-8, and EuroQol visual analog scale were used to assess the study variables. The t-test, Pearson correlation coefficients, and multiple regression tests were conducted using IBM SPSS ver. 26.0. Statistically significant correlations were identified between the health-related quality of life of pregnant women and anxiety (r=.29, p<.001), depression (r=.31, p<.001), social support (r=-.34, p<.001), and physical health status (r=-.44, p<. 001). Physical health status (β=-.31, p<.001) and social support (β=-.21, p=.003) had the greatest effect on health-related quality of life (F=15.50, p<.001), with an explanatory power of 26.0%. The health-related quality of life of pregnant women was affected by social support and physical health status. This study demonstrated that physical health and social support promotion can improve the health-related quality of life of pregnant women. Healthcare providers should consider integrating physical health into social support interventions for pregnant women in the post-pandemic era.

Health-related quality of life in stroke survivors: a 5-year follow-up of The Fall Study of Gothenburg (FallsGOT)

BackgroundThere are limited data on long-term prevalence and predictors of health-related quality of life (HRQoL) in stroke survivors. Therefore, the aim was to describe the prevalence of impaired HRQoL, and to identify factors in acute stroke that are associated with impaired HRQoL, 5 years after stroke.MethodsThe 305 (60.5%) stroke survivors of the original 504 participants from The Fall Study of Gothenburg were invited to participate in a 5-year follow-up including assessment of HRQoL using the EuroQol 5 Dimensions 3 Levels questionnaire (EQ-5D-3L). To identify baseline predictors of impaired HRQoL, based on the EQ-5D-3L’s five dimensions, univariate and multivariate logistic regression analyses were performed.ResultsA total of 129 participants (42.3% of the survivors) completed the questionnaire at a median follow-up time of 58 months. At baseline, their mean age was 70.6 years, and they had a median NIHSS score of 1. The median (interquartile range [IQR]) EQ-5D-3L index score was 0.87 (0.71–0.93) and the median (IQR) EQ-visual analogue scale was 70 (49.8–88). In total, 102 (79%) participants were classified as having impaired HRQoL, stated primarily (among 68.5%) related to Pain/Discomfort. Higher age was identified as a predictor of impaired HRQoL related to Mobility (Odds ratio (OR) 1.05, 95% confidence interval (CI) 1.01–1.10) and Self-Care (OR 1.09, 95% CI 1.02–1.17), and longer hospital stay at baseline was identified as a predictor related to Mobility (OR 1.09, 95% CI 1.01–1.18), Self-Care (OR 1.10, 95% CI 1.02–1.18)) and Usual Activities. (OR 1.10, 95% CI 1.03–1.18).ConclusionAt 5 years after stroke, four out of five participants (79%) reported impaired HRQoL related to any of the five dimensions assessed by using the EQ-5D-3L. Most reported, impaired HRQoL was related to Pain/Discomfort. Higher age and longer hospital care period at index stroke were associated with impaired HRQoL. The findings could assist to identify individuals at high risk of low HRQoL, who might benefit from special attention and psychological support.

Psychometric Comparison of EQ-5D-Y, CHU-9D, and PedsQL 4.0 in Chinese Children and Adolescents With Functional Dyspepsia: A Multicenter Study

ObjectivesThis study aimed to assess and compare psychometric properties of the 3 health-related quality of life (HRQOL) instruments EQ-5D Youth version (EQ-5D-Y), Child Health Utility 9D (CHU-9D), and Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) in children and adolescents with functional dyspepsia (FD) in China. MethodsA consecutive sample of FD outpatients were recruited from 6 tertiary medical centers in Hangzhou. The patients self-completed the 3 instruments in random order. Their feasibility, acceptability, construct validity (convergent, divergent, and known-group validity), and sensitivity were assessed. Multiple linear regression was used for identifying HRQOL-associated factors. ResultsA total of 1100 patients (mean age, 9.2 years; girl, 56.8%) completed the survey with no missing responses. Ceiling effect was quite higher in EQ-5D-Y (60.9%) than CHU-9D (33.8%) and PedsQL 4.0 (1.0%). The EQ-5D-Y and CHU-9D utility scores and PedsQL 4.0 total score were highly correlated (|r| = 0.593-0.661), except for the EuroQol visual analog scale score (EQ-VAS). The intraclass correlation coefficient between the 2 utility scores was fair (0.542). Most conceptually similar dimensions among the 3 instruments showed moderate to high correlations (|r| > 0.3) as hypothesized. The difference was statistically significant for the 2 utility scores and PedsQL 4.0 total score in varied severity groups (P < .001), and PedsQL 4.0 total score had higher relative efficiency and effect size values. The child’s age, severity of FD symptoms, and their guardian’s education had significant impact on HRQOL (P < .001). ConclusionsEQ-5D-Y, CHU-9D, and PedsQL 4.0 demonstrated acceptable psychometric properties in Chinese children with FD. PedsQL 4.0 showed superior sensitivity and is recommended. EQ-5D-Y and CHU-9D utility scores were not interchangeable. The measurement properties of EQ-VAS need to be further explored.

Long-Term Quality of Life After Out-of-Hospital Cardiac Arrest

Allocating resources to increase survival after cardiac arrest requires survivors to have a good quality of life, but long-term data are lacking. To determine the quality of life of survivors of out-of-hospital cardiac arrest from 2001 to 2019. This survey study used the EuroQol Health Questionnaire, 12-Item Short Form Health Survey (SF-12), and Hospital Anxiety and Depression Scale (HADS) to assess the health-related quality of life of all adult survivors of out-of-hospital cardiac arrest included in the Danish Cardiac Arrest Registry between June 1, 2001, and August 31, 2019, who were alive in October 2020 (follow-up periods, 0-1, >1-2, >2-4, >4-6, >6-8, >8-10, >10-15, and >15-20 years since arrest). The survey was conducted from October 1, 2020, through May 31, 2021. All patients who experienced an out-of-hospital cardiac arrest. Self-reported health was measured using the EuroQol Health Questionnaire index (EQ index) score and EQ visual analog scale. Physical and mental health were measured using the SF-12, and anxiety and depression were measured using the HADS. Descriptive statistics were used for the analysis. Of 4545 survivors, 2552 (56.1%) completed the survey, with a median follow-up since their event of 5.5 years (IQR, 2.9-8.9 years). Age was comparable between responders and nonresponders (median [IQR], 67 [58-74] years vs 68 [56-78] years), and 2075 responders (81.3%) were men and 477 (18.7%) women (vs 1473 male [73.9%] and 520 female [26.1%] nonresponders). For the shortest follow-up (0-1 year) and longest follow-up (>15-20 years) groups, the median EQ index score was 0.9 (IQR, 0.7-1.0) and 0.9 (0.8-1.0), respectively. For all responders, the mean (SD) SF-12 physical health score was 43.3 (12.3) and SF-12 mental health score, 52.9 (8.3). All 3 scores were comparable to a general Danish reference population. Based on HADS scores, a low risk for anxiety was reported by 73.0% (54 of 74) of 0- to 1-year survivors vs 89.3% (100 of 112) of greater than 15- to 20-year survivors; for symptoms of depression, these proportions were 79.7% (n = 59) and 87.5% (n = 98), respectively. Health-related quality of life was similar in survivor groups across all follow-up periods. Among this survey study's responders, who comprised more than 50% of survivors of out-of-hospital cardiac arrest in Denmark, long-term health-related quality of life up to 20 years after their event was consistently high and comparable to that of the general population. These findings support resource allocation and efforts targeted to increasing survival after out-of-hospital cardiac arrest.

Blood Vessel Injuries of the Fingers: A Clinical Comparison of One- and Two-Arterial Blood Supply.

Traumatic finger injuries are very common in emergency medicine. When patients present with finger injuries, there is often damage to the vascular nerve bundles, which requires subsequent reconstruction. It is unknown if repairing a unilaterally injured artery affects patients' recovery in a well-perfused finger. This retrospective cohort study compares the clinical outcomes of 11 patients with one-vessel supply (mean age 48.3 years; 7 males, 4 females) to 14 patients with two-vessel supply (mean age 44.5 years; 8 males, 6 females). The patient outcomes were assessed using patient questionnaires (Disabilities of Arm, Shoulder, and Hand (DASH), European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L), and EuroQol visual analog scale (EQ-VAS)) and a clinical examination of hand function and imaging of circulatory efficiency. No significant changes were observed in the DASH, EQ-5D-5L, and EQ-VAS questionnaires. Clinical evaluation of hand function, measured by cold sensitivity, two-point discrimination, pain numerical analog scale, and grip strength also revealed no significant differences between cohorts. Blood flow measurements using thermal imaging revealed no effects on circulation in the affected digit. Collectively, the study finds reconstruction is not absolutely necessary when there is one intact digital artery as it is sufficient for healing and functional outcomes. We recommend finger artery reconstruction when both digital arteries are injured or if an immediate tension-free suture is possible.

Predicting whether patients will achieve minimal clinically important differences following hip or knee arthroplasty.

A substantial fraction of patients undergoing knee arthroplasty (KA) or hip arthroplasty (HA) do not achieve an improvement as high as the minimal clinically important difference (MCID), i.e. do not achieve a meaningful improvement. Using three patient-reported outcome measures (PROMs), our aim was: 1) to assess machine learning (ML), the simple pre-surgery PROM score, and logistic-regression (LR)-derived performance in their prediction of whether patients undergoing HA or KA achieve an improvement as high or higher than a calculated MCID; and 2) to test whether ML is able to outperform LR or pre-surgery PROM scores in predictive performance. MCIDs were derived using the change difference method in a sample of 1,843 HA and 1,546 KA patients. An artificial neural network, a gradient boosting machine, least absolute shrinkage and selection operator (LASSO) regression, ridge regression, elastic net, random forest, LR, and pre-surgery PROM scores were applied to predict MCID for the following PROMs: EuroQol five-dimension, five-level questionnaire (EQ-5D-5L), EQ visual analogue scale (EQ-VAS), Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS), and Knee injury and Osteoarthritis Outcome Score-Physical Function Short-form (KOOS-PS). Predictive performance of the best models per outcome ranged from 0.71 for HOOS-PS to 0.84 for EQ-VAS (HA sample). ML statistically significantly outperformed LR and pre-surgery PROM scores in two out of six cases. MCIDs can be predicted with reasonable performance. ML was able to outperform traditional methods, although only in a minority of cases.

Cognitive behavioral stress management is an effective intervention to relieve anxiety and depression, improve the quality of life in patients with cervical cancer.

Cognitive behavioral stress management (CBSM) modifies individuals' maladaptive cognition and improves their ability in managing stress. The present study was to inquire about the utility of CBSM in mental health and quality of life in patients with cervical cancer. Totally, 172 postoperative cervical cancer patients were randomly classified into CBSM (N=86) and normal care group (N=86) to receive 8-week CBSM and normal care, correspondingly. Self-rating anxiety/depression scale (SAS/SDS), EuroQol-5 dimensions (EQ-5D), EuroQol-visual analogue scale (EQ-VAS), and quality of life questionnaire-core 30 (QLQ-C30) scores were evaluated at discharge (M0), 1st month (M1), M3, and M6 after discharge. SAS scores at M6 (P=0.003), M1 (P=0.042), and M3 (P=0.010), and the proportion of patients with SAS-defined anxiety at M3 (P=0.040) and M6 (P=0.019) were reduced in CBSM group versus normal care group. SDS scores at M3 (P=0.020) and M6 (P=0.016), and the proportion of patients with SDS-defined depression at M6 (P=0.036) was descended in CBSM group versus normal care group. EQ-VAS score at M1 (P=0.044), M3 (P=0.014), and M6 (P=0.002) were increased, while EQ-5D score at M3 (P=0.030) was descended in CBSM group versus normal care group. Meanwhile, QLQ-C30 global health status score at M1 (P=0.046), M3 (P=0.037), and M6 (P=0.007), QLQ-C30 function score at M3 (P=0.033) and M6 (P=0.016) were ascended, but QLQ-C30 symptom score at M3 (P=0.042) was declined in CBSM group versus normal care group. CBSM is an effective intervention for decreasing anxiety and depression, and improving quality of life in patients with cervical cancer.

A prospective study on the efficacy of sequential treatment of technology Lipido-Colloid Impregnated with Silver and Technology Lipido-Colloid Nano-Oligosaccharide Factor in the management of venous leg ulcers.

Venous leg ulcers (VLUs) are associated with significant morbidity and poor quality of life (QOL). Compression therapy and wound dressing are the mainstay treatment options. Technology Lipido-Colloid Impregnated with Silver (TLC-Ag) reduces bacterial load and Technology Lipido-Colloid Nano-Oligosaccharide Factor (TLC-NOSF) reduces elevated matrix metalloproteinases and improve wound healing. However, evidence is scarce on the role of sequential therapy. This study aims to evaluate if sequential treatment with TLC-Ag and TLC-NOSF improves VLU wound healing and QOL. This is a prospective cohort study from May 2020 to October 2021 on patients with VLUs who received sequential therapy, consisting of 2 weeks of TLC-Ag followed by two-layer compression bandage (2LB) with TLC-NOSF until complete wound healing. Participants were followed-up with weekly dressing changes. Our primary outcomes were wound area reduction (WAR) and Pressure Ulcer Scale of Healing (PUSH) score. Our secondary outcomes were QOL measures. There were 28 patients with 57.1% males (n = 16) with a mean age of 65.3 years. Mean duration of VLU was 13.9 ± 11.7 weeks before the initiation of sequential therapy. Mean baseline wound area was 8.44 cm2. Median time to wound healing was 10 weeks. 57.1% of patients achieved complete wound closure at 3 months. There was significant WAR after 1 month (mean area 8.44-5.81 cm2, 31.2% decrease) and after 3 months (mean area 8.44-2.53 cm2, 70.0% decrease). Mean monthly WAR was 28.9%. PUSH score also decreased at 1 month (16.5% decrease, p < 0.001) and 3 months (63.3% decrease, p < 0.001) marks following the sequential therapy. EuroQol Visual Analog Scale (EQ-VAS) improved following sequential therapy (baseline: 69.0 ± 15.0, week 13: 80.2 ± 13.2, p < 0.001). Sequential therapy with TLC-Ag followed by TLC-NOSF and 2LB is feasible, with good wound healing and improvement in QOL of patients with VLUs.

Impact of Vutrisiran on Quality of Life and Physical Function in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy.

Hereditary transthyretin (ATTRv; v for variant) amyloidosis, also known as hATTR amyloidosis, is a progressive and fatal disease associated with rapid deterioration of physical function and patients' quality of life (QOL). Vutrisiran, a subcutaneously administered RNA interference (RNAi) therapeutic that reduces hepatic production of transthyretin, was assessed in patients with ATTRv amyloidosis with polyneuropathy in the pivotal HELIOS-A study. The phase 3 open-label HELIOS-A study investigated the efficacy and safety of vutrisiran in patients with ATTRv amyloidosis with polyneuropathy, compared with an external placebo group from the APOLLO study of the RNAi therapeutic patisiran. Measures of QOL and physical function were assessed. At month 18, vutrisiran improved Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score (least squares mean difference [LSMD] in change from baseline [CFB]: -21.0; p=1.84×10-10) and Norfolk QOL-DN domain scores, compared with external placebo. This benefit relative to external placebo was evident across all baseline polyneuropathy disability (PND) scores and most pronounced in patients with baseline PND scores I-II. Compared with external placebo, vutrisiran also demonstrated benefit in EuroQoL-Visual Analog Scale (EQ-VAS) score (LSMD in CFB: 13.7; nominal p=2.21×10-7), 10-m walk test (LSMD in CFB: 0.239m/s; p=1.21×10-7), Rasch-built Overall Disability Score (LSMD in CFB: 8.4; p=3.54×10-15), and modified body mass index (mBMI) (LSMD in CFB: 140.7; p=4.16×10-15) at month 18. Overall, Norfolk QOL-DN, EQ-VAS, and mBMI improved from pretreatment baseline with vutrisiran, whereas all measures worsened from baseline in the external placebo group. At month 18, Karnofsky Performance Status was stable/improved from baseline in 58.2/13.1% with vutrisiran versus 34.7/8.1% with external placebo. Vutrisiran treatment provided significant clinical benefits in multiple measures of QOL and physical function in patients with ATTRv amyloidosis with polyneuropathy. Benefits were most pronounced in patients with earlier-stage disease, highlighting the importance of early diagnosis and treatment. ClinicalTrials.gov: NCT03759379.

The effectiveness of a thermography-driven preventive foot care protocol on the recurrence of diabetic foot ulcers in low-medical resource settings: An open-labeled randomized controlled trial

BackgroundPlantar temperature monitoring, along with a comprehensive preventive foot care approach, is utilized to prevent recurrence of diabetic foot ulcers. However, there is a lack of standardized protocols for individuals with diabetic foot ulcer history in low-medical resource countries. ObjectiveThis study investigated the efficacy of nurse-led, thermographic-evaluation-guided foot care in preventing diabetic foot ulcer recurrence in a low-medical resource country. DesignSingle-blind, 1:1 allocation randomized controlled trial. SettingsTwo wound care facilities with wound care nurse specialists in Indonesia. Participants120 patients with a diabetic foot ulcer history. InterventionIn the intervention group, baseline risk assessment including smartphone thermography evaluation was performed. Personalized foot care and education were conducted monthly for participants whose thermographs showed increased foot lesion temperature at baseline risk assessment. The control group received usual care and education using a booklet at baseline. The follow-up period was six months. Main outcomeTime to recurrence was evaluated using Kaplan–Meier survival analysis, and between-group comparisons were performed using the log-rank test. Potential risk factors were incorporated into the multivariate Cox regression model. Secondary outcomes included quality of life (European Quality of Life 5 Dimensions 3 Level Version) and foot care behavior, were analyzed using Mixed Models for Repeated Measures at baseline, third, and sixth follow-up (3 and 6 months from baseline). Results120 participants (intervention 60, control 60) were randomized. The intervention group had a significantly lower recurrence rate than the control group (15% vs. 35%, p = 0.011) and a significant difference in time to ulceration (log-rank test, p = 0.009) after a 6-month follow-up period. Intervention care reduced the risk of diabetic foot ulcer recurrence by 59% (Hazard ratio 0.41, 95% confidence interval 0.18, 0.96, p = 0.039) in multivariate Cox regression analysis. On the third follow-up, total diabetic foot care behavior score (p < 0.001) was significantly improved by the intervention. On the sixth follow-up, mobility (p = 0.020), self-care (p = 0.023), pain/discomfort (p < 0.001), anxiety/depression (p = 0.016), EuroQol Visual Analogue Scale score (p = 0.002), and total diabetic foot care behavior score (p < 0.001) showed significant improvements in the intervention group. ConclusionsFoot care and personalized education delivered at a frequency based on the risk level assessed by thermography effectively reduced diabetic foot ulcer recurrence, and improved quality of life and foot care behaviors. Registration numberUMIN000039012. Tweetable abstractNurse-led diabetic foot care and education reduced diabetic foot ulcer recurrence in Indonesia.

Association of Depression and Cognitive Dysfunction With Patient-Centered Outcomes After Transcatheter Aortic Valve Replacement.

Depression and cognitive dysfunction (CD) are not routinely screened for in patients before transcatheter aortic valve replacement (TAVR) and their association with postprocedural outcomes is poorly understood. The objectives of this study are to determine the prevalence of depression and CD in patients with aortic stenosis undergoing TAVR and evaluate their association with mortality and quality of life. We analyzed a prospective, multicenter TAVR registry that systematically screened patients for preexisting depression and CD with the Patient Health Questionnaire-2 and Mini-Cog, respectively. The associations with mortality were assessed with Cox proportional hazard models and quality of life (Kansas City Cardiomyopathy Questionnaire and EuroQol visual analogue scale) were evaluated using multivariable ordinal regression models. A total of 884 patients were included; median follow-up was 2.88 years (interquartile range=1.2-3.7). At baseline, depression was observed in 19.6% and CD in 31.8%. In separate models, after adjustment, depression (HR, 1.45 [95% CI, 1.13-1.86]; P<0.01) and CD (HR, 1.27 [95% CI, 1.02-1.59]; P=0.04) were each associated with increased mortality. Combining depression and CD into a single model, mortality was greatest among those with both depression and CD (n=62; HR, 2.06 [CI, 1.44-2.96]; P<0.01). After adjustment, depression was associated with 6.6 (0.3-13.6) points lower on the Kansas City Cardiomyopathy Questionnaire 1-year post-TAVR and 6.7 (0.5-12.7) points lower on the EuroQol visual analogue scale. CD was only associated with lower EuroQol visual analogue scale. Depression and CD are common in patients that undergo TAVR and are associated with increased mortality and worse quality of life. Depression may be a modifiable therapeutic target to improve outcomes after TAVR.

Influence of preparedness on caregiver burden, depression, and quality of life in caregivers of people with disabilities.

Caregiver preparedness is defined as the perceived preparation of caregivers to care for the physical and emotional needs of the patient. This study investigated caregiver preparedness and its influences on caregiver burden, depression, and quality of life (QoL) in caregivers of individuals with disabilities. We conducted a multicenter cross-sectional survey study on caregivers caring for patients with disabilities. Sociodemographic characteristics were collected via questionnaires. The Preparedness for Caregiving Scale (PCS), Burden Interview (BI), Center for Epidemiologic Studies Depression Scale (CES-D), and EuroQol-Visual Analogue Scale (EQ-VAS) were administered. A total of 151 caregivers were enrolled. The mean age of caregivers was 53.7 ± 12.4 years, and 80.8% were female. The majority of participants were the main caregivers of patients with stroke, spinal cord injury, or traumatic brain injury. The mean PCS score was 2.1 ± 0.9, demonstrating significant relationships with BI (r = -0.512, p < 0.001), CES-D (r = -0.622, p < 0.001), and EQ-VAS (r = 0.441, p < 0.001). The CES-D was significantly associated with the PCS after controlling other variables. However, PCS did not show any correlation with the duration of caregiving or amount of time spent per day on caregiving. The clinical implications of this study are that higher caregiver preparedness is a predictor of less caregiver burden and depression, and better QoL. However, preparedness did not increase as the duration or time spent on caregiving was extended. Therefore, efforts to enhance the caregivers' preparedness are required to reduce caregiver burden and improve health outcomes for both caregivers and patients.

Factors Associated with Sleep Disorder among Korean Cancer Survivors: A Cross-Sectional Study.

The factors associated with sleep disorder are controversial. This study aimed to evaluate the prevalence of sleep disorder and the factors associated with sleep disorder among Korean adult cancer survivors. In this cross-sectional study, we collected data on sleep problems as outcome variables, and sociodemographic and clinical information as predictor variables from cancer survivors at two university-affiliated hospitals. Sleep disorder was defined as "a difficulty in sleep initiation or sleep maintenance at least 3 times a week that started after a cancer diagnosis." Multiple logistic regression analysis was performed with odds ratios (OR) and 95% confidence intervals (95% CI) to evaluate the factors associated with sleep disorder. The participants were 1,893 Korean cancer survivors (mean age, 58.1 years; females 68.0%). The prevalence of sleep disorder among male and female cancer survivors were 16.5% and 20.3%, respectively. An increase of age by 1-year was associated with a 1.04 (95% CI, 1.01-1.07; P=0.011) times higher risk of sleep disorder in males, while an inverse association was found in females. In female survivors, high fear of cancer recurrence (FCR), high anxiety, menopause, and high EuroQol Visual Analog Scale were associated with 1.45 (95% CI, 1.06-1.98; P=0.020), 1.78 (95% CI, 1.25-2.55; P=0.002), 1.70 (95% CI, 1.08-2.67; P=0.022), and 0.59 (95% CI, 0.43-0.82; P=0.002) times higher risk of sleep disorder, respectively. In male survivors, living with a spouse/or partner was associated with 57% (95% CI, 0.20-0.95; P=0.036) lower risk of sleep disorder. Analyses of cancer sites showed that the factors associated with sleep disorder varied across cancer sites. One-fifth of adult cancer survivors had sleep disorder. Age, menopausal status, FCR, anxiety, living with a spouse or partner, and quality of life were independently associated with sleep disorder in Korean cancer survivors.

Exploring the Impact of Medication Regimen Complexity on Health-Related Quality of Life in Patients with Multimorbidity

Background. Patients with multiple chronic conditions often have complex medication regimes which negatively impact their health-related quality of life (HRQoL), and there is limited evidence on this topic, particularly from the resource limiting set-up. Hence, this study is aimed at assessing the impact of medication regimen complexity on HRQoL in patients with multiple chronic conditions at a university hospital in Ethiopia. Method. A cross-sectional study was conducted on adult patients who had at least two long-term diseases and were already receiving medical therapy for the relevant disorders. The validated 65-item Medication Regimen Complexity Index (MRCI) and the EuroQol-5-Dimensions-5-Levels (EQ-5D-5L) instruments were used to assess MRC and HRQoL, respectively. The Welch test for unequal variance and Fisher’s exact test were used to assess the impact of different variables on HRQoL. Results. The study surveyed 416 participants, with a 98.3% response rate, the majority of whom were female (n = 267, 64.2%) and had two chronic conditions (n = 215, 51.7%). About 46.4% of patients were taking five or more medications, with a significantly higher proportion at the high regimen complexity level ( P = 0.001 ). The average MRCI score was 9.73 ± 3.38, indicating a high level of complexity. Patients with high MRCI scores reported more problems in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There was a negative correlation between the MRCI score and HRQoL as measured by the EQ-5D-Index (r = −0.175; P &lt; 0.001 ) and the EuroQol-Visual Analogue Scale score (r = −0.151; P = 0.002 ). In addition, there was a statistically significant difference in the mean EQ-5D-Index ( P = 0.001 ) and EQ-VAS scores ( P = 0.001 ) across low, medium, and high MRCI levels. Conclusion. Medication regimen complexity was prevalent among patients with multimorbidity and was associated with a decrease in HRQoL. Therefore, interventions addressing medication-related issues should be a priority to improve the well-being of patients with multiple chronic conditions.

Long-term sutimlimab improves quality of life for patients with cold agglutinin disease: CARDINAL 2-year follow-up

AbstractCold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia with a substantial burden on patient’s quality of life. CARDINAL was a 2-part, open-label, single-arm, multicenter phase 3 study evaluating the C1s inhibitor, sutimlimab, for treatment of CAD. Part A consisted of the pivotal study phase, with the part B extension phase assessing long-term safety and durability of response including patient-reported outcomes, which is the focus of this report. Altogether, 22 patients continued from part A to part B, majority female (68.2%) with a median age of 71.5 years (range, 55-85). Throughout treatment, score improvement on the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue scale exceeded a predefined, group-level clinically important change of ≥5 points vs baseline, with a mean (standard error [SE]) change of 11.7 (3.7) points at week 135. The 12-Item Short Form Health Survey physical and mental component scores remained above baseline, with week 123 mean change (SE) exceeding clinically important changes of 3.9 for physical and 2.8 for mental component scores at 4.7 (2.8) and 3.8 (5.7) points, respectively. EuroQol Visual Analogue Scale, scoring patients’ self-rated health, also remained above baseline with a change of 17.1 (5.6) points at week 135. Patient Global Impression of (fatigue) Severity improved vs baseline, corroborating FACIT-Fatigue scores. Patient Global Impression of Change indicated a reduction in perceived disease burden. Data from CARDINAL part B support sustained alleviation of CAD disease burden after long-term treatment with sutimlimab over 2 years, returning toward baseline upon treatment cessation. This trial was registered at www.clinicaltrials.gov as #NCT03347396.