EuroQol-5 Dimensions Research Articles

Association between public health measures and the public's well-being during the pandemic: a nationwide Japanese study.

The present study aimed to investigate the association between the duration of anti-coronavirus disease 2019 (COVID-19) public health measures and the quality of life (QOL) and mental health of the Japanese public. The present, nationwide, questionnaire-based, cross-sectional study was conducted in September 2021. The cumulative duration in days of anti-COVID-19 public health measures was calculated for each prefecture in the year prior to the survey, and multilevel linear regression analysis was used to determine the association between the duration of these measures and any impairment of QOL or mental health as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) and the Kessler scale (K6). The study included 28 118 participants from all 47 prefectures. The median duration of public health measures of all prefectures was 179days. Long-term duration of the measures (181-365days) was not independently associated with low EQ-5D-5L (P=0.128) or high K6 (P=0.179) scores after adjusting for potential confounders (Graphical Abstract). Prolongation of the measures may not be associated with a deterioration in the QOL or mental health of the Japanese public. Nevertheless, it may be necessary to reconsider long-term public health measures given the potential they may have to cause collateral damage, such as socioeconomic one.

Factors Associated With Health-Related Quality of Life Among Community-Dwelling Older Adults Without Social Participation in Japan: A Cross-Sectional Study

This study aimed to identify the characteristics of community-dwelling older adults who exhibited high health-related quality of life (HRQOL) without social participation. This cross-sectional observational study collected data using a mailed questionnaire. This study included 1,183 community-dwelling older adults aged ≥65 years who lived in Japan. HRQOL was assessed via the EuroQol 5-Dimensions 5-Levels (EQ-5D-5L). Multivariate analysis was performed; full health status (EQ-5D-5L = 1) was used as the objective variable, and socio-demographic, lifestyle, and health-related variables were used as the explanatory variables. Driving (OR = 3.846), economic situation (1.938), purpose in life (2.211), primary illness (0.398), low physical function (0.051), and depressive symptoms (0.288) were associated with higher HRQOL among community-dwelling older adults without social participation. This exploratory study suggests the possibility of promoting and improving the HRQOL of community-dwelling older adults without social participation by strengthening specific factors among them.

MyMS: An Interface for Patient-Reported Outcomes for Finnish Individuals With Multiple Sclerosis.

Patient-generated data are a cornerstone of individualized multiple sclerosis (MS) treatment. MyMS, an interface for patient-reported outcomes (PROs) was developed by the Finnish MS Register to enable systematic collection of PROs. MyMS collects data on demographics, lifestyle factors, disease-related factors, and validated questionnaires, including the Quality of Life Questionnaire (15D), the Multiple Sclerosis Impact Scale (MSIS-29), and the Fatigue Severity Scale (FSS). At the end of 2020, the patient-reported Expanded Disability Status Scale (PREDSS), the EuroQOL-5 Dimension (EQ-5D), the Fatigue Scale for Motor and Cognitive Functions (FSMC), and the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) were added. As of January 1, 2023, 1201 individuals with MS (79% female) have added data to MyMS. Of the validated PRO measures (PROMs), the 15D, MSIS-29, and FSS are the most used. The mean PREDSS score is 3.0 and median disease duration is 6.4 years. According to the existing PROMs, patients report mildly compromised quality of life and problems with fatigue and cognition. The patient interface of the Finnish MS Register consists of data from 17 of 21 counties with well-being services. The interface is used by 10% of Finnish individuals with MS. The addition of the PREDSS, EQ-5D, FSMC, and MSNQ to the interface has increased health care professional and patient interest in the use of PROMs. We suggest that PROs should be integrated into electronic health records to improve shared decision-making and diminish documentation burden.

Health utilities of patients with epilepsy in a Canadian population.

Health state utilities are required to obtain quality adjusted life years, a common metric that informs clinical decision-making at individual, group, and health policy levels. Health state utilities are different from health-related quality of life, and their distribution across patients with epilepsy, as well as the factors that impact them, have not been studied in depth. We aimed to describe the distribution of health state utilities in people with epilepsy and the impact of different combinations of clinical and demographic factors on health state evaluation. We performed a retrospective analysis of patients' data prospectively collected in the Calgary Comprehensive Epilepsy Program registry. Patient-reported health state utilities were measured using the 5-level EuroQol 5-Dimension scale (EQ-5D-5L) completed at their initial assessment. EQ-5D-5L index scores were derived via the time trade-off approach based on Canadian norms, and their distribution across different health states and patient characteristics was obtained. The Tobit regression model was used to evaluate the determinants of EQ-5D-5L index scores. Of 1446 patients included in this analysis, 724 (50.5%) were female. The median (interquartile range) Canada-normed EQ-5D-5L index score was .87 (.71-.91). Patients with significantly lower health utilities were more likely to be female (p = .008), to be older (p = .034), to be unmarried (p = .013), to have failed to achieve 1-year seizure freedom (p < .001), to have no postsecondary education (p = .028), to be depressed (p < .001), to have antiseizure medication side effects (p = .001), to be unemployed (p < .001), and to be unable to drive (p < .001). A look-up table of health utilities based on combinations of clinical-demographic characteristics was produced. Health utility estimates for combinations of different health states in people with epilepsy attending specialty clinics are now available. These can help guide clinical decision-making in routine clinical practice, economic evaluations of treatment interventions, and health care policies.

Effectiveness of a package of community-based mental healthcare services to address perinatal mental disorders in Bangladesh: A cluster-randomized controlled trial

BackgroundPerinatal mental disorders of women have an impact on their pregnancy and their child’s brain development across low and middle-income countries. However, to address this issue, there are no specific guidelines for community-level service providers in Bangladesh. Therefore, we aimed to develop a community-based mental healthcare (CBMHC) service package and test its effectiveness in reducing depression, anxiety, and stress among mothers during the perinatal period. MethodsA cluster-randomized controlled trial (cRCT) was applied to test the CBMHC package in 2017 and 2018. It was provided to one group of mothers along with routine maternal care while another group received only routine maternal care. Paired sample t-test was applied to assess mean changes at baseline and endline in the Depression, Anxiety, and Stress Scales-21 (DASS-21) and EuroQol-5 Dimension and 3 Level (EQ5D3L) scales. A linear mixed-effects model was used to assess the relationship between the DASS-21 score and EQ5D3L. Results1,215 participants were enrolled, including 605 in the intervention group and 610 in the control group. Measures of depression, anxiety, and stress were significantly decreased in both groups. Reduction in the levels of stress, as measured by changes in the stress score, were significantly greater in the intervention than in the control group (diff: 1.2, 95% CI: 0.1, 2.2). The EQ5D3L index improved significantly, 0.02 units more at endline in the intervention group than in the control group (diff: 0.02, 95% CI: 0.007, 0.03). The levels of mobility, usual activities, pain or discomfort, depression, and anxiety improved by 1.4%, 7.6%, 4.4%, 2.6%, and 0.4% more, respectively, in the intervention group compared to the control groups. These improvements were statistically significant. The DASS-21 score was negatively and significantly correlated with both the EQ-5D3L index and the Visual Analogue Scale (VAS) score for the intervention group as well as for the usual care group, indicating that EQ5D3L improved when common mental disorders decreased. ConclusionAlthough the improvements were modest, a CBMHC service package was effective in reducing perinatal levels of stress among Bangladeshi rural women. Trial registrationClinicalTrials.gov ID: NCT03678415

Efficacy, Safety, and Economic Feasibility of Dokhwalgisaeng-Tang for Degenerative Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor Blinded, Controlled Trial.

Knee osteoarthritis (KOA) is one of the most prevalent degenerative joint diseases worldwide. The herbal decoction, Dokhwalgisaeng-tang (DHGST), has been commonly used in East Asia to treat osteoarthritis. However, there is insufficient evidence to draw clear conclusions concerning its effectiveness and safety for patients with KOA. We aim to determine the efficacy, safety, and economic feasibility of DHGST compared with Celecoxib, an oral COX-2 inhibitor, for patients with degenerative KOA. This multicenter, randomized, noninferiority trial, involving 160 participants who will be randomized using block randomization with 1:1 allocation, will compare DHGST and Celecoxib. The total trial period is 24weeks after random allocation, comprising 12weeks of treatment and 12weeks of follow-up. Participants with KOA will be administered 200 mg of DHGST (treatment group) or Celecoxib capsules (control group) for 12weeks. Efficacy and safety evaluations will be conducted at weeks 0, 4, 8, and 12, and 24. The primary outcome measurement is the Korean Western Ontario McMaster score at week 12. Changes in pain intensity using a 100 mm visual analog scale, changes in quality of life using a EuroQol 5-dimension 5-level self-report survey, and patient satisfaction will also be measured to evaluate effectiveness between the two groups. A trial-based economic feasibility evaluation will be conducted to analyze treatment cost-effectiveness from societal and healthcare system perspectives. Drug safety will be assessed through adverse reactions and laboratory test findings. This trial protocol has the following limitations. Applying a double-dummy design is not possible, as the tablet and granule forms can easily be distinguished visually, and achieving participant blinding is challenging. The trial findings are intended to inform participants, physicians, and other stakeholders in determining whether DHGST could be used as an alternative therapeutic option for KOA. KCT0008424 (Clinical Research Information Service of the Republic of Korea), registered on 12 May 2023.

Predictors of death without prior appropriate therapy in ICD recipients: the comorbidities, frailty and functional status (COMFFORT study)

ObjectiveMost patients who have an implantable cardioverter-defibrillator (ICD) implant do not receive life-prolonging therapy from it. Little research has been undertaken to determine which patients benefit the least from ICD...

Exploration of preferences among people with COPD to inform resource allocation: a discrete choice experiment study

IntroductionTreatment options for chronic obstructive pulmonary disease (COPD) are numerous but adherence remains a key challenge. We performed a discrete choice experiment (DCE) of patients’ preferences in accessing care for...

TV-46000, A Long-Acting Subcutaneous Antipsychotic Agent, Demonstrated Improved Patient-Centered Outcomes in Patients with Schizophrenia.

TV46000 is a long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone approved for the treatment of schizophrenia in adults. The RISE study (NCT03503318) compared TV-46000 once monthly (q1m) and once every 2months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. The SHINE study (NCT03893825) evaluated the long-term safety, tolerability, and effectiveness of TV-46000 in patients who completed RISE without relapse (rollover; placebo rollover randomized [1:1] to q1m or q2m; TV-46000 rollover continued assigned treatment) or who were newly recruited (de novo; randomized [1:1] to q1m or q2m after oral stabilization). Patient-centered outcomes included the Schizophrenia Quality of Life Scale (SQLS), the 5-Level EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L), the Personal and Social Performance Scale (PSP), and the Drug Attitudes Inventory 10-item version (DAI-10). In RISE, SQLS least-squares mean changes (SE) improved to last assessment (LA) for TV-46000 q1m (-4.15 [1.03]) and q2m (-3.28 [1.06]) but worsened for placebo (1.75 [1.07]; P<0.001 for both). PSP, EQ5D-5L, and DAI-10 showed similar trends. In SHINE, SQLS decreased (improved) at LA for both TV-46000 q1m (-0.43 [0.98]) and q2m (-2.16 [0.98]); reductions were observed in the de novo (q2m only) and placebo rollover (q1m and q2m) cohorts, but not for the TV46000 rollover cohort. Results for PSP, EQ5D-5L, and DAI-10 were consistent with those reported in the RISE study. Improvements in patient-centered outcomes were observed across cohorts, with the largest improvements observed for patients who began TV-46000 during SHINE (ie, de novo and placebo rollover cohorts), while gains made during RISE were minimally improved or maintained in the TV-46000 rollover cohort, indicating the benefit of uninterrupted TV-46000 treatment. These data support the effectiveness of TV-46000 to improve patient-centered outcomes in patients with schizophrenia.

Effectiveness of In-Home, Augmented Reality-Based Telerehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.

New digital technology-based rehabilitation may be a viable option for patients after anterior cruciate ligament reconstruction (ACLR), with advantages such as easy access to treatment and learning as well as cost-effectiveness. To investigate the effects of an augmented reality (AR)-based, telerehabilitation system in patients after ACLR compared with a brochure-based rehabilitation program in terms of patient-reported outcomes and functional performance measures. Randomized controlled trial; Level of evidence, 2. This was a multicenter, assessor-blinded study. Enrolled participants were allocated randomly to either the intervention group, who underwent AR-based telerehabilitation system, or to the control group, who underwent a brochure-based rehabilitation program with a self-log. Both groups performed the same postoperative rehabilitation exercise protocol. Subjective knee function was assessed using the International Knee Documentation Committee (IKDC) as the primary outcome; secondary outcomes were a numeric rating scale for pain, the EuroQol 5-Dimension 5-Level, isometric knee strength, range of motion, and the single-leg hop test. The intervention group also completed a satisfaction survey. Follow-up was conducted at 2, 6, 12, and 24 weeks postoperatively. A total of 28 patients were enrolled in each group; 1 patient in the control group was lost to follow-up. Patients in both groups demonstrated improvement on all outcomes over time. There were no significant between-group differences in the IKDC score from baseline to 12 weeks postoperatively. The intervention group saw a greater increase in the relative isometric strength of the quadriceps on the involved limb at 6, 12, and 24 weeks postoperatively (P < .05 for all). No significant group differences were observed in the remaining secondary outcomes. Study findings indicated that patients who underwent AR-based telerehabilitation in the early rehabilitation phase after ACLR demonstrated similar improvements as those who followed a brochure-based rehabilitation program and had a quicker recovery of knee extensor strength. NCT04513327 (ClinicalTrials.gov identifier).

A Comparative Study between Single-Level Oblique Lumbar Interbody Fusion with Transforaminal Lumbar Interbody Fusion for Lumbar Adjacent Segment Disease.

Background/Objectives: Various surgical approaches have been proposed for treating adjacent segment disease (ASD) after lumbar fusion. However, studies using oblique lumbar interbody fusion (OLIF) to treat ASD are lacking. The current study assessed the postoperative outcomes of single-level OLIF for ASD, comparing the results with those for patients undergoing transforaminal lumbar interbody fusion (TLIF). Methods: Patients who underwent single-level OLIF or TLIF for lumbar ASD were retrospectively included. Clinical outcomes, that is, the results of assessments using the Euroqol 5-Dimension quality of life scale (EQ-5D), the Oswestry Disability Index, and the visual analog scale, were evaluated. Radiologic parameters, including disc height (DH), segmental lordosis (SL), segmental coronal angle (SCA), lumbar lordosis, and pelvic incidence-lumbar lordosis mismatch, were also assessed. Results: A total of 65 patients were enrolled: 32 in the OLIF group and 33 in the TLIF group. The median follow-up time was 24.0 months in both groups. The clinical outcomes and radiologic parameters significantly improved in both groups postoperatively. According to intergroup comparisons, the OLIF group had significantly less blood loss and superior improvement in radiologic parameters (DH, SL, and SCA) whereas the TLIF group had significantly shorter operation times. For the OLIF patients who did not undergo posterior decompression, the operation time was similar to that of the TLIF group, but the surgical blood loss and length of hospital stay were significantly reduced compared with the TLIF group. Conclusions: Compared with TLIF, OLIF provides similar clinical outcomes, leads to less surgical blood loss, and has superior radiologic parameters; however, the operation time is significantly longer. OLIF without posterior decompression may be a superior option to TLIF for certain patients.

Impact of the Disc Vacuum Phenomenon on Surgical Outcomes in Lumbar Spinal Stenosis: A Comparative Study between Endoscopic Decompression and Minimally Invasive Oblique Lateral Interbody Fusion.

Objective: This study investigated the influence of the vacuum phenomenon (VP) on surgical outcomes in patients with lumbar spinal stenosis, comparing minimally invasive oblique lateral interbody fusion (MIS OLIF) and endoscopic decompression. Methods: A cohort of 110 patients diagnosed with lumbar spinal stenosis underwent either endoscopic decompression or MIS OLIF. Patients were classified into two groups based on the presence or absence of the VP on preoperative CT scans, non-VP (n = 42) and VP (n = 68). Radiologic and clinical outcomes, including back and leg pain assessed using the visual analogue scale (VAS), the Oswestry Disability Index (ODI), and the EuroQol-5 Dimension (Eq5D), were compared pre- and postoperatively over a 2-year follow-up period. Results: Preoperatively, the VP group exhibited significantly greater leg pain (p = 0.010), while no significant differences were observed in back pain or the ODI between the groups. In the non-VP group, decompression and fusion yielded similar outcomes, with decompression showing a better ODI score at 1 month (p = 0.018). In contrast, in the VP group, patients who underwent fusion showed significantly improved long-term leg pain outcomes compared to those who underwent decompression at both 1-year (p = 0.042) and 2-year (p = 0.017) follow-ups. Conclusions: The VP may indicate segmental instability and may play a role in the persistence of radiculopathy. Fusion surgery appears to offer better long-term relief in patients with the VP, whereas decompression alone is a viable option in non-VP cases. These findings suggest that the VP may be a useful factor in guiding surgical decision-making.

Relationships Between Various Parameters of Prolonged Sedentary Bouts and Health-Related Quality of Life (HRQOL) in Patients on Chronic Hemodialysis: A Cross-Sectional Study.

Previous studies have revealed that sedentary behavior, including quantitative and qualitative parameters, was associated with health-related quality of life (HRQOL) in patients on chronic hemodialysis. The present study examined the relationships between various parameters of prolonged sedentary bouts on non-hemodialysis daysand HRQOLin patients on chronic hemodialysis. A total of 110 patients (47.2%) on chronic hemodialysis (64 men and 46 women, aged 71.4 ± 11.2 years) among 233 patients, who were outpatients at a hospital in Hiroshima prefecture, Japan, were enrolled in this cross-sectional study. Prolonged sedentary bouts were evaluated using a tri-accelerometer, i.e., sedentary behavior (minutes), median sedentary bouts (minutes), maximum sedentary bouts (minutes), sedentary bouts (bouts and minutes/bout), and prolonged sedentary bouts(≥5, ≥10, ≥30, and ≥60minutes; bouts and minutes/bout). HRQOL was assessed using EuroQol 5-Dimension (EQ-5D). The EQ-5D score was 0.755 ± 0.216. All prolonged sedentary parameters, except for sedentary bouts (bouts), correlated with HRQOL, and higher correlation coefficients were observed between sedentary behavior (minutes) and HRQOL (r = -0.416) and between maximum sedentary bouts (minutes) and HRQOL (r = -0.436) than between other parameters. These parameters were also identified as factors affecting HRQOL, even after adjustments for confounding factors. In summary, sedentary behavior (minutes) and maximum sedentary bouts (minutes) on non-hemodialysis days, which may be representative of quantitative parameters for sedentary behavior, correlated with HRQOL in patients on chronic hemodialysis.

A clinical randomized controlled study on the psycho-cardiological therapy for patients with coronary atherosclerosis disease

Objective: To explore the prognosis efficacy of psycho-cardiological therapy and management on patients with coronary atherosclerosis disease (CAD). Methods: This was a clinical randomized controlled study. This study included inpatients with CAD at the cardiology department in Beijing Anzhen Hospital, Capital Medical University from August 2021 to January 2024. The patients enrolled in this study were asked for basic information, and received measurements for depression, anxiety, sleep quality and living quality by the scales of Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder scale-7 (GAD-7), Athens Insomnia Scale (AIS), EuroQol 5-dimension 5-level (EQ-5D-5L) respectively. The patients were randomly grouped into a regular treatment group and a psycho-cardiological treatment group which included WeChat management or antidepressant/antianxiety medical therapy according to the situation. After the patients discharging from hospital for 2, 4, 12, 24, 48, 72, and 96 weeks, professional cardiovascular doctors would follow up by telephone, WeChat, and outpatient department, including scales (2-48 weeks), and cardiac events (2-96 weeks). Kaplan-Meier survival curve and multivariate Cox proportional hazards model were used for analyzing the association between psycho-cardiological treatment and cardiac events. Results: This study recruited a total of 552 patients with CAD, aged 61.0(54.0, 67.0) years, and 379 (68.7%) were male. There were 279(50.5%) in the regular treatment group and 273(49.5%) in the psycho-cardiological treatment group. After treatment for 4, 12 and 48 weeks, the PHQ-9 score in psycho-cardiological was significantly lower than the regular treatment group; After treatment for 12 weeks, the EQ-5D-5L effective value in psycho-cardiological group was higher than the regular treatment group; After treatment for 2, 4, 12, 24 and 48 weeks, the EQ-5D-5L VAS score in psycho-cardiological group was higher than the regular therapy group (all P<0.05). The Kaplan-Meier survival curve showed that, during the different follow-up periods, the rate of cardiac events in psycho-cardiological treatment group was lower than regular treatment group (log-rank P<0.001). The multivariate Cox proportional hazards model adjusted the factor of age, the psycho-cardiological treatment contributed to reducing the cardiac events rate by 80.3% (HR=0.197, 95%CI: 0.067-0.582, P=0.003). Conclusion: Psycho-cardiological treatment is beneficial for improving psychological stress, living quality, and reducing cardiac events, and helps to improve prognosis and psycho-cardiological rehabilitation in CAD patients.

Integrative Korean medicine treatment for low back pain with radiculopathy caused by Bertolotti syndrome: A CARE-compliant article and retrospective review of medical records.

Bertolotti syndrome (BS) is characterized by radiculopathy caused by structural anomalies. Despite the structural deformity, conservative treatment is predominantly recommended due to surgery-related complications. Because of the diagnosis complexity, the incidence and contributing factors of BS, remain controversial. We report the case of a patient with BS who was treated with integrative Korean medicine (IKM). Moreover, we evaluated the epidemiological characteristics of lumbosacral transitional vertebrae (LSTV) from medical records of patients diagnosed with LSTV at 4 different medical clinics of Korean medicine. A 33-year-old male patient with low back pain and severe radiculopathy was diagnosed with BS (Castellvi Type II) on magnetic resonance imaging at a local orthopedic clinic. Additionally, the medical records of patients with BS who had been treated with IKM in 4 different institutions of Korean medicine were analyzed, and the characteristics of patients suffering from BS were identified. The patient underwent IKM treatment for 40 days as an inpatient. The patient's condition was assessed using the Euroqol 5-dimension index and Oswestry Disability Index, and symptom severity was measured using the Numeric Rating Scale. IKM was effective in improving pain and functional disability without causing any adverse effects. In a retrospective review of medical records, the study identified symptom trends reported by patients with LSTV. IKM demonstrates potential efficacy in BS management, with notable trends in LSTV-related symptomatology warranting further investigation.

Association of Novel Ventricular Assist Device Self-report Measures With Overall Health-Related Quality of Life.

Few study authors examined factors influencing health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) implantation. The purpose of this study was to determine whether 5 novel self-report measures and other variables were significantly associated with overall HRQOL at 3 months after LVAD surgery. Patients were recruited between October 26, 2016, and February 29, 2020, from 12 US sites. Data were collected before LVAD implantation and at 3 months post LVAD implantation. Overall HRQOL measures included the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score (OSS) and EuroQol 5-dimension- 3L visual analog scale. Potential factors associated with overall HRQOL included 5 novel self-report measures (Satisfaction with Treatment, Being Bothered by VAD Self-care and Limitations, VAD Team Communication, Self-efficacy regarding VAD Self-care, and Stigma), and demographic and clinical characteristics. Statistics included regression analyses. Of enrollees, 242 completed self-report measures at baseline, and 142 completed measures 3 months postoperatively. Patients were 55 ± 13 years old, with 21% female, 24% non-White, 39% high school or lower educated, and 47% destination therapy. Using the KCCQ-12 OSS, higher Satisfaction with Treatment was associated with a higher KCCQ-12 OSS; Being Bothered by VAD Self-care and Limitations, high school or lower education, chest incision pain, cardiac dysrhythmias within 3 postoperative months, and peripheral edema were associated with a worse KCCQ-12 OSS (R2 = 0.524). Factors associated with a worse 3-month EuroQol 5-dimension-3L visual analog scale were female sex, adverse events within 3 months post implantation (cardiac dysrhythmias, bleeding, and venous thrombosis), and chest incision pain (R2 = 0.229). No factors were associated with a higher EuroQol 5-dimension-3L visual analog scale score at 3 months. Two novel measures, demographics, postimplantation adverse events, and symptoms were associated with post-LVAD KCCQ-12 OSS early after surgery.

Randomized open-label study of second-generation antipsychotics for the treatment of schizophrenia: 104-week final results of the JUMPs study assessing treatment discontinuation, remission, and social functioning

BackgroundWe report the final results of treatment with aripiprazole, blonanserin, and paliperidone from the Japan Useful Medication Program for Schizophrenia (JUMPs), a 104-week naturalistic study.MethodsJUMPs was an open-label, three-arm, randomized, parallel-group, 104-week study. Patients aged ≥ 20 years with schizophrenia requiring antipsychotic treatment or a switch from previous therapy were enrolled. The primary endpoint was treatment discontinuation rate over 104 weeks. Secondary endpoints included remission rate, Personal and Social Performance (PSP), safety, Positive and Negative Syndrome Scale (PANSS), and quality of life (QOL; EuroQol-5 dimension).ResultsIn total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). Treatment discontinuation rates (aripiprazole, 80.5%; blonanserin, 81.2%; paliperidone, 71.4%) were not significantly different (p = 0.2385) among the treatment groups at 104 weeks; comparable outcomes were observed for endpoints, including remission (42.9%, 46.7%, and 45.8%), PANSS, and safety. In the overall cohort, while the improvement in the PSP total score at Week 104 was not significantly different from baseline, a significant improvement (p < 0.05) in QOL and total PANSS scores (including all subscales) was observed at Week 104 compared with baseline. Multivariable analysis identified a shorter disease duration and a higher chlorpromazine-equivalent antipsychotic dosage level (≥ 1000 mg) before switching to monotherapy as predictors of treatment discontinuation.ConclusionsThe 104-week treatment outcomes were comparable between groups; the overall trend of improvement in remission rate, safety, and QOL suggests the importance of continued treatment.Clinical trial registrationUMIN-Clinical Trials Registry UMIN000007942 (public release date: 14/05/2012).

Pre-operative EQ-5D-5L is a strong predictor of meaningful improvement in quality of life following primary total knee arthroplasty.

Predicting which patients will get meaningful benefit from total knee arthroplasty remains a challenge. Our aim was to assess if pre-operative quality of life (EuroQol 5-Dimension, 5-Level instrument; EQ-5D-5L) can predict the likelihood of a patient achieving post-operative improvement in patient-reported outcome measures (PROMS) following total knee arthroplasty to a level of minimum clinically-important difference (MCID). This was a retrospective analysis of a prospective cohort of total knee arthroplasty patients. EQ-5D-5L and Oxford Knee Scores (OKS) were recorded pre-operatively, 6months and 2years post-operatively. The primary outcome measure was achievement of MCID in EQ-5D-5L at 2years. Multivariable analysis through multiple logistic regression was performed to assess for independent predictors of MCID in EQ-5D-5L, OKS and re-operation at 2years. 400 patients were included, with 57% female and a mean age of 66years. Pre-operative EQ-5D-5L was the only strong predictor of post-operative EQ-5D-5L MCID (OR: 0.016, CI: 0.004 to 0.06), when adjusted for age, gender, BMI, ASA, smoking status and surgeon grade. The optimal pre-operative EQ-5D-5L threshold was found to be 0.53 by Youden's index, with a sensitivity of 70% and specificity of 73%. Pre-operative quality of life as measured by EQ-5D-5L is a strong independent predictor of reaching MCID in EQ-5D-5L following total knee arthroplasty. Those with worse EQ-5D-5L are more likely to gain meaningful benefit from knee arthroplasty.

Chair-based yoga programme for older adults with multimorbidity: RCT with embedded economic and process evaluations.

Older adults with multimorbidity experience impaired health-related quality of life and treatment burden. Yoga has the potential to improve several aspects of health and well-being. The British Wheel of Yoga's Gentle Years Yoga© programme was developed specifically for older adults, including those with chronic conditions. A pilot trial demonstrated feasibility of using Gentle Years Yoga in this population, but there was limited evidence of its effectiveness and cost-effectiveness. To determine the effectiveness and cost-effectiveness of the Gentle Years Yoga programme in addition to usual care versus usual care alone in older adults with multimorbidity. Pragmatic, multisite, individually randomised controlled trial with embedded economic and process evaluations. Participants were recruited from 15 general practices in England and Wales from July 2019 with final follow-up in October 2022. Community-dwelling adults aged 65 years and over with multimorbidity, defined as two or more chronic health conditions from a predefined list. All participants continued with any usual care provided by primary, secondary, community and social services. The intervention group was offered a 12-week programme of Gentle Years Yoga. The primary outcome and end point were health-related quality of life measured using the EuroQol-5 Dimensions, five-level version utility index score over 12 months. Secondary outcomes were health-related quality of life, depression, anxiety, loneliness, incidence of falls, adverse events and healthcare resource use. The mean age of the 454 randomised participants was 73.5 years; 60.6% were female, and participants had a median of three chronic conditions. The primary analysis included 422 participants (intervention, n = 227 of 240, 94.6%; usual care, n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EuroQol-5 Dimensions, five-level version utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% confidence interval 0.712 to 0.747) and for usual care it was 0.710 [95% confidence interval (CI) 0.691 to 0.729], with an adjusted mean difference of 0.020 favouring intervention (95% CI -0.006 to 0.045, p = 0.14). No statistically significant differences were observed in secondary outcomes, except for the pain items of the Patient-Reported Outcomes Measurement Information System-29. No serious, related adverse events were reported. The intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 quality-adjusted life-years per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. The intervention was acceptable to participants, with seven courses delivered face to face and 12 online. Self-reported outcome data raise the potential for bias in an unblinded trial. The COVID-19 pandemic affected recruitment, follow-up and the mode of intervention delivery. Although the Gentle Years Yoga programme was not associated with any statistically significant benefits in terms of health-related quality of life, mental health, loneliness or falls, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Longer-term cost-effectiveness modelling and identifying subgroups of people who are most likely to benefit from this type of intervention. This trial is registered as ISRCTN13567538. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/94/36) and is published in full in Health Technology Assessment; Vol. 28, No. 53. See the NIHR Funding and Awards website for further award information.

Comparison of quality-adjusted life years (QALYs) of end-stage patients with gastrointestinal cancers receiving conventional therapies with recipients of supportive-palliative care package.

This study aimed to compare the quality-adjusted life years (QALYs) of patients with gastrointestinal (GI) cancer after receiving palliative and supportive care. Conducted at Firoozgar Hospital in Tehran, Iran, this observational study included 500 end-stage gastrointestinal cancer patients. The study divided these patients into two groups: 250 utilized palliative medicine services, while the remaining 250 did not. The study compared the conditions of patients in both groups. Among those receiving palliative care, only 21% underwent chemotherapy, significantly lower than the 55% in the non-palliative care group (P < 0.001). Hospital mortality rates were considerably reduced in the palliative care group, with 115 patients (46%) compared to 200 patients (80%) in the non-palliative group (P < 0.001). The average hospital stay for patients receiving palliative care was 25.11 ± 5.12 days, significantly shorter than the 96.42 ± 14.15 days in the non-palliative group (P < 0.001). The EuroQol 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire scores showed that patients in the palliative care group experienced significantly better outcomes in pain and mood symptoms, but no significant difference was observed in physical function compared to the non-palliative group. Palliative medicine is recommended for gastrointestinal cancer patients as it can significantly reduce unnecessary hospital referrals and length of hospitalization.