EuroQol Visual Analogue Scale Scores Research Articles

Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant

BackgroundPatients with treatment-resistant depression (TRD) report significant deficits in physical and mental health, as well as severely impaired health-related quality of life (HRQoL) and functioning. Esketamine effectively enhances the daily functioning in these patients while also improving their depressive symptoms. This study assessed HRQoL and health status of patients with TRD, who were treated with esketamine nasal spray and an oral antidepressant (ESK + AD) vs. placebo nasal spray and an AD (AD + PBO).MethodsData from TRANSFORM-2, a phase 3, randomized, double-blind, short-term flexibly dosed study, were analyzed. Patients (aged 18–64 years) with TRD were included. The outcome assessments included the European Quality of Life Group, Five Dimension, Five Level (EQ-5D-5L), EQ-Visual Analogue Scale (EQ-VAS), and Sheehan Disability Scale (SDS). The health status index (HSI) was calculated using EQ-5D-5L scores.ResultsThe full analysis set included 223 patients (ESK + AD: 114; AD + PBO: 109; mean [SD] age: 45.7 [11.89]). At Day 28, a lower percentage of patients reported impairment in the ESK + AD vs. AD + PBO group in all five EQ-5D-5L dimensions: mobility (10.6% vs. 25.0%), self-care (13.5% vs. 32.0%), usual activities (51.9% vs. 72.0%), pain/discomfort (35.6% vs. 54.0%), and anxiety/depression (69.2% vs. 78.0%). The mean (SD) change from baseline in HSI at Day 28 was 0.310 (0.219) for ESK + AD and 0.235 (0.252) for AD + PBO, with a higher score reflecting better levels of health. The mean (SD) change from baseline in EQ-VAS score at Day 28 was greater in ESK + AD (31.1 [25.67]) vs. AD + PBO (22.1 [26.43]). The mean (SD) change in the SDS total score from baseline to Day 28 also favored ESK + AD (-13.6 [8.31]) vs. AD + PBO (-9.4 [8.43]).ConclusionsGreater improvements in HRQoL and health status were observed among patients with TRD treated with ESK + AD vs. AD + PBO.Trial registrationClinicalTrials.gov Identifier: NCT02418585.

Machine learning and patient-reported outcomes for longitudinal monitoring of disease progression in metastatic breast cancer: a multicenter, retrospective analysis

BackgroundAssessments of health-related quality of life (HRQoL) play an important role in transition to palliative care for women with metastatic breast cancer. We developed machine learning (ML) algorithms to analyse longitudinal HRQoL data and identify patients who may benefit from palliative care due to disease progression. MethodsWe recruited patients from two institutions and administered the EuroQoL Visual Analog Scale (EQ-VAS) via an online platform over a 6-month period. We trained a regularised regression algorithm using 10-fold cross-validation to determine if a patient was at high or low risk of disease progression based on changes in the EQ-VAS scores using data of one institution and validated the performance on data of the other institution. Progression-free survival (PFS) was the end-point. We conducted Kaplan-Meier and Cox regression analysis adjusted for clinical risk factors. ResultsOf 179 patients, 98 (54.7%) had progressive disease after a median follow-up of 14weeks. Using EQ-VAS scores collected at weeks 1–6 to predict disease progression at week 12, in the validation set (n = 63), PFS was significantly lower in the intelligent EQ-VAS high-risk versus low-risk group: median PFS 7 versus 10weeks, log-rank P < 0.038). Intelligent EQ-VAS had the strongest association with PFS (adjusted hazard ratio 2.69, 95% confidence interval 1.17–6.18, P = 0.02). ConclusionML algorithms can analyse changes in longitudinal HRQoL data to identify patients with disease progression earlier than standard follow-up methods. Intelligent EQ-VAS scores were identified as independent prognostic factor. Future studies may validate these results to remotely monitor patients.

Golf participation after rotator cuff repair: functional outcomes, rate of return and factors associated with return to play.

Golf is a popular sport involving overhead activity and engagement of the rotator cuff (RC). This study aimed to determine to what level golfers were able to return to golf following RC repair, the barriers to them returning to golf and factors associated with their failure to return to golf. Patients preoperatively identifying as golfers undergoing RC repair at the study centre from 2012 to 2020 were retrospectively followed up with to assess their golf-playing status, performance and frequency of play and functional and quality of life (QoL) outcomes. Forty-seven golfers (40 men [85.1%] and 7 women [14.9%]) with a mean age of 56.8 years met the inclusion criteria, and 80.1% were followed up with at a mean of 27.1 months postoperatively. Twenty-nine patients (76.3%) had returned to golf with a mean handicap change of +1.0 (P=0.291). Golf frequency decreased from a mean of 1.8 rounds per week preinjury to 1.5 rounds per week postoperatively (P=0.052). The EuroQol 5-dimension 5-level (EQ-5D-5L) index and visual analog scale (EQ-VAS) score were significantly greater in those returning to golf (P=0.024 and P=0.002), although functional outcome measures were not significantly different. The primary barriers to return were ipsilateral shoulder dysfunction (78%) and loss of the habit of play (22%). Golfers were likely (76%) to return to golf following RC repair, including mostly to their premorbid performance level with little residual symptomatology. Return to golf was associated with a greater QoL. Persistent subjective shoulder dysfunction (78%) was the most common barrier to returning to golf. Level of evidence: Level IV.

Primary knee arthroplasty for osteoarthritis restores patients' health-related quality of life to normal population levels.

This study investigates whether primary knee arthroplasty (KA) restores health-related quality of life (HRQoL) to levels expected in the general population. This retrospective case-control study compared HRQoL data from two sources: patients undergoing primary KA in a university-teaching hospital (2013 to 2019), and the Health Survey for England (HSE; 2010 to 2012). Patient-level data from the HSE were used to represent the general population. Propensity score matching was used to balance covariates and facilitate group comparisons. A propensity score was estimated using logistic regression based upon the covariates sex, age, and BMI. Two matched cohorts with 3,029 patients each were obtained for the adjusted analyses (median age 70.3 (interquartile range (IQR) 64 to 77); number of female patients 3,233 (53.4%); median BMI 29.7 kg/m2 (IQR 26.5 to 33.7)). HRQoL was measured using the three-level version of the EuroQol five-dimension questionnaire (EQ-5D-3L), and summarized using the Index and EuroQol visual analogue scale (EQ-VAS) scores. Patients awaiting KA had significantly lower EQ-5D-3L Index scores than the general population (median 0.620 (IQR 0.16 to 0.69) vs median 0.796 (IQR 0.69 to 1.00); p < 0.001). By one year postoperatively, the median EQ-5D-3L Index score improved significantly in the KA cohort (mean change 0.32 (SD 0.33); p < 0.001), and demonstrated no clinically relevant differences when compared to the general population (median 0.796 (IQR 0.69 to 1.00) vs median 0.796 (IQR 0.69 to 1.00)). Compared to the general population cohort, the postoperative EQ-VAS was significantly higher in the KA cohort (p < 0.001). Subgroup comparisons demonstrated that older age groups had statistically better EQ-VAS scores than matched peers in the general population. Patients awaiting KA for osteoarthritis had significantly poorer HRQoL than the general population. However, within one year of surgery, primary KA restored HRQoL to levels expected for the patient's age-, BMI-, and sex-matched peers.

Lateral lumbar interbody fusion (LLIF) reduces total lifetime cost compared with posterior lumbar interbody fusion (PLIF) for single-level lumbar spinal fusion surgery: a cost-utility analysis in Thailand

BackgroundLumbar interbody fusion techniques treat degenerative lumbar diseases effectively. Minimally invasive lateral lumbar interbody fusion (LLIF) decreases soft tissue disruption and accelerates recovery better than standard open posterior lumbar interbody fusion (PLIF). However, the material cost of LLIF is high, especially in Thailand. The cost-effectiveness of LLIF and PLIF in developing countries is unclear. This study compared the cost-utility and clinical outcomes of LLIF and PLIF in Thailand.MethodsData from patients with lumbar spondylosis who underwent single-level LLIF and PLIF between 2014 and 2020 were retrospectively reviewed. Preoperative and 1-year follow-up EuroQol-5D-5L and healthcare costs were collected. A cost-utility analysis with a lifetime time horizon was performed using a societal perspective. Outcomes are reported as the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-year (QALY) gained. A Thai willingness-to-pay threshold of 5003 US dollars (USD) per QALY gained was used.ResultsThe 136 enrolled patients had a mean age of 62.26 ± 11.66 years. Fifty-nine patients underwent LLIF, while 77 underwent PLIF. The PLIF group experienced greater estimated blood loss (458.96 vs 167.03 ml; P < 0.001), but the LLIF group had a longer operative time (222.80 vs 194.62 min; P = 0.007). One year postoperatively, the groups’ Oswestry Disability Index and EuroQol-Visual Analog Scale scores were improved without statistical significance. The PLIF group had a significantly better utility score than the LLIF group (0.89 vs 0.84; P = 0.023). LLIF’s total lifetime cost was less than that of PLIF (30,124 and 33,003 USD). Relative to PLIF, LLIF was not cost-effective according to the Thai willingness-to-pay threshold, with an ICER of 19,359 USD per QALY gained.ConclusionsLLIF demonstrated lower total lifetime cost from a societal perspective. Regard to our data, at the 1-year follow-up, the improvement in patient quality of life was less with LLIF than with PLIF. Additionally, economic evaluation modeling based on the context of Thailand showed that LLIF was not cost-effective compared with PLIF. A strategy that facilitates the selection of patients for LLIF is required to optimize patient benefits.

EARLY PROMS FOLLOWING TOTAL HIP ARTHROPLASTY WITH AND WITHOUT COMPUTER NAVIGATION SYSTEM: A STUDY FROM THE AUSTRALIAN NATIONAL JOINT REPLACEMENT REGISTRY

Total hip arthroplasty (THA) is an effective treatment for symptomatic hip osteoarthritis (OA). While computer-navigation technologies in total knee arthroplasty show survivorship advantages and are widely used, comparable applications within THA show far lower utilisation. Using national registry data, this study compared patient reported outcome measures (PROMs) in patients who underwent THA with and without computer navigation.Data from Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) PROMs program included all primary THA procedures performed for OA up to 31 December 2020. Procedures using the Intellijoint HIP® navigation system were identified and compared to procedures using other computer navigation systems or conventional instrumentation only. Changes in PROM scores between pre-operative and 6-month post-operative time points were analysed using multiple regression model, adjusting for pre-operative score, patient age, gender, ASA score, BMI, surgical approach, and hospital type.There were 65 primary THA procedures that used the Intellijoint HIP® system, 90 procedures used other types of computer navigation, and the remaining 5,284 primary THA procedures used conventional instrumentation. The estimated mean changes in the EuroQol visual analogue scale (EQ VAS) score and Oxford Hip score did not differ significantly when Intellijoint® was compared to conventional instruments (estimated differences of 2.4, 95% CI [-1.7, 6.5], p = 0.245, and −0.5, 95% CI [-2.5, 1.4], p = 0.592, respectively). The proportion of patients who were satisfied with their procedure was also similar when Intellijoint® was compared to conventional instruments (rate ratio 1.06, 95% CI [0.97, 1.16], p = 0.227).The preliminary data demonstrate no significant difference in PROMs when comparing the Intellijoint HIP® THA navigation system with both other navigation systems and conventional instrumentation for primary THAs performed for OA. Level of evidence: III (National registry analysis)

P468 Association of uncontrolled disease with quality of life and healthcare resource utilisation in Ulcerative Colitis patients treated with advanced therapy in the United States

Abstract Background Advanced therapies (AT; i.e., biologics, biosimilars, Janus kinase inhibitors) are used to treat patients with moderate to severe ulcerative colitis (UC) after inadequate response to conventional treatments; yet some patients continue to have uncontrolled disease. We examined the association between uncontrolled UC and health-related quality of life (HRQoL) and healthcare resource utilisation (HCRU) in a real-world clinical setting. Methods The analysis was conducted using secondary data from the Adelphi UC Disease Specific Programme™,1 a cross-sectional, retrospective survey of gastroenterologists and patients, from January 2020-March 2021. Gastroenterologists provided clinical characteristics and HCRU information for 5-7 consecutive UC patients, while EuroQol-5-dimensions (EQ-5D), EQ-visual analogue scale (EQ-VAS), short inflammatory bowel disease questionnaire (SIBDQ) and work productivity and impairment questionnaire (WPAI) were patient-administered to capture HRQoL status. Patients receiving AT for ≥6 weeks were classified as uncontrolled if: physician assessment was currently moderate or severe, they had ≥2 flares in the last 12 months, or currently had ≥3 symptoms. Patient characteristics and outcomes were compared using T-test and Fisher’s exact test. Multivariable linear regressions estimating the association between UC control status and HRQoL were adjusted for age, ethnicity, disease duration and severity at diagnosis. Results Of the 236 patients included in the sample, 57.6% had uncontrolled disease and were likely to be non-White (27.9% v 14.0% controlled; p=0.01). Although healthcare provider consultations were similar in both groups, uncontrolled patients had more radiological imaging (mean 1.9 v 1.3, p&amp;lt;0.01), endoscopies (mean 0.6 v 0.3, p&amp;lt;0.01) and hospitalisations (mean 0.2 v 0.1, p=0.01) in the last 12 months compared to controlled patients. Uncontrolled patients reported significantly lower (worse) total and subdomain SIBDQ scores (total: 47.2 v 59.6; systemic symptoms: 4.8 v 5.9; bowel symptoms: 4.7 v 6.1; emotional function: 4.6 v 5.6; social function: 4.8 v 6.2; all p&amp;lt;0.01; Table 3). EQ-5D (0.85 v 0.92, p&amp;lt;0.01), EQ-VAS scores (76.3 v 86.1, p&amp;lt;0.01) and activity impairment (29.2 v 16.7, p&amp;lt;0.01) were significantly worse in the uncontrolled group. Conclusion A substantial number of UC patients continue to have uncontrolled disease and high unmet need despite AT use. These patients experience poorer HRQoL and contribute a significant burden on healthcare resources. Study findings highlight the need for innovative therapeutic options that would further reduce disease burden for patients and the healthcare system. 1. Anderson P et al. Curr Med Res Opin 2008;24;3063–72.

Patient-Reported Outcomes During and After Hepatitis C Virus Direct-Acting Antiviral Treatment Among People Who Inject Drugs

ObjectivesPeople who inject drugs (PWID) are at a high risk of hepatitis C virus (HCV) infection. HCV cure is associated with improved patient-reported outcomes (PROs), but there are little data among PWID. This study aimed to assess the change in PROs during and after HCV direct-acting antiviral (DAA) treatment. MethodsThis analysis used data from 2 clinical trials of DAA treatment in PWID. PROs assessed included health-related quality of life, social functioning, psychological distress, housing, and employment. Generalized estimating equations and group-based trajectory modeling were used to assess changes in PROs over time. ResultsNo significant changes in the 3-level version of EQ-5D scores, EQ visual analogue scale scores, social functioning, psychological distress, and housing were observed over the 108-week study period. There was a significant increase in the proportion of participants employed (18% [95% confidence interval (CI) 12%-23%] at baseline to 28% [95% CI 19%-36%] at the end of the study). Participants were more likely to be employed at 24 weeks and 108 weeks after commencing treatment. Having stable housing increased the odds of being employed (odds ratio 1.70; 95% CI 1.00-2.90). The group-based trajectory modeling demonstrated that most outcomes remained stable during and after DAA treatment. ConclusionsAlthough no significant improvement was identified in health-related quality of life after HCV DAA treatment, there was a modest but significant increase in employment during study follow-up. The study findings support the need for multifaceted models of HCV care for PWID addressing a range of issues beyond HCV treatment to improve quality of life.

Depression and anxiety in persons with Von Willebrand disease.

We assessed sociodemographic and clinical characteristics associated with depression and anxiety in individuals with Von Willebrand disease (VWD) aged ≥12years. The study collected data on patients' sociodemographic, joint problems and health-related quality of life (HRQoL) using EQ-5D-3L, 8-item patient health questionnaire for depression and 7-item Generalized Anxiety Disorder Questionnaire from participants in seven geographically diverse US haemophilia treatment centres. Analyses included 77 participants. The rates of depression and anxiety were 63.6% and 58.3%, respectively. Persons with low VWF displayed higher rates of depression (86.7%) or anxiety (69.2%) compared to those with VWD (58.1%, p=.04 for depression, and 55.9%, p=.38 for anxiety). Logistic regression analyses demonstrated that having joint problems (odds ratio [OR]=6.3, confidence interval [CI]=2.0-20.1) was the most important variable associated with depression, followed by being single, divorced, widowed, or separated in adult participants or parents of participants age<18 years (OR=7.0, CI=1.7-29.0. The most important variable associated with anxiety was being single or lacking a partner (OR=10.8, CI=2.5-47.5), followed by age 12-17years old (OR=6.7, CI=1.6-26.9), or having worse health compared to 3-months ago (OR=12.3, CI=1.3-116.2). Mean covariates adjusted EQ visual analogue scale score was significantly lower among persons with depression (68.77±3.15 vs. 77.58±4.24, p=.03) than those without depression. Our study revealed concerning levels of depression and anxiety in this VWD sample. Lack of social support was determined an important factor associated with depression and anxiety in this sample. Mental health screening is critical in VWD clinical evaluation and care.

Impact of COVID-19 and effects of BNT162b2 on patient-reported outcomes: quality of life, symptoms, and work productivity among US adult outpatients

BackgroundAlthough there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health-Related Quality of Life (HRQoL) and Work Productivity and Impairment (WPAI) prior to and one month following infection between individuals vaccinated with BNT162b2 and those unvaccinated.MethodsSubjects with ≥ 1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022 and 04/30/2022. Socio-demographics, clinical characteristics and vaccination status were evaluated. Self-reported symptoms, HRQoL, and WPAI outcomes were assessed using questionnaires and validated instruments (EQ-5D-5L, WPAI-GH) across acute COVID time points from pre-COVID to Week 4, and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for several covariates. Effect size (ES) of Cohen’s d was calculated to quantify the magnitude of outcome changes within and between vaccination groups.ResultsThe study population included 430 subjects: 197 unvaccinated and 233 vaccinated with BNT162b2. Mean (SD) age was 42.4 years (14.3), 76.0% were female, 38.8% reported prior infection and 24.2% at least one comorbidity. Statistically significant differences in outcomes were observed compared with baseline and between groups. The EQ-Visual analogue scale scores and Utility Index dropped in both cohorts at Day 3 and increased by Week 4 but did not return to pre-COVID levels. The mean changes were statistically lower in the BNT162b2 cohort at Day 3 and Week 4. The BNT162b2 cohort reported lower prevalence and fewer symptoms at index date and Week 4. At Week 1, COVID-19 had a large impact on all WPAI-GH domains: the work productivity time loss among unvaccinated and vaccinated was 65.0% and 53.8%, and the mean activity impairment was 50.2% and 43.9%, respectively. Except for absenteeism at Week 4, the BNT162b2 cohort was associated with statistically significant less worsening in all WPAI-GH scores at both Week 1 and 4.ConclusionsCOVID-19 negatively impacted HRQoL and work productivity among mildly symptomatic outpatients. Compared with unvaccinated, those vaccinated with BNT162b2 were less impacted by COVID-19 infection and recovered faster.

Patient-reported outcomes for arthroscopic resection of the distal clavicle with concomitant arthroscopic subacromial decompression at a 2-year follow-up: a prospective study of 131 consecutive patients.

Arthroscopic distal clavicle resection (DCR) can be offered to patients with persistent acromioclavicular (AC) joint pain who do not benefit from conservative treatment. The aim of this study was to evaluate the outcome of combined arthroscopic DCR and concomitant arthroscopic subacromial decompression in a large consecutive and prospective cohort using patient-reported outcomes. Consecutive patients were identified from our online database and included based on their primary treatment code. All patients had a diagnosis of shoulder impingement syndrome and persistent AC joint pain resistant to at least six months of conservative treatment. The outcomes from the combined intervention were evaluated by patients through the Oxford Shoulder Score (OSS) questionnaire and EuroQol 5-Dimension 3-Level questionnaire, including a EuroQol visual analog scale score collected preoperatively and at a 2-year follow-up. Patient-reported satisfaction with the procedure was reported at the follow-up. Subgroups were formed to further evaluate outcome based on preoperative OSS (low, moderate, high) and age. 131 patients (75%) were available for analysis at the 2-year follow-up. Sixty seven patients (51%) were female and the mean age was 51 years (range 19-82). A mean OSS change of 12.1 (95% confidence interval, 10.3-14.0; P<.001) was observed within the entire study group. In both the low and moderate preoperative-OSS (pre-OSS) groups, a mean change of 14 was found with no difference between groups (P=.971). A mean change of 7 was found in the high pre-OSS group, which differed from both the moderate (P<.001) and low (P=.036) pre-OSS groups. A significant change in EuroQol 5-Dimension and EuroQol visual analog scale was observed within all the pre-OSS groups, and 107 patients (82%) replied that they were satisfied or very satisfied with their outcome of surgery at the follow-up. Patients who suffer from persistent AC joint pain largely benefit from arthroscopic DCR with arthroscopic subacromial decompression through relief of symptoms and improved quality of life, including those with a high self-reported and preoperative level of shoulder function.

The effect of a pay-for-performance program on health-related quality of life for patients with hepatitis in Taiwan

PurposeChronic viral hepatitis is a major global public health problem. The guidelines suggest the long-term performance of regular ongoing liver examinations to monitor liver inflammation and screen for hepatocellular carcinoma. However, the effects of regular liver examinations on health-related quality of life (HRQoL) have not been adequately evaluated. Therefore, this study evaluated the effects of regular ongoing examinations on the quality of life of patients with hepatitis.MethodsA cross-sectional study was conducted from October to December 2016 in four hospitals in northern Taiwan. A hepatitis pay-for-performance (P4P) program was launched in 2010 to ensure that hepatitis patients have regular ongoing liver examinations. The study group consisted of patients who joined and stayed in the program for more than one year. The study assessed HRQoL utilizing the five-level version of the EuroQol-5 Dimension (EQ-5D-5L) and the EuroQoL visual analog scale (EQ-VAS). The responses for the EQ-5D-5L in hepatitis patients were transformed into the EQ-5D index according to the Taiwanese population’s value set. Sociodemographic and clinical characteristics were collected by questionnaire, and descriptive statistics were presented. A two-part model and generalized linear model with a Poisson distribution and a log link function, respectively, were used to examine the associations of the EQ-5D index and EQ-VAS score with participation in the hepatitis P4P program. We applied propensity score weighting with inverse probability weighting to control for selection bias.ResultsIn all, 508 patients (aged 57.6 ± 11.6 years; 60.8% male) were enrolled in this study. The mean (standard deviation, SD) reported EQ-5D index and EQ-VAS scores were 0.93 (0.12) and 75.1 (13.8), and the median (interquartile range, IQR) values were 1 (0.108) and 80 (15), respectively. The study group had a moderately significantly higher EQ-VAS score (mean ratio = 1.029, P < 0.001). However, the differences in the EQ-5D index scores between the study and control groups were not significant.ConclusionPatients with hepatitis partially benefited from receiving hepatitis P4P in Taiwan, which featured regular ongoing liver examinations, in that their EQ-VAS scores were enhanced but not their EQ-5D index scores.

Disease burden in patients with acute hepatic porphyria: experience from the phase 3 ENVISION study

BackgroundAcute hepatic porphyria (AHP) is a family of four rare genetic diseases, each involving deficiency in a hepatic heme biosynthetic enzyme. Resultant overproduction of the neurotoxic intermediates δ-aminolevulinic acid (ALA) and porphobilinogen (PBG) leads to disabling acute neurovisceral attacks and progressive neuropathy. We evaluated the AHP disease burden in patients aged ≥ 12 years in a post hoc analysis of the Phase 3, randomized, double-blind, placebo-controlled ENVISION trial of givosiran (NCT03338816), an RNA interference (RNAi) therapeutic that targets the enzyme ALAS1 to decrease ALA and PBG production. We analyzed baseline AHP severity via chronic symptoms between attacks, comorbidities, concomitant medications, hemin-associated complications, and quality of life (QOL) and evaluated givosiran (2.5 mg/kg monthly) in patients with and without prior hemin prophylaxis on number and severity of attacks and pain scores during and between attacks.ResultsParticipants (placebo, n = 46; givosiran, n = 48) included patients with low and high annualized attack rates (AARs; range 0–46). At baseline, patients reported chronic symptoms (52%), including nausea, fatigue, and pain; comorbidities, including neuropathy (38%) and psychiatric disorders (47%); concomitant medications, including chronic opioids (29%); hemin-associated complications (eg, iron overload); and poor QOL (low SF-12 and EuroQol visual analog scale scores). A linear relationship between time since diagnosis and AAR with placebo suggested worsening of disease over time without effective treatment. Givosiran reduced the number and severity of attacks, days with worst pain scores above baseline, and opioid use versus placebo.ConclusionsPatients with AHP, regardless of annualized attack rates, have considerable disease burden that may partly be alleviated with givosiran.

Does titanium cage subsidence affect clinical outcomes in ACDF surgery? A tertiary centre experience.

Cage subsidence after anterior cervical discectomy and fusion (ACDF) surgery has been well documented with rates of up to 40%. Cages fill the void after cervical discectomy and promote fusion. These materials have different biomechanical profiles with differing rates of subsidence. This retrospective cohort study aimed to determine subsidence rates specifically associated with the novel Emerging Implant Technologies (EIT) titanium cage, identify risk factors associated with subsidence, and evaluate whether subsidence affects clinical outcomes. ACDF with insertion of stand-alone EIT cage was performed in 39 patients (64 levels) between December 2016 and February 2019 with a median follow-up of 11 months. Patients were classified into two groups; subsidence and non-subsidence, and were compared in terms of the resultant clinical outcomes as well as presence of risk factors. Health-related quality of life (HRQOL) outcomes were assessed using Visual Analogue Scale (VAS) for neck and arm pain, EuroQol 5-Dimension 5-Level (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ VAS) and Neck Disability Index (NDI) scores. Cage subsidence (>3mm) was present in nine patients (23%), which corresponded to ten levels treated (16%). Development of subsidence was not associated with gender (p = 0.12), age (p = 0.27), smoking (p = 0.13), number of treatment levels (p = 0.10) or cage size used (p = 0.34). It had no effect on any of the HRQOL outcomes, namely VAS Neck (p = 0.07), VAS Arms (p = 0.08), EQ-5D-5L (p = 0.36), EQ VAS (p = 0.85) and NDI (p = 0.80). The EIT cage seems to be associated with lower rates of subsidence compared with other cage types. Cage subsidence was not associated with HRQOL outcomes or risk factors.

Sustained improvements in EQ-5D utility scores and self-rated health status in patients with ankylosing spondylitis after spa treatment including low-dose radon – an analysis of prospective radon indication registry data

BackgroundPatients with ankylosing spondylitis (AS) have significantly lower quality of life (QoL) than the general population. Holistic interventions addressing QoL comprise spa- or balneotherapy including radon. These interventions have shown to be beneficial in reducing pain and improving QoL in AS-patients. We explored the association of spa-therapy including low-dose radon with QoL in AS-patients over an extended time period.MethodsRegistry data collected for the “Radon indication registry” in the Austrian Gastein valley comprising data on QoL (EuroQol EQ-5D) directly before the treatment (baseline), directly(t1), 3 (t2); 6(t3) and 9(t4) months after the treatment, age, sex and body mass index (BMI) were analysed. Linear regression models explored the association of measurement time with 1) EQ-5D-5L utilities and 2) EuroQol visual analogue scale (VAS) score. Alterations of 0.05 (utilities) and 5.00 (VAS) were considered clinically relevant.ResultsTwo-hundred-ninety-one AS-patients were included in the analyses. Forty-four percent (n = 128) were women, the mean age was 52 (SD 10) and the average BMI was 26 (SD 4). Utilities (t1: 0.09 [0.07;0.11]; t2: 0.08 [0.06; 0.10]; t3: 0.06 [0.05;0.09]; t4: 0.04 [0.02;0.06]) and VAS (t1: 11.68 [9.38; 13.97]; t2: 12.20 [9.78; 14.61]; t3: 9.70 [7.24; 12.17]; t4: 6.11 [3.57; 8.65]) were significantly higher at all timepoints compared to baseline. Improvements were clinically relevant at all timepoints in case of the VAS and until 6 months after treatment for the utilities.ConclusionAS-patients who received spa therapy including radon show significantly and clinically relevant improvements in Qol until 6–9 months after treatment.

Evaluation of Postoperative Outcomes of Endoscopic Submucosal Dissection in Primary Gastric Cancer

Background: Few studies have investigated the changes in postoperative quality of life; serum Livin, epidermal growth factor (EGF), and interleukin (IL)-8 levels; and traumatic stress in patients with early gastric carcinoma after endoscopic submucosal dissection. Objectives: We aimed to determine the effect of endoscopic submucosal dissection on postoperative life satisfaction and serum Livin, EGF, and IL-8 levels in early gastric carcinoma patients. Methods: Seventy-three early gastric carcinoma patients were divided into the control (n = 35, traditional radical surgery) and case (n = 38, endoscopic submucosal dissection) groups based on surgical approaches. Results: The operative time, gastrointestinal recovery time, length of hospital stay, perioperative bleeding, EuroQol visual analog scale scores, gastrin, and motilin levels were significantly superior to those in the control group, whereas serum Livin, EGF, IL-8, and C-reactive protein levels, as well as the total incidence of postoperative complications, were significantly lower in the case group than in the control group (all P &lt; 0.05). Conclusion: Endoscopic submucosal dissection in early gastric carcinoma patients provides the advantages of a short operative time, less perioperative bleeding, rapid postoperative recovery, and less traumatic stress and postoperative complications, as well as reduced serum Livin, EGF, IL-8, and tumor marker levels.

The Association Between Preoperative Patient-Reported Health Status and Postoperative Survey Completion Following Arthroplasty: Registry-Based Cohort Study.

BackgroundPatient-reported outcome measures (PROMs) are commonly used to report outcomes after hip and knee arthroplasty, but response rates are rarely complete. Given that preoperative health status (as measured by PROMs) is a strong predictor of outcomes (using the same measures) and that these outcomes may influence the response rate, it is possible that postoperative response rates (the proportion of patients providing preoperative PROMs who also provide postoperative PROMs) may be influenced by preoperative health status.ObjectiveThis study aims to test the association between preoperative PROMs and postoperative response status following hip and knee arthroplasty.MethodsData from the PROMs program of the Australian national joint registry were used. The preoperative PROMs were the Oxford Hip Score or Oxford Knee Score, The EQ-5D Utility Index, and the EQ visual analog scale (VAS) for overall health. Logistic regression, adjusting for age, sex, BMI, and the American Society of Anesthesiologists (ASA) Physical Status Classification System, was used to test the association between each preoperative PROM and response status for the 6-month postsurgery survey.ResultsData from 9499 and 16,539 patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA) for osteoarthritis, respectively, were included in the analysis. Adjusting for age, sex, BMI, and ASA, there was no significant difference in response status at the postoperative follow-up based on the preoperative Oxford Hip or Knee Scores (odds ratio [OR] 1.00, 95% CI 0.99-1.01 for both; P=.70 for THA and P=.85 for TKA). Healthier patients (based on the EQ VAS scores) preoperatively were more likely to respond postoperatively, but this difference was negligible (OR 1.00, 95% CI 1.00-1.01 for THA and TKA; P=.004 for THA and P<.001 for TKA). The preoperative EQ Utility Index was not associated with the postoperative response rate for THA (OR 1.14, 95% CI 0.96-1.36; P=.13) or TKA patients (OR 1.05, 95% CI 0.91-1.22; P=.49).ConclusionsThe likelihood of responding to a postoperative PROMs survey for patients undergoing hip or knee arthroplasty was not associated with clinically important differences in preoperative patient-reported joint pain, function, or health-related quality of life. This suggests that the assessment of postoperative outcomes in hip and knee arthroplasty is not biased by differences in preoperative health measures between responders and nonresponders.

Evaluation of the effectiveness of the standard traditional Korean medicine-based health promotion program for disadvantaged children in South Korea

BackgroundTraditional Korean Medicine (TKM) is highly integrated with the modern health care system of South Korea and is actively used in the public health field. Since 2014, the Ministry of Health and Welfare of South Korea has supported the development of standard models for TKM-based health promotion programs. This study aimed to develop and evaluate a standard TKM-based health promotion program for disadvantaged children.MethodsUsing convenience sampling, we recruited 16 Community Children’s Centers (CCCs) located in Busan and Yangsan, South Korea, which are welfare daytime facilities for children from socially disadvantaged families. The CCCs were divided into two groups of eight CCCs—intervention CCCs and control CCCs—through random allocation, and children in each group were selected as subjects for the study. For 12 weeks, the TKM-based health promotion program developed in this study along with the basic services of CCCs were applied to children in the intervention group, and only the basic services of CCCs were provided to children in the control group. Data were obtained through pre- and post-surveys with the legal representatives of the children prior to implementing the program and after the 12-week program, respectively. The outcome variables—the number of outpatient visits, absences, lateness/early leaves, infectious symptoms, and EuroQol-5D and EQ-visual analog scale scores–were measured and statistically compared between the groups by descriptive analysis, chi-square test, t-test, and difference-in-differences model with regression analysis.ResultsAt baseline, there were 156 children in the intervention group and 153 children in the control group, among which 155 and 147 children, respectively, were included in the analysis. Results indicated that the number of outpatient visits was significantly lower (by 65%) in the intervention group than in the control group (p = 0.03), and this was similar in the sensitivity analysis. Regarding other outcome variables, the effects were not consistently significant.ConclusionsA standard TKM-based health promotion program has the potential to improve the health of disadvantaged children. In the future, studies with long-term interventions and a larger sample are needed to enhance the applicability of these programs in communities.

Robot-assisted partial nephrectomy with minimum follow-up of 5 years: A multi-center prospective study in Japan.

Robot-assisted partial nephrectomy is widely performed for small renal masses, achieving excellent perioperative and intermediate oncological outcomes. However, long-term oncological, functional, and quality of life outcomes after robot-assisted partial nephrectomy remain unclear. In this study, we aimed to evaluate quality of life at 1 year and oncological and functional outcomes of robot-assisted partial nephrectomy after a minimum follow-up of 5 years. Personal, perioperative, postoperative, functional, oncological, and quality of life data were evaluated. The EQ-5D-5L tool, which incorporates health profiles and a EuroQol Visual Analog Scale, was used to assess quality of life preoperatively and 365 days postoperatively. Regarding oncological and functional outcomes, overall survival, recurrence-free survival, and changes in estimated glomerular filtration rate were calculated. There were few changes in levels between the two time points for all EQ-5D dimensions. The mean change in EQ-5D-5L was 0.020 (95% confidence interval 0.006-0.033, P = 0.006), and in EuroQol Visual Analog Scale score 4.60 (95% confidence interval 2.17-7.02, P = 0.0003). Overall and recurrence-free survival 5 years after robot-assisted partial nephrectomy were 97.9% and 92.8%, respectively. After an early postoperative decrease, the estimated glomerular filtration rate remained stable over time. Robot-assisted partial nephrectomy in patients with a T1 renal tumor is safe, feasible, and effective from the perspective of quality of life and survival, even after 5 years. When making treatment decisions, perioperative and quality of life outcomes should be considered together with long-term oncological outcomes.

Perceptions of the General Public About Health-related Quality of Life and the EQ-5D Questionnaire: A Qualitative Study in Korea.

ObjectivesThe aim of this qualitative study was to investigate how members of the general public in Korea interpret the concept of health, and which dimensions of health are most important to them. We also explored their perceptions of the EuroQoL 5-Dimension (EQ-5D), including the EuroQoL visual analogue scale (EQ-VAS).MethodsWe conducted face-to-face, in-depth interviews with 20 individuals from the general population, using a semi-structured interview guide. Content analysis was performed with verbatim transcripts and field notes to identify codes and categorize them according to their similarities and associations.ResultsIn total, 734 different codes were derived and classified into 4 categories. Participants cited the importance of both the mental and physical aspects of health, although they emphasized that the physical aspects appeared to play a larger role in their conceptualization of health. Participants noted that the EQ-5D has the advantage of being composed of 5 dimensions that are simple and contain both physical and mental areas necessary to describe health. However, some of them mentioned the need to add more dimensions of mental health and social health. Participants showed great satisfaction with the visually well-presented EQ-VAS. However, participants opined that the EQ-VAS scores might not be comparable across respondents because of different ways of responding to the scale.ConclusionsWhile physical health is a fundamental aspect of health, mental and social aspects are also important to Koreans. The content of the EQ-5D broadly matched the attributes of health considered important by Koreans.