EuroQol-5 Dimensions Research Articles

The relationship between dementia caregivers and quality of life in South Korean populations.

The purpose of this study was to assess the relationship between quality of life and dementia caregivers. The 2019 Korean Community Health Survey participants were assessed using the Patient Health Questionnaire-9, subjective cognitive decline (SCD) and SCD-related functional limitation, and EuroQol 5-dimension (EQ-5D). Sociodemographic and psychosocial variables were evaluated and compared between participants with dementia caregivers (n = 37,614) and non-dementia caregivers (n = 140,518). The dementia caregivers group reported significantly higher rates of depression, SCD, SCD-related functional restriction, and mean EQ-5D compared to the non-dementia caregivers group (P < .001). After adjusting for multiple confoundings, the odds ratio (OR) for depression (Patient Health Questionnaire-9 ≥ 10), SCD, SCD-related functional limitation, and lowest quartile of the EQ-5D index scores in the dementia caregivers group were 1.43 (95% confidence interval [CI], 1.29-1.59), 1.30 (95% CI: 1.24-1.36), 1.26 (95% CI: 1.20-1.32), and 1.22 (95% CI: 1.16-1.29), respectively. Physical activity (OR: 1.47; 95% CI: 1.43-1.52), self-control (OR: 1.41; 95% CI: 1.35-1.47), daily activity (OR: 1.55; 95% CI: 1.50-1.60), pain (OR: 1.62; 95% CI: 1.58-1.67), and anxiety/depression (OR: 2.17; 95% CI: 2.10-2.24) were all more common among participants in the dementia caregivers group than in the non-dementia family caregivers group. Depression, SCD, and a lower quality of life are linked to dementia caregivers, especially if there is moderate to severe anxiety or depression.

Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study

BackgroundAlthough several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC. MethodsThis pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis. ResultsAmong 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13. ConclusionIn this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study. Trial registrationClinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain.

There is no approved effective drug for diabetic peripheral neuropathic pain (DPNP) in China. Gabapentinoids including mirogabalin have shown promise, although data in Chinese patients are scarce. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of mirogabalin for treating DPNP in China. Mirogabalin was administered at 5mg twice daily for the first week and uptitrated to 15mg twice daily for a total duration of 14weeks. The primary efficacy endpoint was the change from baseline in weekly average daily pain score (ADPS) at week 14; secondary endpoints included the ADPS responder rate, Short-Form McGill Pain Questionnaire visual analogue scale score, patient global impression of change (PGIC), average daily sleep interference score (ADSIS), EuroQol 5-dimensions 5-levels (EQ-5D-5L), and incidence of treatment-emergent adverse events (TEAEs). Of 393 patients (mirogabalin, n = 196; placebo n = 197), the mean age was 58.2years (mirogabalin, 58.7years; placebo, 57.7years) and 54.2% were male (mirogabalin, 56.1%; placebo, 52.3%). Mirogabalin elicited a greater change from baseline in the weekly ADPS vs. placebo at week 14: least-squares mean difference (95% confidence interval) vs. placebo - 0.39 (- 0.74, - 0.04), p = 0.0301. PGIC, ADSIS, and EQ-5D-5L data reflected significantly better improvements for patients receiving mirogabalin vs. placebo. The incidence of TEAEs was 75.0% and 75.1% in the mirogabalin and placebo groups, respectively. Most TEAEs were mild or moderate, and the incidence of TEAEs leading to treatment discontinuation was 2.6% in the mirogabalin group and 1.5% in the placebo group. Although the effect size of mirogabalin was reduced due to the placebo effect, mirogabalin is a safe and effective treatment option for Chinese patients with DPNP. ClinicalTrials.gov identifier, NCT04094662.

GLA:D to Be Walking Better: Change in Self-Reported Difficulty Walking After Exercise Therapy and Education in Persons With Knee Osteoarthritis.

Difficulty walking is a primary reason that individuals with knee osteoarthritis (OA) seek care. We examined the change in self-reported difficulty walking after participating in the Good Life With Osteoarthritis in Denmark (GLA:D) 8-week education and exercise program and assessed patient factors associated with improvement in difficulty walking. This was a registry-based cohort study of individuals in Denmark with knee OA who enrolled in GLA:D. Assessments were administered at baseline, program completion (~3 months), and 12 months. Our prespecified primary outcome was change in self-reported difficulty walking assessed using the EuroQol 5-dimension 5-level walking item. Exposures included sociodemographic factors, measures of OA illness severity, comorbidities, and psychological factors. In those with baseline moderate/severe difficulty walking, using multivariable regression analysis, we assessed the relationship between exposures of interest and improvement to no/slight difficulty walking. We included 5262 participants. Of 2178 (41.4%) individuals with baseline moderate/severe difficulty walking, 51.4% and 58.3% reported no/slight difficulty walking at 3 and 12 months, respectively. Greater self-efficacy, younger age, female sex, lower BMI, less intense knee pain, and better function at baseline were associated with greater likelihood of improvement in difficulty walking, whereas severe difficulty walking at baseline and back pain intensity were associated with decreased likelihood of improvement. More than half of those with baseline difficulty walking experienced substantial improvement after completing GLA:D and this improvement was maintained at 12 months. Several patient factors were associated with the outcome, suggesting that some individuals may require additional support and extended treatment.

Efficacy of a non-pharmaceutical multimodal intervention program in a group setting for patients with mild cognitive impairment: A single-arm interventional study with pre-post and external control analyses

AimThis study aimed to evaluate the efficacy of a non-pharmaceutical multimodal intervention program consisting of physical exercise, cognitive stimulation, and health education in a group setting to slow the progression of mild cognitive impairment (MCI). MethodsA single-arm interventional study was conducted on 27 patients with MCI. To evaluate the efficacy of the intervention program, a pre-post analysis was performed using EuroQol-5 Dimension (EQ-5D), Mini-Mental State Examination (MMSE), Cognitive Function Instrument (CFI), 5 Cog test, depression, and physical performance before and after the 8-month intervention. Additionally, propensity score and the semi-Bayes analyses were performed to compare the intervention program with standard medical care, using the external control patients’ data for MMSE scores. ResultsTwenty-four patients completed the intervention program. During the study period, although EQ-5D and MMSE scores remained unchanged (mean change 0.02 [95 % confidence interval (CI): −0.004, 0.04], 0.5 [-0.2, 1.3]), CFI and the subcategories of 5Cog (attention and reasoning) improved (mean change −1.23 [-2.24, −0.21], 4.3 [0.9, 7.7], 3.0 [0.4, 5.6]). In the additional analysis comparing changes in MMSE scores, patients who underwent the intervention program had less decline than the external control patients (mean change −1.7 [-2.1, −1.3]) with an observed mean difference of 2.25 [1.46, 3.03], and propensity score-adjusted difference of 2.26 [1.46, 3.05]. The semi-Bayesian approach also suggested that the intervention slowed the progression of MCI. ConclusionA non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.

Association of Untreated Pre-surgical Depression With Pain and Outcomes After Spinal Surgery.

Prospective Cohort Study. Untreated pre-surgical depression may prolong post-surgical pain and hinder recovery. However, research on the impact of untreated pre-surgical depression on post-spinal surgery pain is lacking. Therefore, this study aimed to assess pre-surgical depression in patients and analyze its relationship with post-surgical pain and overall post-surgical outcomes. We recruited 100 patients scheduled for lumbar spine surgery due to spondylolisthesis, degenerative lumbar disc diseases, and herniated lumbar disc diseases. Psychiatrists evaluated them for the final selection. We assessed the Beck Depression Inventory (BDI), Japanese Orthopaedic Association (JOA), Oswestry Disability Index (ODI), and EuroQoL 5 Dimensions (EQ-5D) scores, numerical back and leg pain scales, and medication dosage data collected before and at 6 weeks, 3 months, and 6 months after surgery. Ninety-one patients were included in this study; 40 and 51 were allocated to the control and depression groups, respectively. The pre- and post-surgical leg pain, back pain, and functional scores were not different. However, the depression group showed higher ODI and EQ-5D and lower JOA scores than the control group 3 months post-surgery. Partial correlation analysis revealed an inverse correlation between the JOA and BDI scores and a positive correlation between the EQ-5D and BDI scores at 3 months postoperatively. Untreated depression can prolong postoperative pain and hinder recovery. Detecting and treating depression in patients before spine surgery may improve their overall quality of life and functional recovery.

A crossover comparison of patient satisfaction with two teriparatide regimens: primary results of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06)

IntroductionThis study aimed to compare treatment satisfaction with two dosing regimens (two teriparatide [TPTD] self-injection systems) in osteoporosis patients at high risk of fracture.Materials and methodsIn this open-label crossover randomized trial comparing self-injected once-daily (1/D)-TPTD with self-injected twice-weekly (2/W)-TPTD, three satisfaction variables were evaluated by questionnaire for 2 years. The primary endpoint was overall satisfaction and secondary endpoints were satisfaction with treatment effectiveness and with utility of the self-injection device. Changes in quality of life (QOL) assessed by EuroQol-5 Dimension, pain assessed by visual analogue scale (VAS), and anthropometric parameters were also analyzed. Safety was evaluated based on the incidence and severity of adverse events (AEs).ResultsThe 1/D-TPTD and 2/W-TPTD groups consisted of 180 (75.9 ± 7.3 years) and 179 (age: 75.5 ± 6.9 years) patients, respectively. After 26 weeks of treatment, no significant between-group difference in the persistence rate (79.4% vs 72.6% in the 1/D-TPTD and 2/W-TPTD groups, respectively), distributions of overall satisfaction scores, and satisfaction with treatment (p > 0.05) were observed. However, several items of satisfaction with the utility of the injection device were significantly higher in the 2/W-TPTD group (p < 0.05). Statistical improvements from baseline values were observed in QOL and pain VAS in both groups (p < 0.05). No serious AEs were reported.ConclusionThe between-group similarity of overall treatment satisfaction and effectiveness scores and between-group difference in satisfaction with the utility of the self-injection device was useful information for real-world treatment of osteoporosis. Both medication regimens were well tolerated.

Association of Cough Severity with Asthma Control and Quality of Life in Patients with Severe Asthma.

Symptoms are important components in determining asthma control and in the adjustment of treatment levels. However, clinical relevance of cough in severe asthma is not well-understood. This study aimed to evaluate the severity and association of cough with patient-reported outcomes (PROs) in patients with severe asthma. This study analyzed cross-sectional data from the Korean Severe Asthma Registry. The severity of coughing and wheezing symptoms was assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 for each symptom. Additionally, PROs included the Asthma Control Test (ACT), the Severe Asthma Questionnaire (SAQ), and the EuroQoL 5-Dimension (EQ-5D) index. Multivariate linear regression analysis was employed to explore the relationship between cough severity and other PRO scores. A total of 498 patients with severe asthma (age: 57.9 ± 13.1years, females: 60.2%) were analyzed. The cough VAS score was higher than the wheeze score (median 30, [interquartile range 10-50] vs. 20 [0-50]; P < 0.001). Additionally, 22.5% of patients ranked in a higher tertile for cough severity compared to wheezing, while 18.5% ranked higher for wheezing severity than cough. Significant correlations were observed between cough and wheeze VAS scores (r = 0.61, P < 0.05) and between each symptom's VAS score and the SAQ (cough: r = -0.41, P < 0.001; wheeze: r = -0.52, P < 0.001), ACT scores (cough: r = -0.50, P < 0.001; wheeze: r = -0.63, P < 0.001) and EQ-5D index (cough: r = -0.40, P < 0.001; wheeze: r = -0.45, P < 0.001). In univariate regression analysis, the cough VAS score had weaker descriptive power (R2) values than the wheeze VAS score in relation to the PRO measures. Nevertheless, cough severity remained significantly associated with ACT, SAQ scores and EQ-5D index in multivariate analyses adjusted for wheeze severity and other confounders. Cough frequently presents as a severe symptom in patients with severe asthma and could have distinct impact on asthma control and quality of life.

Patient-reported outcomes and healthcare resource utilization in systemic lupus erythematosus: impact of disease activity

BackgroundLimited real-world data exists on clinical outcomes in systemic lupus erythematosus (SLE) patients by SLE Disease Activity Index 2000 (SLEDAI-2 K), hereafter, SLEDAI. We aimed to examine the association between SLEDAI score and clinical, patient-reported and economic outcomes in patients with SLE.MethodsRheumatologists from the United States of America and Europe provided real-world demographic, clinical, and healthcare resource utilization (HCRU) data for SLE patients. Patients provided self-reported outcome data, capturing their general health status using the EuroQol 5-dimension 3-level questionnaire (EQ-5D-3 L), health-related quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) and work productivity using the Work Productivity and Activity Impairment questionnaire (WPAI). Low disease activity was defined as SLEDAI score ≤ 4 and ≤ 7.5 mg/day glucocorticoids; patients not meeting these criteria were considered to have “higher” active disease. Data were compared between patients with low and higher disease activity. Logistic regression estimated a propensity score for SLE based on demographic and clinical characteristics. Propensity score matched analyses compared HCRU, patient-reported outcomes, income loss and treatment satisfaction in patients with low disease activity versus higher active disease.ResultsData from 296 physicians reporting on 730 patients (46 low disease activity, 684 higher active disease), and from 377 patients’ self-reported questionnaires (24 low disease activity, 353 higher active disease) were analyzed. Flaring in the previous 12 months was 2.6-fold more common among patients with higher versus low active disease. Equation 5D-3 L utility index was 0.79 and 0.88 and FACIT-Fatigue scores were 34.78 and 39.79 in low versus higher active disease patients, respectively, indicating better health and less fatigue, among patients with low versus higher active disease. Absenteeism, presenteeism, overall work impairment, and total activity impairment were 47.0-, 2.0-, 2.6- and 1.5-fold greater in patients with higher versus low disease activity. In the previous 12 months there were 28% more healthcare consultations and 3.4-fold more patients hospitalized in patients with higher versus low disease activity.ConclusionCompared to SLE patients with higher active disease, patients with low disease activity experienced better health status, lower HCRU, less fatigue, and lower work productivity impairment, with work absenteeism being substantially lower in these patients.

Patient-Reported and Clinical Outcomes of Surgically Treated Patients With Symptomatic Spinal Metastases: Results From Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO), a Prospective, Multi-Institutional and International Study.

The palliative impact of spine surgery for metastatic disease is evolving with improvements in surgical technique and multidisciplinary cancer care. The goal of this study was to prospectively evaluate long-term clinical outcomes including health-related quality-of-life (HRQOL) measures, using spine cancer-specific patient-reported-outcome (PRO) measures, in patients with symptomatic spinal metastases who underwent surgical management. The Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO, ClinicalTrials.gov identifier: NCT01825161) trial is a prospective-observational cohort study that included 10 specialist centers in North America and Europe. Patients aged 18 to 75 years who underwent surgery for spinal metastases were included. Prospective assessments included both spine tumor-specific and generic PRO tools which were collected for a minimum of 2 years post-treatment or until death. Two hundred and eighty patients (51.8% female, mean age 57.9 years) were included. At presentation, the mean Charlson Comorbidity Index was 6.0, 35.7% had neurological deficits as defined by the American Spinal Cord Injury Association scores, 47.2% had high-grade epidural spinal cord compression (2-3), and 89.6% had impending or frank instability as measured by a Spinal Instability Neoplastic Score of ≥7. The most common primary tumor sites were breast (20.2%), lung (18.8%), kidney (16.2%), and prostate (6.5%). The median overall survival postsurgery was 501 days, and the 2-year progression-free-survival rate was 38.4%. Compared with baseline, significant and durable improvements in HRQOL were observed at the 6-week, 12-week, 26-week, 1-year, and 2-year follow-up assessments from a battery of PRO questionnaires including the spine cancer-specific, validated, Spine Oncology Study Group Outcomes Questionnaire v2.0, the Short Form 36 version 2, EuroQol-5 Dimension (3L), and pain numerical rating scale score. Multi-institutional, prospective-outcomes data confirm that surgical decompression and/or stabilization provides meaningful and durable improvements in multiple HRQOL domains, including spine-specific outcomes based on the Spine Oncology Study Group Outcomes Questionnaire v2.0, for patients with metastatic spine disease.

HOW DOES CARTIVA INTERPOSITIONAL ARTHROPLASTY COMPARE TO ARTHRODESIS IN THE TREATMENT OF HALLUX RIGIDUS? A RETROSPECTIVE COMPARATIVE STUDY WITH 12-MONTH FOLLOW-UP

BackgroundHallux rigidus is a common condition characterised by first metatarsophalangeal joint (MTPJ) degeneration, pain and limited range of motion (ROM). The gold standard surgical treatment is arthrodesis, providing good pain relief but sacrifices ROM. Recently the Cartiva synthetic cartilage implant (SCI) has been utilised as an interpositional arthroplasty, aiming to reduce pain whilst preserving range of motion. Current evidence for Cartiva SCI is largely based on a single cohort with mixed outcomes. We sought to evaluate the clinical outcomes of Cartiva SCI compared to arthrodesis undertaken in our centre.MethodsRetrospective review of patients undergoing Cartiva SCI or arthrodesis for treating hallux rigidus was conducted. Preoperative arthritis was radiographically graded using the Vanore classification. Patient reported outcomes (PROMs) were assessed using EuroQol 5-dimension score (EQ-5D-5L) and Manchester-Oxford Foot Questionnaire (MOXFQ).ResultsBetween 2017 and 2020 there were 33 cases (17 Cartiva, 16 arthrodesis, mean age 59.0±9.9 years) with a mean follow up of 2.3 years. For the first MTPJ arthrodesis cohort, the MOXFQ domain scores were: Index 3.9±5.8, Walking/Standing 5.1±7.6, Pain 3.2±5.0, and Social Interaction 2.6±4.0. EQ-5D-5L Index score was 0.828±0.270 and the EQ-VAS was 72.5±23.3. For the Cartiva cohort, the MOXFQ domain scores were: Index 7.7±6.0, Walking/Standing 8.9±7.9, Pain 7.1±5.0, and Social Interaction 6.4±5.4. EQ-5D-5L Index score was 0.631±0.234 and the EQ-VAS was 74.8±20.8. There was no statistically significant difference between any MOXFQ domain or EQ-5D-5L scores. However, a negative trend in MOXFQ domains was identified for the Cartiva group, as well as a reoperation rate of 23.5%.ConclusionsThe Cartiva SCI demonstrated no advantage over arthrodesis in PROMs, despite the presumed benefit of preserved ROM. A significant reoperation rate was also observed. Surgeons should be cautious in the use of this novel implant.

Immediate vs Gradual Brace Weaning Protocols in Adolescent Idiopathic Scoliosis

Lack of evidence and consensus for brace weaning protocol in adolescent idiopathic scoliosis (AIS) results in clinicians prescribing gradual weaning in the hope of avoiding curve deterioration after weaning. However, gradual weaning contributes to prolonged brace wear, which can affect spinal stiffness and health-related quality of life (HRQoL). To determine whether gradual weaning results in better curve magnitude and truncal balance maintenance after brace weaning vs immediate brace removal for patients with AIS. This was an open-labeled randomized clinical trial commenced in April 2017 with 24-month follow-up completed in January 2023. Outcome assessors were masked to weaning protocol assigned. The study took place at a territory-wide tertiary scoliosis clinic serving the largest number of referrals in the local population. Patients with AIS ready to wean off of brace wear were eligible (402 were screened; 33 were excluded [15 for <18 hours/day of brace-wear compliance before weaning, 11 were treated with Milwaukee brace, and 7 declined to participate]; and 369 were included), and those who were treated with a custom molded thoracolumbosacral orthosis and had reached skeletal maturity were consecutively recruited. Patients were randomized to gradual weaning protocol (n = 176) with an additional 6 months of nighttime wear before completely stopping or immediate weaning protocol (n = 193) with immediate brace removal at recruitment. Changes in major curve Cobb angle and truncal balance from the time of weaning to 6-month, 12-month, and 24-month follow-up. HRQoL was also assessed using the refined Scoliosis Research Society 22-item and EuroQol 5-dimension questionnaires. A total of 369 patients (mean [SD] age, 14.9 [1.1] years; 304 [83.4%] girls) were randomized with 284 (77.0%) completing 24-month longitudinal follow-up. Immediate and gradual weaning groups had no significant differences in change of major Cobb angle at postweaning 6-month (difference, -0.6°; 95% CI, -1.4 to 0.2; P = .17), 12-month (difference, -0.3°; 95% CI, -1.2 to 0.6; P = .47), and 24-month (difference, -0.3°; 95% CI, -1.2 to 0.7; P = .60) follow-up. The number of curve progression, nonprogression, and rebound cases were comparable (χ22 = 2.123; P = .35). Postweaning changes in truncal balance and HRQoL demonstrated no significant differences between groups. Gradual weaning did not demonstrate superiority to immediate weaning with predefined criteria of Cobb angle and truncal balance maintenance and HRQoL after brace weaning. Gradual and immediate weaning achieved very similar maintenance of brace outcomes in AIS. We therefore recommend the consideration of immediate brace weaning, which aims to benefit patients with earlier time for increased exercises and activity level. ClinicalTrials.gov Identifier: NCT03329716.

Time From Hospital Arrival Until Endovascular Thrombectomy and Patient-Reported Outcomes in Acute Ischemic Stroke

The time-benefit association of endovascular thrombectomy (EVT) in ischemic stroke with patient-reported outcomes is unknown. To assess the time-dependent association of EVT with self-reported quality of life in patients with acute ischemic stroke. Data were used from the Safety and Efficacy of Nerinetide in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) trial, which tested the effect of nerinetide on functional outcomes in patients with large vessel occlusion undergoing EVT and enrolled patients from March 1, 2017, to August 12, 2019. The ESCAPE-NA1 trial was an international randomized clinical trial that recruited patients from 7 countries. Patients with EuroQol 5-dimension 5-level (EQ-5D-5L) index values at 90 days and survivors with complete domain scores were included in the current study. Data were analyzed from July to September 2023. Hospital arrival to arterial puncture time and other time metrics. EQ-5D-5L index scores were calculated at 90 days using country-specific value sets. The association between time from hospital arrival to EVT arterial-access (door-to-puncture) and EQ-5D-5L index score, quality-adjusted life years, and visual analog scale (EQ-VAS) were evaluated using quantile regression, adjusting for age, sex, stroke severity, stroke imaging, wake-up stroke, alteplase, and nerinetide treatment and accounting for clustering by site. Using logistic regression, the association between door-to-puncture time and reporting no or slight symptoms (compared with moderate, severe, or extreme problems) was determined in each domain (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) or across all domains. Time from stroke onset was also evaluated, and missing data were imputed in sensitivity analyses. Among 1105 patients in the ESCAPE-NA1 trial, there were 1043 patients with EQ-5D-5L index values at 90 days, among whom 147 had died and were given a score of 0, and 1039 patients (mean [SD] age, 69.0 [13.7] years; 527 male [50.7%]) in the final analysis as 4 did not receive EVT. There were 896 survivors with complete domain scores at 90 days. There was a strong association between door-to-puncture time and EQ-5D-5L index score (increase of 0.03; 95% CI, 0.02-0.04 per 15 minutes of earlier treatment), quality-adjusted life years (increase of 0.29; 95% CI, 0.08-0.49 per 15 minutes of earlier treatment), and EQ-VAS (increase of 1.65; 95% CI, 0.56-2.72 per 15 minutes of earlier treatment). Each 15 minutes of faster door-to-puncture time was associated with higher probability of no or slight problems in each of 5 domains and all domains concurrently (range from 1.86%; 95% CI, 1.14-2.58 for pain or discomfort to 3.55%; 95% CI, 2.06-5.04 for all domains concurrently). Door-to-puncture time less than 60 minutes was associated higher odds of no or slight problems in each domain, ranging from odds ratios of 1.49 (95% CI, 1.13-1.95) for pain or discomfort to 2.59 (95% CI, 1.83-3.68) for mobility, with numbers needed to treat ranging from 7 to 17. Results were similar after multiple imputation of missing data and attenuated when evaluating time from stroke onset. Results suggest that faster door-to-puncture EVT time was strongly associated with better health-related quality of life across all domains. These results support the beneficial impact of door-to-treatment speed on patient-reported outcomes and should encourage efforts to improve patient-centered care in acute stroke by optimizing in-hospital processes and workflows.

Patient-reported outcomes corresponding to most common symptomatic adverse events in lung cancer clinical trials.

11103 Background: FDA recommends assessing the most relevant expected symptomatic adverse events (AEs) with patient-reported outcomes (PROs) in cancer clinical trials (CTs) to complement traditional safety data. To inform selection of symptomatic AEs, we previously identified the most common (i.e., all-grade, clinician-reported in ≥20% of patients) symptomatic AEs from FDA-approved lung cancer product approvals from 2015 through 2021 based on CT monotherapy experimental arm safety data from US Prescribing Information (USPI). The present research aims to assess whether these CTs included PROs which adequately captured common symptomatic AEs. Methods: We assessed 30 CTs that supported lung cancer approvals from 2015 through 2021. We reviewed the study protocol, statistical analysis plan, and/or clinical study report to determine the PRO measures included. We matched symptoms included within PRO measures and items to the most common clinician-reported symptomatic AEs per the USPI to determine the extent to which the PROs and symptomatic AEs corresponded. Results: Twenty-three out of 30 (77%) CTs supporting non-small cell lung cancer (NSCLC) approvals included PRO(s). Nineteen included more than one PRO measure. The most frequently used PRO measures were the European Organisation for Research and Treatment of Cancer-Core Questionnaire (EORTC QLQ-C30; n=19), EORTC-Lung Cancer (EORTC QLQ-L13; n=17), EuroQoL 5-Dimension (EQ-5D; n=12), and selected items from the Patient-reported Outcomes version of the Common Terminology Criteria for Adverse Events item library (PRO-CTCAE; n=4). Nearly all (20 of 23) CTs included PRO items corresponding to more than half of the common symptomatic AEs reported. Symptomatic AEs for types of pain corresponded to general pain PRO items (e.g., “musculoskeletal pain” matched to EORTC item for “pain”). However, PRO items for specific types of pain were not often used. While important symptomatic AEs such as fatigue, diarrhea, nausea, and decreased appetite were often assessed by PROs, others including rash and edema were not usually captured. Ultimately, only 4 of 23 (17%) CTs with PROs included items that assessed all symptomatic AEs that occurred in ≥20% of patients. Of the 4 CTs which included an item library, 3 (75%) comprehensively assessed patient-reported symptomatic AEs, compared to 3 of 19 (16%) CTs that did not employ an item library for patient-reported symptom collection. Conclusions: Based on USPI safety data and PRO measures from CT monotherapy experimental arms of recently approved NSCLC cancer drugs, we determined that while the majority of CTs include PRO items for some relevant symptomatic AEs, other important expected symptomatic AEs (e.g., edema, rash, specific types of pain) were not measured. Future NSCLC CTs should include PRO items for common expected symptomatic AEs which is feasible using well-established PRO item libraries.

Immunotherapy related patient-reported outcomes from five randomized controlled trials in patients with triple negative breast cancer: A systematic review.

e23167 Background: Immunotherapy (IO) has improved clinical outcomes in patients with early-stage Triple Negative Breast Cancer (TNBC) receiving neoadjuvant therapy and certain patient subsets in the metastatic setting. This study aims to evaluate IO-related Patient-Reported Outcomes (PRO) in patients older than 65 years. Methods: We searched Medline ALL (Ovid), Embase (Elsevier), Cochrane Central (Wiley), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. The searches combined terms reflecting (1) the immune checkpoint inhibitors atezolizumab, durvalumab, and pembrolizumab; (2) breast cancer; and (3) randomized controlled trials. Results were limited to items published in English from 2013 through September 2023. We excluded review articles and clinical trial records without results. Two independent reviewers (C.S. and M.L.) screened the studies using the systematic review management tool Covidence, and conflicts were resolved by a third reviewer (W.I.Z.). We included studies that reported on PRO in adults with TNBC receiving any of the three immunotherapies of interest. Results: Five publications composed of two peer-reviewed papers and three abstracts were identified, including 3878 total patients and 3184 with PRO. Three pembrolizumab studies had 2643 total patients (2056 with PRO) and two atezolizumab studies (IMPASSION 130, IMPASSION 031) had 1235 total patients (1128 with PRO). The PRO analysis in KEYNOTE 522 included 1145 patients in the neoadjuvant phase and 847 in the adjuvant phase. The PRO analysis in KEYNOTE 355 included total 847 patients and 317 with Combined Positive Score (CPS) ≥10. No study specified PRO data for patients older than 65 years. Baseline completion rates for all studies were &gt; 80%. All studies used standardized PRO instruments, including the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ C30) and its Breast Cancer Module (QLQ-BR23), the Functional Assessment of Cancer-Therapy-General (FACT-G GP5), and the EuroQol-5 Dimension (EQ-D5). All studies showed no statistical difference, or clinical meaningful decline in PRO endpoints between patients who received chemo with IO versus chemo with placebo, during and post treatment follow up. The PRO analysis from KEYNOTE 119, which included total 594 patients of which 187 had CPS ≥10, demonstrated that patients receiving single agent chemotherapy had worse PROs related to systemic therapy side effects and hair loss while the pembrolizumab group had decreased worry about future health. None included subgroup analysis by age, including patients older than 65 years. Conclusions: Our systematic review demonstrates that in both early and advanced TNBC, IO did not worsen PRO. Prospective and retrospective data in IO-related PRO in older patient population are needed.

Cost-effectiveness of craniotomy versus decompressive craniectomy for UK patients with traumatic acute subdural haematoma

ObjectiveTo estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH).DesignEconomic evaluation undertaken using health resource use and outcome data...

Patient-reported symptom interference with activity- and mood-related functioning prior to start of an early-phase oncology combination trial including immune checkpoint blockade.

12084 Background: We examined symptom interference with activity- and mood-related functioning at baseline in early-stage trials of combination treatments that included at least one immune checkpoint inhibitor, and its association with quality of life (QOL)-, clinical-, and trial-related factors. Methods: Patients scheduled to begin an early-phase trial of a combination treatment with immune checkpoint blockade, and who had not received trial-related treatment were recruited into a prospective longitudinal study design (NCI R01CA242565), and completed the following validated patient-reported outcome (PRO) measures prior to trial start: MD Anderson Symptom Inventory- Immunotherapy (score range: 0-10, higher scores = worse symptom interference); NCI’s PRO Common Terminology Criteria for Adverse Events (0-4, higher = worse severity); EuroQoL-5 dimensions assessing health status (0-100, higher = better health) and problems with self-care, and the Sloan Global QOL scale (0-10, higher = better QOL). Statistical tests included Spearman’s correlation rho (r) and multivariable linear regression. Results: 977 baseline PRO measures were completed by 247 patients (median age = 59 y; 46% female). Worst symptom-related interference was with activity (3.0 on a 0-10 scale), work (2.9), and enjoyment of life (2.4). Composite score means were 2.8 for symptom interference with walking, activity, and work (WAW; activity-related functioning), and 2.1 for interference with relationships, enjoyment of life, and mood (REM; mood-related functioning). Symptoms most associated with worse WAW were fatigue (P&lt;0.001) and appetite loss (P=0.001). Worse WAW was linked to worse REM (r=0.78, P&lt;0.001). Diminished sexual interest/mood (DSI) was associated with worse WAW (r=0.35, P&lt;0.001) and REM (r=0.33, P&lt;0.001). Worse WAW was linked to shorter trial duration (P=0.003) and worse response (progression of disease/immune-related progression) on the clinical trial (P=0.05). Conclusions: This first, comprehensive and prospective examination of symptom interference with functioning at trial baseline found that worse symptom interference was linked to worse QOL, poorer clinical outcomes, and shorter trial duration. These findings suggest that baseline patient-reported symptom interference with functioning can serve as a potential biomarker of poor prognosis in investigational trials, and that trial patients may benefit from initiation of supportive care prior to trial start. [Table: see text]

Cystine and theanine for chemoradiotherapy-induced esophagitis in non-small cell lung cancer: a prospective observational study.

Although several potential radioprotectants have been explored, radiation esophagitis is still difficult to control. Further development of supportive therapies is required. Our purpose was to investigate the efficacy and safety of cystine and theanine for esophagitis in non-small cell lung cancer (NSCLC) patients undergoing chemoradiotherapy (CRT). This study is a prospective observational study. The participants were recruited from unresectable locally advanced NSCLC who had scheduled to receive weekly paclitaxel or nab-paclitaxel/carboplatin plus radiation therapy (60Gy in 30 fractions) for 6weeks. They took an oral amino acid supplement containing 700mg cystine and 280mg theanine once daily regardless of CRT timing from the start of CRT until completion. The primary endpoint was the incidence of any grade esophagitis. The secondary endpoints were quality of life (QoL) and adverse events (AEs). A total of 26 patients were evaluated. All participants completed 60Gy of RT in 30 fractions. The overall incidence of esophagitis was 73%; however, no ≥ grade 3 was reported. There were no AEs likely to be related to cystine and theanine. The mean EuroQoL 5-Dimension 5-Level health index score before and after chemoradiotherapy was 0.952 ± 0.0591 and 0.952 ± 0.0515 (P = 0.89), and the mean Visual Analogue Scale scores before and after treatment were 67.9 ± 15.4 and 79.4 ± 13.2 (P = 0.0047), respectively. Our study showed no severe esophagitis, any AEs, nor QoL decrease in NSCLC patients receiving CRT. Cystine and theanine are potentially effective to reduce severe CRT-induced esophagitis. UMIN000052622, 26 October 2023, retrospectively registered.

Effectivity of Telemonitoring Toward Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD): A Systematic Review and Meta-Analysis

Introduction: Chronic obstructive pulmonary disorder (COPD) is the third-leading cause of death worldwide. COPD treatment is essential to manage and attenuate the progression of symptoms. Home-based telemonitoring interventions showed several promises in increasing COPD patients’ quality of life (QoL) and outcomes. However, various results were obtained in recent studies, making a secondary research presence needed to establish clear risks and benefits. This study aimed to analyze the effect of telemonitoring on QoL among COPD patients. Methods: This study used the Preferred Reporting Items of Systematic Review and Meta-Analysis (PRISMA) reporting guidelines on several databases from February until April 2023. We performed screening and selection, followed by data extraction and quantitative analysis with Review Manager 5.4 Software. The risk of bias assessment was performed using the RoB 2.0 Cochrane tool. Results: Ten randomized controlled trials (RCTs), mostly low-risk of bias, were included. We found a reduction in Saint George's Respiratory Questionnaire (SGRQ) score (mean difference (MD) -1.13 [95% CI -4.23, 1.97; p = 0.47]) and Hospital Anxiety and Depression Scale (HADS) for anxiety (MD-0.16 [95% Cl -0.96, 0.63; p = 0.69]). There was no significant effect of HADS on depression and EuroQol-5 Dimension (EQ-5D). Conclusion: This study suggests that telemonitoring improves QoL in COPD patients, especially for SGRQ and HADS anxiety scores. We suggest a larger number of studies to evaluate the effect of telemonitoring on depression and anxiety. We also encourage the integration of telemedicine with the present care system to achieve the best beneficial outcome for patients.

Impact of comorbidities on EQ-5D quality-of-life index in severe asthma

BackgroundSevere asthma pathology encompasses a wide range of pulmonary and extra-pulmonary treatable traits with a high prevalence of comorbidities. Although asthma-specific health related quality of life measures are most sensitive to changes in asthma control, generic measures, such as EQ-5D-5L (EuroQol 5-Dimension 5-Level questionnaire), are potentially better for capturing the impact of comorbidities. ObjectiveTo examine the impact of pulmonary and extra-pulmonary treatable traits on quality of life at initial severe asthma assessment, and to compare the characteristics of those patients whose quality of life does and does not improve during follow-up at severe asthma centres. MethodsPatients characteristics at baseline assessment within the UK Severe Asthma Registry were compared by EQ-5D-5L utility index quartile. Patients with follow-up review data were stratified by change in EQ-5D-5L utility index from baseline to follow-up, and characteristics similarly examined. ResultsPatients in the quartiles with worst dysutility at baseline were observed to exhibit more treatable traits and in particular extra-pulmonary traits associated with cumulative systemic corticosteroids, including obesity, anxiety/depression, and osteoporosis. In those patients whose quality of life improved over follow-up, a reduction in exacerbations, uncontrolled symptoms and requirement for maintenance oral corticosteroids (OCS) was observed. ConclusionBoth pulmonary and extra-pulmonary treatable traits are important determinants of quality of life in severe asthma. Comorbidities associated with cumulative systemic corticosteroid exposure are particularly associated with worse quality of life, emphasising the importance of early identification and management of severe asthma before comorbidities develop.