EuroQol-5 Dimensions-5 Levels Research Articles

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.

Transforaminal versus posterior lumbar interbody fusion for symptomatic single-level spondylolisthesis (LIFT): a multicentre controlled, patient blinded, randomised non-inferiority trial

The effectiveness of transforaminal lumbar interbody fusion (TLIF) compared to posterior lumbar interbody fusion (PLIF) in patients with single-level spondylolisthesis has not been substantiated. To address the evidence gap, a well-powered randomized controlled non-inferiority trial comparing the effectiveness of TLIF with PLIF, entitled the Lumbar Interbody Fusion Trial (LIFT), was conducted. In a multicenter randomized controlled non-inferiority trial among five Dutch hospitals, 161 patients were randomly allocated to either TLIF or PLIF (1:1), stratified according to study site. Patients and statisticians were blinded for group assignment. All patients were over 18 years old with symptomatic single-level degenerative, isthmic or iatrogenic lumbar spondylolisthesis, and eligible for lumbar interbody fusion surgery through a posterior approach. The primary outcome was change in disability measured with the Oswestry Disability Index (ODI) from preoperative to one year postoperative. The non-inferiority limit was set to 7.0 points based on the MCID of ODI. Secondary outcomes were change in quality-adjusted life years (QALY) assessed with EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) and Short Form Health Survey (SF-36), as well as back and leg pain (Numerical rating scale, NRS), anxiety and depression (Hospital Anxiety Depression Scale; HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and complications. Trial registration: Netherlands Trial Registry, number 5722 (registration date March 30, 2016), Lumbar Interbody Fusion Trial (LIFT): A randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis. Patients were included between August 2017 and November 2020. The total study population was 161 patients. Total loss-to-follow-up after one year was 16 patients. Per-protocol analysis included 66 patients in each group. In the TLIF group (mean age 61.6, 36 females), ODI improved from 46.7 to 20.7, whereas in the PLIF group (mean age 61.9, 41 females), it improved from 46.0 to 24.9. This difference (-4.9, 90% CI-12.2 to+2.4) did not reach the non-inferiority limit of 7.0 points in ODI. A significant difference in the secondary outcome measurement, QALY (SF-36), was observed in favor of TLIF (P<0.05). However, this was not clinically relevant. No difference was found for all other secondary outcome measurements; PROMs (EQ-5D, NRS leg/back, HADS), perioperative blood loss, duration of surgery, duration of hospitalization, and perioperative and postoperative complications. For patients with single-level spondylolisthesis, TLIF is non-inferior to PLIF in terms of clinical effectiveness. Disability (measured with ODI) did not differ over time between groups. No funding was received for this trial.

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.

Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases

Study design. Multicenter, prospective registry study. Objective. To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life (QoL) assessments with clinical outcomes. Summary of background data. Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. Methods. This study included 171 (out of 413) patients from the multicenter “Prospective Registration Study on Surgery for Metastatic Spinal Tumors” by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the visual analog scale (VAS), and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. Results. The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-VAS, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. Conclusion. We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.

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.

Associations between HIV stigma and health-related quality-of-life among people living with HIV: cross-sectional analysis of data from HPTN 071 (PopART)

People living with HIV (PLHIV) report lower health-related quality-of-life (HRQoL) than HIV-negative people. HIV stigma may contribute to this. We explored the association between HIV stigma and HRQoL among PLHIV. We used cross-sectional data from 3991 randomly selected PLHIV who were surveyed in 2017–2018 for HPTN 071 (PopART), a cluster randomised trial in Zambia and South Africa. Participants were 18–44 years, had laboratory-confirmed HIV infection, and knew their status. HRQoL was measured using the EuroQol-5-dimensions-5-levels (EQ-5D-5L) questionnaire. Stigma outcomes included: internalised stigma, stigma experienced in the community, and stigma experienced in healthcare settings. Associations were examined using logistic regression. Participants who had experienced community stigma (n = 693/3991) had higher odds of reporting problems in at least one HRQoL domain, compared to those who had not (adjusted odds ratio, aOR: 1.51, 95% confidence interval, 95% Cl: 1.16–1.98, p = 0.002). Having experienced internalised stigma was also associated with reporting problems in at least one HRQoL domain (n = 552/3991, aOR: 1.98, 95% CI: 1.54–2.54, p < 0.001). However, having experienced stigma in a healthcare setting was less common (n = 158/3991) and not associated with HRQoL (aOR: 1.04, 95% CI: 0.68–1.58, p = 0.850). A stronger focus on interventions for internalised stigma and stigma experienced in the community is required.

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.

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...

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.

Tenecteplase Versus Alteplase in Medium Vessel Occlusion Ischemic Stroke: A Secondary Analysis of the Alteplase Compared to Tenecteplase Randomized Trial.

The safety and efficacy of tenecteplase in patients with ischemic stroke due to medium vessel occlusion (MeVO) are not well studied. We aimed to compare tenecteplase with alteplase in stroke due to MeVO. Patients with baseline M2-middle cerebral artery (MCA), M3/M4-MCA, P2/P3/P4-posterior cerebral artery (PCA), A2/A3/A4-anterior cerebral artery (ACA) occlusions from the Alteplase Compared to Tenecteplase (AcT) trial were included. Primary outcome was the proportion of 90-day modified Rankin Scale (mRS) 0-1. Secondary outcomes were 90-day mRS 0-2, ordinal mRS, mortality, quality of life measures (EuroQol 5-Dimension 5-Level, EuroQol visual analog scale), and symptomatic intracerebral hemorrhage (sICH). Initial and final successful reperfusion were reported in patients undergoing endovascular thrombectomy (EVT). Among 1,558 patients with available baseline computed tomography angiography; 455 (29.2%) had MeVO of which 27.5% (125/455) were proximal M2; 16.3% (74/455) were distal M2; 35.2% (160/455) were M3/M4; 7.5% (34/455) were A2/A3/A4; and 13.6% (62/455) were P2/P3/P4 occlusions. EVT was performed in 87/455 (19.1%) patients. mRS 0-1 at 90 days was achieved in 37.9% in the tenecteplase versus 34.7% in the alteplase group (adjusted risk ratio [aRR] 1.07; 95% confidence interval [CI] 0.91-1.25). Rates of 90-day mRS 0-2, sICH, and mortality were similar in both groups. No statistical difference was noted in initial successful reperfusion rates (13.0% vs. 7.5%) among the 87 patients who underwent endovascular thrombectomy. However, final successful reperfusion was higher in the tenecteplase group (71.7% vs. 60.0%, aRR 1.29, 95% CI 1.04-1.61). Intravenous tenecteplase had comparable safety, functional outcomes and quality of life compared to intravenous alteplase among patients with MeVO. Among those treated with EVT, tenecteplase was associated with higher successful reperfusion rates than alteplase.

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.

Preliminary results of stabilization of far distal tibia fractures with the distal tibial nail: A prospective, multicenter case series study

IntroductionThe distal tibial nail (DTN) is a novel retrograde intramedullary nail used for distal tibial fracture stabilization. We investigated the clinical results of DTN use for distal tibial fractures and compared them with those reported in the literature on locking plates and antegrade intramedullary nails. Materials and methodsThis multicenter, prospective, observational cohort study examined distal tibial fractures with AO/OTA classification 43 types: A1, A2, A3 or C1. The primary outcomes included bone union rate, soft tissue problems, and surgical complications. Secondary outcomes were EuroQol-5 Dimension-5 Level (EQ-5D-5L), Self-Administered Foot Evaluation Questionnaire (SAFE-Q), and American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot clinical scores 1 year postoperatively. Incidence of varus or valgus/anterior-posterior flexion deformity with a difference of ≥5° and postoperative reduction loss rate were evaluated. ResultsFive men and five women were enrolled (mean age, 69 years [range, 30–77 years]), including one open-fracture-type Gustilo type IIIB case. Bone union was observed in all patients at 6 months postoperatively. Delayed union, leg edema, and guide pin breakage were observed in three, one, and one cases, respectively. No soft tissue or surgical complications were observed. During the final follow-up, the EQ-5D-5L, SAFE-Q, and AOFAS hindfoot scores were 0.876 (0.665–1.0), 83–92, and AOFAS 92.6 (76–100), respectively. Varus and retroflexion deformities were observed in one case each. DiscussionDTN has been reported to have biomechanically equivalent or stronger fixation strength than locking plates or antegrade intramedullary nails. In addition, while DTN was thought to be less invasive for soft tissue and can avoid injury to the knee, it was thought that care should be taken to avoid medial malleolus fractures and posterior tibialis tendon injuries. Comparisons with literature treatment results for locking plates and antegrade intramedullary nails showed comparable to advantageous results. ConclusionsDTN treatment results for distal tibial fractures were as good as those for locking plates and antegrade intramedullary nails. DTN is useful for stabilization and does not compromise the surrounding soft tissues.

Meniscal allograft transplantation (MAT) combined with revision ACL reconstruction and lateral extra-articular tenodesis results in significantly improved outcomes, but patient-reported knee function is inferior compared to an isolated MAT.

Meniscal allograft transplantation (MAT) is a valuable option for postmeniscectomy syndrome in young and active patients, which can successfully improve symptoms, function and quality of life. This study aimed to report outcomes and complications in patients treated with isolated MAT or MAT combined with revision anterior cruciate ligament reconstruction (ACLR) and lateral extra-articular tenodesis (LET). In total, 18 patients who were treated with MAT using a soft tissue fixation technique were retrospectively analysed. Patients were allocated into two groups, the isolated MAT group and the MAT plus revision ACLR + LET group (MAT+ group). Both groups were assessed using the following Patient-Reported Outcome Measures (PROMs): Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), Tegner Activity Scale, Lysholm score, EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire and a patient acceptable symptom state (PASS) statement. The mean follow-up was 3.2 years and the mean age of patients was 29 (±7.6) years. Ten patients were treated with isolated MAT and eight patients were treated with MAT combined with revision ACLR and LET. No complications and no reoperations were reported. In both groups, all PROMs significantly improved postoperatively (p < 0.05), except for the Tegner score in the MAT+ group, which did not reach statistical significance (not significant [n.s.]). No significant difference was found postoperatively in PROMs between the MAT and the MAT+ group; however, differences in the KOOS Symptoms, Sports and Quality-of-life subscales reached the minimal clinically important threshold. Mean values were: IKDC 61.2 (±13.9) versus 64.7 (±23.2), KOOS Total 72.8 (±14.9) versus 68.0 (±16.7), Lysholm score 83.2 (±11) versus 84.2 (±8.7) and EQ-5D-5L 71.8 (±14.9) versus 72.2 (±22.4). Median values for the Tegner Activity Scale were 4 versus 3. PASS statement was negative in 37.5% of the MAT+ group in comparison to 20% of the MAT group (n.s.). In terms of patient-reported outcomes, MAT is an effective and safe procedure, even when combined with revision ACLR + LET. Compared to the preoperative assessment, a significant improvement of the postoperative PROMs can be expected either when MAT is performed isolated or in combination with ACLR + LET. However, clinically important differences between the two groups can be noted in favour of the isolated MAT procedure, especially regarding symptoms and sporting activity. Level III.

Safety and effectiveness of integrative Korean medicine for the management of patients sustaining injuries in traffic accidents during pregnancy: A retrospective chart review and questionnaire survey.

The number of traffic accidents (TAs) is rising each year, and the severity of injuries can vary. Many people experience limitations in activities of daily living following TAs, affecting their quality of life. In pregnant women, even simple injuries caused by a TA could lead to unfavorable obstetric outcomes. Thus, we conducted a retrospective chart review and follow-up questionnaire survey to assess the safety and effectiveness of integrative Korean medicine (KM) treatment for pregnant women injured in TAs. To assess integrative KM effectiveness, the numeric rating scale (NRS) for TA-related symptoms, neck disability index (NDI) score, Oswestry disability index (ODI) score, shoulder pain and disability index score, Western Ontario and McMaster Universities Arthritis Index score, EuroQol 5-dimension 5-level (EQ-5D-5L) score, and patient global impression of change score were investigated for pregnant women injured in TAs. Additionally, for safety evaluation, obstetric and neonatal outcomes, as well as symptoms related to pregnancy, were assessed. At the end of treatment and follow-up, there were significant reductions in NDI and ODI scores, as well as NRS for neck pain, lower back pain, and headache, compared to scores at baseline. EQ-5D-5L scores significantly increased. A follow-up of 50 patients showed no major differences in obstetric and neonatal outcomes compared to the typical outcomes that occur in pregnant women and neonates. Major improvements were observed in the symptoms of patients who underwent integrative KM treatment after being injured in TAs. The symptoms occurred at a rate similar to those in typical pregnant women, while causality with integrative KM treatment was assessed to be unlikely or unclear. Therefore, integrative KM treatment may be considered an alternative treatment option for pregnant women who currently have limited treatment options.

Internal Responsiveness of EQ-5D-5L and EORTC QLQ-C30 in Dutch Breast Cancer Patients during the First Year Post-Surgery: A Longitudinal Cohort Study.

The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care.

Effect of aquatic exercise versus aerobic exercise on primary dysmenorrhea and quality of life in adolescent females: Arandomized controlled trial.

Primary dysmenorrhea leads to significant gynecological consultations, school absenteeism, disrupted daily activities, and adversely affects overall quality of life (QOL). This study compared the effects of aquatic exercise versus aerobic exercise on primary dysmenorrhea and QOL in adolescent females. Sixty adolescent females suffering from primary dysmenorrhea with moderate to severe intensity were distributed randomly and equally into two groups was registered at ClinicalTrials.gov (NCT06129708) the Registration Date, November 13, 2023; group A was treated by aquatic exercise for 12weeks, while group B was treated by aerobic exercise for 12weeks. Assessment of both groups before and after treatment involved evaluating dysmenorrhea severity using the WaLIDD Score, measuring pain intensity with the numeric pain rating scale (NPRS), determining pressure pain threshold (PPT) with an algometry, and evaluating the QOL using EuroQol-5 Dimension-3 Level (EQ-5D-3L) and EuroQol-visual analog scale (EQ-VAS). Both groups, A and B, experienced significant reductions in the WaLIDD score, NPRS, and all domains of EQ-5D-3L (p<0.05), coupled with significant increases in PPT and EQ-VAS (p<0.05). Posttreatment comparisons between the groups showed insignificant differences in WaLIDD score, NPRS, and PPT (p>0.05). However, there was a significant decrease in EQ-5D-3L and a significant increase in EQ-VAS, favoring group A (p<0.05). Both aquatic and aerobic exercises are effective methods in primary dysmenorrhea management and QOL improvement in adolescent females, with a better effect of aquatic exercise in enhancing QOL.

Matched vs Nonmatched Placebos in a Randomized Trial of COVID-19 Treatments

Matched placebo interventions are complex and resource intensive. Recent evidence suggests matched placebos may not always be necessary. Previous studies have predominantly evaluated potential bias of nonmatched placebos (ie, differing on dose, frequency of administration, or formulation) in pain and mental health, but to date no systematic examination has been conducted in infectious disease. To test for differences between nonmatched and matched placebo arms with respect to clinical outcome measures across multiple therapeutics for COVID-19. In a comparative effectiveness research study, a post hoc analysis was conducted of data on individual patients enrolled in a large, multiarm, platform randomized clinical trial in symptomatic adult outpatients with COVID-19 between January 15, 2021, to September 28, 2023, in which the outcomes of both matched and nonmatched placebo groups were reported. Bayesian and frequentist covariate-adjusted techniques were compared with 7 intervention-placebo pairs. Seven matched and nonmatched placebo pairs (for a total of 7 comparisons) were evaluated throughout the primary platform trial. Comparisons were made between treatment and its associated matched (concurrent) placebo, as well as with nonmatched placebo (alone and in combination) assessed at a similar time point. Outcomes assessed included hospitalizations, EuroQol 5-Dimension 5-level scores, and PROMIS Global-10 scores. A total of 7 intervention-control pairs (N = 2684) were assessed, including 1620 (60.4%) women, with mean (SD) age, 47 (15.2) years; the most common comorbidities were obesity (41.9%) and hypertension (37.9%). In a meta-analysis with decoupled SEs, accounting for overlapping placebo patients, the overall odds ratio (OR) of nonmatched compared with matched placebo was 1.01 (95% credible interval, 0.77-1.32), with posterior probability of equivalence, defined as 0.8 ≤ OR ≤ 1.2 (a deviation from perfect equivalence ie, OR = 1, by no more than 0.2) of 85.4%, implying no significant difference. Unadjusted analysis of the event rate difference between all nonmatched and matched placebo groups did not identify any notable differences across all 7 treatment-placebo combinations assessed. Similar analysis that was conducted for patient-reported quality of life outcomes did not yield statistically significant differences. In this post hoc study of a randomized clinical platform trial, pooling matched and nonmatched placebo patient data did not lead to inconsistencies in treatment effect estimation for any of the investigational drugs. These findings may have significant implications for future platform trials, as the use of nonmatched placebo may improve statistical power, or reduce barriers to placebo implementation.

Dapagliflozin and quality of life measured using the EuroQol 5-dimension questionnaire in patients with heart failure with reduced and mildly reduced/preserved ejection fraction.

Although much is known about the usefulness of heart failure (HF)-specific instruments for assessing patient well-being, less is known about the value of generic instruments for the measurement of health-related quality of life (HRQL) in HF. The aim of this study was to assess the relationship between the EuroQol 5-dimension 5-level (EQ-5D-5L) visual analogue scale (VAS) and index scores, clinical characteristics, and outcomes in patients with HF and the effect of dapagliflozin on these scores. We performed a patient-level pooled analysis of the DAPA-HF and DELIVER trials, which investigated the effectiveness and safety of dapagliflozin in patients with HF and reduced ejection fraction (HFrEF) and mildly reduced/preserved ejection fraction (HFmrEF/HFpEF), respectively. Patients reporting higher (better) EQ-5D-5L VAS and index scores had a lower prevalence of comorbidities, including atrial fibrillation and hypertension, than patients with a worse score. They were also more likely to have better investigator-reported (New York Heart Association class) and patient-self-reported (Kansas City Cardiomyopathy Questionnaire) health status and lower median N-terminal pro-B-type natriuretic peptide levels. Compared to patients with the lowest scores (Q1), those with higher EQ-5D-5L VAS scores had better outcomes: the hazard ratio for the composite of cardiovascular death or worsening HF was 0.81 (95% confidence interval 0.72-0.91) in Q2, 0.74 (0.65-0.84) in Q3, and 0.62 (0.54-0.72) in Q4. The risk of each component of the composite outcome, and all-cause death, was also lower in patients with better scores. Similar findings were observed for the index score. Treatment with dapagliflozin improved both EQ-5D-5L VAS and index scores across the range of ejection fraction. Both higher (better) EQ-5D-5L VAS and index scores were associated with better outcomes. Dapagliflozin treatment improved EQ-5D-5L VAS and index scores, irrespective of ejection fraction.

Long-Term Health-Related Quality of Life in Working-Age COVID-19 Survivors: A Cross-Sectional Study

BackgroundMost working-age (18-64) adults have been infected with SARS-CoV-2, and some may have developed post-COVID-19 condition (PCC). However, long-term health-related quality of life (HRQOL) following infection remains uncharacterized. MethodsIn this cross-sectional study, COVID-19 survivors from throughout British Columbia (BC), Canada, completed a questionnaire >2 years after infection. PCC status was self-reported, and HRQOL was assessed using the EuroQol 5-dimension 5-level (EQ-5D-5L) instrument. We compared HRQOL in those with current PCC, those with recovered PCC, and those without a history of PCC. Multivariable analyses were weighted to be representative of COVID-19 survivors in BC. ResultsOf the 1,135 analyzed participants, 19.2% had current PCC, and 27.6% had recovered PCC. Compared to those without a history of PCC, participants with recovered PCC had a similar mean EQ-5D health utility (adjusted difference -0.02 [95%CI -0.03, 0.00]), but those with current PCC had a lower health utility (adjusted difference -0.08 [95%CI -0.12, -0.05]). Participants with current PCC were also more likely to report problems with mobility (adjusted odds ratio (aOR) 6.00 [95%CI 2.88-12.52]), self-care (aOR 5.96 [95%CI 1.84-19.32]), usual activities (aOR 8.00 [95%CI 4.27-14.99]), pain/discomfort (aOR 4.28 [95%CI 2.46-7.48]), and anxiety/depression (aOR 3.45 [95%CI 1.90-6.27]). ConclusionsIn working-age adults who have survived >2 years following COVID-19, HRQOL is high among those who never had PCC or have recovered from PCC. However, individuals with ongoing symptoms have lower HRQOL and are more likely to have functional deficits. These findings underscore the importance of implementing targeted healthcare interventions to improve HRQOL in adults with long-term PCC.

Construct validation of the Japanese Core Outcome Measures Index and the impact of diseases on patient-reported outcome measures in preoperative patients with lumbar spinal stenosis and disk herniation: a single-center observational study

PurposeThe primary objective was to validate the construct validity of the Japanese Core Outcome Measures Index (COMI) in preoperative patients aged 60 years or older undergoing lumbar spine surgery for lumbar spinal stenosis (LSS) and lumbar disk herniation (LDH). Additionally, as a secondary aim, we explored the impact of these diseases on quality of life (QOL).MethodsThe analysis included 199 preoperative patients aged 60 and above who were scheduled for lumbar spine surgery. To assess QOL, Japanese versions of the COMI, Oswestry Disability Index (ODI), EuroQol-5 Dimension-3 Level (EQ-5D-3L), and SF-12v2 were employed. The study assessed the validity of the COMI and compared demographic and clinical characteristics between the LSS (147 cases) and LDH (52 cases) groups. It used multivariate covariance analysis (MANCOVA) to examine the impact of diseases (LSS and LDH) on each patient-reported outcome measure while considering covariates.ResultsCompared to the LSS group, the LDH group showed more difficulty with the COMI summary score (LSS/LDH [mean]: 6.9/8.1, p < 0.001), ODI score (46.8/57.4, p < 0.001), and EQ-5D utility (0.53/0.43, p < 0.001). The LDH group also reported more difficulties in the COMI-function, COMI-symptom-specific well-being, COMI-disability, ODI-personal care, ODI-social life, and SF-12v2-bodily pain subscales. MANCOVA demonstrated that these results were not influenced by covariates such as gender and medical history.ConclusionsThis study highlights the distinct impact of LSS and LDH on preoperative QOL in older patients undergoing lumbar spinal surgery. Tailored interventions are essential to address the specific challenges posed by these conditions and improve patient-centered outcomes and postoperative recovery.