EuroQol-5 Dimensions Research Articles

User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial.

Energy storing and return (ESAR) prosthetic feet often provide high energy return at the cost of increased foot height, compromised appearance, and reduced flexibility. An ESAR foot, Ottobock Evanto, with a novel compact design has been introduced (novel foot). To characterize user preference and benefits of a novel foot compared with the subject's previously worn (everyday foot) and comparator foot, Össur Pro-Flex XC.Study Design:Multicenter, randomized, nonblinded, cross-over trial (ClinicalTrials.gov,NCT05628064). Transtibial amputees using ESAR feet were eligible. Outcome measures included perceived mobility, the extent of meeting amputees' needs, pain intensity, EuroQol 5-Dimension 5-Level, Activities-specific Balance Confidence, pain interference, foot preference, and walking experience. The first 3 measures with the novel foot vs. the everyday and comparator feet were used for primary objectives. Data from 20 participants were analyzed. For all primary outcomes, improved scores while wearing the novel foot were obtained. The change in perceived mobility vs. the everyday foot score was highly significant (P = 0.0007). The novel foot was the most preferred foot overall (55% participants) and for many activities, e.g., walking on inclines (85%) and over uneven terrain (70%). Participants confirmed that the novel foot made walking up slopes easier (95%), standing more flexible (85%), and heel strike more comfortable (85%) vs. their everyday feet. The novel foot offers advantages compared with the tested feet, including making walking on uneven terrain and slopes easier and more comfortable heel strike. Activities in which the novel foot would perform worse than the other feet have not been reported.

Impact of postoperative cauda equina clumping on recovery after biportal endoscopic decompression for severe lumbar stenosis.

This study determined the prevalence of cauda equina clumping among patients with Schizas grade C or higher central stenosis after decompression and compared the radiographic and clinical outcomes between patients with and without clumping. We conducted a single-center retrospective cohort study involving 98 patients who underwent biportal endoscopic spine surgery between January 2019 and June 2022. Based on postoperative magnetic resonance imaging findings, the patients were divided into the clumping (n = 40) and non-clumping (n = 58) groups. Clinical outcomes were assessed using the visual analog scale for back and leg pain, Oswestry Disability Index (ODI), and EuroQol 5-Dimension (EQ-5D-5L) questionnaire at 1, 3, 6, and 12 months postoperatively. Radiographic evaluations included measuring the cross-sectional area of the dural sac preoperatively and 1 month postoperatively using the PACS software. Postoperative cauda equina clumping was observed in 40.8% of the patients. Despite an average dural sac expansion of approximately 270%, the clumping group exhibited significantly higher radiating pain at 3 and 6 months (p < 0.05) than the non-clumping group. The ODI and EQ-5D scores were worse in the clumping group at 3 months (p < 0.05). At 12 months postoperatively, differences in clinical outcomes between the two groups were not significant. Patients in the clumping group required longer duration of postoperative medication than those in the non-clumping group (p = 0.024). Post-decompression cauda equina clumping is commonly observed in patients with severe lumbar stenosis and impacts intermediate-term clinical recovery. Although long-term outcomes at 1 year are similar, tailored postoperative care is essential for patients exhibiting clumping to effectively manage prolonged symptoms.

Factors influencing the decision to receive total knee replacement among patients with severe knee osteoarthritis under universal health insurance coverage

This study aimed to investigate the factors influencing the decision of patients with severe knee osteoarthritis, who are covered by universal health insurance, to undergo total knee replacement (TKR) surgery, as recommended by orthopedic physicians. A questionnaire survey was used to collect participants’ demographics, socio-economic status, medical history, baseline Oxford Knee Score (OKS), and EuroQol-5 Dimension Questionnaire (EQ-5D). We included 704 patients with severe knee osteoarthritis, of which 487 underwent TKR (surgery group), while 217 did not (non-surgery group). Descriptive statistics was used to compare the characteristics of patients in the two groups, while logistic regression identified the factors influencing patients’ choice for TKR. Patients aged 75–79 or older were less likely to undergo TKR; those with poorer OKS (OR = 0.83, 95% CI: 0.79–0.86) and lower EQ-5D VAS scores (OR = 0.97, 95% CI: 0.95–0.99) were more likely to undergo TKR. Household income did not significantly affect the decision of the patients to undergo surgery. In conclusion, for patients with severe knee osteoarthritis, the impact of joint discomfort on function and quality of life is the primary factor influencing their decision to undergo TKR, while economic factors do not have a significant impact under the provision of universal health insurance coverage.

Pain characteristics in patients with hip osteoarthritis

PurposeExacerbations of osteoarthritis (OA) pain significantly impair activities of daily living and walking, thereby reducing quality of life. Despite various treatments, persistent pain remains a challenge, particularly in patients with hip OA, where pain perception mechanisms extend beyond nociceptive pain. This study examined the pain characteristics in patients with hip OA, with an emphasis on neuropathic pain and central sensitization (CS). MethodsA total of 421 patients scheduled for unilateral total hip arthroplasty were analyzed using the painDETECT score and Central Sensitization Inventory to classify the pain types as nociceptive (Noc), CS, neuropathic (Neu), or neuropathic with CS (NeuCS). ResultsThe results indicated that 72.9% of patients experienced Noc pain, while 5.0% experienced combined NeuCS pain. The Neu and NeuCS groups exhibited significantly lower modified Harris Hip Score and EuroQol-5 Dimensions Questionnaire (EQ-5D) scores than the Noc group, indicating worse clinical outcomes and quality of life. Neu pain was more intense at rest, and when combined with CS it significantly diminished the quality of life. ConclusionThese findings highlight the need for mechanism-based pain treatment strategies, such as Neu pain and CS components, which independently and cumulatively affect clinical scores and quality of life. This study highlights the importance of early recognition and targeted treatment of these pain mechanisms in patients with hip OA. Future research should focus on evaluating therapeutic interventions for Neu pain and CS to optimize patient outcomes.

Health utility attributable to oral conditions in Japanese adults.

Utility values enable relative comparisons across various health conditions, providing information for efficient allocation of healthcare resources. This study aimed to (1) quantify the utility values attributable to oral health-related quality of life (OHRQoL) in Japanese adults and (2) develop models for converting the 14-item Oral Health Impact Profile (OHIP-14) scores into EuroQoL 5-dimension 5-level (EQ-5D-5L)-based utility values. This was a cross-sectional study. Data from a large-scale Internet survey of Japanese adults conducted in 2022 (n = 28 405; mean age 48.2 years) were analysed. Multiple linear regression models were fitted to investigate the association between OHIP-14 scores and EQ-5D-5L-based utility values, adjusting for confounders. Conversion models were developed using a random half of the participants, and the observed and predicted utility values in the other half were compared to evaluate the model performance. Among the participants, 55.2% scored 0, 20.9% scored 1-5 and 23.9% scored 6-56 on the OHIP-14, corresponding mean utility values of 0.93, 0.90 and 0.84, respectively. A one-point increase in the OHIP-14 score was associated with a lower utility value (coefficient: -0.0053; 95% confidence interval:health-related quality of life -0.0056, -0.0051). The estimated utility value attributable to OHIP-14 was -23.3 per 1000 individuals, greater than that for other prevalent chronic conditions, including hypertension and diabetes (-2.9 and -7.1 per 1000 individuals, respectively). The conversion model incorporated the OHIP-14 total score, age, sex and self-rated health, predicted utility scores on average and captured differences according to the number of teeth lost. However, there was a discrepancy between predicted and observed utility values in the lower utility value groups. OHRQoL substantially impacted utility values at the population level. The OHIP-14 holds the potential as a valuable tool for predicting average utility values based on oral health conditions; however, the prediction performance was relatively low for individuals with a lower health-related quality of life.

Efficacy and Safety of Virtual Reality-Based Versus Traditional Emotion-to-Emotion Therapy for Treatment of Hwa-Byung: A Protocol for a Single-Center, Randomized, Assessor-Blind, Parallel-Group Clinical Trial

Background: Hwa-Byung is a culturally bound syndrome prevalent in Korea, characterized by intense emotional distress and physical symptoms related to suppressed anger. Patients frequently report experiencing chest tightness, heat sensations, and globus pharyngeus (the sensation of a lump in the throat). These physical symptoms often accompany psychological distress and can exacerbate the sense of frustration and helplessness associated with the condition. The distinctive presentation of these symptoms highlights the necessity for therapeutic interventions that address both the emotional and physical aspects of Hwa-Byung. Conventional therapeutic methods, such as Emotion-to-Emotion Therapy (ETE), have shown efficacy in treating this condition. This study aims to assess the efficacy of Virtual Reality-based Emotion-to-Emotion Therapy (VR-based ETE) compared to conventional ETE, utilizing immersive digital platforms to enhance therapeutic engagement. Methods: This single-center, randomized, assessor-blind, parallel-group clinical trial will enroll 96 participants, evenly divided into two experimental groups and one control group. Over eight weeks, each participant will undergo 12 intervention sessions. Experimental group 1 will receive conventional ETE, experimental group 2 will receive VR-based ETE, and the control group will receive Hwa-Byung management training materials. The primary outcome will be the change in symptoms, measured by the Likert Scale for Major Symptoms of Hwa-Byung from baseline to 8 weeks. Secondary outcomes will include psychometric scales and physiological measures such as the core seven-emotions inventory short form, physical health questionnaire, stress response index, Beck depression inventory, state-trait anger expression inventory, state-trait anxiety inventory, functional near-infrared spectroscopy, and heart rate variability. For economic efficiency assessment, quality-adjusted life-years will be the primary outcome using the EuroQol-5 dimension, and the secondary outcome will be using the EuroQol visual analog scale. Discussion: ETE is a recognized oriental psychotherapy that enhances symptom management, self-regulation, and stress coping. VR is expected to deepen treatment immersion. By combining these strengths, VR-ETE may further improve emotion regulation and alleviate psychosomatic symptoms. If successful, this study will not only advance the treatment of Hwa-Byung but also contribute to the modernization of traditional Korean medicine through the integration of digital therapies.

The association between locomotive function and incidence of proximal junctional kyphosis following adult spine deformity surgery

Background and objectivesThis retrospective review study aimed to determine whether functional mobility test (FMT) results are related to the incidence of proximal junctional kyphosis (PJK) after surgical correction of adult spinal deformity (ASD).MethodsA total of 157 patients who underwent reconstructive spinal surgery for ASD between July 2019 and December 2021 were included in this study. Three types of FMTs were performed preoperatively: timed-up-and-go (TUG) test, five times sit-to-stand (STS) test, and alternate step (AS) test. The primary outcome measure was the occurrence of PJK at 1 year after surgery. Oswestry disability index (ODI) and EuroQOL-5-dimension (EQ-5D) scores were surveyed as patient-reported outcome measures of the surgery.ResultsThe occurrence of PJK was observed in 41 of the 157 patients (26.1%) at 1 year after surgery. Among the three functional mobility tests, STS test results were significantly higher in the patients who developed PJK. The receiver operating characteristics curve drawn with the STS test had an area under the curve of 0.69 and the optimal cutoff value was suggested as 22 seconds. Multivariate logistic regression analysis identified the STS test along with age and preoperative ODI score as the significant predictors of PJK (p = 0.026, 0.005 and 0.001, respectively).ConclusionsA longer test time on the STS test result was associated with a higher occurrence of postoperative PJK. A cutoff value of 22 s can be suggested. Preoperative surveillance of these patients and providing additional efforts and surgical procedures for the prevention of PJK are anticipated to improve the surgical outcome of ASD correction.

Comparison of clinical and radiologic outcomes between biportal endoscopic transforaminal lumbar interbody fusion and posterior lumbar interbody fusion

Biportal endoscopic spinal surgery has become increasingly popular, and indications have expanded. Among these, biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) has yielded good results. Herein, we compared the clinical and radiological outcomes of 155 patients treated with BE-TLIF and open posterior lumbar interbody fusion (PLIF) for single-level lumbar degenerative diseases. Clinical outcomes included the visual analog scale for the back (VAS-back) and leg (VAS-leg), Oswestry Disability Index, and EuroQol 5-Dimensions. Radiological parameters and fusion rates were evaluated, and postoperative complications were recorded. In this cohort 68 and 87 patients were treated with BE-TLIF and PLIF, respectively. Both groups showed significant improvements in all clinical parameters compared with baseline, but BE-TLIF exhibited a more significant improvement in VAS-back at 1 and 6 months postoperatively. There were no significant differences in the radiological parameters or fusion rates. BE-TLIF had a significantly longer operation time, whereas PLIF exhibited a significantly higher estimated blood loss and surgical drainage, but no significant differences in postoperative complications. Compared to PLIF, BE-TLIF showed similarly good clinical and radiologic outcomes, with better results in terms of early postoperative outcomes. Thus, BE-TLIF is a viable alternative to PLIF with less back pain at 1 and 6 months postoperatively.

Effectiveness of a Video-Conference Cognitive Behavioral Therapy for Patients with Schizophrenia: A Pilot Randomized Controlled Trial.

Background: Cognitive behavioral therapy for psychosis (CBTp) is not widespread enough in clinical practice, although evidence has been presented. Objective: The purpose of this study was to explore whether one-on-one CBTp using video-conference (vCBTp) was more effective than usual care (UC) treatment alone in improving psychiatric symptoms in patients with schizophrenia attending outpatient clinics. Methods: In this exploratory randomized controlled trial, patients with schizophrenia and schizoaffective disorders who were still taking medication in an outpatient clinic were randomly assigned to either the vCBTp plus UC group (n=12) or the UC group (n=12). The vCBTp was conducted once a week, with each section lasting for 50 min, for a total of seven sessions in real-time and one-on-one format remotely using a loaned tablet computer (iPad). The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score, which measures the difference in the mean change from baseline at week 0 to post-test at week 8. Results: There were 24 participants in the study. There were no significant differences between the two groups at baseline. With regard to significant differences between the two groups on the primary outcome, the mean change in PANSS total score from baseline to week 8 in the vCBTp plus UC group was -9.5 (95% CI -12.09 to -6.91); the mean change in the UC alone group was 6.9 (95% CI 1.54 to 12.30). The difference between the two groups was significant at P<.001. In addition, significant improvements were observed in the subscales of positive (P<.001) and negative (P=.004) symptoms and general psychopathology (P<.001). Significant differences were also observed in the secondary outcomes of the General Anxiety Disorder (GAD-7, P=.042) and the EuroQol 5-dimensions 5-lines (EQ-5D-5L, P=.005). There were no dropouts and no serious adverse events in this study. Conclusions: A total of seven remote vCBTp sessions conducted in the vCBTp plus UC group could be safely administered to patients with schizophrenia. They were also observed to be effective for psychiatric symptoms, general anxiety, and quality of life (QoL). However, because of the observed worsening of scores in the UC group, caution is required in interpreting significant differences between the two groups. This approach is expected to improve accessibility to CBTp for outpatients with schizophrenia and social anxiety about transportation use and financial and physical burdens related to transportation, and to contribute to promoting CBTp acceptability by compensating for the shortage of implementers. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000043396; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049544. RR2-DOI: 10.1136/bmjopen-2022-069734.

Early physiotherapy referral for low back pain reduces healthcare utilisation for advanced imaging and specialist spine surgery consultations.

Low back pain (LBP) is one of the most common presenting complaints among patients and the costliest orthopaedic condition. This study aimed to compare the healthcare utilisation rates of advanced imaging and specialist consultations for LBP between patients presenting with early physiotherapy (EPT) before specialist review and routine physiotherapy (RPT) after specialist review. Consecutive patients who (n = 311) had been referred to specialist spine surgery for LBP in 2021 were retrospectively reviewed. Baseline demographics, healthcare utilisation rates and clinical outcomes were compared between those who attended EPT before spine surgery consultation and those who attended RPT after specialist consultation. There were no significant differences in baseline demographics or clinical outcomes of Visual Analogue Scale pain scores, EuroQol 5-Dimension scores and surgery rates between the EPT (n = 183) and RPT (n = 128) groups. At 6 months follow-up, EPT was associated with significantly lower magnetic resonance imaging (MRI) rates (P = 0.026), decreased likelihood of requiring MRI (odds ratio [OR] 0.865, 95% confidence interval [CI] 0.757-0.990), reduced number of specialist spine surgery consultations (P < 0.001), decreased likelihood of requiring additional specialist consultations (OR 0.770, 95% CI 0.655-0.905), fewer physiotherapy sessions (P = 0.001) and decreased likelihood of requiring additional physiotherapy sessions (OR 0.835, 95% CI 0.553-1.261). Early physiotherapy reduces the (a) overall treatment duration from the first referral by the primary physician, (b) number of advanced imaging ordered (and thus, associated imaging costs), and (c) total number of clinic and therapy sessions, and it is safe and allows patients to achieve comparable functional outcomes to their counterparts undergoing RPT. These findings support the implementation of EPT for patients with LBP to reduce healthcare utilisation and associated costs for patients, providers and healthcare systems.

Systematic literature review and meta-analysis of health state utility values in metastatic castration-resistant prostate cancer.

Despite being an important goal, the preservation of quality of life of patients with metastatic castration-resistant prostate cancer (mCRPC) is poorly characterized across lines of therapy. In this review, a systematic literature review and meta-analysis were conducted to synthesize EuroQoL 5-Dimension (EQ-5D) data among adult men with asymptomatic or mildly symptomatic mCRPC in both first line (1L) and second line and later (2L+) therapy. MEDLINE, Embase, and Cochrane CENTRAL were searched from inception to October 2022 using Ovid. Supplemental searches of other data sources were also conducted (PROSPERO registration: CRD42021283512). Meta-analyses were conducted to estimate pooled EQ-5D index utility values and EQ visual analog scale (VAS) scores in both 1L and 2L+. Various sensitivity analyses were also conducted. Forty-five unique publications met the inclusion criteria. In primary studies, baseline EQ-5D index utility values ranged from 0.7 to 0.9 in 1L and 0.63 to 0.7 in 2L+. Twelve trials and observational studies were feasible for inclusion in the meta-analysis. The pooled mean baseline EQ-5D index utility value was estimated as 0.79 (95% CI, 0.70-0.84) and 0.69 (95% CI, 0.67-0.71) for 1L (n = 7 studies) and 2L + (n = 4 studies), respectively. The pooled mean baseline EQ VAS score was estimated as 74.63 (95% CI, 70.97-78.29) and 65.82 (95% CI, 64.53-67.11) in 1L and 2L+, respectively. Limitations include hampered comparability between studies due to heterogeneity in study design and geographical regions. This study provides a comprehensive synthesis of EQ-5D data presently available in adults with mCRPC in both 1L and 2L + therapy.

Comparison between microendoscopic laminectomy and open posterior decompression surgery for two-level lumbar spinal stenosis: a multicenter retrospective cohort study

BackgroundExcellent surgical outcomes of microendoscopic laminectomy (MEL) have been reported for patients with lumbar spinal canal stenosis (LSCS). However, few reports have directly compared MEL with open laminectomy for multi-level LSCS. This study conducted a comparative analysis of patient-reported outcomes (PROs) and perioperative complications in patients undergoing two-level posterior decompression for LSCS by MEL versus open laminectomy.MethodsThis multicenter retrospective cohort study involved prospectively registered patients who underwent two-level posterior lumbar decompression surgery for LSCS at one of eight high-volume spine centers between April 2017 and February 2020. Chart sheets were used to prospectively evaluate demographic data, including diagnosis, operative procedure, operation time, estimated blood loss, and perioperative complications. The PROs evaluated were the numerical rating scale (NRS) score for lower back pain and leg pain, 12-item Short Form Health Survey (SF-12) score, EuroQol 5-Dimension (EQ-5D) score, Oswestry Disability Index (ODI) score, and patient satisfaction with the treatment.ResultsOf the 882 patients enrolled, 410 underwent MEL (MEL group) and 472 underwent open decompression (open group). A total of 667 (75.6%) patients completed the 1-year follow-up. Intraoperative blood loss was significantly lower in the MEL group than in the open group. The complication rate was comparable (12.4% in MEL group, 12.5% in open group). Although the revision rate did not differ significantly, the incidence of surgical site infection (SSI) was markedly lower in the MEL group (0.0% in MEL group, 1.3% in open group). Propensity score matching was employed to compare 333 patients who underwent MEL with 333 patients who underwent open laminectomy. Intraoperative blood loss was significantly lower in the matched MEL group than in the matched open group. The incidence of SSI was markedly lower in the matched MEL group (0.0% in matched MEL group, 1.2% in matched open group). No significant differences in the preoperative and postoperative values of the PROs or patient satisfaction were observed between the two groups.ConclusionsMEL required an equivalent operating time and resulted in less intraoperative blood loss compared with laminectomy in two-level procedures. The incidence of SSI was significantly lower in the MEL group.

Smoking Does Not Negatively Impact Outcomes Following Cervical Laminoplasty: A Quality Outcomes Database Study.

Retrospective cohort study. To assess the impact of smoking on outcomes following elective cervical laminoplasty for degenerative cervical myelopathy (DCM). The detrimental effect of cigarette smoking on cervical spinal fusion surgery outcomes is well documented. However, the impact of smoking on outcomes following nonfusion cervical spine procedures is unknown. One commonly utilized nonfusion technique for cervical decompression is laminoplasty. Adult smokers or nonsmokers who underwent primary elective laminoplasty for DCM were included. The propensity score (PS) was constructed for being a current smoker based on covariates. Only patients contained in the PS overlapped region were included in the analysis set. Patient-reported outcomes (PROs) at baseline and 12 months postoperation included Visual Analog Scale (VAS) neck and arm pain, neck disability index (NDI)%, EuroQol-5 Dimension (EQ-5D), and modified Japanese Orthopedic Association (mJOA) scores. Other outcomes included perioperative complications, 3-month readmissions/reoperations, and patient satisfaction. Wilcoxon and Pearson tests were used to compare outcomes between smokers and nonsmokers. The study included 132 patients: 30 were smokers (22.7%) and 102 were nonsmokers (77.3%). No significant differences were found at baseline between groups in demographics or medical history. Smokers had significantly worse baseline VAS neck pain (5.7±3.2 vs. 4.4±3.04, P=0.028) and arm pain (5.7±3.5 vs. 4.3±3.2, P=0.045) scores, but all other baseline PROs were not statistically different between groups. No differences were found between smokers and nonsmokers in any 12-month PRO, or in rates of perioperative complications, 3-month readmissions, or 3-month reoperations. On multivariable logistic regression analysis, smoking had no significant impact on any outcome of interest. Clinical and PROs following elective laminoplasty for DCM are not significantly different between smokers and nonsmokers. Laminoplasty should be considered a good surgical option in smokers presenting with DCM.

Effects of Vacuum Phenomenon on Cage Subsidence and Fusion Outcomes in Oblique Lumbar Interbody Fusion: A Cohort Study

Background: Oblique lumbar interbody fusion (OLIF) is a minimally invasive technique used to manage degenerative lumbar conditions. The presence of vacuum phenomenon (VP) and associated endplate sclerosis may increase the risk of cage subsidence. This study evaluated the relationship between VP grade, endplate sclerosis, and subsidence in OLIF. Methods: This retrospective cohort study included 165 patients who underwent a single-level OLIF for lumbar stenosis. Patients were stratified into VP grades (0–3) based on preoperative computed tomography scans. Disc height, endplate sclerosis, and cage subsidence were radiologically assessed. Clinical outcomes, including back and leg pain visual analog scale, Oswestry Disability Index, and EuroQol-5 Dimension, were measured preoperatively and at follow-up. Results: High VP grades were associated with low preoperative disc height and increased endplate sclerosis. Although no significant differences in clinical outcomes or final fusion rates across VP grades were observed, the subsidence rate increased with VP grade, with a significant difference between VP grades 1 and 2 (p = 0.045) and between VP grades 2 and 3 (p = 0.032), indicating that subsidence rates increased as the VP grade advanced. Conclusions: High VP grades, particularly grades 2 and 3, may increase the risk of cage subsidence following OLIF. Therefore, VP grading may be worth considering during surgical planning to reduce the subsidence risk and improve outcomes.

Cost-utility of cochlear implantation in single-sided deafness and asymmetric hearing loss: results of a randomized controlled trial.

To determine the Incremental Cost-Utility Ratio (ICUR) of cochlear implantation in the treatment of adult patients with single-sided deafness (SSD) and asymmetric hearing loss (AHL). This prospective multicenter pragmatic study including a randomized controlled trial (RCT) enrolled 155 subjects with SSD or AHL. Subjects chose a treatment option between: abstention, Contralateral Routing Of the Signal hearing aids, Bone Conduction Device or Cochlear Implant (CI). Participants who opted for CI were then randomized between two arms: "immediate CI" where the cochlear implantation was performed within one month and "initial observation" where subjects were first observed. The ICUR of CI was determined at 6 months follow-up by comparing the two arms. Utility was measured using EuroQoL- 5 dimensions (EQ-5D), to calculate the gain in Quality-Adjusted Life Years (QALY). Individual costs were extracted from the French National Health Insurance database. A Markovian MultiState (MMS) model assessed the ICUR evolution over the lifetime horizon. Among the 155 included participants, 51 opted for a CI and were randomized. For a 6 months follow-up period, the ICUR was €422,279/QALY gained after CI. Using the MMS model, the ICUR of CI decreased to €57,561/QALY at 10 years follow-up, €38,006/QALY at 20 years, and dropped to €26,715 at 50 years. In the participants with severe tinnitus, mean ICUR was €31,105/QALY at 10 years. CI can be considered as an efficient treatment in SSD and AHL from 20 years follow-up in the global population, and before 10 years follow-up in patients with severe associated tinnitus.

Cost-Effectiveness of the National Diabetes Prevention Program: A Real-World, 2-Year Prospective Study.

We evaluated the real-world cost-effectiveness of the National Diabetes Prevention Program (NDPP) for people with prediabetes in a large workforce with employer-sponsored health insurance. We performed difference-in-differences analyses using individual-level health insurance claims and survey data for 5,948 adults with prediabetes who enrolled (n = 575) or did not enroll (n = 5,373) in the NDPP to assess NDPP's effects on health economic outcomes. We assessed direct medical costs for the year before the NDPP enrollment/index date and for 2 years thereafter; EuroQol 5-Dimension 5-level questionnaire (EQ-5D-5L) utility scores at baseline, 1 year, and 2 years; and quality-adjusted life-years (QALYs) over 2 years. We used propensity score weighting to adjust for potential bias due to self-selection for enrollment, multiple imputation to handle missing data, and bootstrapping to produce CIs. We adopted a health care sector perspective and discounted costs and QALYs at 3% annually. Costs were expressed in 2020 U.S. dollars. Compared with nonenrollees, each NDPP enrollee had an average reduction of $4,552 (95% CI -13,231, 2,014) in 2-year total direct medical costs. Cost savings were primarily related to hospitalizations, outpatient visits, and emergency room visits. Compared with nonenrollees, each enrollee had no difference in EQ-5D-5L utility scores at 2 years or QALYs gained over 2 years. The uncertainty analyses found that enrollment in the NDPP had an 88% probability of saving money and 84% probability of being cost-effective at a willingness-to-pay threshold of $100,000/QALY-gained over 2 years. In this real-world population with prediabetes, enrollment in the NDPP was likely to provide cost savings.

A phase 4, multicenter, global clinical study to evaluate discontinuation and rechallenge of pexidartinib in patients with tenosynovial giant cell tumor previously treated with pexidartinib.

Pexidartinib is effective in patients with tenosynovial giant cell tumor (TGCT) for whom surgery is not feasible. Durability of response after discontinuation of pexidartinib and the safety and efficacy of restarting pexidartinib have not been previously recorded. This phase 4 study was designed to mimic the real-world experience with pexidartinib to evaluate the effects of discontinuation of and retreatment with pexidartinib in patients with TGCT who previously benefited from the drug. This was a global, multicenter, phase 4 study that enrolled patients with TGCT who were experiencing clinical benefit from pexidartinib in one of four prior phase 1 or phase 3 studies investigating pexidartinib in the disease. Patients could choose to continue pexidartinib at the same dose (the treatment-continuation cohort) or discontinue treatment with the option to restart pexidartinib (the treatment-free/retreatment cohort). Tumor progression determined by Response Evaluation Criteriain Solid Tumors (RECIST) version 1.1, patient-reported outcomes (the Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS-PF] questionnaire and the EuroQol 5-dimension, 5-level [EQ-5D-5L] visual analog scale), and safety were assessed every 3 months. The primary end point was the proportion of patients in the treatment-free/retreatment cohort who remained treatment-free at month 12 and 24; this did not depend on disease progression. Thirty-two patients were enrolled: 21 chose to enter the treatment-continuation cohort, and 11 entered the treatment-free/retreatment cohort. During the treatment-free period, six of 11 (54.5%) patients in the treatment-free/retreatment cohort had progressive disease (PD) according to RECIST, version 1.1, whereas no patient in the treatment-continuation cohort had disease progression. Over the 24-month study, three of 11 (27.3%) patients in the treatment-free/retreatment cohort restarted treatment because of RECIST version 1.1 PD, symptomatic progression, or both (n=1 each). The probability of remaining treatment-free in the treatment-free/retreatment cohort was 73% (95% confidence interval, 37%-90%). In the treatment-free/retreatment cohort, the median progression-free survival of the treatment-free period was 22.8 months (95% confidence interval, 1.6 months to not estimable). By 6 months of retreatment, all retreated patients achieved new disease stabilization with no new safety concerns; two patients had clinically significant improvements in PROMIS-PF and EQ-5D-5L visual analog scale scores. The mean PROMIS-PF and EQ-5D-5L scores remained stable throughout the study. There was no hepatotoxicity and no new safety signal in either cohort. In this small phase 4 study designed to evaluate outcomes in patients who stopped and restarted pexidartinib, 54.5% of patients who discontinued pexidartinib showed PD, with a median progression-free survival of 22.8 months. Each of the three patients who restarted pexidartinib stopped progressing, and some reported a new gain in physical function. No PD was detected in patients who remained on treatment, and the safety profile did not indicate long-term hepatotoxicity or any new safety concerns. Pexidartinib is a medication for people with tenosynovial giant cell tumor (TGCT) for whom surgery is not recommended. This study examined what happens when patients stop taking pexidartinib (after it has helped them) to see whether it is safe and effective to restart if needed. Thirty-two patients were followed for 2 years: 21 chose to continue pexidartinib and did not experience disease progression, while 11 chose to stop pexidartinib; 54.5% of them had disease progression within 2 years. Three patients who stopped pexidartinib restarted treatment after their tumor size increased or their symptoms worsened. Restarting pexidartinib was safe and effective in these patients.

Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines

Limited randomized clinical trial data exist on the safety of simultaneous administration of COVID-19 and influenza vaccines. To compare the reactogenicity, safety, and changes in health-related quality of life (HRQOL) after simultaneous vs sequential receipt of messenger RNA (mRNA) COVID-19 vaccine and quadrivalent inactivated influenza vaccine (IIV4). This randomized, placebo-controlled clinical trial was conducted between October 8, 2021, and June 14, 2023, at 3 US sites. Participants were nonpregnant persons aged 5 years or older with the intention of receiving both influenza and mRNA COVID-19 vaccines. Intramuscular administration in opposite arms of either IIV4 or saline placebo simultaneously with mRNA COVID-19 vaccine at visit 1. Those who received placebo at visit 1 received IIV4 and those who received IIV4 at visit 1 received placebo 1 to 2 weeks later at visit 2. The primary composite reactogenicity outcome was the proportion of participants with fever, chills, myalgia, and/or arthralgia of moderate or greater severity within 7 days after vaccination visits 1 and/or 2, using a 10% noninferiority margin. Secondary outcomes were solicited reactogenicity events and unsolicited adverse events (AEs) for 7 days after each visit separately and HRQOL after visit 1, assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. Serious AEs (SAEs) and AEs of special interest (AESIs) were assessed for 121 days. Outcomes were compared between groups. A total of 335 persons (mean [SD] age, 33.4 [15.1] years) were randomized (169 to the simultaneous group and 166 to the sequential group); 211 (63.0%) were female, and 255 (76.1%) received bivalent BNT162b2 mRNA COVID-19 vaccine. The proportion with the primary composite reactogenicity outcome in the simultaneous group (25.6% [n = 43]) was noninferior to the proportion in the sequential group (31.3% [n = 52]) (site-adjusted difference, -5.6 percentage points [pp]; 95% CI, -15.2 to 4.0 pp). Respective proportions in each group were similar after each visit separately (visit 1, 40 [23.8%] vs 47 [28.3%]; visit 2, 5 [3.0%] vs 9 [5.4%]). No significant group differences in participants with AEs (21 [12.4%] vs 16 [9.6%]), SAEs (1 [0.6%] vs 1 [0.6%]), and AESIs (19 [11.2%] vs 9 [5.4%]) were observed in the simultaneous vs sequential groups, respectively. Among participants with severe reactogenicity, the mean (SD) EQ-5D-5L Index score decreased from 0.92 (0.08) to 0.92 (0.09) prevaccination to 0.81 (0.09) to 0.82 (0.12) postvaccination. In this randomized clinical trial assessing simultaneous vs sequential administration of mRNA COVID-19 and IIV4 vaccines, reactogenicity was comparable in both groups. These findings support the option of simultaneous administration of these vaccines. ClinicalTrials.gov Identifier: NCT05028361.

Prognostic nutritional index (PNI) is an independent predictor for functional outcome after hip fracture in the elderly: a prospective cohort study

SummaryThe prognostic nutritional index (PNI) is a useful tool for assessing nutritional status using serum albumin and lymphocyte count. This study indicates that a higher preoperative PNI correlates with improved mobility and health-related quality of life during the initial postoperative period in elderly patients with hip fractures.PurposeTo investigate the prognostic value of the prognostic nutritional index (PNI) in predicting mobility and health-related quality of life (HRQoL) in elderly hip fracture patients after surgery.MethodsWe prospectively involved patients aged 65 and above, who could walk freely before injury and underwent surgery between 2018 and 2019. Admission PNI was calculated as serum albumin (g/L) + 5 × total lymphocyte count (× 109/L). Patients were classified into two groups based on PNI median value. All patients were followed up by telephone for four times (30-day, 120-day, 1-year, and 3-year after surgery). The Fracture Mobility Score (FMS) and EuroQol 5-Dimension 5-Level (EQ-5D 5L) were used to evaluate mobility and HRQoL, respectively.ResultsOf 705 eligible patients, 487 completed all assessments. Patients in the higher PNI group had a significantly increased possibility of achieving unrestricted mobility at the 120-day follow-up (OR 1.69, 95% CI 1.10–2.61, P.adj = 0.017), while no significant differences were observed at other follow-ups. Additionally, patients in the higher PNI group had a significantly higher EQ-5D utility value at the 30-day follow-up (P.adj = 0.015). A linear regression model with adjusting for all confounders showed that admission PNI value was positively associated with EQ-5D utility values at 30-day, 120-day, and 1-year follow-up assessments (P.adj = 0.011, P.adj = 0.001, and P.adj = 0.030, respectively). However, this correlation was not observed at the 3-year time point (P.adj = 0.079).ConclusionThe PNI is a valuable predictor of functional outcomes in elderly patients with hip fractures following surgery.

Development of a Predictive Model for Chewing Difficulty Using EuroQol-5 Dimension Among Korean Older Adults.

We aimed to develop a predictive model for chewing difficulty using the EuroQol-5 dimension measure (EQ-5D). We included 6643 individuals aged ≥ 65 years (mean age: 72.6 ± 4.96 years; women: 3761 [56.6%]) who had completed the sixth (2013-2015) and seventh (2016-2018) Korea National Health and Nutrition Examination Survey (KNHANES). The participants were further divided into young-old (65-74 years) and old-old (≥ 75 years) adults. Data from the sixth KNHANES were used to establish an internal validation model (overall, young-old and old-old adult populations were 3472, 2271 and 1201, respectively). Data from the seventh KNHANES were used to establish an external validation model (overall, young-old and old-old adult populations were 3171, 1879 and 1292 participants, respectively). We evaluated chewing difficulty using the EQ-5D (Model 1) and comparative models, subjective oral health status indicators (SOHSI) and objective oral health status indicators (OOHSI). Compared with SOHSI and OOHSI, EQ-5D showed similar predictive utility for chewing difficulty in both the internal and external validation models. Effect sizes, quantified using Cohen's d, indicated that EQ-5D parameters had a moderate impact on the prediction accuracy for chewing difficulties.