Mean Change Research Articles

Excessive posterior pelvic tilt from preoperative supine to postoperative standing after total hip arthroplasty.

Excessive posterior pelvic tilt (PT) may increase the risk of anterior instability after total hip arthroplasty (THA). The aim of this study was to investigate the changes in PT occurring from the preoperative supine to postoperative standing position following THA, and identify factors associated with significant changes in PT. Supine PT was measured on preoperative CT scans and standing PT was measured on preoperative and one-year postoperative standing lateral radiographs in 933 patients who underwent primary THA. Negative values indicate posterior PT. Patients with > 13° of posterior PT from preoperative supine to postoperative standing (ΔPT ≤ -13°) radiographs, which corresponds to approximately a 10° increase in functional anteversion of the acetabular component, were compared with patients with less change (ΔPT > -13°). Logistic regression analysis was used to assess preoperative demographic and spinopelvic parameters predictive of PT changes of ≤ -13°. The area under receiver operating characteristic curve (AUC) determined the diagnostic accuracy of the predictive factors. PT changed from a mean of 3.8° (SD 6.0°)) preoperatively to -3.5° (SD 6.9°) postoperatively, a mean change of -7.4 (SD 4.5°; p < 0.001). A total of 95 patients (10.2%) had ≤ -13° change in PT from preoperative supine to postoperative standing. The strongest predictive preoperative factors of large changes in PT (≤ -13°) from preoperative supine to postoperative standing were a large posterior change in PT from supine to standing, increased supine PT, and decreased standing PT (p < 0.001). Flexed-seated PT (p = 0.006) and female sex (p = 0.045) were weaker significant predictive factors. When including all predictive factors, the accuracy of the AUC prediction was 84.9%, with 83.5% sensitivity and 71.2% specificity. A total of 10% of patients had > 13° of posterior PT postoperatively compared with their supine pelvic position, resulting in an increased functional anteversion of > 10°. The strongest predictive factors of changes in postoperative PT were the preoperative supine-to-standing differences, the anterior supine PT, and the posterior standing PT. Surgeons who introduce the acetabular component with the patient supine using an anterior approach should be aware of the potentially large increase in functional anteversion occurring in these patients.

The Impact of Hypoglossal Nerve Stimulation on Secondary Health Outcomes.

Objectives: Obstructive sleep apnea (OSA) is a prevalent sleep disorder that can increase the risk of hypertension, diabetes, obesity, and cardiovascular diseases. Hypoglossal nerve stimulation (HGNS) is an alternative therapy for OSA in patients who cannot tolerate continuous positive airway pressure. Understanding the impact of HGNS on blood pressure, hemoglobin A1C (A1C), and body mass index (BMI) currently remains limited. Methods: A retrospective review study of HGNS outcomes at a single practice from January 2020 to November 2022 was conducted. Inclusion/exclusion criteria were based on HGNS eligibility and postoperative titration study. Statistical analysis and data management were performed using statistical software, R (v.4.2.1; R Core Team). Paired Student's T test, Fisher's exact test, and McNemar's exact test were utilized for statistical analysis. P values less than .05 were considered statistically significant. Results: Sixty-three patients were included in this study. A significant decrease in mean apnea-hypopnea index was noted following HGNS (mean change -28; P < .0001). Similar significant decreases were also seen in mean arterial pressures (mean change -8.4, P < .0001). There was a significant change in overall antihypertensive medication requirements and in requirements ≥3 medications (P < .0005, P = .03). There was a trend toward reduction in A1C; however, there was no change in BMI or number of diabetes medications taken. Conclusions: Our results reinforce previous findings that HGNS is an effective treatment option for carefully selected patients with OSA. In addition, our findings suggest that HGNS may improve patients' quality of life while minimizing OSA associated morbidity.

Feasibility of Guided Internet-Based Cognitive Behavioral Therapy for Panic Disorder and Social Anxiety Disorder in Japan: Pilot Single-Arm Trial.

Cognitive behavioral therapy (CBT) is effective in treating anxiety disorders. Accessibility to CBT has been limited in Japan due to the shortage of therapists. While an open-source e-learning system can be used to create a simple internet-based cognitive behavioral therapy (ICBT) program, the safety and outpatient acceptance of this treatment approach have not been explored in Japan. The aim of this study was to investigate whether outpatients with anxiety disorders could accept and successfully complete the ICBT program with guidance by CBT therapists when implementing therapeutic modules and CBT tasks. Due to being in the initial phase of a novel treatment in Japan, this study was intended for verification with a small sample size. In total, 6 adults, including 4 male participants and 2 female participants, were enrolled in a single-arm trial. The intervention involved guided ICBT comprising 12 sessions, including CBT text, comprehension confirmation tests, and explanatory videos about cognitive behavioral models, accessible through a website. The therapist guided the participants in accessing the ICBT program and answering their questions using a chat tool. The primary outcome was anxiety severity assessed using the State-Trait Anxiety Inventory-Trait. Secondary outcomes included the Panic Disorder Severity Scale, Liebowitz Social Anxiety Scale (LSAS), Beck Anxiety Inventory (BAI), Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Working Alliance Inventory-Short Form (WAI-SF). Statistical analyses were performed using paired 2-tailed t tests to assess the changes in clinical symptoms. The total WAI-SF score at the final session was used to evaluate the therapeutic alliance. For statistical analyses, mean changes for total State-Trait Anxiety Inventory-Trait, BAI, Panic Disorder Severity Scale, LSAS, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7 scores were analyzed using the paired 2-tailed t test. The 2-sided significance level for hypothesis testing was set at 5%, and 2-sided 95% CIs were calculated. Most participants diligently engaged with the ICBT program. No adverse events were reported. The mean total scores for the primary outcome decreased by 11.0 (SD 9.6) points (95% CI -22.2 to 0.20; Hedges g=0.95), but it was not statistically significant. The mean total scores for the secondary outcomes that assess clinical symptoms decreased, with a significant reduction observed in the BAI of 15.7 (SD 12.1) points (95% CI -28.4 to -3.0; P=.03; Hedges g=1.24). The mean total scores for PDSS and LSAS decreased significantly, by 12.0 (SD 4.24) points (95% CI -50.1 to 26.1; P=.16; Hedges g=1.79) and 32.4 (SD 11.1) points (95% CI -59.7 to -4.3; P=.04; Hedges g=1.38), respectively. Of the participants, 67% (n=4) showed treatment response, and 50% (n=3) achieved remission after the intervention. The therapeutic alliance, measured using the WAI-SF, was moderate. Guided ICBT may be feasible for the treatment of outpatients with panic disorder and social anxiety disorder in Japan. University Hospital Medical Information Network Clinical Trials Registry UMIN0000038118; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043439.

Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health-Related Quality of Life.

Our objective was to evaluate the ability of Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) remission and low disease activity (LDA) to discriminate active drug from placebo and to discriminate outcomes in the patients' perspective (health-related quality of life [HR-QoL]) in SLE trials. This was a post hoc analysis of the pooled Belimumab in Subjects With SLE (BLISS)-52 (NCT00424476) and BLISS-76 (NCT00410384) trials data. SLE-DAS remission and LDA attainment and discrimination between belimumab and placebo at 52 weeks were compared using chi-square tests. At week 52, 36-item Short Form Health Survey (SF-36) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores were compared between patients attaining SLE-DAS remission versus nonremission and SLE-DAS LDA versus non-LDA using the t-test and Mann-Whitney test. Mean changes from week 0 to 52 in SF-36 and FACIT-F scores were compared between groups using multivariate regression analysis adjusted for baseline scores. At week 52, significantly more patients attained SLE-DAS LDA taking belimumab 1 mg/kg (17.9% vs 13.0%; P = 0.023; odds ratio [OR] 1.459; relative risk [RR] 1.377; number needed to treat [NNT] 20.4) and 10 mg/kg (21.7% vs 13.0%; P < 0.001; OR 1.853; RR 1.668; NNT 11.5) compared with placebo. Likewise, more patients attained SLE-DAS remission taking belimumab 10 mg/kg compared to placebo (14.7% vs 10.1%; P = 0.019; OR 1.532; RR 1.454; NNT 21.7). At week 52, patients attaining SLE-DAS remission and LDA presented higher SF-36 domain and summary scores (all P < 0.001) and FACIT-F scores (both P < 0.001). Mean improvements from baseline in SF-36 and FACIT-F scores were significantly higher in patients achieving SLE-DAS remission and LDA. SLE-DAS remission and LDA showed discriminant ability for identifying patients receiving active drug in SLE clinical trials. Attainment of these SLE-DAS targets are associated with better HR-QoL.

104-week efficacy and safety of cipaglucosidase alfa plus miglustat in adults with late-onset Pompe disease: a phase III open-label extension study (ATB200-07).

The phase III double-blind PROPEL study compared the novel two-component therapy cipaglucosidase alfa + miglustat (cipa + mig) with alglucosidase alfa + placebo (alg + pbo) in adults with late-onset Pompe disease (LOPD). This ongoing open-label extension (OLE; NCT04138277) evaluates long-term safety and efficacy of cipa + mig. Outcomes include 6-min walk distance (6MWD), forced vital capacity (FVC), creatine kinase (CK) and hexose tetrasaccharide (Hex4) levels, patient-reported outcomes and safety. Data are reported as change from PROPEL baseline to OLE week 52 (104 weeks post-PROPEL baseline). Of 118 patients treated in the OLE, 81 continued cipa + mig treatment from PROPEL (cipa + mig group; 61 enzyme replacement therapy [ERT] experienced prior to PROPEL; 20 ERT naïve) and 37 switched from alg + pbo to cipa + mig (switch group; 29 ERT experienced; 8 ERT naive). Mean (standard deviation [SD]) change in %predicted 6MWD from baseline to week 104 was + 3.1 (8.1) for cipa + mig and - 0.5 (7.8) for the ERT-experienced switch group, and + 8.6 (8.6) for cipa + mig and + 8.9 (11.7) for the ERT-naïve switch group. Mean (SD) change in % predicted FVC was - 0.6 (7.5) for cipa + mig and - 3.8 (6.2) for the ERT-experienced switch group, and - 4.8 (6.5) and - 3.1 (6.7), respectively, in ERT-naïve patients. CK and Hex4 levels improved in both treatment groups by week 104 with cipa + mig treatment. Three patients discontinued the OLE due to infusion-associated reactions. No new safety signals were identified. Cipa + mig treatment up to 104 weeks was associated with overall maintained improvements (6MWD, biomarkers) or stabilization (FVC) from baseline with continued durability, and was welltolerated, supporting long-term benefits for patients with LOPD.Trial registration number: NCT04138277; trial start date: December 18, 2019.

Psychometric performance of the CFQ-R-8D compared to the EQ-5D-3L and SF-6D in people with cystic fibrosis.

This study aimed to compare the psychometric performance of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions (CFQ-R-8D), a new, condition-specific, preference-based measure, with that of generic preference-based measures EQ-5D-3L and Short Form 6 dimensions (SF-6D). Data from three trials of participants with CF aged ≥ 14 years who completed the CFQ-R and EQ-5D-3L or SF-6D were used. Analyses were undertaken to evaluate convergent validity based on correlations with CFQ-R domain scores. Known-group validity was assessed based on percent predicted forced expiratory volume in one second and pulmonary exacerbations. Responsiveness was based on correlation of change and sensitivity to change based on change in symptom severity. Effect sizes and standardized response means were estimated. CFQ-R-8D utilities and dimensions were strongly correlated with most of the overlapping CFQ-R domain scores (ρ > 0.5); EQ-5D-3L and SF-6D utilities and dimensions had moderate (ρ > 0.3) to strong correlations in dimensions capturing similar concepts. All measures showed evidence of known-group validity (P < 0.05). Change correlations were strong for CFQ-R-8D utilities and dimensions and CFQ-R, but they were moderate for SF-6D and mostly weak ((ρ > 0.1) for EQ-5D-3L. The SF-6D had the largest mean change over time and effect sizes, followed by CFQ-R-8D and then EQ-5D-3L. Neither CFQ-R-8D or SF-6D utility scores had ceiling effects (< 9% responses in full health) compared with those of EQ-5D-3L (61-62%). In participants classified as being in full health by EQ-5D-3L, CFQ-R-8D captured CF-specific health problems, particularly cough, abdominal pain, and breathing difficulty. The CFQ-R-8D reflected known-group differences and changes over time with stronger evidence of good psychometric performance than EQ-5D-3L and similar evidence as SF-6D. Additionally, the CFQ-R-8D captured more condition-specific symptoms than EQ-5D-3L or SF-6D, which are important determinants of health-related quality of life for people with CF.

Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens: patient-reported outcomes from the phase 3, randomised, open-label KarMMa-3 clinical trial

Chimeric antigen receptor T-cell therapy idecabtagene vicleucel (ide-cel) showed significantly improved progression-free survival compared with standard regimens in adults with relapsed and refractory multiple myeloma who had received two to four previous regimens in the ongoing phase 3 KarMMa-3 trial (NCT03651128). This study analysed patient-reported outcomes (PROs), a KarMMa-3 secondary endpoint. In the randomised, open-label, phase 3 KarMMa-3 trial, 386 patients in hospitals (≥18 years of age, with measurable disease and an Eastern Cooperative Oncology Group performance status score of 0 or 1, who had received two to four previous regimens-including an immunomodulatory agent, a proteasome inhibitor, and daratumumab-and had documented disease progression after receiving their last dose of the last therapy) were randomly assigned to ide-cel (n=254) or standard regimens (daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone; n=132). Patients were expected to complete the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire (QLQ-C30), Multiple Myeloma Module (QLQ-MY20), EQ 5 dimensions (EQ-5D), and EQ-5D visual analogue scale (VAS) at baseline and follow-up timepoints (data cutoff April 18, 2022). PROs included nine prespecified primary domains: EORTC QLQ-C30 GHS-quality of life (QoL), physical functioning, cognitive functioning, fatigue, and pain; QLQ-MY20 disease symptoms and side effects of treatment; and five-level EQ-5D (EQ-5D-5L) index score and EQ-5D visual VAS. Differences in overall least-squares mean changes from baseline to month 20 were analysed using post-hoc constrained longitudinal data analysis. Time to confirmed improvement or deterioration from baseline was analysed using Cox proportional hazard models. Patients were randomly assigned between May 6, 2019, and April 8, 2022. Overall, the median age was 63 years (IQR 55-68); 151 (39%) patients were female; and 250 (65%) patients were White, 36 (9%) Black or African American, 19 (5%) Hispanic or Latino, 12 (3%) Asian, and seven (2%) of other race. The median follow-up was 18·6 months (IQR 14·0-26·4). PRO compliance was higher than 75% throughout. Overall least-squares mean changes from baseline favoured ide-cel with Hedges' g effect sizes from 0·3 to 0·7 for most domains. Patients in the ide-cel group showed statistically significant and clinically meaningful improvements across the primary PRO domains of interest, with the exception of QLQ-MY20 disease symptoms, side effects of treatment, and EQ-5D-5L index score, which showed improvement across assessment visits but did not exceed the within-group minimally important difference thresholds. The ide-cel group had shorter times to clinically meaningful improvement than the standard regimens group in QLQ-C30 domains except in role functioning, diarrhoea, and financial difficulties; in QLQ-MY20 domains except body image; and in EQ-5D-VAS. Ide-cel offers improved health-related quality of life compared with standard regimens for patients with relapsed and refractory multiple myeloma after previous lines of therapy. The PRO data highlight the extended QoL benefits of a one-time infusion with ide-cel compared with continuous treatment with standard regimens in the treatment of triple-class exposed patients with relapsed and refractory multiple myeloma. 2seventy bio and Celgene, a Bristol Myers Squibb Company.

The Influence of Spinous Process Union on Clinical Outcomes After Spinous Process Osteotomy for Lumbar Spinal Stenosis After 2 Years: A Secondary Analysis From the NORDSTEN-Study.

Lumbar spinal stenosis is a prevalent and increasingly important cause of low back pain, leg pain, and walking impairment. Minimally invasive decompressive techniques such as spinous process (SP) osteotomy have become more common in recent years. The main aim of this study was to investigate the proportion of complete SP union and whether complete radiological healing after the osteotomy is associated with superior clinical outcome after 2 years. In this retrospective cohort study, 149 patients were included from the Spinal Stenosis Trial, a part of the NORwegian Degenerative spondylolisthesis and spinal STENosis study. Computed tomography imaging was performed 2 years postoperatively. The number of osteotomies and the number of SP unions were recorded. Patients were divided into groups based on the degree of union: nonunion, partial union, and complete union. Rate of success (>30% improvement in Oswestry Disability Index [ODI]) and mean change in ODI were the primary outcome measures. We compared the differences between baseline and follow-up between the Degree of Union groups. The study included 102 of 149 eligible patients. Ten patients (9.8%) were classified as having nonunion, 15 (14.7%) as having partial union, and 77 (75.5%) as having complete union. Of the 155 osteotomies, there were 122 classified as union (77%). The success rate was 74%, with no influence of SP union. The mean change in the ODI was -20.1 (95% CI -37.0, 14.2) with no influence of SP union. We found no influence of SP union, classified by computed tomography, on clinical outcome 2 years after SP osteotomy in patients with lumbar spinal stenosis. Supplying useful information about SPO to assist surgeons in the choice of decompressive technique.

Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension

PurposeEvaluate the safety and intraocular pressure (IOP)-lowering efficacy of two models of the travoprost intraocular implant (fast-eluting [FE-implant] and slow eluting [SE-implant]) from one of two pivotal trials (GC-010). DesignPhase 3, multicenter, randomized, double-masked, sham-controlled, non-inferiority trial. ParticipantsSubjects with open-angle glaucoma or ocular hypertension, using 0 to 3 IOP-lowering medications at screening and having an unmedicated baseline mean diurnal IOP (average of 8AM, 10AM and 4PM timepoints) of ≥ 21 mmHg, and an unmedicated baseline IOP of ≤ 36 mmHg at each timepoint in the study eye. MethodsStudy eyes were randomized to the travoprost intraocular implant (FE-implant [n=200] or SE-implant [n=197] model) plus twice-daily (BID) placebo eye drops, or to sham procedure plus timolol ophthalmic solution, 0.5% BID (n=193). Main Outcome MeasuresThe primary outcome was mean change from baseline IOP in the study eye at 8AM and 10AM, at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs), corneal endothelial cell counts, visual acuity, and conjunctival hyperemia assessment. ResultsMean IOP reduction from baseline over the 6 timepoints ranged from 6.6 to 8.4 mmHg for the FE-implant group, from 6.6 to 8.5 mmHg for the SE-implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy endpoint was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 timepoints. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2% and 10.8% of subjects in the FE-implant, SE-implant and timolol groups, respectively. The most common AEs included iritis (FE-implant, 0.5%; SE-implant, 5.1%), ocular hyperaemia (FE-implant, 3.0%; SE-implant, 2.6%), visual acuity reduced (FE-implant, 1.0%; SE-implant, 4.1%; timolol, 0.5%), and IOP increased (FE-implant, 3.5%; SE-implant, 2.6%; timolol, 2.1%). There was one serious study eye AE (endophthalmitis). ConclusionsThe travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period following a single administration. The IOP-lowering efficacy of both implant groups was statistically and clinically non-inferior to the timolol group, with a favorable safety profile.

The effectiveness of Chinese instrumental music embedded with binaural beats in relieving anxiety related to academic stress among undergraduates: A randomized controlled trial

The study aimed to determine the effectiveness of binaural beat (BB) Chinese music, with dynamic theta- to delta-frequency progression, in relieving anxiety among Singapore undergraduates. It also examined whether the binaural effects differ between students with high and normal trait anxiety. This was a randomized controlled trial with 151 undergraduates assigned to listen to a single 30 min episode of BB Chinese music, Chinese music, or audiobook. The Perceived Stress Scale (PSS) measured stress, while the state subscale of the State-Trait Anxiety Inventory (STAI-S) and root mean square of successive R–R interval differences (RMSSD) were outcome measures for anxiety. Results indicated that mean STAI-S and PSS reductions were not statistically significant between groups. No significant difference in mean change of RMSSD was detected when the BB Chinese music group was compared with the Chinese music or audiobook groups. However, students with high baseline trait anxiety experienced a greater, marginally significant reduction in STAI-S scores and an increase in RMSSD than those with normal trait anxiety after BB exposure. BB Chinese instrumental music may not have anxiolytic effects on healthy undergraduate populations, as evidence for an anxiolytic effect was observed only among students with high baseline trait anxiety, warranting further research on this population.

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial

Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. Versus Arthritis.

Higher Eccentric Hamstring Muscle Fatigue After Participation in a Soccer Match in Young Female Athletes.

Hamstring (HS) strength deficits and imbalances have been identified as risk factors for sustaining anterior cruciate ligament (ACL) injuries and muscular strains, with HS injuries being the most prevalent muscle injuries in soccer athletes. The aim of this study was to investigate HS eccentric strength before and after a soccer match in both male and female soccer athletes. Soccer athletes have changes in eccentric HS strength after a soccer game. Cohort observational study. Level 3. HS eccentric strength (mean and absolute peak torque and total work) was measured in 64 healthy male and female competitive football athletes (14-25 years) with an automatic device during the execution of the Nordic hamstring exercise (NHE) test before and after a 90-minute soccer match. The anterior-knee laxity (AKL) was quantified with an arthrometer. Mean and absolute eccentric HS peak torque decreased by 24.5 N.m (-12.34%; P < 0.01) and 21.9 N.m (-10.08%; P < 0.01) in female athletes, whereas their male peers improved by 19.9 N.m (+9.01%; P = 0.01) and by 20.9 N.m (+8.51%; P = 0.02), respectively. HS total work in female athletes decreased by 831.1 J (P < 0.01) compared with the male athlete reduction of 235.3 J. Both the pre- versus postmatch intersex mean and absolute eccentric HS peak torque changes were significant (P < 0.01), as were the changes in HS total work (P < 0.01). The pre- versus postmatch AKL difference and the dominant versus nondominant limb comparison of the strength parameters were not significantly different. Younger female athletes (14-19 years old) presented a greater decrease in mean and absolute peak HS eccentric strength compared with those in older female athletes and men. HS eccentric strength and work differ based on athlete sex, as measured by the NHE test. Mean peak, absolute peak, and total work showed greater reductions in female athletes than those in their male peers. The subgroup of 14- to 19-year-old female athletes experienced the highest reduction in strength parameters.

Modification of Woven Endo-Bridge After Intracranial Aneurysm Treatment: A Methodology for Three-Dimensional Analysis of Shape and Relative Position Changes.

During follow-up of patients treated with WEB devices, shape changes have been observed. The quantitative three-dimensional measurement of the WEB shape modification (WSM) would offer useful information to be studied in association with the anatomical results and try to better understand mechanisms implicated in this modification phenomenon. We present a methodology to quantify the morphology and position of the WEB device in relation to the vascular anatomy. Three-dimensional rotational angiography (3DRA) images of seven aneurysms patients treated with WEBs were used, which also accompanied by a post-treatment 3DRA image and a follow-up 3DRA image. The device was manually segmented, obtaining the 3D models after treatment and at the follow-up. Volume, surface area, height, maximum diameter and WSM ratio of both surfaces were calculated. Position changes were evaluated measuring WEB axis and relative position between post-treatment and follow-up. Changes in WEB volume and surface area were observed with a mean modification of and , respectively. The positional variables also showed differences, mean change of device axis direction was and mean change of distance was . Inter-observer and intra-observer variability analyses did not show differences (ANOVA ). This methodology allows quantifying the morphological and position changes suffered by the WEB device after treatment, offering new information to be studied in relation to the occurrence of WEB shape modification.

Effectiveness and safety of alcohol-free minoxidil in the management of treatment-naive patients with androgenetic alopecia

Background: Androgenetic alopecia (AGA) is a common dermatological condition in India, with potentially adverse psychosocial consequences. Here, we assess the effectiveness and safety of an alcohol-free, procapil-based formulation of minoxidil 5% in patients with AGA. Methods: Treatment-naïve, male patients (aged 18 to ≤45 years) with AGA were enrolled in this open-label, single-arm, non-comparative, investigator-initiated study. The change in anagen/telogen ratio (ATR), hair density, and hair shaft thickness from baseline to days 45, 90, 135 and 180, investigator and patients’ global assessment for effectiveness and tolerability, and safety were assessed. A total of 53 men were enrolled. Results: The mean (standard deviation [SD]) age of the study population was 28.3 (6.0) years. The mean (SD) ATR improvement post-treatment with minoxidil 5% was seen from day 90 (mean change: 0.4; p=0.009; 95% confidence interval [CI]: 0.1-0.7) till Day 180 (mean change: 0.4; p=0.011; 95% CI: 0.1-0.6). Improvement in hair density (p&lt;0.01) and hair shaft thickness (p&lt;0.01) across frontal, temporal, and occipital regions was also evident. The investigator assessment for effectiveness was ‘excellent’/’good’/’satisfactory’ for 90% of patients, which corroborated with patients’ assessment (90%) at day 180. All the investigators and patients indicated that minoxidil had ‘good’ tolerability for all patients. No adverse events were reported during the study. Conclusions: Alcohol-free minoxidil 5% was found to have a good safety profile and was efficacious in Indian male patients with AGA, with a high level of patient acceptance.

Neighborhood built and food environment in relation to glycemic control in people with type 2 diabetes in the moving to health study

ObjectiveTo examine whether built environment and food metrics are associated with glycemic control in people with type 2 diabetes.Research Design and Methods: We included 14,985 patients with type 2 diabetes using electronic health records from Kaiser Permanente Washington. Patient addresses were geocoded with ArcGIS using King County and Esri reference data. Built environment exposures estimated from geocoded locations included residential unit density, transit threshold residential unit density, park access, and having supermarkets and fast food restaurants within 1600-m Euclidean buffers. Linear mixed effects models compared mean changes of HbA1c from baseline at 1, 3 (primary) and 5 years by each built environment variable. ResultsPatients (mean age = 59.4 SD = 13.2, 49.5% female, 16.6% Asian, 9.8% Black, 5.5% Latino/Hispanic, 57.1% White, 20% insulin dependent, mean BMI = 32.7±7.7) had an average of 6 HbA1c measures available. Participants in the 1st tertile of residential density (lowest) had a greater decline in HbA1c (−0.42, −0.43, and −0.44 in years 1, 3, and 5 respectively) than those in the 3rd tertile (HbA1c = −0.37 at 1- and 3-years and −0.36 at 5-years; all p-values <0.05). Having any supermarkets within 1600 m of home was associated with a greater decrease in HbA1c at 1-year and 3-years compared to having none (all p-values <0.05). ConclusionsLower residential density and better proximity to supermarkets may benefit HbA1c control in people with people with type 2 diabetes. However, effects were small and indicate limited clinical significance.

Combined repetitive facilitative exercise under continuous neuromuscular electrical stimulation and task-oriented training for hemiplegic upper extremity during convalescent phase after stroke: before-and-after feasibility trial.

Whereas repetitive facilitative exercise (RFE) affects primarily recovery of motor impairment after stroke, task-oriented training (TOT) focuses on facilitating daily use of the affected upper extremity. However, feasibility of combined RFE and TOT has not been reported. We originated "task-oriented RFE," as a new combination therapy for patients with hemiplegic upper extremity after subacute stroke, to examine its feasibility in convalescent rehabilitation wards. This is a before-and-after pilot study. Eight patients with hemiplegic upper extremity after subacute stroke received the task-oriented RFE program for 6 weeks at 80 min per day (20-60 min of TOT applied after 60-20 min of RFE under continuous neuromuscular electrical stimulation) in a convalescent rehabilitation ward. In the current program, we introduced the Aid for Decision-making in Occupation Choice (ADOC) iPad application as a goal-setting method for determining tasks. Feasibility was assessed with adherence to the protocol, adverse events in response to the intervention, and preliminary efficacy. Motor functions, amount of use and quality of movement in the hemiparetic upper extremity, and satisfaction of the patients were evaluated with Fugl-Meyer Assessment (FMA), the Action Research Arm Test (ARAT), the motor activity log (MAL) for the amount of use (AOU) and quality of movement (QOM) of the paralyzed hand, and ADOC. All participants accomplished the program, which was implemented as originally planned; neither nonattendance nor an adverse event occurred during the study. Favorable outcomes were obtained with all measures; mean changes in FMA, ARAT in the dominant hand, MAL-AOU, and MAL-QOM were greater than minimal clinically important differences. Mean changes in ADOC were greater than the minimal detectable change. The task-oriented RFE program was safe, well-tolerated, beneficial, and feasible within 80 min a day of occupational therapy, which means also within the procedural constraints of the Japanese health insurance system during the convalescent phase. Future studies are warranted to examine whether combined RFE and TOT enhances the efficacies of each program alone.

Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis.

To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial. Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100mg every 4weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (throughweek 24 with crossoverto guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (- 23.8% to - 28.0%) and nonwork daily activity impairment (- 26.6% to - 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1-16.4% were not employed at week 100, and 20.0-25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409. Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. Clinicaltrials.gov identifier: NCT03158285.

Exploring the association between cancer and cognitive impairment in the Australian Imaging Biomarkers and Lifestyle (AIBL) study

An inverse association between cancer and Alzheimer’s disease (AD) has been demonstrated; however, the association between cancer and mild cognitive impairment (MCI), and the association between cancer and cognitive decline are yet to be clarified. The AIBL dataset was used to address these knowledge gaps. The crude and adjusted odds ratios for MCI/AD and cognitive decline were compared between participants with/without cancer (referred to as C+ and C− participants). A 37% reduction in odds for AD was observed in C+ participants compared to C− participants after adjusting for all confounders. The overall risk for MCI and AD in C+ participants was reduced by 27% and 31%, respectively. The odds of cognitive decline from MCI to AD was reduced by 59% in C+ participants after adjusting for all confounders. The risk of cognitive decline from MCI to AD was halved in C+ participants. The estimated mean change in Clinical Dementia Rating-Sum of boxes (CDR-SOB) score per year was 0.23 units/year higher in C− participants than in C+ participants. Overall, an inverse association between cancer and MCI/AD was observed in AIBL, which is in line with previous reports. Importantly, an inverse association between cancer and cognitive decline has also been identified.

Efficacy of ravulizumab in patients with generalized myasthenia gravis by time from diagnosis: A post hoc subgroup analysis of the CHAMPION MG study.

The CHAMPION MG study demonstrated that ravulizumab significantly improved Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) total scores versus placebo in adults with acetylcholine receptor antibody-positive generalized myasthenia gravis (AChR+ gMG). This post hoc analysis aimed to assess these outcomes by time from MG diagnosis. Changes from baseline to week 26 in MG-ADL and QMG total scores were analyzed by time from MG diagnosis to study entry (≤2 vs. >2 years). Within each subgroup, least-squares (LS) mean changes for ravulizumab and placebo were compared using mixed models for repeated measures. In ravulizumab-treated patients, differences in LS mean (standard error of the mean) changes from baseline to week 26 were not statistically significant in the ≤2-years subgroup versus the >2-years subgroup for MG-ADL (-4.3 [0.70] vs. -2.9 [0.37]; p = .0511) or QMG (-4.3 [0.94] vs. -2.5 [0.50]; p = .0822) scores. No clear trends were observed in the placebo group. LS mean changes from baseline were significantly greater for ravulizumab versus placebo in both the ≤2 and >2 years from diagnosis subgroups for MG-ADL and QMG scores (all p < .05). The difference in treatment effect between the ≤2-years and >2-years subgroups was not statistically significant. No clinically meaningful between-subgroup differences in treatment-emergent adverse events were observed in ravulizumab-treated patients. Ravulizumab treatment improved clinical outcomes for patients with AChR+ gMG regardless of time from diagnosis. A numerical trend was observed favoring greater treatment effect with earlier versus later treatment after diagnosis. Further studies are required for confirmation.

Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV: Mechanistic Substudy of the REPRIEVE Randomized Clinical Trial.

Cardiovascular disease (CVD) is increased in people with HIV (PWH) and is characterized by premature noncalcified coronary plaque. In the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), pitavastatin reduced major adverse cardiovascular events (MACE) by 35% over a median of 5.1 years. To investigate the effects of pitavastatin on noncalcified coronary artery plaque by coronary computed tomography angiography (CTA) and on inflammatory biomarkers as potential mechanisms for MACE prevention. This double-blind, placebo-controlled randomized clinical trial enrolled participants from April 2015 to February 2018 at 31 US clinical research sites. PWH without known CVD who were taking antiretroviral therapy and had low to moderate 10-year CVD risk were included. Data were analyzed from April to November 2023. Oral pitavastatin calcium, 4 mg per day. Coronary CTA and inflammatory biomarkers at baseline and 24 months. The primary outcomes were change in noncalcified coronary plaque volume and progression of noncalcified plaque. Of 804 enrolled persons, 774 had at least 1 evaluable CTA. Plaque changes were assessed in 611 who completed both CT scans. Of 611 analyzed participants, 513 (84.0%) were male, the mean (SD) age was 51 (6) years, and the median (IQR) 10-year CVD risk was 4.5% (2.6-7.0). A total of 302 were included in the pitavastatin arm and 309 in the placebo arm. The mean noncalcified plaque volume decreased with pitavastatin compared with placebo (mean [SD] change, -1.7 [25.2] mm3 vs 2.6 [27.1] mm3; baseline adjusted difference, -4.3 mm3; 95% CI, -8.6 to -0.1; P = .04; 7% [95% CI, 1-12] greater reduction relative to placebo). A larger effect size was seen among the subgroup with plaque at baseline (-8.8 mm3 [95% CI, -17.9 to 0.4]). Progression of noncalcified plaque was 33% less likely with pitavastatin compared with placebo (relative risk, 0.67; 95% CI, 0.52-0.88; P = .003). Compared with placebo, the mean low-density lipoprotein cholesterol decreased with pitavastatin (mean change: pitavastatin, -28.5 mg/dL; 95% CI, -31.9 to -25.1; placebo, -0.8; 95% CI, -3.8 to 2.2). The pitavastatin arm had a reduction in both oxidized low-density lipoprotein (-29% [95% CI, -32 to -26] vs -13% [95% CI, -17 to -9]; P < .001) and lipoprotein-associated phospholipase A2 (-7% [95% CI, -11 to -4] vs 14% [95% CI, 10-18]; P < .001) compared with placebo at 24 months. In PWH at low to moderate CVD risk, 24 months of pitavastatin reduced noncalcified plaque volume and progression as well as markers of lipid oxidation and arterial inflammation. These changes may contribute to the observed MACE reduction in REPRIEVE. ClinicalTrials.gov Identifier: NCT02344290.