Important Differences Research Articles

Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study

BackgroundThe ability to walk is an important factor in quality of life after stroke. Co-activation of hip adductors and knee extensors has been shown to correlate with gait impairment. We have shown previously that training with a myoelectric interface for neurorehabilitation (MINT) can reduce abnormal muscle co-activation in the arms of stroke survivors.MethodsHere, we extend MINT conditioning to stroke survivors with leg impairment. The aim of this pilot study was to assess the safety and feasibility of using MINT to reduce abnormal co-activation between hip adductors and knee extensors and assess any effects on gait. Nine stroke survivors with moderate to severe gait impairment received 6 h of MINT conditioning over six sessions, either in the laboratory or at home.ResultsMINT participants completed a mean of 159 repetitions per session without any adverse events. Further, participants learned to isolate their muscles effectively, resulting in a mean reduction of co-activation of 70% compared to baseline. Moreover, gait speed increased by a mean of 0.15 m/s, more than the minimum clinically important difference. Knee flexion angle increased substantially, and hip circumduction decreased.ConclusionMINT conditioning is safe, feasible at home, and enables reduction of co-activation in the leg. Further investigation of MINT’s potential to improve leg movement and function after stroke is warranted. Abnormal co-activation of hip adductors and knee extensors may contribute to impaired gait after stroke.Trial registration This study was registered at ClinicalTrials.gov (NCT03401762, Registered 15 January 2018, https://clinicaltrials.gov/study/NCT03401762?tab=history&a=4).

Impact of Wiberg Patellar Type on Outcomes and Survival Following Cell-Based Cartilage Repair for Patellar Chondral Lesions at Midterm Follow-up.

Cell-based cartilage repair procedures of the patellofemoral joint have less reliable outcomes than those of the tibiofemoral joint. No previous studies have evaluated the influence of patellar shape on cell-based cartilage repair outcomes. Patellar dysplasia may predispose patients to worse outcomes after cell-based cartilage repair. The purpose of this study was to evaluate the relationship between Wiberg patellar type and outcomes after cell-based cartilage repair (autologous chondrocyte implantation or particulated juvenile allograft cartilage transplantation) for the treatment of patellar chondral lesions at a minimum 2-year follow-up. It was hypothesized that Wiberg classification of patellar shape would have no effect on patient-reported outcome measures (PROMs) or graft survival. Cohort study; Level of evidence, 3. Patients undergoing autologous chondrocyte implantation or particulated juvenile allograft cartilage transplantation for full-thickness patellar chondral defects between 2016 and 2020 were retrospectively reviewed after institutional review board approval. The change in PROMs, including International Knee Documentation Committee (IKDC), Kujala, and Veterans RAND 12-item Health Survey Mental and Physical scores, from pre- to postoperatively and the percentage of patients who achieved the minimal clinically important difference (MCID) for IKDC and Kujala scores were compared for the Wiberg type A versus Wiberg type B versus Wiberg type C groups. The log-rank test was used to evaluate for differences in survival between subgroups. A total of 59 patients (63 knees) were included, with a mean age of 33.3 ± 8.6 years, median body mass index of 26.0 (IQR, 21.8-30.2), and median follow-up time of 3.5 years (IQR, 2.6-4.2 years). In total, 26 (41%) patellae were Wiberg type A, 29 (46%) were Wiberg type B, and 8 (13%) were Wiberg type C. There were no differences between Wiberg type A versus Wiberg type B versus Wiberg type C groups with respect to change in PROMs from pre- to postoperatively or the percentage of patients who achieved the MCID for IKDC or Kujala scores (P > .05 for all). There were no differences in survival between groups (P = .45). Wiberg patellar type has no effect on patient-reported outcomes or graft survival at midterm follow-up. Patellar dysplasia should not be seen as a contraindication for cell-based cartilage repair procedures.

TECH preserves global cognition of older adults with MCI compared with a control group: a randomized controlled trial

BackgroundCognitive training using touchscreen tablet casual game applications (apps) has potential to be an effective treatment method for people with mild cognitive impairment (MCI).AimsThis study aimed to establish the effectiveness of ‘Tablet Enhancement of Cognition and Health’ (TECH), a novel cognitive intervention for improving/preserving cognition in older adults with MCI.MethodsA single-blind randomized controlled trial with assessments pre-, post-, and at 6-month follow-up was conducted. TECH entailed 5 weeks of daily self-training utilizing tablet apps, facilitated by weekly group sessions. Global cognition was assessed by the Montreal Cognitive Assessment (MoCA), and specific cognitive components were assessed using WebNeuro computerized battery. Short Form Health Survey (SF-12) assessed health-related quality of life (HRQoL). Intention-to-treat analysis was conducted and the %change was calculated between pre–post and between pre–follow-up. Cohen’s d effect size was also calculated.ResultsSixty-one participants aged 65–89 years were randomly allocated to TECH (N = 31, 14 women) or to standard care (N = 30, 14 women). Pre–post and pre–follow-up MoCA %change scores were significantly higher in TECH than control (U = 329.5, p < .05; U = 294.5, p < .05) with intermediate effect size values (Cohen’s d = .52, Cohen’s d = .66). Forty percent of TECH participants versus 6.5% of control participants achieved a minimal clinical important difference in MoCA. Pre–post between-group differences for specific cognitive components were not found and HRQoL did not change.Discussion and conclusionsTECH encouraged daily self-training and showed to preserve global cognition of older adults with MCI. The implementation of TECH is recommended for older adults with MCI, who are at risk for further cognitive decline.

Psychological Health and Ischemic Heart Disease in Women: A Review of Current Evidence and Clinical Considerations across the Healthspan.

Psychological health encompasses a constellation of negative and positive factors-i.e., psychosocial stress, depression, anxiety, trauma, loneliness and social isolation, anger and hostility, optimism, and a sense of purpose. This narrative review presents current evidence at the intersection of psychological health, risk of ischemic heart disease (IHD), and IHD-related outcomes, with an emphasis on associations in women. For women, relations between psychological health and IHD reflect important sex and gender differences in biological and psychosocial factors. Although efforts devoted to understanding psychological health and IHD risk have varied by psychological factor-scientific evidence is strongest for psychosocial stress and depression, while anxiety, trauma, and positive psychological factors warrant more investigation-less optimal psychological health is consistently associated with an earlier and greater risk of IHD morbidity and mortality in women. Still, many past prospective studies of psychological factors and IHD risk had a limited representation of women, did not include analyses by sex, or failed to account for other influential, sex-specific factors. Thus, there are multiple pathways for further, rigorous investigation into psychological health-IHD associations, mechanisms, and empirically supported psychological interventions to mitigate IHD risk among women. Given the robust evidence linking psychological health with women's risk for IHD, implementing routine, brief, psychological screening is recommended. Significant life events, developmental milestones specific to women, and IHD diagnoses or events could cue further psychological assessment and referral, efforts which will mutually strengthen the evidence for integrated psychological and IHD care and delivery of such care to this vulnerable group.

Does Tighter Glycemic Control Beyond Hemoglobin A1c of 8% Improve Outcome for Lumbar Spine Surgery? A MSSIC Study.

Diabetes mellitus is associated with increased risk of postoperative adverse outcomes. Previous studies have emphasized the role of glycemic control in postoperative complications. This study aims to ascertain whether controlling hemoglobin A1c (HbA1c) lower than 8% preoperatively results in meaningful risk reduction or improved outcomes. We used patient-level data from the Michigan Spine Surgery Improvement Collaborative registry, focusing on patients who underwent elective lumbar spine surgery between 2018 and 2021. The primary outcomes were length of stay and the occurrence of postoperative adverse events. Secondary outcomes included patient satisfaction, achievement of a minimum clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System-Physical Function, the EuroQol-5D and NRS of leg and back pain, and return to work. A total of 11 348 patients were included in this analysis. Patients with HbA1c above the thresholds before surgery had significantly higher risks of urinary retention for all 3 possible threshold values (incidence rate ratio [IRR] = 1.30, P = .015; IRR = 1.35, P = .001; IRR = 1.25, P = .011 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively). They also had longer hospital stay (IRR = 1.04, P = .002; IRR = 1.03, P = .001; IRR = 1.03, P < .001 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively) and had higher risks of developing any complication with HbA1c cutoff of 7.5% (IRR = 1.09, P = .010) and 7% (IRR = 1.12, P = .001). Diabetics with preoperative HbA1c above all 3 thresholds were less likely to achieve Patient-Reported Outcomes Measurement Information System MCID at the 90-day follow-up (IRR = .81, P < .001; IRR = .86, P < .001; IRR = .90, P = .007 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively) and less likely to achieve EuroQol-5D MCID at the 2-year follow-up (IRR = .87, P = .027; IRR = .84, P = .005 for the HbA1c cutoffs of 7.5% and 7%, respectively). Our study suggests that reducing HbA1c below 8% may have diminishing returns regarding reducing complications after spine surgery.

Social Determinants of Health in Maryland Hip Arthroscopy Patients.

Background Prior studies have demonstrated racial and socioeconomic disparities in patient-reported outcome measure(PROM) completion rates, and improvement exists across multiple orthopedic conditions. The purpose of this study was to assess whether these disparities are present in patients undergoing hip arthroscopy (HA) procedures. Methods A retrospective study of 306 patients undergoing HA from 2021 to 2023 was performed. Social determinants of health (SDOH) were compared between HA patients and the general Maryland population. Patients were then classified by whether they completed baseline and six-month PROMs (Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) instrument). Patients who completed PROMIS-PF were classified by whether or not they achieved minimal clinically important difference (MCID) at six months. Demographics and SDOH were compared using univariate analyses between patients who did and did not complete PROMs and between those who did and did not achieve MCID. SDOH were evaluated at the zip-code level using regional health information exchange measures. Results Compared to the Maryland population, HA patients resided in areas of lower social vulnerability. Preoperative and six-month PROMs were completed by 102 (33%) patients. No significant differences in demographics or any SDOH were found between patients who did and did not complete PROMs. Six-month MCID was achieved in 75 of 102 (74%) patients with complete PROMs; no significant differences in demographics or SDOH were observed between patients who did and did not achieve MCID. Conclusions For patients undergoing HA, disparities in patient-reported outcome completion rates and postoperative functional improvement do not appear to be present across demographics and SDOH, indicating equitable care is being delivered.

Exercise-Induced Functional Changes in People with Parkinson's Disease following External Cueing and Task-Based Intervention.

The purpose of this study was to evaluate change in motor function, gait speed, dynamic balance, balance confidence, and quality of life (QoL) in nine participants with Parkinson's disease (PwPD) completing Lee Silverman Voice Treatment BIG (LSVT-BIG), an external cueing and task-based intervention. Although supported as an efficacious treatment in PwPD, there is limited research examining clinically meaningful change in outcome measures related to external cueing and task-based interventions. This was a case series of nine PwPD (age range 64-76 years, 55% male) who completed the LSVT-BIG protocol. Disease duration ranged from 1 to 17 years and was classified as moderate in all participants (Hoehn and Yahr = 2 or 3). Outcome measures included motor function (MDS-UPDRS Part III Motor), gait speed, dynamic balance (MiniBEST), Activities-specific Balance Confidence (ABC), and Summary Index for PD Quality of Life 39 (PDQ-SI). Assessments were completed at baseline (BASE), end of treatment (EOT), and 4 weeks after EOT (EOT+4). Minimal detectable change (MDC) or minimal clinical important difference (MCID) was observed in one or more outcome measures in 8 of 9 participants at EOT and EOT+4 across domains of motor function (67%, 78%), gait speed (78%, 67%), balance confidence (44%, 33%), quality of life (44%, 78%), and dynamic balance (22%, 22%). Discussion. In this case series, 8 of 9 participants showed MDC or MCID changes across multiple functional domains. Improvements were observed immediately post (EOT) and 4-week post-treatment (EOT+4) suggesting a temporal component of the LSVT-BIG impact on functional change. Future research should include clinical trials to examine additional external cueing and task-based intervention efficacy with consideration of intensity, frequency, and mode of delivery across disease severity.

Validation of China Health-Related Outcomes Measures-Cardiovascular Disease

ObjectivesChina Health-Related Outcomes Measures (CHROME) was an initiative aimed at developing a system of preference-based health-related quality of life instruments for China. CHROME-cardiovascular disease (CVD) is a CVD-specific instrument with 14 items developed under this initiative. This study aimed to test the psychometric properties of CHROME-CVD. MethodsThis validation study was conducted using cross-sectional questionnaire survey in China. Eligible patients with CVD were recruited and asked to complete the CHROME-CVD, the EQ-5D-5L, and a CVD-specific nonpreference-based health-related quality of life instrument selected according to the confirmed diagnosis of the patients. Item evaluation, internal consistency, measurement invariance, test-retest reliability, structural validity, and construct validity were tested using classic test theory. Item response theory was used to evaluate item-level performance. ResultsA total of 444 patients with CVD (coronary artery disease, n = 276, heart failure, n = 104, angina, n = 33, and atrial fibrillation, n = 16) from 6 provinces in China were enrolled for the validation. Exploratory factor analysis identified 4 factors: chest pain, other symptoms, physical health, and mental and social health. Cronbach’s alpha and intraclass correlation coefficient were >0.8. A total of 20 of 26 (76.9%), and 90 of 95 (94.7%) predefined hypotheses were met for convergent and discriminant validities, respectively. No important difference was identified between subgroups of gender and residency. Response options of 10 items were found overlapped based on categorical response curves, which led to modification to 4-level response options. Wording of 3 items were modified by referring wordings of reference instruments. ConclusionThe validation of the CHROME-CVD demonstrated generally good psychometric properties. Further validation on the modified CHROME-CVD is needed.

Examining the outstanding Euro-Mediterranean drought of 2021–2022 and its historical context

The Euro-Mediterranean region experienced a remarkable drought during the hydrological year 2021/22. Substantial and widespread impacts on water supply systems, agricultural crops, and the production of hydroelectric power were observed. This assessment characterises the drought from a long-term perspective using a multi-index approach and analyses the associated atmospheric circulation at the annual and monthly time scales. The main dynamical forcing of the drought was the unusual recurrence of high-pressure systems over western Europe, at least partly due to an anomalous southward shift in blocking activity and a remarkable occurrence of low-latitude blocks. This led to record-breaking positive geopotential height anomalies over western Europe and a poleward displacement of the North Atlantic eddy-driven jet. Although most of the region was affected by mild drought conditions, the 2021/22 event was not unprecedented in terms of precipitation deficits since other periods of the 20th century (e.g., in the 1920s, 1940s and 1970s) displayed moderate and severe drought conditions over larger areas. However, the 2021/22 drought has been the most intense since at least 1891 because of high atmospheric evaporative demand (AED) values associated with extreme temperatures, especially during the summer of 2022. This enhanced AED also contributed to depleting soil moisture and reducing runoff generation, leading to unprecedented deficits since at least 1965. Finally, we find important differences in the 2021/22 event as compared to other major historical droughts over the Euro-Mediterranean region. In particular, the contrasting effect of AED evidences its increasing role over the last decades and warns about the current risk of experiencing unprecedented droughts.

Clinical Outcomes After Arthroscopic Treatment of Extraspinal Diffuse Idiopathic Skeletal Hyperostosis (DISH) Involving the Hip Joint.

The hip joint can be affected by extraspinal diffuse idiopathic skeletal hyperostosis (DISH). This study aimed to compare the clinical characteristics of hips with DISH to those with mixed-type femoroacetabular impingement symptoms (FAIS). In addition, patient-reported outcome (PRO) scores were reported among patients with DISH involving the hip joint who underwent arthroscopic treatment. A retrospective analysis was performed using data from patients who underwent hip arthroscopy between 2017 and 2021. Patients who had a preoperative diagnosis of extraspinal DISH of the hip joint and postoperative Hip Outcome Score-Activities of Daily Living (HOS-ADL), Hip Outcome Score-Sports Subscale (HOS-SSS), International Hip Outcome Tool 12-component form (iHOT-12), modified Harris Hip Score (mHHS) and visual analog scale (VAS) for pain scores were enrolled in the study. The patients' characteristics were compared with those of a control group (1:2) consisting of mixed-type patients with FAIS. The control group was matched in terms of age, sex, body mass index (BMI), and symptom duration. Eleven hips (0.87%) with extraspinal DISH (study group) were matched to 22 FAIS hips (control group). All the patients were male. The mean age of patients was 42.0 ± 8.0 in the study group. The study group was characterized by a larger preoperative alpha angle (79.1 ± 6.8 vs 64.8 ± 9.7, P < .001), lateral center-edge angle (LCEA) (49.7 ± 6.0 vs 40.7 ± 3.2, P < .001), and postoperative LCEA (36.6 ± 3.0 vs 34.2 ± 2.0, P = .013). In addition, a higher proportion of acetabular (81.8% vs 31.8%, P = .007) and femoral head chondral lesions (45.5% vs 9.1%, P = .016). Cartilage damage has the potential to affect the prognosis of arthroscopic treatment. Nevertheless, at the final follow-up, patients with DISH experienced a significant increase in range of motion (ROM), notable enhancements in all PROs, and favorable rates of minimal clinically important difference (MCID) for the PROs. The occurrence of DISH in the hip joint is considerably infrequent, characterized by hip pain and limited ROM. Despite increased alpha angle and LCEA, and more acetabular and femoral head chondral damage noted at the time hip arthroscopy, patients with DISH observed a significant improvement in ROM, notable enhancements in all PROs, and favorable rates of MCID for the PROs.

Negative consequences associated with daily alcohol use as a nonlinear function of number of drinks in a daily diary study

IntroductionDrinking intensity among young adults is associated with greater negative alcohol-related consequences, but often studied using categorical drinking thresholds. This study examined how alcohol-related consequences varied as a continuous function of number of drinks consumed, without imposing thresholds, to identify drink ranges for which risk is greatest. MethodsAnalyses included daily surveys from the Young Adult Daily Life study (2019–22) in which individuals reported drinking 1 or more alcoholic drinks (n=5219 days; 832 individuals). Time-varying effect models estimated total number of negative alcohol-related consequences and five individual consequences (hangover, drank more than planned, nausea/vomiting, did something embarrassing, blacked out) as a function of the number of drinks consumed among young adult males and females. ResultsOften, increases in the number and prevalence of negative consequences were a nonlinear function of the number of drinks consumed. Females reported few negative consequences on 1-to-3-drink occasions but steep increases in consequences on 4-to-9-drink occasions. Among females, the prevalence of blacking out increased six-fold from 4-drink (3.4%; 95% CI=2.6,4.7) to 9-drink occasions (20.6%; 95% CI=16.1,26.1). Among males, the prevalence of some consequences, while not linear, increased across the full drink range. Blacking out among males increased from 9.6% (95% CI=6.2,14.7) on 10-drink occasions to 23.9% (95% CI=15.0,35.8) on 15-drink occasions. ConclusionsSubstantial heterogeneity is missed when typical drinking categories are used. In particular, variability in consequences across levels of the traditional binge drinking category suggests that important differences in risk may be missed when assessed as a uniform category.

The oral and systemic health impact profile for periodontal disease (OSHIP-Perio)-Part 2: Responsiveness and minimal important difference.

The Oral and Systemic Health Impact Profile for Periodontal Disease (OSHIP-Perio) was developed to measure health-related quality of life (HRQoL) and oral health-related quality of life (OHRQoL). This study aimed to determine the responsiveness and minimal importance difference (MID) of the OSHIP-Perio. Subjects with periodontal disease completed the OSHIP-Perio at baseline and six to ten weeks after non-surgical periodontal therapy. Comparisons of the clinical variables and the OSHIP-Perio scores before and after treatment were analysed using the Wilcoxon signed-rank test, together with the Oral Health Impact Profile (OHIP-49, OHIP-14 and OHIP-5) scores. The MIDs for all the instruments were calculated using distribution-based methods. Fifty-one case subjects who completed periodontal treatment and the OSHIP-Perio instrument were included for analysis. Significant improvement in all clinical variables after treatment (p < 0.001) was observed. The OSHIP-Perio total score as well as its four-dimensional scores (periodontal, oral function, orofacial pain and psychosocial impact) were significantly reduced after treatment (p < 0.001), indicating better OHRQoL. Findings were consistent with the other OHIP instruments. In determining the MID, the percentage point change of the OSHIP-Perio was found to be lower than the shorter OHIP-5 instrument when using both effect sizes (ES) (10.71% vs. 15.0% at 0.5SD) and standard error of measurement (SEM) (5.36% vs. 10.0% at 1SEM; 8.93% vs. 20.0% at 2SEM) calculations. The OSHIP-Perio demonstrated good responsiveness which was comparable to the OHIP-49 and its short-form derivatives. Its required percentage point change in determining its MID is smaller than the OHIP-5.

Predicting Response to In-Hospital Pulmonary Rehabilitation in Individuals Recovering From Exacerbations of Chronic Obstructive Pulmonary Disease

BackgroundPredicting the response to pulmonary rehabilitation (PR) could be valuable in defining admission priorities. We aimed to investigate whether the response of individuals recovering from a COPD exacerbation (ECOPD) could be forecasted using machine learning approaches. MethodThis multicenter, retrospective study recorded data on anthropometrics, demographics, physiological characteristics, post-PR changes in six-minute walking distance test (6MWT), Medical Research Council scale for dyspnea (MRC), Barthel Index dyspnea (BId), COPD assessment test (CAT) and proportion of participants reaching the minimal clinically important difference (MCID). The ability of multivariate approaches (linear regression, quantile regression, regression trees, and conditional inference trees) in predicting changes in each outcome measure has been assessed. ResultsIndividuals with lower baseline 6MWT, as well as those with less severe airway obstruction or admitted from acute care hospitals, exhibited greater improvements in 6MWT, whereas older as well as more dyspnoeic individuals had a lower forecasted improvement. Individuals with more severe CAT and dyspnea, and lower 6MWT had a greater potential improvement in CAT. More dyspnoeic individuals were also more likely to show improvement in BId and MRC. The Mean Absolute Error estimates of change prediction were 44.70m, 3.22 points, 5.35 points, and 0.32 points for 6MWT, CAT, BId, and MRC respectively. Sensitivity and specificity in discriminating individuals reaching the MCID of outcomes ranged from 61.78% to 98.99% and from 14.00% to 71.20%, respectively. ConclusionWhile the assessed models were not entirely satisfactory, predictive equations derived from clinical practice data might help in forecasting the response to PR in individuals recovering from an ECOPD. Future larger studies will be essential to confirm the methodology, variables, and utility.

The ultrasound-based cardiac output monitoring is a useful tool to define baseline hemodynamic parameters in healthy permanent residents at high altitude: results of a monocentric pilot study.

Previous studies on the cardiac data of healthy permanent residents living in high-altitude regions such as Tibet and the Andes have yielded inconsistent findings and significant disparities. These discrepancies can be mainly attributed to the invasive methods conventionally used for parameter evaluation. However, with the introduction of cutting-edge ultrasound technology, there is now an innovative approach to addressing and reconciling these variations. In this pilot study, we employed an ultrasound-based cardiac output monitoring (USCOM) device to evaluate cardiac output and related hemodynamic variables in a group of 20 healthy high-altitude Andean residents (comprising 10 men and 10 women) aged between 26 and 35 years old. The monocentric study was carried out in La Paz, Bolivia, located between at an altitude of 3,600-4,000m. A total of 60 hemodynamic measurements were evaluated, accounting for three technical replicates per subject. Our results showed strong intrasubject reproducibility and revealed important differences related to both sex and hemodynamic parameters in highlanders compared to individuals residing at sea level. We conclude that USCOM represents a highly reliable technology for performing hemodynamic measurements in high-altitude residents. Our preliminary findings underscore the need for larger studies, encompassing larger sample sizes, specifically tailored to gender considerations, and extendable to broader highland populations. These findings have special significant implications for the management of hemodynamics in intensive care and postoperative settings, warranting further comprehensive research efforts.

Internet-delivered lifestyle physical activity intervention for cognitive processing speed in multiple sclerosis

BackgroundWe propose a randomized controlled trial(RCT) of a Social Cognitive Theory-based(SCT), Internet-delivered behavioral intervention targeting lifestyle physical activity(LPA) for yielding improvements in cognitive processing speed(CPS), learning and memory(L/M), symptoms, and quality of life(QOL) among persons with mild multiple sclerosis(MS)-related ambulatory impairment who have impaired CPS. Methods/designThe study involves a Phase-II, parallel group, RCT design. Participants with MS(N = 300) will be randomly assigned on an equal basis(1:1) into behavioral intervention(n = 150) or attention and social contact control(n = 150) conditions. The conditions will be administered over 6-months by trained behavior coaches who will be uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcome data remotely every 6-months over the 12-month period(baseline, immediate follow-up, and 6-month follow-up) using a treatment blinded assessor. The primary outcome is the raw, oral Symbol Digit Modalities Test as a neuropsychological measure of CPS. The secondary outcomes include the California Verbal Learning Test-II as an objective measure of L/M, and patient-reported outcomes of fatigue, depressive symptoms, anxiety, pain, and QOL. The tertiary outcome is accelerometry as an objective, device-based measure of steps/day for generating a minimal clinically important difference(MCID) value that guides the prescription of LPA for improving CPS in clinical practice. The primary data analyses will involve intent-to-treat principles, and mixed-effects models and logistic regression. DiscussionIf successful, the proposed study will provide Class I evidence for the efficacy of a theory-based, Internet-delivered behavioral intervention focusing on LPA for improving CPS and mitigating its negative impact on other outcomes in persons with MS.Clinicaltrials.gov: NCT04518657

Cardiac dimensions and hemodynamics in healthy juvenile Landrace swine

BackgroundSwine are frequently used as animal model for cardiovascular research, especially in terms of representativity of human anatomy and physiology. Reference values for the most common species used in research are important for planning and execution of animal testing. Transesophageal echocardiography is the gold standard for intraoperative imaging, but can be technically challenging in swine. Its predecessor, epicardial echocardiography (EE), is a simple and fast intraoperative imaging technique, which allows comprehensive and goal-directed assessment. However, there are few echocardiographic studies describing echocardiographic parameters in juvenile swine, none of them using EE. Therefore, in this study, we provide a comprehensive dataset on multiple geometric and functional echocardiographic parameters, as well as basic hemodynamic parameters in swine using EE.MethodsThe data collection was performed during animal testing in ten female swine (German Landrace, 104.4 ± 13.0 kg) before left ventricular assist device implantation. Hemodynamic data was recorded continuously, before and during EE. The herein described echocardiographic measurements were acquired according to a standardized protocol, encompassing apical, left ventricular short axis and long axis as well as epiaortic windows. In total, 50 echocardiographic parameters and 10 hemodynamic parameters were assessed.ResultsEpicardial echocardiography was successfully performed in all animals, with a median screening time of 14 min (interquartile range 11–18 min). Referring to left ventricular function, ejection fraction was 51.6 ± 5.9% and 51.2 ± 6.2% using the Teichholz and Simpson methods, respectively. Calculated ventricular mass was 301.1 ± 64.0 g, as the left ventricular end-systolic and end-diastolic diameters were 35.3 ± 2.5 mm and 48.2 ± 3.5 mm, respectively. The mean heart rate was 103 ± 28 bpm, mean arterial pressure was 101 ± 20 mmHg and mean flow at the common carotid artery was 627 ± 203 mL/min.ConclusionEpicardial echocardiography allows comprehensive assessment of most common echocardiographic parameters. Compared to humans, there are important differences in swine with respect to ventricular mass, size and wall thickness, especially in the right heart. Most hemodynamic parameters were comparable between swine and humans. This data supports study planning, animal and device selection, reinforcing the three R principles in animal research.Graphical

Feedback loops drive ecological succession: towards a unified conceptual framework.

The core principle shared by most theories and models of succession is that, following a major disturbance, plant-environment feedback dynamics drive a directional change in the plant community. The most commonly studied feedback loops are those in which the regrowth of the plant community causes changes to the abiotic (e.g. soil nutrients) or biotic (e.g. dispersers) environment, which differentially affect species availability or performance. This, in turn, leads to shifts in the species composition of the plant community. However, there are many other PE feedback loops that potentially drive succession, each of which can be considered a model of succession. While plant-environment feedback loops in principle generate predictable successional trajectories, succession is generally observed to be highly variable. Factors contributing to this variability are the stochastic processes involved in feedback dynamics, such as individual mortality and seed dispersal, and extrinsic causes of succession, which are not affected by changes in the plant community but do affect species performance or availability. Both can lead to variation in the identity of dominant species within communities. This, in turn, leads to further contingencies if these species differ in their effect on their environment (priority effects). Predictability and variability are thus intrinsically linked features of ecological succession. We present a new conceptual framework of ecological succession that integrates the propositions discussed above. This framework defines seven general causes: landscape context, disturbance and land-use, biotic factors, abiotic factors, species availability, species performance, and the plant community. When involved in a feedback loop, these general causes drive succession and when not, they are extrinsic causes that create variability in successional trajectories and dynamics. The proposed framework provides a guide for linking these general causes into causal pathways that represent specific models of succession. Our framework represents a systematic approach to identifying the main feedback processes and causes of variation at different successional stages. It can be used for systematic comparisons among study sites and along environmental gradients, to conceptualise studies, and to guide the formulation of research questions and design of field studies. Mapping an extensive field study onto our conceptual framework revealed that the pathways representing the study's empirical outcomes and conceptual model had important differences, underlining the need to move beyond the conceptual models that currently dominate in specific fields and to find ways to examine the importance of and interactions among alternative causal pathways of succession. To further this aim, we argue for integrating long-term studies across environmental and anthropogenic gradients, combined with controlled experiments and dynamic modelling.

Policy process theories in autocracies: Key observations, explanatory power, and research priorities

AbstractThe policy process frameworks and theories that are currently considered mainstream were originally developed in the United States, before traveling to other countries. Despite their roots in democratic values, these frameworks and theories are increasingly applied to autocracies. Given important differences between democracies and autocracies, this raises questions about the desirability, limitations, and future directions of this development. In response, this article synthesizes findings from studies that apply existing policy process frameworks and theories to autocracies with the aim of assessing the extent to which the theories are, can, and should be used to explain key aspects of the policy process in autocracies. Based on qualitative content analysis of 146 English‐language peer‐reviewed journal articles that apply the Advocacy Coalition Framework, the Multiple Streams Framework, the Narrative Policy Framework, and the Punctuated Equilibrium Theory to 39 autocracies, we show that these theories help identify influential institutions, actors, networks, ideas, beliefs, and events. The analysis reveals important differences in policy processes between autocracies and democracies. Future research ought to bring existing literature on authoritarianism and authoritarian politics into policy process research to test existing and new hypotheses.

Tralokinumab Real-World Patient-Reported Outcomes in Moderate-to-Severe Atopic Dermatitis Adult Patients in the United States: 6-Month Interim Analysis

Introduction: Tralokinumab, an IL-13 targeted biologic approved in the United States (US) for adult patients with moderate-to-severe atopic dermatitis (AD), improved patient-reported outcomes (PROs) in clinical trials and after 4 weeks of use in the real-world setting. This 6-month interim analysis evaluated the real-world impact of tralokinumab on PROs in adult patients.&#x0D; Methods: This is an interim analysis of an ongoing 52-week patient survey study enrolling US AD patients from the AdbryTM AdvocateTM Program. Patients completed the baseline survey close to tralokinumab initiation. Data on demographics and PROs including weekly itch numeric rating scale (NRS), eczema-related weekly sleep NRS, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM-9) were collected. Percent and absolute changes from baseline to 6 months of treatment were calculated. Outcomes are stratified by previous dupilumab use. The percentage of patients experiencing minimal clinically important difference (MCID) was also calculated for itch NRS (3-point reduction) and DLQI (4-point reduction).&#x0D; Results: As of May 2023, 102 patients completed baseline, 1-month, and 6-month surveys. Of these, 59.8% were female, mean age was 44.2 years (SD=15.7), 82.4% were white, and 85.3% had private insurance. 84.3% were previously treated with topical corticosteroids (TCS) and 52.9% were dupilumab-experienced patients. Over 6 months, there was an improvement in the mean sleep interference NRS (40%), average weekly itch NRS (39%), worst weekly itch NRS (33%), PO-SCORAD (37%), and DLQI (52%). There were improvements in mean TSQM-9 global satisfaction (11.06 points), TSQM-9 convenience (3.92 points), and TSQM-9 effectiveness (14.60 points) scores. Median MCIDs were met by 57.1% on the sleep interference NRS, 51.7% of patients on the average weekly itch NRS, 50.0% on the worst weekly itch NRS, and 68.7% on the DLQI. Relative to the dupilumab-experienced cohort, the dupilumab-naïve patients showed markedly improved outcomes [median MCIDs of 65.6% v 48.4% on sleep NRS; 59.5% v 44.4% on average weekly itch NRS; 61.4% v 39.6% on worst weekly itch NRS; 61.4% v 35.3% on PO-SCORAD; and 75.6% v 61.9% on DLQI].&#x0D; Conclusion: This 6-month interim analysis shows that tralokinumab improved quality of life outcomes related to itch, sleep, and treatment satisfaction when used either in dupilumab-naïve or in dupilumab-experienced patients. These patients will continue to be followed for up to 52 weeks of treatment with tralokinumab.

Improved quality of life in patients with chronic rhinosinusitis with nasal polyps associated with expanded types of endoscopic sinus surgery: A 2-year retrospective study.

Expanded types of functional endoscopic sinus surgery (FESS) significantly improve quality of life and reduce revision surgeries rates, supporting their early application for moderate-to-severe cases. Minimal clinically important difference may play as a crucial role in defining surgical treatment response (i.e., responder and super-responder conditions). Expanded FESS benefits patients with chronic rhinosinusitis with nasal polyps but more data are required to have a clearer understanding of its uses due to varied approaches and reported outcomes in the literature.