Important Differences Research Articles

Clinically important effect sizes for clinical trials using infarct growth reduction as the primary outcome: a systematic review

BackgroundInfarct growth on multimodal imaging is a common lead outcome in phase 2 proof-of-concept and dose-optimization neuroprotective agent stroke trials. However, the effect size in infarct growth reduction that correlates...

How Different Are the Influences of Mediterranean and Japanese Diets on the Gut Microbiome?

The gut microbiome is a complex ecosystem, mainly composed of bacteria, that performs essential functions for the host. Its composition is determined by many factors; however, diet has emerged as a key regulator. Both the Mediterranean (MD) and Japanese (JD) diets have been associated with significant health benefits and are therefore considered healthy dietary patterns. Both are plant-based diets and although they have much in common, they also have important differences mainly related to total calorie intake and the consumption of specific foods and beverages. Thus, it has been hypothesized that they exert their beneficial properties through different nutrients and bioactive compounds that interact with gut microbes and induce specific changes on gut metabolic pathways. In this review, we present current data on the effects of the MD and JD on the gut microbiome. Furthermore, we aim to examine whether there are differences or shared effects on the gut microbiome of people who adhere to these dietary patterns.

Acarbose impairs gut Bacteroides growth by targeting intracellular glucosidases.

Acarbose is a type 2 diabetes medication that works primarily by stopping starch breakdown into glucose in the small intestine. This is accomplished by the inhibition of host enzymes, leading to better blood sugar control via reduced ability to derive glucose from dietary starches. The drug and undigested starch travel to the large intestine where acarbose interferes with the ability of some bacteria to grow on starch. However, little is known about how gut bacteria interact with acarbose, including microbes that can use starch as a carbon source. Here, we show that two gut species, Bacteroides ovatus (Bo) and Bacteroides thetaiotaomicron (Bt), respond differently to acarbose: Bt growth is inhibited by acarbose, while Bo growth is less affected. We reveal a complex set of mechanisms involving differences in starch import and sensing behind the different Bo and Bt responses. This indicates the gut microbiome may be a source of variable response to acarbose treatment for diabetes via complex mechanisms in common gut microbes.

Readiness for treatment predicts depression outcomes in a partial hospital program.

Evidence-based interventions vary in effectiveness for individuals with depression, which has a large public health burden. Readiness for change or treatment can be an important individual difference predictor of depression outcomes. To inform public service initiatives targeting readiness for treatment, characterizing readiness across settings and levels of care is key. However, limited data exist on the role of readiness for treatment in acute psychiatric settings and in particular, partial hospital programs which are key points in the continuity of inpatient and outpatient care. The present study assessed readiness for treatment in terms of importance, confidence, and motivation to engage in a partial hospital program and tested whether higher levels of readiness were associated with better treatment outcomes among clients with depression. Participants (N = 192) with major depressive disorder rated their readiness for treatment (Readiness Rulers), depression (Patient Health Questionnaire-9), and global improvement (Clinical Global Impression Scale-Improvement Self-Report) while enrolled in a partial hospital program. Generalized linear regression models assessed the effect of baseline readiness on outcomes at discharge, adjusted for baseline level of the outcome, age, sex, race, and ethnicity. Greater baseline readiness predicted reduced depression and better global improvement at discharge. Higher confidence and motivation to engage in treatment, but not importance, were associated with better depression outcomes. Identifying and addressing readiness for treatment by leveraging public health systems and services (e.g., help lines, family interventions) prior to or upon starting a partial hospital program may be useful to maximize gains in treatment. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The reflux phase in monetary circuit theory and stock–flow consistent models

Stock–flow consistent (SFC) modelling and monetary circuit theory (MCT) have many similarities. However, an important difference concerns the reflux phase, during which the credits issued by banks are repaid. This phase is constitutive of MCT models, but does not generally appear explicitly in SFC models. The authors propose here to develop an SFC model in which the bank loans issued at the beginning of a period are explicitly repaid at the end of it. The repayment of long-term bank loans financing investments will then represent a leakage outside the monetary circuit and affect the level of aggregate demand and the dynamics of the model. The authors show that considering these repayments could have a lasting effect on corporate profits, corporate indebtedness, and growth of production. This result suggests that it could be interesting to focus more on the reflux phase within SFC models, taking inspiration from MCT.

Ontology of active and passive environmental exposure

Exposure is a central concept of the health and behavioural sciences needed to study the influence of the environment on the health and behaviour of people within a spatial context. While an increasing number of studies measure different forms of exposure, including the influence of air quality, noise, and crime, the influence of land cover on physical activity, or of the urban environment on food intake, we lack a common conceptual model of environmental exposure that captures its main structure across all this variety. Against the background of such a model, it becomes possible not only to systematically compare different methodological approaches but also to better link and align the content of the vast amount of scientific publications on this topic in a systematic way. For example, an important methodical distinction is between studies that model exposure as an exclusive outcome of some activity versus ones where the environment acts as a direct independent cause (active vs. passive exposure). Here, we propose an information ontology design pattern that can be used to define exposure and to model its variants. It is built around causal relations between concepts including persons, activities, concentrations, exposures, environments and health risks. We formally define environmental stressors and variants of exposure using Description Logic (DL), which allows automatic inference from the RDF-encoded content of a paper. Furthermore, concepts can be linked with data models and modelling methods used in a study. To test the pattern, we translated competency questions into SPARQL queries and ran them over RDF-encoded content. Results show how study characteristics can be classified and summarized in a manner that reflects important methodical differences.

Song determined by phylogeny and body mass in two differently constrained groups of birds: manakins and cardinals

The songs of birds are complex signals that may have several functions and vary widely among species. Different ecological, behavioural and morphological factors, as well as phylogeny, have been associated as predictors of the evolution of song structure. However, the importance of differences in development, despite their relevance, has seldom been considered. Here, we analysed the evolution of song in two families of songbirds that differ in song development, manakins (suboscines) and cardinals (oscines), with their phylogeny, morphology, and ecology. Our results show that song characteristics had higher phylogenetic signal in cardinals than in manakins, suggesting higher evolutionary lability in the suboscines. Body mass was the main predictor of song parameters in manakins, and together with habitat type, had a major effect on cardinals’ song structure. Precipitation and altitude were also associated with some song characteristics in cardinals. Our results bring unexpected insights into birdsong evolution, in which non-learners (manakins) revealed greater evolutionary lability than song learners (cardinals).

Hyper IgE Syndromes.

The Hyper IgE Syndromes are rare primary immunodeficiencies characterized by eczema, recurrent skin and respiratory infections and elevated serum IgE levels. Nowadays a geneticmolecular characterization is possible and allows the distinction in various monogenic pathologies, which share some clinical characteristics but also important differences. In addition to long-known STAT3 and DOCK8 gene mutations, in fact, also ZNF341, CARD11, ERBB2IP, IL6R and IL6ST genes mutations can cause the disease. The main clinical manifestations are represented by newborn rash, eczema similar to atopic dermatitis, bacterial and viral skin infections, cold abscesses, respiratory infections with possible pulmonary complications, allergies, gastrointestinal manifestations, malignancies and connective tissue abnormalities. Diagnosis is still a challenge because, especially in the early stages of life, it is difficult to distinguish from other pathologies characterized by eczema and high IgE, such as atopic dermatitis. Several scores and diagnostic pathways have been developed, but it is essential to seek a genetic diagnosis. Treatment is based on prevention and early treatment of infections, meticulous skincare, intravenous immunoglobulins and HSCT, which, in some HIES subtypes, can modify the prognosis. Prognosis is related to the affected gene, but also to early diagnosis, timely treatment of infections and early HSCT.

Obesity Does Not Negatively Affect Patient-perceived Outcomes After Cervical Disc Replacement for Disc Herniation.

Retrospective review. To assess the impact of Body Mass Index (BMI) on patient-reported outcome measures (PROMs) after cervical disc replacement (CDR). BMI may affect PROMs after spine surgery. Primary CDR recipients for herniated disc(s) with BMI <40 were retrospectively selected from a single-surgeon registry. Cohorts were divided into non-obese (BMI <30) and obese (BMI ≥30). Intercohort in-hospital complication rates were compared through independent samples t tests. Pre/postoperative PROMs were compared between cohorts through multivariable regression accounting for demographic differences. Final follow-up dates between patients averaged 11.8 ± 9.3 months. PROMs assessed included Patient-reported Outcomes Measurement Information System-Physical Function, Neck Disability Index, Visual Analog Scale-Neck, Visual Analog Scale-Arm, and the 9-item Patient Health Questionnaire. Improvements in PROMs were evaluated and compared at each follow-up within cohorts through paired t tests. The magnitude of improvement in PROMs from preoperative baseline at 6-week follow-up (∆PROM-6W) and final follow-up (∆PROM-FF) along with achievement rates of minimum clinically important differences were compared between cohorts through multivariable regression accounting for demographic differences. Of 153 patients, 53 patients were noted as obese. Demographic differences included age, prevalence of hypertension and diabetes, and comorbidity burden scores ( P ≤ 0.011, all). No significant variations in in-hospital complications were found. The non-obese cohort demonstrated improvements in all PROMs at 6 weeks and final follow-up periods ( P ≤ 0.005, all). The obese cohort demonstrated improvements in all postoperative PROMs besides 9-item Patient Health Questionnaire at 6 weeks ( P ≤ 0.015, all). After accounting for age and comorbidity variations, there were no significant intercohort differences in raw PROM scores, ∆PROM-6W, ∆PROM-FF, or minimum clinically important difference achievement rates. Regardless of BMI, patients experience significant improvements in physical function, disability, pain, and mental health after CDR for disc herniation. Patients with obesity do not suffer inferior patient-perceived outcomes after CDR. These findings may help surgeons counsel patients in the preoperative period.

Incorporating immigrant optimism into critical consciousness and civic development models: An integrative review and synthesis of civic action among immigrant youth of color in the United States.

Civic action describes participation in political and prosocial activities aimed at benefiting one's communities. A growing literature rooted in critical consciousness (CC) theory suggests that engaging in critical action, which challenges societal inequities, is important for the positive development of youth of color. Although valuable, existing literatures have yet to consider how psychological processes related to the immigrant experience, such as immigrant optimism (IO), may differentially influence the civic participation of immigrant youth of color. IO is a phenomenon in which immigrant groups hold higher aspirations and more positive views of the host society than their nonimmigrant peers, and this often is associated with positive outcomes. This article reviews and integrates relevant research on the civic development of immigrant youth of color, considering both how IO may be a particularly relevant process in shaping immigrant youths' CC development and how civic action may take different forms among these youth. We define concepts, integrate previously siloed literatures, and make recommendations for future research. We propose expanding existing frameworks to consider IO and forms of action, along with their intended outcome. Incorporating IO into studies of CC or civic development can clarify important differences and enhance our understanding of how best to support immigrant youth. Similarly, examining forms of action and their intended outcome may be advantageous in facilitating young immigrants' development as active and engaged members of society. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Reliability of scapular position and periscapular muscle strength tests in healthy subjects with forward neck and rounded shoulder posture

BACKGROUND: People with forward head posture (FHP) and rounded shoulder posture (RSP) may experience shifts in scapular position and alterations in the strength of the muscles surrounding the scapula. Therefore, a reliable scapula position and scapula muscle strength test are required to identified scapula problem and provided appropriate intervention programs. OBJECTIVE: This study aimed to determine the reliability of scapular position measurements obtained using a modified digital inclinometer and palpation meter, as well as muscle strength using a hand-held dynamometer (HHD) in individuals with FHP and RSP. METHODS: Thirty healthy subjects underwent scapular position tests (upward rotation, anterior tilt, depression, and protraction) and strength tests of periscapular muscles (serratus anterior, upper trapezius, middle trapezius, and lower trapezius) on both the dominant and non-dominant sides. The reliability of the measurements was confirmed by computing the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimal clinically important difference (MCID). Test and re-tests were conducted over a period of one week and actual values for each measurement were also obtained and assessed. RESULTS: The ICC ranged from 0.802 to 0.935 for the scapular position tests and from 0.808 to 0.949 for muscle strength tests on the dominant and non-dominant sides. For scapular position tests, SEM values ranged from 0.3 cm to 0.6 cm (protraction and depression), from 1.0∘ to 1.7∘ (upward rotation and anterior tilt) and MCID values ranged from 0.7 cm to 1.6 cm (protraction and depression), from 2.8∘ to 4.7∘ (upward rotation and anterior tilt). Regarding muscle strength tests, SEM and MCID values were in the range 14.4N–27.3N and 39.9N–75.7N, respectively. CONCLUSIONS: Scapular position and periscapular muscle strength can be reproducibly measured in healthy subjects individuals with FHP and RSP. These instruments can hence be recommended for evaluating these functional traits in subjects with FHP and RSP.

Deep Peroneal Neurectomy for Midfoot Arthritis: A Comprehensive Review, Surgical Technique, and Case Series

Patients with painful midfoot arthritis unsuccessfully treated with conservative measures have been historically left with the surgical option of midfoot arthrodesis as a definitive treatment. In recent years, excision of the deep peroneal nerve has been offered as a potential alternative. Existing literature on the outcomes of patients undergoing deep peroneal neurectomy for the treatment of midfoot arthritis is limited and piecemeal. In this comprehensive review, technique guide, and retrospective case series, we consolidate the evidence around deep peroneal neurectomy for midfoot arthritis, review operative technique, and determine the outcomes of 4 patients who underwent deep peroneal neurectomy from February 2021 to December 2022 using Patient-Reported Outcome Measurement Information System Physical Function and Pain Interference scores. Four original articles from National Center for Biotechnology Information Medline, published through May 2023, were included. The outcomes of patients treated with deep peroneal neurectomy for midfoot arthritis are discussed. In our case series, the average amount of time between surgery and final postoperative Patient-Reported Outcome Measurement Information System scores was 289 days. The average preoperative physical function score was 36.8. Three patients showed a minimal clinically important difference in physical function; postoperative average was 41.3. Three patients had a minimally clinical important reduction in pain levels (average preoperative pain interference score was 65.8; average postoperative pain interference score was 59.3). One patient underwent a revision neurectomy for inadequate pain relief, and another sought additional treatment for inadequate pain relief. All patients returned to walking in a shoe within 1 month. The outcomes of our case series are similar to those of previously published case series, which demonstrate satisfactory results and acceptable complication rates. For patients with symptomatic midfoot arthritis, deep peroneal neurectomy can be an effective treatment option to reduce pain and improve physical function while requiring minimal postoperative recovery time.

Acarbose Impairs Gut Bacteroides Growth by Targeting Intracellular GH97 Enzymes.

Acarbose is a type-2 diabetes medicine that inhibits dietary starch breakdown into glucose by inhibiting host amylase and glucosidase enzymes. Numerous gut species in the Bacteroides genus enzymatically break down starch and change in relative abundance within the gut microbiome in acarbose-treated individuals. To mechanistically explain this observation, we used two model starch-degrading Bacteroides, Bacteroides ovatus (Bo) and Bacteroides thetaiotaomicron (Bt). Bt growth is severely impaired by acarbose whereas Bo growth is not. The Bacteroides use a starch utilization system (Sus) to grow on starch. We hypothesized that Bo and Bt Sus enzymes are differentially inhibited by acarbose. Instead, we discovered that although acarbose primarily targets the Sus periplasmic GH97 enzymes in both organisms, the drug affects starch processing at multiple other points. Acarbose competes for transport through the Sus beta-barrel proteins and binds to the Sus transcriptional regulators. Further, Bo expresses a non-Sus GH97 (BoGH97D) when grown in starch with acarbose. The Bt homolog, BtGH97H, is not expressed in the same conditions, nor can overexpression of BoGH97D complement the Bt growth inhibition in the presence of acarbose. This work informs us about unexpected complexities of Sus function and regulation in Bacteroides, including variation between related species. Further, this indicates that the gut microbiome may be a source of variable response to acarbose treatment for diabetes.

Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis

ObjectivesThe use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis...

A global set of barley varieties shows a high diversity in starch structural properties and related gelatinisation characteristics

The gelatinisation temperature and bimodal granule size distribution of barley starch are important characteristics regarding resource efficiency and product quality in the brewing industry. In this work, the diversity in starch amylose content and granule proportions in a set of modern barley varieties (N = 23) was investigated and correlated with their starch gelatinisation behaviour. Milled barley samples had peak starch gelatinisation temperatures ranging from 60.1 to 66.5 °C. Upon separating the barley starch from the non-starch compounds, sample-dependent decreases in starch gelatinisation temperatures were observed, indicating the importance of differences in barley composition. The peak gelatinisation temperatures of milled barley and isolated barley starches were strongly correlated (r = 0.96), indicating that the behaviour of the starch population is strongly reflected in the measurements performed on milled barley. Therefore, we investigated whether amylose content or starch granule size distribution could predict the gelatinisation behaviour of the starches. Broad ranges in the small starch granule volumes (13.9–32.0 v/v%) and amylose contents (18.2–30.7 w/w%) of the barley starches were observed. For the barley samples collected in the north of the USA (N = 8), the small starch granule volumes correlated positively with the peak gelatinisation temperatures of barley starches (r = 0.90, p < 0.01). The considerable variation in starch properties described in this work highlights that, besides starch content, starch gelatinisation temperature or granule size distribution might provide brewers with useful information to optimise resource efficiency.

Deconstructing Fears of Terrorism: A Comparison between Fear from Domestic and International Terrorist Groups

ABSTRACT Although research on fears of terrorism has been growing, previous studies approached the topic of the fear of terrorism as a monolithic concept without considering the various political aspects of terrorism as a crime. The current research employed a novel approach to studying the fear of terrorism as a polylithic phenomenon by comparing three different types of fears of terrorism among Americans: general fears of terrorism, fears of domestic terrorist groups, and fears of international terrorist groups. Drawing on a nationally representative sample from the Chapman Survey of American Fears, Wave 5 (2018), the results of the analysis indicated that the predictors were differentially associated with the three types of fear with respect to their statistical significance and correlation directions. Thus, this study provides a significant contribution to the literature on the fear of terrorism topic by illustrating the important differences among general fears of terrorism, fears of domestic terrorist groups, and fears of international terrorist groups.

Lecanemab Questions.

The recently published results of the 18-month randomized controlled trial of lecanemab, reporting the efficacy of the drug in slowing the progression of early Alzheimer disease, quickly led to approval by the FDA and widespread acceptance of lecanemab treatment. However, there are a number of matters that deserve further consideration. The success of blinding was not assessed, even as infusion reactions and the cerebral pathology underlying amyloid-related imaging abnormalities could have signaled to many participants that they were on drug, potentially exerting a potent placebo effect. The value of the outcome to participants is not defined in the absolute terms necessary for clinical decision-making, and the difference attributable to lecanemab was between 18% and 46% of estimates of the minimal clinically important difference on the Clinical Dementia Rating Scale Sum of Boxes. The attenuation of change on the Alzheimer's Disease Assessment Scale-Cognitive 14 achieved by lecanemab at 18 months was 50% of that achieved by donepezil at 6 months. Lecanemab treatment imposes a high treatment burden. The fact that the burden commences at the initiation of lecanemab treatment, whereas the benefit accrues years later requires us to take into account value discounting over time, which would significantly reduce the benefit/burden ratio. Finally, treatment with monoclonal antibodies to cerebral amyloid has consistently been associated with progressive cerebral atrophy. At the least, these issues should be raised in treatment discussions with patients. They also suggest a need to very seriously reconsider how we evaluate clinical trial results preparatory to translating them into clinical practice. Some suggestions are provided.

South Cuidrach

A new site in north Skye has revealed evidence of human occupation from the Late Upper Palaeolithic as well as the Early and Late Mesolithic periods, suggesting repeated visits by humans for at least 5,000 years from the Late Glacial Interstadial through the Loch Lomond Readvance and up to the mid-Holocene, a time of dynamic climatic and sea-level change. South Cuidrach is one of several sites in the north of the Isle of Skye and around the Inner Sound with lithic (stone tool) evidence diagnostic of a human presence before the mid-Holocene. These sites currently represent a unique concentration of pre-Late Mesolithic sites in Scotland. The lithic evidence which forms the backbone of the cultural and temporal characterisation of the site at South Cuidrach is outlined here. This includes characteristic points and microliths, burins, cores and other items diagnostic of specific cultural groups. Additionally, it has become evident that Rum bloodstone, a raw material well known from the Late Mesolithic period in the region, may be absent before the Early/Late Mesolithic transition, with baked mudstone from Staffin in North Skye being the primary raw material used before this time. The need for detailed knowledge of the region’s lithic technology and typology is well illustrated here, as small details frequently reflect important chronological differences.

1081 Risk Factors for Long Term Opioid Use After Elective Lumbar Spine Surgery: A MSSIC Study

INTRODUCTION: Long-term opioid use after elective lumbar spine surgery is a significant concern, given the current opioid epidemic and its impact on public health. Identifying risk factors for long-term opioid use after spine surgery is crucial in developing effective interventions to reduce the incidence of opioid dependence in this patient population. METHODS: A retrospective analysis of patient data was conducted using the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry. Patients who underwent elective lumbar spine surgery between March 2018, and September 2021, were included, resulting in a total of 3599 patients at one year and 966 patients at two years follow-up. Poisson generalized estimating equation models were used for multivariate analyses. RESULTS: A total of 493 (13.7%) and 137 (14.2%) patients were still using opiates at one-year and two-years post-surgery respectively. Discharge morphine milligram equivalents (MMEs), baseline PROMIS PF functional scores, baseline pain scores, age, gender, education level, pre-operative opioid use, and not achieving the minimal clinically important difference (MCID) in PROMIS PF scores at follow-up were significantly associated with long-term opioid use. Specifically, pre-operative opioid use had the strongest association with opioid use at one year (IRR = 2.83, CI: 2.40-3.34, p &lt; 0.001) and two years (IRR = 3.79, CI: 2.53-5.68, p &lt; 0.001). Additionally, not achieving MCID in PROMIS scores at follow-up was strongly associated (IRR = 2.00, CI: 1.72-2.32, p &lt; 0.001 and IRR = 2.18, CI: 1.64-2.91, p &lt; 0.001) with opioid use at both time points (1-year and 2-year respectively). CONCLUSIONS: Pre-operative opioid use and not achieving MCID in PROMIS scores at follow-up were the strongest predictors of long-term opioid use after elective lumbar spine surgery. Identifying these risk factors can help clinicians target interventions to reduce opioid use in at-risk patients and improve postoperative outcomes.

Predicting effects of a digital stress intervention for patients with depressive symptoms: Development and validation of meta-analytic prognostic models using individual participant data.

Digital stress interventions could be helpful as an "indirect" treatment for depression, but it remains unclear for whom this is a viable option. In this study, we developed models predicting individualized benefits of a digital stress intervention on depressive symptoms at 6-month follow-up. Data of N = 1,525 patients with depressive symptoms (Center for Epidemiological Studies' Depression Scale, CES-D ≥ 16) from k = 6 randomized trials (digital stress intervention vs. waitlist) were collected. Prognostic models were developed using multilevel least absolute shrinkage and selection operator and boosting algorithms, and were validated using bootstrap bias correction and internal-external cross-validation. Subsequently, expected effects among those with and without a treatment recommendation were estimated based on clinically derived treatment assignment cut points. Performances ranged from R² = 21.0%-23.4%, decreasing only slightly after model optimism correction (R² = 17.0%-19.6%). Predictions were greatly improved by including an interim assessment of depressive symptoms (optimism-corrected R2 = 32.6%-35.6%). Using a minimally important difference of d = -0.24 as assignment cut point, approximately 84.6%-93.3% of patients are helped by this type of intervention, while the remaining 6.7%-15.4% would experience clinically negligible benefits (δ^ = -0.02 to -0.19). Using reliable change as cut point, a smaller subset (39.3%-46.2%) with substantial expected benefits (δ^ = -0.68) receives a treatment recommendation. Meta-analytic prognostic models applied to individual participant data can be used to predict differential benefits of a digital stress intervention as an indirect treatment for depression. While most patients seem to benefit, the developed models could be helpful as a screening tool to identify those for whom a more intensive depression treatment is needed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).