Socioeconomic status and the risk for colonisation or infection with priority bacterial pathogens: a global evidence map.

Low socioeconomic status likely exacerbates risks for bacterial infections; however, global evidence for this relationship has not been synthesised. We systematically reviewed the existing literature for studies detailing the socioeconomic status of participants and their risk for colonisation or community-acquired infection with priority bacterial pathogens that are increasingly becoming antibiotic resistant. 50 studies from 14 countries reported outcomes by the participants' educational attainment, access to health care, income level, residential crowding status, socioeconomic status deprivation score, community setting, or access to clean water, sanitation, and hygiene.

Similarities and Differences in the WAIS-IV Performances in Korean and U.S. Populations.

Objective: This exploratory study examines the cognitive profiles of South Koreans using the WAIS-IV. It compares scores from the original U.S.

Neuronal alpha-Synuclein Disease integrated staging system performance in PPMI, PASADENA, and SPARK baseline cohorts.

The Neuronal alpha-Synuclein Disease (NSD) biological definition and Integrated Staging System (NSD-ISS) provide a research framework to identify individuals with Lewy body pathology and stage them based on underlying biology and increasing degree of functional impairment. Utilizing data from the PPMI, PASADENA, and SPARK studies, we developed and applied biologic and clinical data-informed definitions for the NSD-ISS across the disease continuum. Individuals enrolled as Parkinson's disease, Prodromal, or Healthy Controls were defined and staged based on biological, clinical, and functional anchors at baseline.

The effect of computerized cognitive training and transcranial direct current stimulation on working memory among post-stroke individuals: a systematic review with meta-analysis and meta-regression.

Background: Working memory (WM) impairment is a common phenomenon after stroke; however, its management in rehabilitation is less researched. This systematic review and meta-analysis aimed to provide a quantitative synthesis of the impact of computerised cognitive training (CCT) and transcranial direct current stimulation (tDCS) on WM span in post-stroke individuals.

Methods: The literature search in PubMed, Embase, Scopus, and Cochrane Library focused on randomized controlled trials testing the effect of CCT and tDCS on treated stroke patients as compared to untreated controls.

Patient Perspectives on Portal-Based Anxiety and Depression Screening in HIV Care: A Qualitative Study Using the Consolidated Framework for Implementation Research.

Electronic patient portals represent a promising means of integrating mental health assessments into HIV care where anxiety and depression are highly prevalent. Patient attitudes toward portal-based mental health screening within HIV clinics have not been well described. The aim of this formative qualitative study is to characterize the patient-perceived facilitators and barriers to portal-based anxiety and depression screening within HIV care in order to inform implementation strategies for mental health screening.

A qualitative investigation of the Montgomery-Åsberg depression rating scale: discrepancies in rater perceptions and data trends in remote assessments of rapid-acting antidepressants in treatment resistant depression.

Introduction: Despite the development of many successful pharmaceutical interventions, a significant subset of patients experience treatment-resistant depression (TRD). Ketamine and its derivatives constitute a novel therapeutic approach to treat TRD; however, standard tools, such as the Montgomery-Åsberg Depression Rating Scale (MADRS) are still being used to measure symptoms and track changes.

Methods: The aim of this study was to review item-level differences between rate of data change (MADRS score) and rater-weighted perception of the most useful items for assessing change in symptoms while remotely conducting the 10-item version of the MADRS in TRD in a clinical trial of rapid-acting antidepressants.

Race, ethnicity, and risk for colonization and infection with key bacterial pathogens: a scoping review.

Background: Racial and ethnic disparities in infectious disease burden have been reported in the USA and globally, most recently for COVID-19. It remains unclear whether such disparities also exist for priority bacterial pathogens that are increasingly antimicrobial-resistant. We conducted a scoping review to summarize published studies that report on colonization or community-acquired infection with pathogens among different races and ethnicities.

Ensuring Stakeholder Feedback in the Design and Conduct of Clinical Trials for Rare Diseases: ISCTM Position Paper of the Orphan Disease Working Group.

The 1983 Orphan Drug Act in the United States (US) changed the landscape for development of therapeutics for rare or orphan diseases, which collectively affect approximately 300 million people worldwide, half of whom are children. The act has undoubtedly accelerated drug development for orphan diseases, with over 6,400 orphan drug applications submitted to the US Food and Drug Administration (FDA) from 1983 to 2023, including 350 drugs approved for over 420 indications. Drug development in this population is a global and collaborative endeavor.

A biological definition of neuronal α-synuclein disease: towards an integrated staging system for research.

Parkinson's disease and dementia with Lewy bodies are currently defined by their clinical features, with α-synuclein pathology as the gold standard to establish the definitive diagnosis. We propose that, given biomarker advances enabling accurate detection of pathological α-synuclein (ie, misfolded and aggregated) in CSF using the seed amplification assay, it is time to redefine Parkinson's disease and dementia with Lewy bodies as neuronal α-synuclein disease rather than as clinical syndromes. This major shift from a clinical to a biological definition of Parkinson's disease and dementia with Lewy bodies takes advantage of the availability of tools to assess the gold standard for diagnosis of neuronal α-synuclein (n-αsyn) in human beings during life.

The Rapid Access Memory Program for Addressing Concerns of Incipient Dementia in Academic Primary Care Settings.

Background: Expedient diagnosis of incipient dementia is often hindered by time constraints in primary care visits, shortage of dementia specialists, and extended waitlists for comprehensive neuropsychological evaluations.

Methods: We developed the Rapid Access Memory Program (RAMP) to improve access of neuropsychological services for older adults presenting to our institutional primary care clinics with concerns of cognitive decline. RAMP provides abbreviated neurocognitive assessment, same-day patient feedback, expedited reporting to referring providers, and is financially self-supported.

Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.

The US Food and Drug Agency (FDA) requires clinical trials targeting cognitive impairment associated with schizophrenia (CIAS) to demonstrate the functional relevance of cognitive improvements by employing a functional co-primary measure. Although quantitative evidence supports the suitability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for this purpose, FDA guidelines for qualification of clinical outcome assessments require evidence of content validity, defined as qualitative evidence that key stakeholders view the measure as relevant and important. To collect this important qualitative data, semi-structured interviews were conducted with outpatients with schizophrenia ( = 24), caregivers ( = 12), and professional peer support specialists ( = 12) to elicit their views about the definition and importance of functional independence, the importance of the functional domains assessed by the VRFCAT (meal planning, using transportation, handling money, shopping), and the relevance of the VRFCAT tasks to these domains.

Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations.

Alzheimer's disease (AD) staging criteria lack standardized, empirical description. Well-defined AD staging criteria are an important consideration in protocol design, influencing a more standardized inclusion/exclusion criteria and defining what constitutes meaningful differentiation among the stages. However, many trials are being designed on the basis of biomarker features and the two need to be coordinated.

Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS).

Background: Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response.

Methods: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed logical consistency (LC) checks for ratings of the Young Mania Rating Scale (YMRS), which is widely used in studies of mood and bipolar disorders. LC and statistical outlier-response pattern checks (SC) were applied to 63,228 YMRS administrations from 14 clinical trials evaluating treatments for bipolar disorder.

[Memories of the Future - A Narrative Literature Review of Episodic Future Thinking].

In recent years, the question of how we can grasp the ability to plan future events has come to the forefront in light of the retrieval of personal memories from the past. If episodic memory is responsible for envisioning future events, there appears to be an overlap between autobiographical memory and imagining the future. The aim of this current narrative literature review is to present existing theories and research findings, thereby facilitating the development of an organizational framework necessary for the unified investigation of future thinking.

Effects of donation frequency on U.S. source plasma donor health.

Background: Plasma-derived medicinal products (PDMPs) are essential, life-saving medicines manufactured from plasma donated by healthy human volunteers. PDMPs are used to treat a range of rare, serious, and chronic conditions, often genetic in origin. Approximately 70% of the Source Plasma (SP) used for PDMP manufacturing comes from United States (US).

Frontal two-electrode transcranial direct current stimulation protocols may not affect performance on a combined flanker Go/No-Go task.

Transcranial direct current stimulation (tDCS) has been tested to modulate cognitive control or response inhibition using various electrode montages. However, electrode montages and current polarities have not been systematically compared when examining tDCS effects on cognitive control and response inhibition. In this randomized, sham-controlled study, 38 healthy volunteers were randomly grouped into receiving one session of sham, anodal, and cathodal each in an electrode montage that targeted either the dorsolateral prefrontal cortex (DLPFC) or the fronto-medial (FM) region.

Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants.

The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months. These novel targets include the N-methyl-D-glutamate receptor antagonist ketamine, along with its enantiomers and various derivatives, and the allosteric modulators of gamma-aminobutyric acid (GABA) receptors. There has also been a strong resurgence in interest in psychedelic compounds that impact a range of receptor sites including D1, 5-HT7, KOR, 5-HT5A, Sigma-1, NMDA, and BDNF.

Cross-sectional and longitudinal assessments of function in prodromal-to-mild Alzheimer's disease: A comparison of the ADCS-ADL and A-IADL-Q scales.

Introduction: Prior observational work in a heterogeneous cohort of participants with mild cognitive impairment suggests the Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q) may have greater sensitivity for functional decline than the more established Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. However, the relative utility of the A-IADL-Q versus the ADCS-ADL for clinical trials in early Alzheimer's disease (AD) remains uncertain.

Methods: We compared baseline and longitudinal performance of the A-IADL-Q and ADCS-ADL in participants with biomarker-confirmed prodromal (pAD;  = 158) or mild (mAD;  = 283) AD enrolled in the 18-month Tauriel study of semorinemab (NCT03289143).

Poor effort on cognitive testing in voluntary research predicts failure in US Army Ranger School: Implications for clinical trial design.

Introduction: Failure to provide effortful performance on cognitive testing is not uncommon for participants in clinical trials and can significantly impact sensitivity to treatment effect. Whether poor effort on cognitive testing might relate to other behaviors of interest is unknown. In the current investigation, we examined whether effort on baseline cognitive testing in a randomized controlled trial to enhance resiliency in US Army Officers predicted subsequent success in Ranger school.

Culturally Competent Approaches for Neuropsychological Assessment for Differential Diagnosis of Dementia of Korean-Speaking Patients in the United States.

Objective: To serve the over 1.82 million people of Korean descent who reside in the United States, we assembled a core and supplemental battery of culturally and linguistically appropriate neuropsychological measures for differential diagnosis of dementia for Korean-speaking patients.

Method: Test instruments in Korean were identified through systematic searches of PubMed and Google Scholar, US-based website searches in Korean, and in consultation with Korean-speaking cultural brokers, residing in the United States and Korea.

Recommendations for the Electronic Migration and Implementation of Clinician-Reported Outcome Assessments in Clinical Trials.

Objectives: Although best practices from electronic patient-reported outcome (PRO) measures are transferable, the migration of clinician-reported outcome (ClinRO) assessments to electronic modes requires recommendations that address their unique properties, such as the user (eg, clinician), and complexity associated with programming of clinical content. Faithful migration remains essential to ensuring that the content and psychometric properties of the original scale (ie, validated reference) are preserved, such that clinicians completing the ClinRO assessments interpret and respond to the items the same way regardless of data collection mode. The authors present a framework for how to "faithfully" migrate electronic ClinRO assessments for successful deployment in clinical trials.

Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week.

The momentum of cardiovascular drug development has slowed dramatically. Use of validated cardiac biomarkers in clinical trials could accelerate development of much-needed therapies, but biomarkers have been used less for cardiovascular drug development than in therapeutic areas such as oncology. Moreover, there are inconsistences in biomarker use in clinical trials, such as sample type, collection times, analytical methods, and storage for future research.