Providing 'professionalism with compassion'; how the time for caring communication can improve experiences at the end-of-life at home, findings from a realist evaluation.

Background: For many patients and caregivers, attending to dying and death at home will be a new and fearful experience. This research brings new evidence on the central support of the Rapid Response Service (RRS), provided to those who chose to die at home. RRS's are variable, although all seek to avoid unwanted hospital admissions and to respond flexibly to suit individual preferences for support.

A systematic review of condition-specific preference-based measures used in young people and their valuation methods.

Background: Condition-specific health-related quality-of-life (HRQoL) instruments can be more responsive and sensitive to specific conditions and diseases than generic HRQoL instruments. This systematic review aims to identify the condition-specific preference-based instruments that have been used with young people and identify how preference values have been obtained for these instruments. This review will inform future researchers about the methods used to elicit utilities for condition-specific HRQoL instruments.

Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information.

A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication between pharmacovigilance experts (PVEs) and healthcare professionals (HCPs) for exchanging unique and informative adverse event (AE) information. The solution was implemented in a commercially available electronic health record (EHR) system/platform, no direct contact between PVEs and the HCPs was possible. The Clinical Affairs team of the EHR vendor was used as an intermediary to ensure appropriate information was exchanged while protecting HCP and patient privacy.

Exploring caregiver perspectives in the context of parental substance use: A qualitative study.

Background: Parental substance use is a substantial public health and safeguarding concern. Research examining the impact of parental substance use upon children is well-established, but there is a lack of research examining how parents/caregivers cope with their parenting role within the context of another parent's substance use, or how best to support these parents/caregivers.

Objective: This paper examines the experiences and support needs of parents/caregivers impacted by another parent's substance use.

Guidance on Conversations About Race and Racism in Pediatric Clinical Settings.

Objective: To develop guidance for pediatric clinicians on how to discuss race and racism in pediatric clinical settings.

Methods: We conducted a modified Delphi study from 2021 to 2022 with a panel of pediatric clinicians, psychologists, parents, and adolescents with expertise in racism and child health through scholarship or lived experience. Panelists responded to an initial survey with open-ended questions about how to talk to youth about race and racism.

Timing Matters: A Machine Learning Method for the Prioritization of Drug-Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure.

Introduction: Current drug-drug interaction (DDI) detection methods often miss the aspect of temporal plausibility, leading to false-positive disproportionality signals in spontaneous reporting system (SRS) databases.

Objective: This study aims to develop a method for detecting and prioritizing temporally plausible disproportionality signals of DDIs in SRS databases by incorporating co-exposure time in disproportionality analysis.

Methods: The method was tested in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Updated core competencies in pharmacoepidemiology to inform contemporary curricula and training for academia, government, and industry.

Purpose: The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for Pharmacoepidemiology) workgroup in 2012 (Jones JK et al. PDS 2012; 21[7]:677-689). Due to the broader and evolving scope of pharmacoepidemiology, ISPE considers it important to proactively identify, update and expand the list of core competencies to inform curricula of education programs; thus, better positioning pharmacoepidemiologists across academic, government (including regulatory), and industry positions.

Tree-temporal scan statistics for safety signal detection in vaccine clinical trials.

The evaluation of safety is critical in all clinical trials. However, the quantitative analysis of safety data in clinical trials poses statistical difficulties because of multiple potentially overlapping endpoints. Tree-temporal scan statistic approaches address this issue and have been widely employed in other data sources, but not to date in clinical trials.

Factors that influence paramedic decision-making about resuscitation for treatment of out of hospital cardiac arrest: Results of a discrete choice experiment in National Health Service ambulance trusts in England and Wales.

Background: During out of hospital cardiac arrest (OHCA) paramedics must make decisions to commence, continue, terminate or withhold resuscitation. These decisions are known to be complex, subject to variability and often dependent on provider preference. This study aimed to understand paramedic decision-making regarding the commencement of resuscitation using a discrete choice experiment.

Psoas Muscle Area as a Predictor of Transcatheter Aortic Valve Implantation Outcomes.

Background: Frailty is a well-recognised predictor of outcomes after transcatheter aortic valve implantation (TAVI). Psoas muscle area (PMA) is a surrogate marker for sarcopaenia and is a validated assessment tool for frailty. The objective of this study was to examine frailty as a predictor of outcomes in TAVI patients and assess the prognostic usefulness of adding PMA to established frailty assessments.

Racial and ethnic inequities in the quality of paediatric care in the USA: a review of quantitative evidence.

Racial and ethnic inequities in paediatric care have received increased research attention over the past two decades, particularly in the past 5 years, alongside an increased societal focus on racism. In this Series paper, the first in a two-part Series focused on racism and child health in the USA, we summarise evidence on racial and ethnic inequities in the quality of paediatric care. We review studies published between Jan 1, 2017 and July 31, 2022, that are adjusted for or stratified by insurance status to account for group differences in access, and we exclude studies in which differences in access are probably driven by patient preferences or the appropriateness of intervention.

Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies.

Introduction: For signal detection studies investigating either drug safety or method evaluation, the choice of drug-outcome pairs needs to be tailored to the planned study design and vice versa. While this is well understood in hypothesis-testing epidemiology, it should be as important in signal detection, but this has not widely been considered. There is a need for a taxonomy framework to provide guidance and a systematic reproducible approach to the selection of appropriate drugs and outcomes for signal detection studies either investigating drug safety or assessing method performance using real-world data.

Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing.

Introduction: The Vaccine Adverse Event Reporting System (VAERS) has already been challenged by an extreme increase in the number of individual case safety reports (ICSRs) after the market introduction of coronavirus disease 2019 (COVID-19) vaccines. Evidence from scientific literature suggests that when there is an extreme increase in the number of ICSRs recorded in spontaneous reporting databases (such as the VAERS), an accompanying increase in the number of disproportionality signals (sometimes referred to as 'statistical alerts') generated is expected.

Objectives: The objective of this study was to develop a natural language processing (NLP)-based approach to optimize signal management by excluding disproportionality signals related to listed adverse events following immunization (AEFIs).

Outbreak of Bilateral Endophthalmitis After Immediate Sequential Bilateral Cataract Surgery.

Importance: Since bilateral simultaneous postoperative endophthalmitis (BSPOE) after immediate sequential bilateral cataract surgery (ISBCS) can be devastating for the patient, evaluating such cases in depth is important to maintaining patient safety.

Objective: To evaluate whether a systemic breach of sterility was associated with an outbreak of BSPOE after ISBCSs performed on the same day at a single community-based eye clinic.

Design, Setting, And Participants: This retrospective case series included all patients diagnosed with BSPOE at ophthalmology departments in Denmark following an infectious outbreak after ISBCSs performed at a single community-based eye clinic in December 2022.

Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility.

Introduction: Spontaneous reporting of adverse events has increased steadily over the past decades, and although this trend has contributed to improving post-marketing surveillance pharmacovigilance activities, the consequent amount of data generated is challenging to manually review during assessment, with each individual report requiring review by pharmacovigilance experts. This highlights a clear need for alternative or complementary methodologies to help prioritise review.

Objective: Here, we aimed to develop and test an automated methodology, the Clinical Utility Score for Prioritisation (CUSP), to assist pharmacovigilance experts in prioritising clinical assessment of safety data to improve the rapidity of case series review when case volumes are large.

Achieving integrated treatment: a realist synthesis of service models and systems for co-existing serious mental health and substance use conditions.

Approximately 30-50% of people with serious mental illness have co-existing drug or alcohol problems (COSMHAD), associated with adverse health and social care outcomes. UK guidelines advocate both co-occurring needs being met within mental health services, but uncertainty remains about how to operationalise this to improve outcomes. Various unevaluated service configurations exist in the UK.

Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data.

Introduction: Time- and resource-demanding activities related to processing individual case safety reports (ICSRs) include manual procedures to evaluate individual causality with the final goal of dismissing false-positive safety signals. Eminent experts and a representative from pharmaceutical industries and regulatory agencies have highlighted the need to automatize time- and resource-demanding procedures in signal detection and validation. However, to date there is a sparse availability of automatized tools for such purposes.

Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

Background: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial.

Aim: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact.

Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk.

Introduction: Identifying individual characteristics or underlying conditions linked to adverse drug reactions (ADRs) can help optimise the benefit-risk ratio for individuals. A systematic evaluation of statistical methods to identify subgroups potentially at risk using spontaneous ADR report datasets is lacking.

Objectives: In this study, we aimed to assess concordance between subgroup disproportionality scores and European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) discussions of potential subgroup risk.