Patient-reported outcomes and measures are under-utilised in advanced therapy medicinal products trials for orphan conditions.

Objectives: Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells and can include gene therapy, somatic-cell therapy, and tissue-engineered medicines. Patient-reported outcomes (PROs) are reports on health and well-being that come directly from the individual without external interpretation. Patient-reported outcome measures (PROMs) are questionnaires aimed at assessing the individual and subjective experience with health and other psychosocial aspects.

Quality indicators for schizophrenia care: A scoping review.

Measuring quality of care is a critical first step towards improving the healthcare contributing to persistent poor outcomes experienced by many people living with schizophrenia. This scoping review aims to identify and characterize indicators for measuring the quality of care for people living with schizophrenia. We searched 6 academic databases, 4 grey literature databases, and 23 organization websites for documents containing quality indicators developed for or applied in a population with schizophrenia-spectrum disorders.

Current trends, barriers, and facilitators of use of core outcome sets in Cochrane systematic reviews: Protocol.

: Core outcome sets (COS) represent agreed-upon minimum outcomes that should be reported in all studies in a given topic area. Cochrane reviews are considered among the most rigorously conducted systematic reviews (SRs). In 2019, seven of the first 100 published Cochrane SRs (7%) cited a COS in relation to choosing outcomes.

Responding to the Growing Need for Medical Experts in Testamentary and Estate Related Capacities: A Course for Physicians.

Objectives: The objective of this continuing medical education course was to improve the knowledge and skills of physicians in the assessment of testamentary and related capacities.

Methods: We developed, conducted, and evaluated an accredited medical education course focusing on the role and responsibilities of medical experts in estate litigation and held in Toronto, Ontario, Canada in June 2022.

Results: Participants reported a 65% and 35% improvement in confidence in conducting retrospective and contemporaneous assessments of testamentary capacity, respectively.

A survey of experts to identify methods to detect problematic studies: stage 1 of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews project.

Background And Objective: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.

Introduction: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice.

FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy - protocol for a prospective multicentre mixed-methods feasibility study.

Introduction: Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management difficulties: on the one hand, continuation of the pregnancy carries a risk of death of the smaller twin, with a high risk of co-twin demise (40%) or co-twin neurological sequelae (30%). On the other, early delivery to prevent the death of the smaller twin may expose the larger twin to prematurity, with the associated risks of long-term physical, emotional and financial costs from neurodisability, such as cerebral palsy.

Assessing the impact of colostrum feeding delay on serum immunoglobulin G and total protein in dairy goat kids.

This experiment was motivated by the need to understand the impacts of delaying the first colostrum feeding on the prevalence of failed transfer of passive immunity (FTPI). A cohort of 216 kids was stratified into groups based on the colostrum feeding delay postbirth: 0-4 h, 4-8 h, 8-12 h, and 12-16 h. All kids received a single colostrum meal of 300 mL, and blood samples were collected approximately 36 h after feeding.

Diagnosis and management of selective fetal growth restriction in monochorionic twin pregnancies: A cross-sectional international survey.

Objective: To identify current practices in the management of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies.

Design: Cross-sectional survey.

Setting: International.

Selective outcome reporting in trials of behavioural health interventions in health psychology and behavioural medicine journals: a review.

Selective outcome reporting can result in overestimation of treatment effects, research waste, and reduced openness and transparency. This review aimed to examine selective outcome reporting in trials of behavioural health interventions and determine potential outcome reporting bias. A review of nine health psychology and behavioural medicine journals was conducted to identify randomised controlled trials of behavioural health interventions published since 2019.

Exploring the effect on primary endpoints in trials testing targeted therapy interventions for rheumatoid arthritis: a meta-epidemiological study on the appropriate use of a core outcome set.

Objectives: To explore which core domain is best associated with the American College of Rheumatology (ACR) 20% response in trials assessing the effect of targeted interventions in rheumatoid arthritis (RA).

Methods: A meta-epidemiological study was performed on randomised trials investigating biologics and targeted agents compared with placebo or conventional disease-modifying antirheumatic drugs in patients with RA. The main outcome measures were ORs for the ACR 20% response and at least one of the eight core domains according to the existing RA core outcome set (COS) analysed based on standardised mean differences.

Guideline Recommendations on Behavioral and Psychological Symptoms of Dementia: A Systematic Review.

Objective: To synthesize recommendations on assessing and managing behavioral and psychological symptoms of dementia (BPSDs) in existing clinical practice guidelines on dementia care to learn from and adapt recommendations to a Canadian context and language for describing BPSDs.

Design: Systematic review.

Setting And Participants: Moderate to high-quality clinical practice guidelines on dementia care that made 1 or more recommendations on BPSD assessment or management.

Characterizing Frontal Lobe Seizure Semiology in Children.

Objective: The objective was to analyze seizure semiology in pediatric frontal lobe epilepsy patients, considering age, to localize the seizure onset zone for surgical resection in focal epilepsy.

Methods: Fifty patients were identified retrospectively, who achieved seizure freedom after frontal lobe resective surgery at Great Ormond Street Hospital. Video-electroencephalography recordings of preoperative ictal seizure semiology were analyzed, stratifying the data based on resection region (mesial or lateral frontal lobe) and age at surgery (≤4 vs >4).

A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project.

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic.

Timely Yet Long Overdue: Canadian Standards for Long-Term Care Homes.

The impact of the COVID-19 pandemic highlighted systemic problems in Canadian long-term care (LTC). While high mortality rates in LTC received significant attention, the pandemic also took an enormous toll on mental health of LTC residents, where mental health conditions, including cognitive disorders, are already much higher than in other community settings. The pandemic resulted in a renewed interest in improving quality of care in LTC and led to the recent development of several National Standards of Canada.

Study found increasing use of core outcome sets in Cochrane systematic reviews and identified facilitators and barriers.

Objectives: In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS.

Study Design And Setting: We examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS.

Representation of published core outcome sets in practice guidelines.

Objectives: A core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in specific areas of health or health care. A COS is developed through a consensus process to ensure health care outcomes to be measured are relevant to decision-makers, including patients and health-care professionals. Use of COS in guideline development is likely to increase the relevance of the guideline to those decision-makers.

Synchronous retreat of Thwaites and Pine Island glaciers in response to external forcings in the presatellite era.

Today, relatively warm Circumpolar Deep Water is melting Thwaites Glacier at the base of its ice shelf and at the grounding zone, contributing to significant ice retreat. Accelerating ice loss has been observed since the 1970s; however, it is unclear when this phase of significant melting initiated. We analyzed the marine sedimentary record to reconstruct Thwaites Glacier's history from the early Holocene to present.

Using behavioral science to increase core outcome set use in trials.

Objectives: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials.