Can prospective usability evaluation predict data errors?

Increasing amounts of clinical research data are collected by manual data entry into electronic source systems and directly from research subjects. For this manual entered source data, common methods of data cleaning such as post-entry identification and resolution of discrepancies and double data entry are not feasible. However data accuracy rates achieved without these mechanisms may be higher than desired for a particular research use. We evaluated a heuristic usability method for utility as a tool to independently and prospectively identify data collection form questions associated with data errors. The method evaluated had a promising sensitivity of 64% and a specificity of 67%. The method was used as described in the literature for usability with no further adaptations or specialization for predicting data errors. We conclude that usability evaluation methodology should be further investigated for use in data quality assurance

Building Open Education Capacity: Introducing the Canadian Code of Best Practices in Fair Dealing for Open Educational Resources

This article builds upon a presentation given at the 2024 ABC Copyright Conference in which the authors outlined the process for adapting the Code of Best Practices in Fair Use for Open Educational Resources (OER) for a Canadian audience. Originally published in 2021, the U.S. Code is an important tool for evaluating common OER use cases, providing a framework of analysis that can guide a creator towards making judiciously defensible fair use decisions. Alongside practical guidance, the Code represents a significant contribution in support of the United Nations Educational, Scientific and Cultural Organization (UNESCO)’s Recommendation on OER, which encourages member states to build capacity concerning exceptions and limitations for the use of copyrighted works for educational and research purposes. Supported by the Canadian Association of Research Libraries, the Canadian Adaptation Working Group began their adaptation process in late 2021 and the final Code was published in early 2024. In addition to providing an overview of the adaptation process, this article offers a comprehensive summary of the legal considerations that informed the writing of the Code and provides examples of how the Code has been operationalized at educational institutions in Canada. 

A qualitative study to explore fathers’ attitudes towards breastfeeding in South West England

Aim: To explore the beliefs, attitudes, and behaviours of fathers towards breastfeeding and how they impact either positively or negatively on their partners’ decisions to initiate or continue breastfeeding. Background: Despite policy initiatives at a national and international level and the increased number of baby-friendly hospitals within the UK, breastfeeding rates are slow to rise. Support from both parents has been proven to increase uptake and continuation rates, but there is little research into the emotional experience of fathers when it comes to breastfeeding. Methods: We conducted qualitative interviews with 18 fathers in Wiltshire, England. Principles of grounded theory were used throughout this study to guide the sampling, data collection, and data analysis. Findings: Fathers knew the health benefits of breastfeeding and wanted their child to breastfeed but were unsure of their place in the feeding process because they felt it was not their body. While they were aware of the benefits of breast milk for infants, fathers felt less informed of the practicalities of breastfeeding and the potential challenges they and their partner might have to overcome to breastfeed successfully for the recommended six-month period. Based on these findings, three segments were identified: the problem bonders, the dual bonders, and the pragmatists. All segments were concerned with the well-being of their partner and child and wanted their child to be breastfed. Health professionals can use the results of this study to create prenatal educational resources that take more of a preventive and problem-solving approach as opposed to promoting breastfeeding in efforts to comply with National Health Service guidelines, without offering solutions to common breastfeeding problems

Practical Guidance for the Management of Adverse Events in Patients with KRASG12C-Mutated Non-Small Cell Lung Cancer Receiving Adagrasib

Adagrasib (MRTX849) is a KRASG12C inhibitor with favorable properties, including long half-life (23 h), dose-dependent pharmacokinetics, and central nervous system (CNS) penetration. As of September 1, 2022, a total of 853 patients with KRASG12C-mutated solid tumors, including patients with CNS metastases, had received adagrasib (monotherapy or in combination). Adagrasib-related treatment-related adverse events (TRAEs) are generally mild to moderate in severity, start early in treatment, resolve quickly with appropriate intervention, and result in a low rate of treatment discontinuation. Common TRAEs seen in clinical trials included gastrointestinal-related toxicities (diarrhea, nausea, and vomiting); hepatic toxicities (increased alanine aminotransferase/aspartate aminotransferase) and fatigue, which can be managed through dose modifications, dietary modifications, concomitant medications (such as anti-diarrheals and anti-emetics/anti-nauseants) and the monitoring of liver enzymes and electrolytes. To manage common TRAEs effectively, it is imperative that clinicians are informed, and patients are fully counseled on management recommendations at treatment initiation. In this review, we provide practical guidance on the management of adagrasib TRAEs and discuss some best practices for patient and caregiver counseling to facilitate optimal outcomes for patients. Safety and tolerability data from the phase II cohort of the KRYSTAL-1 study will be reviewed and presented with practical management recommendations based on our experience as clinical investigators

Supporting Aboriginal Community Controlled Health Services to deliver alcohol care : Protocol for a cluster randomised controlled trial

Introduction Indigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms. In Australia, Aboriginal Community Controlled Health Services (ACCHSs) offer culturally accessible care to Aboriginal and Torres Strait Islander (Indigenous) peoples. However there are many competing health, socioeconomic and cultural client needs. Methods and analysis A randomised cluster wait-control trial will test the effectiveness of a model of tailored and collaborative support for ACCHSs in increasing use of alcohol screening (with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)) and of treatment provision (brief intervention, counselling or relapse prevention medicines). Setting Twenty-two ACCHSs across Australia. Randomisation Services will be stratified by remoteness, then randomised into two groups. Half receive support soon after the trial starts (intervention or ‘early support’); half receive support 2 years later (wait-control or ‘late support’). The support Core support elements will be tailored to local needs and include: support to nominate two staff as champions for increasing alcohol care; a national training workshop and bimonthly teleconferences for service champions to share knowledge; onsite training, and bimonthly feedback on routinely collected data on screening and treatment provision. Outcomes and analysis Primary outcome is use of screening using AUDIT-C as routinely recorded on practice software. Secondary outcomes are recording of brief intervention, counselling, relapse prevention medicines; and blood pressure, gamma glutamyltransferase and HbA1c. Multi-level logistic regression will be used to test the effectiveness of support. Ethics and dissemination Ethical approval has been obtained from eight ethics committees: the Aboriginal Health and Medical Research Council of New South Wales (1217/16); Central Australian Human Research Ethics Committee (CA-17-2842); Northern Territory Department of Health and Menzies School of Health Research (2017-2737); Central Queensland Hospital and Health Service (17/QCQ/9); Far North Queensland (17/QCH/45-1143); Aboriginal Health Research Ethics Committee, South Australia (04-16-694); St Vincent’s Hospital (Melbourne) Human Research Ethics Committee (LRR 036/17); and Western Australian Aboriginal Health Ethics Committee (779). Trial registration number ACTRN12618001892202; Pre-results

Basic science232. Certolizumab pegol prevents pro-inflammatory alterations in endothelial cell function

Background: Cardiovascular disease is a major comorbidity of rheumatoid arthritis (RA) and a leading cause of death. Chronic systemic inflammation involving tumour necrosis factor alpha (TNF) could contribute to endothelial activation and atherogenesis. A number of anti-TNF therapies are in current use for the treatment of RA, including certolizumab pegol (CZP), (Cimzia ®; UCB, Belgium). Anti-TNF therapy has been associated with reduced clinical cardiovascular disease risk and ameliorated vascular function in RA patients. However, the specific effects of TNF inhibitors on endothelial cell function are largely unknown. Our aim was to investigate the mechanisms underpinning CZP effects on TNF-activated human endothelial cells. Methods: Human aortic endothelial cells (HAoECs) were cultured in vitro and exposed to a) TNF alone, b) TNF plus CZP, or c) neither agent. Microarray analysis was used to examine the transcriptional profile of cells treated for 6 hrs and quantitative polymerase chain reaction (qPCR) analysed gene expression at 1, 3, 6 and 24 hrs. NF-κB localization and IκB degradation were investigated using immunocytochemistry, high content analysis and western blotting. Flow cytometry was conducted to detect microparticle release from HAoECs. Results: Transcriptional profiling revealed that while TNF alone had strong effects on endothelial gene expression, TNF and CZP in combination produced a global gene expression pattern similar to untreated control. The two most highly up-regulated genes in response to TNF treatment were adhesion molecules E-selectin and VCAM-1 (q 0.2 compared to control; p > 0.05 compared to TNF alone). The NF-κB pathway was confirmed as a downstream target of TNF-induced HAoEC activation, via nuclear translocation of NF-κB and degradation of IκB, effects which were abolished by treatment with CZP. In addition, flow cytometry detected an increased production of endothelial microparticles in TNF-activated HAoECs, which was prevented by treatment with CZP. Conclusions: We have found at a cellular level that a clinically available TNF inhibitor, CZP reduces the expression of adhesion molecule expression, and prevents TNF-induced activation of the NF-κB pathway. Furthermore, CZP prevents the production of microparticles by activated endothelial cells. This could be central to the prevention of inflammatory environments underlying these conditions and measurement of microparticles has potential as a novel prognostic marker for future cardiovascular events in this patient group. Disclosure statement: Y.A. received a research grant from UCB. I.B. received a research grant from UCB. S.H. received a research grant from UCB. All other authors have declared no conflicts of interes

Emergency hospital admissions associated with a non-randomised housing intervention meeting national housing quality standards: a longitudinal data linkage study

Background We investigated tenant healthcare utilisation associated with upgrading 8558 council houses to a national quality standard. Homes received multiple internal and external improvements and were analysed using repeated measures of healthcare utilisation. Methods The primary outcome was emergency hospital admissions for cardiorespiratory conditions and injuries for residents aged 60 years and over. Secondary outcomes included each of the separate conditions, for tenants aged 60 and over, and for all ages. Council home address and intervention records for eight housing cointerventions were anonymously linked to demographic data, hospital admissions and deaths for individuals in a dynamic cohort. Counts of health events were analysed using multilevel regression models to investigate associations between receipt of each housing improvement, adjusting for potential confounding factors and regional trends. Results Residents aged 60 years and over living in homes when improvements were made were associated with up to 39% fewer admissions compared with those living in homes that were not upgraded (incidence rate ratio=0.61, 95% CI 0.53 to 0.72). Reduced admissions were associated with electrical systems, windows and doors, wall insulation, and garden paths. There were small non-significant reductions for the primary outcome associated with upgrading heating, adequate loft insulation, new kitchens and new bathrooms. Conclusion Results suggest that hospital admissions can be avoided through improving whole home quality standards. This is the first large-scale longitudinal evaluation of a whole home intervention that has evaluated multiple improvement elements using individual-level objective routine health data

Multi-sectoral data linkages to explore associations between the built environment and BMI.

Objectives In Wales almost a quarter of adults and 1 in 8 reception age children are obese. Linked data is a key tool to understanding the role of the built environment on obesity rates and is an important part of developing strategies to combat the obesity epidemic in Wales. Approach We set out to develop an analytical platform for generating evidence on key aspects of the built environment which impact child and adult obesity including; walkability, fast food availability, green space size and qualities, active transport routes and school environments. Utilising the Secure Anonymised Information Linkage (SAIL) Databank We linked multi-sectoral data including routine health data, cohort data, administrative data and linked Geographic Information Systems generated metrics at household and school level. The platform will inform policy makers with and facilitate a  better understanding of associations between a range of social, health and built environment factors. Results We have created a range of built environment variables including temporally and age varying walkability indices, viewable greenspace, garden and house size, access to services and parks for 1.5 million households. In the first instance, as part of the BEACHES project, this data has been linked to several health datasets including the Child Measurement Programme (CMP, n=188,800) where initial results have shown that associations between garden size and Body Mass Index in children displays a non-linear negative correlation. We have also created follow-up measures for the CMP using routinely collected general practice data which further enables linking 28,389 height and weight measurements. However, potential bias in these follow-up measures is poorly understood with further work being undertaken to assess usability. Conclusion The integrated multi-sectoral data platform approach to linking environmental, administrative, health and cohort data aims to develop insights on a range of public health issues. We are working with a range of stakeholders to develop evidence-based policy initiatives to reduce obesity in Wales

The Cancer Research UK Stratified Medicine Programme as a model for delivering personalised cancer care

Genomic screening is routinely used to guide the treatment of cancer patients in many countries. However, several multi-layered factors make this effort difficult to deliver within a clinically relevant timeframe. Here we share the learnings from the CRUK-funded Stratified Medicine Programme for advanced NSCLC patients, which could be useful to better plan future studies