Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials.

Background: It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials.

Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review.

Background: Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland.

Exploring the effects of Factor Xa inhibitors on thrombin generation in people with haemophilia.

Optimal management of cardiovascular disease (CVD) in people with haemophilia (PWH) is a growing issue, given the continuing improvement in life expectancy among PWH. The evolving treatment paradigms targeting higher trough levels and the advent of non-factor replacement therapies (NFRT) means much of the 'protection' PWH were thought to have against CVD may be lost. There is a paucity of evidence regarding the safety of using anticoagulants in PWH.

Low-cost, versatile, and highly reproducible microfabrication pipeline to generate 3D-printed customised cell culture devices with complex designs.

Cell culture devices, such as microwells and microfluidic chips, are designed to increase the complexity of cell-based models while retaining control over culture conditions and have become indispensable platforms for biological systems modelling. From microtopography, microwells, plating devices, and microfluidic systems to larger constructs such as live imaging chamber slides, a wide variety of culture devices with different geometries have become indispensable in biology laboratories. However, while their application in biological projects is increasing exponentially, due to a combination of the techniques, equipment and tools required for their manufacture, and the expertise necessary, biological and biomedical labs tend more often to rely on already made devices.

Fostering collaborative practice through interprofessional simulation for occupational therapy, physiotherapy, dietetics, and nursing students.

Literature regarding simulation for learning interprofessional collaborative practice (IPCP) indicates a need to include a range of health professions and to focus on students' development of team communication and conflict resolution skills in day-to-day healthcare delivery. This study evaluated the impact of interprofessional simulation for occupational therapy, physiotherapy, dietetics, and nursing students on interprofessional collaboration competencies, specifically collaborative communication and conflict resolution during day-to-day interactions, and their intention for IPCP during placement. A series of simulations featuring the potential for interprofessional conflict and involving explicit coaching on communication and conflict resolution were conducted.

Reducing the risk of atherosclerotic cardiovascular disease in people with hemophilia: the importance of primary prevention.

Revolutionary advances in the treatment of hemophilia has led to a significant improvement in life expectancy. Associated with this has been an increase in age-related diseases especially atherosclerotic cardiovascular disease (CVD). While people with hemophilia (PWH) develop atherosclerosis at rates similar to those of the general population, rates of atherothrombosis and mortality related to CVD have been much lower, due to their hypocoagulable state.

Thrombo-inflammatory response in hospitalised patients with COVID-19: a single institution experience.

Background: Severe COVID-19 causes acute inflammation, which is complicated by venous thromboembolism events (VTE). However, it is unclear if VTE risk has evolved over time since the COVID-19 outbreak.

Aims: To determine markers of thrombo-inflammation and rates of symptomatic VTE in patients hospitalised for COVID-19 in a metropolitan hospital in Sydney, Australia.

Venous Thromboembolism and Estrogen-Containing Gender-Affirming Hormone Therapy.

Gender-affirming therapy involves the use of hormones to develop the physical characteristics of the identified gender and suppressing endogenous sex hormone production. Venous thromboembolism (VTE) is a known risk of exogenous estrogen therapy, and while evidence of VTE risk among transgender women using modern gender-affirming hormone therapy (GAHT) is still emerging, it is thought to affect up to 5% of transgender women. Historically, GAHT was associated with a high risk of VTE; however, modern preparations are less thrombogenic mainly due to significantly lower doses used as well as different preparations.

Applying the Integrated Sustainability Framework to explore the long-term sustainability of nutrition education programmes in schools: a systematic review.

Objective: This review aimed to identify and synthesise the enablers and barriers that influence the long-term (≥ 2 years) sustainment of school-based nutrition programmes.

Design: Four databases (PubMed, Cochrane Library, Embase and Scopus) were searched to identify studies reporting on the international literature relating to food and nutrition programmes aimed at school-age (5-14 years) children that had been running for ≥ 2 years (combined intervention and follow-up period). Eligible studies were analysed using the Integrated Sustainability Framework (ISF), which involved deductive coding of programme enablers and barriers.

Adherence and persistence to direct factor Xa inhibitors in the community following newly diagnosed venous thromboembolism: a retrospective pharmacy-linkage study.

Objectives: To assess adherence and persistence to the direct factor Xa inhibitor oral anticoagulants in the community following newly diagnosed venous thromboembolism (VTE).

Methods: We retrospectively reviewed community pharmacy dispensing data on all patients with newly diagnosed VTE who were prescribed direct factor Xa inhibitors, apixaban or rivaroxaban, between January 2018 and December 2019 at our institution. Proportion of days covered (PDC) was used to assess adherence at 90 days, and 6- and 12 months.

Measuring Emicizumab Levels in the Hemostasis Laboratory.

Emicizumab is a bi-specific antibody that in recent years has been introduced in many countries as a prophylactic agent for bleed prevention in cases of severe hemophilia A, and in some cases of moderate HA. It can be used in individuals with HA with and without FVIII inhibitors, because the drug is not a target for these inhibitors. Emicizumab was developed as a fixed weight-based dose and does not normally need laboratory monitoring, but in some circumstances such as a treated HA patient with unexpected bleeding episodes, a laboratory assay is justified.

A Systematic Review Investigating Maternal Nutrition During Pregnancy After Bariatric Surgery.

The aim of this review was to report on maternal diet, micronutrient supplementation, and gestational weight gain (GWG) during pregnancy following bariatric surgery and explore the impact on maternal micronutrient deficiency, offspring growth, and perinatal outcomes. A search in PubMed, CINAHL, EMBASE, and ProQuest in July 2022 returned 23 eligible studies (n = 30-20, 213). Diet was reported in two studies, supplementation in six and GWG in 19 studies.

Venous anomalies and thromboembolism.

Patients with venous anomalies are at increased risk of developing venous thromboembolism (VTE) and subsequent complications, but they are often under-recognised. While unprovoked VTE may trigger testing for inherited thrombophilias and malignancy screening, anatomic variants are considered less often. Venous anomalies increase the risk due to venous flow disturbance, resulting in hypertension, reduced flow velocity and turbulence.

Exercise-Based Knee and Anterior Cruciate Ligament Injury Prevention.

The Academy of Orthopaedic Physical Therapy and the American Academy of Sports Physical Therapy have an ongoing effort to create evidence-based clinical practice guidelines (CPGs) for orthopaedic and sports physical therapy management and prevention of musculoskeletal impairments described in the World Health Organization's International Classification of Functioning, Disability and Health (ICF). This guideline focuses on the exercise-based prevention of knee injuries and provides an update on the 2018 guideline, 2018;48(9):A1-A42. doi:10.

C-reactive protein, immunothrombosis and venous thromboembolism.

C-reactive protein (CRP) is a member of the highly conserved pentraxin superfamily of proteins and is often used in clinical practice as a marker of infection and inflammation. There is now increasing evidence that CRP is not only a marker of inflammation, but also that destabilized isoforms of CRP possess pro-inflammatory and pro-thrombotic properties. CRP circulates as a functionally inert pentameric form (pCRP), which relaxes its conformation to pCRP* after binding to phosphocholine-enriched membranes and then dissociates to monomeric CRP (mCRP).

Pulmonary embolus.

Background: Pulmonary embolism (PE) remains a common problem and can present with nonspecific symptoms and signs. Anticoagulation is the mainstay of management, the duration of which often depends on the clinical circumstances of the PE.

Objective: The aim of this article is to review the epidemiology, clinical presentation, diagnosis, management and long-term complications of PE.

Communicating Health to Young Adults Using Social Media: How, Where, and When?

Communication with young adults about healthy lifestyle behaviours needs to result in improvements in dietary choices to impact the prevalence of diet-related diseases. This paper presents the health beliefs, behaviours, and communication practices in young Australian adults (n = 2019) by their pre-defined psycho-behavioural characteristics: Lifestyle Mavens, Health-Conscious, Aspirational Healthy Eaters, Balanced-All Rounders, Contemplating Another Day, or Blissfully Unconcerned. The Lifestyle Mavens and Health-Conscious groups were more likely to actively seek out health information on social media (p < 0.

Hepatic patatin-like phospholipase domain-containing 3 levels are increased in I148M risk allele carriers and correlate with NAFLD in humans.

In nonalcoholic fatty liver disease (NAFLD) the patatin-like phospholipase domain-containing 3 (PNPLA3) rs738409 variant is a contributor. In mice, the Pnpla3 148M variant accumulates on lipid droplets and probably leads to sequestration of a lipase cofactor leading to impaired mobilization of triglycerides. To advance our understanding of the localization and abundance of PNPLA3 protein in humans, we used liver biopsies from patients with NAFLD to investigate the link to NAFLD and the PNPLA3 148M genotype.

What Do Health Professionals and Parents Want as Part of an Online Childhood Obesity Prevention Program?

There are limited evidence-based programs for children living in Queensland, Australia, who are at risk of overweight or obesity. Despite the known importance of prevention initiatives, an online, locally relevant program supporting sustainable health behaviors does not exist. This study aimed to understand the perspectives of parents/guardians and health professionals regarding important aspects of an online childhood obesity prevention program.