A systematic study of CSTD-generated stress on different biomolecular modalities.

Although Closed System Transfer Devices (CSTDs) are used in oncology for dose preparation and administration, the impact of CSTDs on biologics and other non-small molecular modalities are not fully understood. We investigated particle formation when preparing and mock administering three experimental biologics (mAb, ADC, and fusion protein) using seven models of CSTDs. A wide range of visible and subvisible particle formation was observed among CSTD models.

A Practical Tool for Risk-Based In-use Compatibility Assessments.

In drug development, in-use compatibility studies are crucial steps to ensure that the critical quality attributes of the drug product are maintained when in contact with administration components. But once the drug is in clinical trials, unanticipated variations in these components can stretch limited resources and lengthen timelines to market, as these changes must be assessed and approved to ensure continued patient safety. It's desirable to use a science-based risk evaluation to determine the extent of data and testing needed in these situations, but there is no standard for how such evaluations are done.

Public perceptions of advance care planning (ACP) from an international perspective: a scoping review.

Background: Advance Care Planning (ACP) helps people discuss personal values, goals and priorities regarding future care with family and professionals. It can support care coordination and guide decision-making as health deteriorates. However, uptake remains low internationally.

Online public information about advance care planning: An evaluation of UK and international websites.

Introduction: Healthcare information is increasingly internet-based. Standards require websites to be 'perceivable, operable, understandable and robust' with relevant content for citizens in appropriate language. This study examined UK and international websites offering public healthcare information on advance care planning (ACP) using current recommendations for website accessibility and content and informed by a public engagement exercise.

"Selecting the right tool for the job" a narrative overview of experimental methods used to measure or estimate active and passive drag in competitive swimming.

Free-swimming performance depends strongly on the ability to develop propulsive force and minimise resistive drag. Therefore, estimating resistive drag (passive or active) may be important to understand how free-swimming performance can be improved. The purpose of this narrative overview was to describe and discuss experimental methods of measuring or estimating active and passive drag relevant to competitive swimming.

Advance care planning in primary care for patients with gastrointestinal cancer: feasibility randomised trial.

Background: Advance (anticipatory) care planning (ACP) requires discussions between patients and healthcare professionals about planning for future deterioration in health. ACP improves care coordination but uptake is limited and often deferred.

Aim: To assess the feasibility and acceptability to patients, carers, and GPs of a primary care ACP intervention for people with incurable oesophageal, gastric, or pancreatic cancer.

Integrating lived experiences of out-of-hours health services for people with palliative and end-of-life care needs with national datasets for people dying in Scotland in 2016: A mixed methods, multi-stage design.

Background: Unscheduled care is used increasingly during the last year of life by people known to have significant palliative care needs.

Aim: To document the frequency and patterns of use of unscheduled healthcare by people in their last year of life and understand the experiences and perspectives of patients, families and professionals about accessing unscheduled care out-of-hours.

Design: A mixed methods, multi-stage study integrating a retrospective cohort analysis of unscheduled healthcare service use in the last year of life for all people dying in Scotland in 2016 with qualitative data from three regions involving service users, bereaved carers and general practitioners.

The role of the biomechanics analyst in swimming training and competition analysis.

Swimming analysts aid coaches and athletes in the decision-making by providing evidence-based recommendations. The aim of this narrative review was to report the best practices of swimming analysts that have been supporting high-performance athletes. It also aims to share how swimming analysts can translate applied research into practice.

Unscheduled and out-of-hours care for people in their last year of life: a retrospective cohort analysis of national datasets.

Objectives: To analyse patterns of use and costs of unscheduled National Health Service (NHS) services for people in the last year of life.

Design: Retrospective cohort analysis of national datasets with application of standard UK costings.

Participants And Setting: All people who died in Scotland in 2016 aged 18 or older (N=56 407).

Analytical artifacts in characterization of recombinant monoclonal antibody therapeutics.

A battery of analytical methods is used to analyze recombinant monoclonal antibodies for lot release to ensure consistent product quality, safety, and efficacy. Additionally, state-of-the-art analytical methods have been used to thoroughly characterize various post-translational modifications and degradation pathways of those molecules. Scientifically sound and robust analytical methods are essential to providing reliable results for defining control strategy, including setting phase-appropriate specifications.

Studying the effects of asymmetry on freestyle swimming using smoothed particle hydrodynamics.

The use of asymmetrical strokes is common in freestyle swimming because of breathing and strength laterality. In this study, the asymmetrical freestyle swimming performance of a male elite level swimmer who breathed every second arm stroke (unilaterally) was investigated. A laser body scan and multi-angle video footage of the athlete were used to generate a swimming biomechanical model.

Disrupted biographies and balancing identities: A qualitative study of cancer patients' communication with healthcare professionals about dependent children.

Objective: About 14% of cancer patients live with dependent children. Healthcare professionals are well placed to help patients support their children as part of a patient-centred practice. Children tend to appreciate open communication during the course of illness, but patients often find this difficult.

Structure, heterogeneity and developability assessment of therapeutic antibodies.

Increasing attention has been paid to developability assessment with the understanding that thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid delays during late-stage development. The concept of developability is based on the knowledge gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products and from the lessons learned from many failed development programs over the last three decades. Here, we reviewed antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes.

Computer screening for palliative care needs in primary care: a mixed-methods study.

Background: Though the majority of people could benefit from palliative care before they die, most do not receive this approach, especially those with multimorbidity and frailty. GPs find it difficult to identify such patients.

Aim: To refine and evaluate the utility of a computer application (AnticiPal) to help primary care teams screen their registered patients for people who could benefit from palliative care.

Analytical comparability study of recombinant monoclonal antibody therapeutics.

Process changes are inevitable in the life cycle of recombinant monoclonal antibody therapeutics. Products made using pre- and post-change processes are required to be comparable as demonstrated by comparability studies to qualify for continuous development and commercial supply. Establishment of comparability is a systematic process of gathering and evaluating data based on scientific understanding and clinical experience of the relationship between product quality attributes and their impact on safety and efficacy.

Forced degradation of recombinant monoclonal antibodies: A practical guide.

Forced degradation studies have become integral to the development of recombinant monoclonal antibody therapeutics by serving a variety of objectives from early stage manufacturability evaluation to supporting comparability assessments both pre- and post- marketing approval. This review summarizes the regulatory guidance scattered throughout different documents to highlight the expectations from various agencies such as the Food and Drug Administration and European Medicines Agency. The various purposes for forced degradation studies, commonly used conditions and the major degradation pathways under each condition are also discussed.

Contribution of uncertainty in estimation of active drag using assisted towing method in front crawl swimming.

Active drag force in swimming can be calculated from a function of five different variables: swim velocity, tow velocity, belt force, power output and exponent of velocity. The accuracy of the drag force value is dependent on the accuracy of each variable, and on the contribution of each variable to drag estimation. To calculate uncertainty in drag value, first the derivatives of the active drag equation with respect to each variable were obtained.

Reliability of estimating active drag in swimming using the assisted towing method with fluctuating speed.

The reliability of active drag values was examined using a method that compared free swim speed with measurements taken by towing swimmers slightly faster than their maximum swim speed, while allowing their intra-stroke speed fluctuations. Twelve national age and open level swimmers were tested on two alternate days (Day 1 and Day 2). All participants completed four maximum swim speed, three passive drag and five active drag trials on each of the days.

Improving primary palliative care in Scotland: lessons from a mixed methods study.

Background: Since 2012, all GP practices across Scotland have been supported to take a systematic approach to end-of-life care, by helping them to identify more patients for palliative care through a Palliative Care Directed Enhanced Service (DES). We aimed to understand the impact of this initiative.

Methods: Routine quantitative data from the 2012/13, and 2013/14 DES were collected from regional health boards, analysed and discussed.

The Role of the Hand During Freestyle Swimming.

The connections between swimming technique and the fluid dynamical interactions they generate are important for assisting performance improvement. Computational fluid dynamics (CFD) modeling provides a controlled and unobtrusive way for understanding the fundamentals of swimming. A coupled biomechanical-smoothed particle hydrodynamics (SPH) fluid model is used to analyze the thrust and drag generation of a freestyle swimmer.

Developing a computerised search to help UK General Practices identify more patients for palliative care planning: a feasibility study.

Background: Approximately 600,000 people die in the UK annually, usually after months or years of increasing debility. Many patients with advanced conditions are not identified for appropriate support before they die because they are not seen as having "palliative" care needs. General practice information technology systems can improve care by identifying patients with deteriorating health so that their healthcare needs can be reviewed more systematically and effectively.