Human subjects research regulation: perspectives on the future.

This book is the 43rd in a series entitled ‘Basic bioethics’, and is intended to make work in bioethics accessible to a broad audience. This volume looks at the regulations safeguarding research involving human participants, and explores the legislative framework governing research in the US, in particular the ‘Common Rule for the Protection of Human Subjects’. The reason for this focus is that there have been a number of proposed changes (described within the Advanced Notice for Proposed Rulemaking, or ANPRM) which aim to take a risk-based approach to targeting regulatory oversight, as well as modifying regulations to keep pace with research, particularly regarding multi-site trials and the challenges facing research involving use of biological specimens. One of the points made in the introduction is that at the time of writing (late 2013) little progress had been made in terms of this legislative review. Indeed, at the time of writing this review, the process is far from complete. The aim of the book, therefore, is to stimulate dialogue around the proposed changes

Factors influencing the development of effective error management competencies in undergraduate UK pharmacy students

Patient safety (PS) is a key healthcare goal, yet health professionals struggle to acquire appropriate expertise, including Human Factors/Ergonomics skills, reflected in undergraduate curricula content. More than 50% of adverse events are medicines-related, yet focus on pharmacists as experts in medicines is scant. This pilot investigation used focus groups and interviews to explore undergraduate PS teaching in purposively-selected UK pharmacy schools. Results revealed barriers to PS teaching including risk-averse pharmacist ‘personality’ and Educational Standards negatively influencing students’ error-management behaviours

The NHS health check for developing HFE competencies.

Patient safety is an emergent property of complex sociotechnical healthcare systems. Human Factors and Ergonomics (HFE), with its design-based systems focus, offers frameworks for developing resilient systems, although use in healthcare has been limited to date. Most healthcare educational curricula articulate requirements for students to develop patient safety competencies, but there is scant direction as to how this might be achieved. The authors have produced guidance on embedding HFE in healthcare curricula, but recognise that examples of effective HFE teaching would further support educational practice. This case study outlines a related set of activities based around the NHS Health Check, a population-wide screening programme designed to identify and manage cardiovascular risk. The Health Check represents a cardiovascular risk management system and is amenable to analysis using HFE frameworks. The educational activities described support students in developing a deep awareness of HFE theory, and early development of HFE competencies. The Health Check is a highly relevant professional activity for pharmacy students but would also be relevant to medical and nursing students, as well as healthcare management staff. This case study will form the focus of a discussion that will provide delegates with an opportunity to share experiences of different approaches to HFE education

Clinical benefits and costs of an outpatient parenteral antimicrobial therapy service.

Background: The enrolment of patients to an outpatient parenteral antimicrobial therapy (OPAT) service can be a means of mitigating financial burdens related to the provision of care and optimisation of hospital bed management. Objective: This study aimed to identify the clinical benefit of the Maltese OPAT service and to quantify the costs incurred to run it. Methods: The study period ran for 156 weeks during 1st October 2016 to 1st October 2019. Patient demographics, infection type, referring care team, antimicrobial agent/s used, type of vascular access device (VAD) available and service completion status (defined as provision of care without re-hospitalisation) were recorded. Time allocated for OPAT service delivery and expenses incurred were collected and an activity-based costing exercise was performed. Results: The patient population who benefited from the service was of 117, 15 of whom used the service twice, for a total of 132 episodes. Patients received 149 antimicrobial treatment courses, with ceftriaxone being the most common single agent used (n = 52, 34.9%). Teicoplanin with ertapenem was the most common regimen selected for combination therapy (n = 9, 52.9%). A total of 23 episodes (17.4%) resulted in a readmission, 6 (30%) of which were because of patient deterioration. The mean service running weekly cost was €455.47/$538.68 and a total of 3287 days of hospital stay were avoided. This effectively illustrates that the OPAT service optimised hospital bed availability without compromising care delivery. Conclusion: The national OPAT service proved to be a safe and effective alternative for patient management to promote patient-centred care without hospitalisation

Staff team perceptions of the Maltese outpatient parenteral antimicrobial therapy service.

The Outpatient Parenteral Antimicrobial Therapy (OPAT) service was developed to cater for hospitalised patients receiving antimicrobial treatment and who are stable enough to be discharged to an outpatient or home setting. The authors have used the Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 as a framework for exploring OPAT performance in the Maltese context. This study investigated the perceptions of the system from the perspective of the OPAT staff. Analysis of the output from a focus group was mapped onto the SEIPS 2.0 framework in order to identify and assess how OPAT work system factors interacted to produce outcomes. Thematic analysis allowed key interactions to be explored. Four key themes were identified: the referral process, training/education, trust and service expansion. Combined with output from a future study phase exploring the patient experience, it is envisaged that these findings will assist in future intelligent re-design of the service

The peroxisome proliferator activated receptor δ is required for the differentiation of THP-1 monocytic cells by phorbol ester

BACKGROUND: PPARδ (NR1C2) promotes lipid accumulation in human macrophages in vitro and has been implicated in the response of macrophages to vLDL. We have investigated the role of PPARδ in PMA-stimulated macrophage differentiation. The THP-1 monocytic cell line which displays macrophage like differentiation in response to phorbol esters was used as a model system. We manipulated the response to PMA using a potent synthetic agonist of PPARδ , compound F. THP-1 sub-lines that either over-expressed PPARδ protein, or expressed PPARδ anti-sense RNA were generated. We then explored the effects of these genetic modulations on the differentiation process. RESULTS: The PPARδ agonist, compound F, stimulated differentiation in the presence of sub-nanomolar concentrations of phorbol ester. Several markers of differentiation were induced by compound F in a synergistic fashion with phorbol ester, including CD68 and IL8. Over-expression of PPARδ also sensitised THP-1 cells to phorbol ester and correspondingly, inhibition of PPARδ by anti-sense RNA completely abolished this response. CONCLUSIONS: These data collectively demonstrate that PPARδ plays a fundamental role in mediating a subset of cellular effects of phorbol ester and supports observations from mouse knockout models that PPARδ is involved in macrophage-mediated inflammatory responses

Human factors approaches to evaluating outpatient parenteral antimicrobial therapy services: a systematic review.

Background: The expansion in terms of available treatment options and models of care has led to a growing global momentum for outpatient antimicrobial therapy (OPAT) services. A systematic review was undertaken to explore Human Factors aspects relating to OPAT service delivery and to evaluate whether OPAT is amenable to description using the Systems Engineering Initiative for Patient Safety (SEIPS 2.0) model. Method: Following a preliminary search, a search string was applied to four databases, including Medline, Cumulative Index of Nursing and Allied Health Literature, International Pharmaceutical Abstracts and PsychINFO. Inclusion criteria ensured only articles published after the year 2000 and written in English were accepted. The methodological quality of studies was assessed by three reviewers. Narrative synthesis was performed to uncover the key interactions between work system entities which underpin OPAT processes and outcomes as described using the SEIPS 2.0 model. Results: A total of twenty-seven studies were deemed eligible for the final review. Of these, most described sample populations representative of the population under study, while duration of the studies varied from a few months to years. Some studies evaluated a single model of care whilst others evaluated all three currently available models. The breadth and scope of the studies included enabled extraction of rich Human Factors data describing barriers and enablers to service provision. Conclusion: OPAT is a service which offers significant benefits to both patients and care providers. These benefits include patient satisfaction and wellbeing, as well as financial performance. OPAT is a complex sociotechnical system, and a systems approach may offer the opportunity to enhance system design, maximising system performance. This review demonstrates that the service can be better understood using the SEIPS 2.0 model to identify key work system interactions that support performance

Human factors and patient safety in undergraduate healthcare education : A systematic review

Peer reviewedPublisher PD

Twelve tips for embedding human factors and ergonomics principles in healthcare education.

Safety and improvement efforts in healthcare education and practice are often limited by inadequate attention to human factors/ergonomics (HFE) principles and methods. Integration of HFE theory and approaches within undergraduate curricula, postgraduate training and healthcare improvement programs will enhance both the performance of care systems (productivity, safety, efficiency, quality) and the well-being (experiences, joy, satisfaction, health and safety) of all the people (patients, staff, visitors) interacting with these systems. Patient safety and quality improvement education/training are embedded to some extent in most curricula, providing a potential conduit to integrate HFE concepts. To support evolving curricula and professional development at all levels - and also challenge prevailing 'human factors myths and misunderstandings' - we offer professional guidance as 'tips' for educators on fundamental HFE systems and design approaches. The goal is to further enhance the effectiveness of safety and improvement work in frontline healthcare practice