Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110).

INTRODUCTION: SEL-212 is a developmental treatment for uncontrolled gout characterized by serum uric acid (sUA) levels ≥ 6 mg/dl despite treatment. It comprises a novel PEGylated uricase (SEL-037; also called pegadricase) co-administered with tolerogenic nanoparticles containing sirolimus (rapamycin) (SEL-110; also called ImmTOR®), which mitigates the formation of anti-drug antibodies (ADAs) against uricase and SEL-037 (PEGylated uricase), thereby enabling sustained sUA control (sUA < 6 mg/dl). The aim of this study was to identify appropriate dosing for SEL-037 and SEL-110 for use in phase 3 clinical trials. METHODS: This open-label phase 2 study was conducted in adults with symptomatic gout and sUA ≥ 6 mg/dl. Participants received five monthly infusions of SEL-037 (0.2 or 0.4 mg/kg) alone or in combination with three or five monthly infusions of SEL-110 (0.05-0.15 mg/kg). Safety, tolerability, sUA, ADAs, and tophi were monitored for 6 months. RESULTS: A total of 152 adults completed the study. SEL-037 alone resulted in rapid sUA reductions that were not sustained beyond 30 days in most participants due to ADA formation and loss of uricase activity. Levels of ADAs decreased with increasing doses of SEL-110 up to 0.1 mg/kg, with anti-uricase titers < 1080 correlating with sustained sUA control and reductions in tophi. Overall, 66% of evaluable participants achieved sUA control at week 20 following five monthly doses of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg, whereas only 26% achieved sUA control at week 20 when SEL-110 was withdrawn after week 12. Compared to other dose combinations, SEL-037 0.2 mg/kg + SEL-110 0.15 mg/kg achieved the greatest sUA control at week 12 and was well-tolerated with no safety concerns. CONCLUSION: Results provide continued support for the use of multiple monthly administrations of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg in clinical trials for SEL-212. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02959918.

The role of student ambassadors in university recruitment.

Recruitment to nursing programmes is becoming increasingly difficult. At Staffordshire University we applied to a project called Higher Education Full Circle for the funding of paid student ambassadors to help with our nurse recruitment programmes. Two nursing students took on the role while continuing with their training. This article discusses the work of the student ambassadors.

An evaluation of taster days to recruit untrained health care staff to pre-registration mental health nurse education within one UK university.

With a decrease in the amount of college leavers available to recruit to nurse training and a simultaneous increase in demand for nurses, achieving recruitment targets is becoming more difficult. The widening participation agenda has encouraged us to look wider and one very rich area for recruitment is untrained health and social care staff. Some of this group do eventually opt for professional education, but many could take up places sooner, but lack the confidence or the information they need to make informed decisions. The mental health directorate of an NHS Trust (Shropshire County PCT) agreed to fund 2 'Taster Days' for up to 40 untrained healthcare staff. The Trust was keen that this opportunity was offered to value the contribution, continued learning and skills development of their untrained staff. The Taster Days were to be delivered within the Faculty of Health & Sciences of Staffordshire University. The Trust gave permission for their name to be used on advertising materials and in subsequent publication. A literature review highlighted a dearth of material, consequently allowing freedom to develop and trial our own ideas. Current students and student nurse ambassadors (funded by Advantage West Midlands and Stoke Local Strategic Partnership through Full Circle) were involved in developing materials and the delivery of the day. An evaluation of the day and recommendations are included.

Personal tutors' views of their role with pre-registration nursing students: an exploratory study.

The focus of this article is an exploratory qualitative study which examined personal tutors' views of their role within pre-registration nurse education. Following review of relevant literature and gaining ethical approval a sample of 10 personal tutors was purposively selected from the teaching staff at a University in the UK. Each personal tutor agreed to participate in an audio taped one-to-one, face-to-face, in-depth interview. Data were analysed using a thematic content analysis approach. Data themes identified included, the role of the personal tutor; perceptions of personal students; student attendance and progress issues and responding to issues disclosed by personal students. These themes were underpinned by the perceived over-riding importance in providing support to personal students. The unpopular patient syndrome is contrasted and compared with perceptions of successful and unsuccessful students. Whilst an all encompassing system of personal tutor support may require a high commitment of time and people resources it remains an important support mechanism for students.

A survey of interprofessional education in communication skills in health care programmes in the UK.

There is considerable evidence to indicate that patient satisfaction is directly related to the communication skills of health care providers. However, communication is an area in which health care practitioners often fail to meet patients' needs. Interprofessional education (IPE) is advocated as one way of improving health care communication for the consequent development of interprofessional care. However, poorly planned and delivered IPE can reinforce professional differences, so it is imperative that its introduction is based upon sound evidence of local need, opportunity and resources. A multidisciplinary and cross university project was designed to identify opportunities for, and best practice in, IPE in communication skills amongst undergraduate health care practitioners within one Workforce Development Directorate (WDD) in England. Methods included a comprehensive literature review of relevant educational initiatives, together with telephone and e-mail interviews with key informants in higher education institutions (HEIs) across the UK. This paper reports the findings from the interviews. Based upon these findings, a series of recommendations are made for the planning, implementation, and evaluation of IPE in communication skills, which should be taken into account by local curriculum planning groups.