Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS).

The Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) collected historical data from 20 biopharmaceutical industry members on their experience with the in vivo adventitious virus test, the in vitro virus test, and the use of next generation sequencing (NGS) for viral safety. Over the past 20 years, only three positive in vivo adventitious virus test results were reported, and all were also detected in another concurrent assay. In more than three cases, data collected as a part of this study also found that the in vivo adventitious virus test had given a negative result for a sample that was later found to contain virus. Additionally, the in vivo adventitious virus test had experienced at least 21 false positives and had to be repeated an additional 21 times all while using more than 84,000 animals. These data support the consideration and need for alternative broad spectrum viral detection tests that are faster, more sensitive, more accurate, more specific, and more humane. NGS is one technology that may meet this need. Eighty one percent of survey respondents are either already actively using or exploring the use of NGS for viral safety. The risks and challenges of replacing in vivo adventitious virus testing with NGS are discussed. It is proposed to update the overall virus safety program for new biopharmaceutical products by replacing in vivo adventitious virus testing approaches with modern methodologies, such as NGS, that maintain or even improve the final safety of the product.

Sleep is the best medicine: How rest facilities and EnergyPods can improve staff wellbeing.

INTRODUCTION: Healthcare workers' wellbeing is critical to the NHS. Night shifts have a big impact on their physical and mental health. Recently there has been national funding for rest facilities. METHODS: An EnergyPod was installed in the acute medical unit. The study comprised two surveys: one quantitative survey performed prior to the pod introduction and repeated 3 months after; and one qualitative survey performed immediately after pod use. RESULTS: We observed more staff taking breaks of 30 minutes after the pod introduction (37% before vs 69% after). Of users, 81% felt more alert and 83% were more energised. Half of the respondents felt more able to drive after use.The feedback showed three themes: appreciation of designated space away from clinical areas, relaxation and improved interdisciplinary cohesion. CONCLUSION: We have shown consistent data that rest is important for wellbeing. We recommend the use of EnergyPods in high acuity areas.

Does medical students' gender affect their clinical learning of gynaecological examination? A retrospective cohort study.

INTRODUCTION: Medical graduates should be competent in gynaecological examination as well as associated skills including speculum use and swabbing. Male and female medical students may have different opportunities to practise these skills in clinical environments, potentially impacting on confidence and competence. This study explores this further via reviewing students' learning experience in genitourinary medicine (GUM) and obstetrics and gynaecology (O&G) clinics. METHODS: Cross-sectional study of 759 year 4 and year 5 University of Birmingham medical students via an online questionnaire. This explored degree of participation, impact of gender and self-reported confidence. RESULTS: Overall response rate was 31% (233/759). Students of either gender who observed an examination being performed by a clinician were more likely to perform the same examination. Female students reported more opportunities to practise gynaecological examination and associated skills. Female students were more likely to be granted consent to perform speculum examinations, vaginal swabbing and vaginal bimanual examinations. Sixty-five per cent of male students felt that their gender affected their learning experience with female patients. Despite this, there was no significant difference in self-reported confidence level in performing gynaecological examinations between genders at the end of placement. CONCLUSION: The majority of male students perceived that their gender impacted their clinical experience in O&G and GUM. Self-reported confidence levels were unaffected, which could reflect varying approaches to competence between genders. The link between observing examinations and subsequent opportunities to practise is key. This could demonstrate students developing rapport and trust with patients, and clinicians' roles as gatekeepers.