Global intercompany assessment of ICIEF platform comparability for the characterization of therapeutic proteins.

An international team spanning 19 sites across 18 biopharmaceutical and in vitro diagnostics companies in the United States, Europe, and China, along with one regulatory agency, was formed to compare the precision and robustness of imaged CIEF (ICIEF) for the charge heterogeneity analysis of the National Institute of Standards and Technology (NIST) mAb and a rhPD-L1-Fc fusion protein on the iCE3 and the Maurice instruments. This information has been requested to help companies better understand how these instruments compare and how to transition ICIEF methods from iCE3 to the Maurice instrument. The different laboratories performed ICIEF on the NIST mAb and rhPD-L1-Fc with both the iCE3 and Maurice using analytical methods specifically developed for each of the molecules. After processing the electropherograms, statistical evaluation of the data was performed to determine consistencies within and between laboratory and outlying information. The apparent isoelectric point (pI) data generated, based on two-point calibration, for the main isoform of the NIST mAb showed high precision between laboratories, with RSD values of less than 0.3% on both instruments. The SDs for the NIST mAb and the rhPD-L1-Fc charged variants percent peak area values for both instruments are less than 1.02% across different laboratories. These results validate the appropriate use of both the iCE3 and Maurice for ICIEF in the biopharmaceutical industry in support of process development and regulatory submissions of biotherapeutic molecules. Further, the data comparability between the iCE3 and Maurice illustrates that the Maurice platform is a next-generation replacement for the iCE3 that provides comparable data.

Testing of midwife neonatal resuscitation skills with a simulator manikin in a low-risk delivery unit.

BACKGROUND: Expertise in neonatal resuscitation is essential for personnel involved in the care of newborns. In this observational cohort study the skills of 52 midwives in a simulated scenario were assessed. METHODS: A total of 52 midwives in a low-risk unit and five specialist nurses in a high-risk unit were tested to establish their competence in newborn resuscitation. The 52 midwives were divided into groups 1 (n = 39; no pretest training) and 2 (n = 13; 1 day training prior to study). The video-recorded test scenario was a newborn with asphyxia. Thirty items were graded by a neonatologist and nursing team in real time. Using the Angoff method, a pass score was 18.71 for skills that were graded 0 or 1. RESULTS: The average score of specialist nurses was 26 (range, 23-29). A total of 49% of midwives in group 1 and 92% in group 2 passed the test. The average score was 17.7 (range, 9-25) in group 1 and 21.9 (range, 17-27) in group 2. A total of 27% and 77% of midwives in groups 1 and 2, respectively, carried out ventilation at a frequency as per the algorithm. Mask leakage was higher in group 1 (44%) versus group 2 (23%). Five and three midwives in groups 1 and 2, respectively, overexpanded the lungs. CONCLUSION: Many midwives had imperfect resuscitation skills. A 1 day course improved such skills. The standard scenario is an objective and useful performance marker in assessing and documenting improvements in competence in delivery room resuscitation.

Interaction during equine-facilitated rehabilitation from the rehabilitees' perspective - A phenomenological study.

INTRODUCTION: Interaction has a multidimensional role in equine-facilitated rehabilitation. PURPOSE: The aim of this study was to understand rehabilitees' experiences of interaction during equine-facilitated rehabilitation. METHODS: Six children and four adults with individual diagnoses or reasons to participate in equine-facilitated rehabilitation were included in this qualitative study. Data were collected by interviewing individually the rehabilitees. A phenomenological Spiegelberg's seven-phase meaning analysis was performed to reveal the meanings. RESULTS: Seven meanings were identified: 1) Trust; 2) Friendly horse; 3) Mirror of feelings; 4) Inspiring riding; 5) Feeling competent; 6) Rehabilitee-oriented approach; and 7) Uniting experience. In addition, the essential meanings of the phenomenon form three different circles: circle of recognition, circle of supporting active agency and circle of empowerment. CONCLUSION: Interaction during equine-facilitated rehabilitation is essential to rehabilitees in many ways that have important roles in the entire rehabilitation process that aims for empowerment in the rehabilitees' daily lives.

Importance of molecular studies on major blood groups--intercellular adhesion molecule-4, a blood group antigen involved in multiple cellular interactions.

Several blood groups, including the LW-blood group were discovered in the first part of last century, but their biochemical characteristics and cellular functions have only more recently been elucidated. The LW-blood group, renamed ICAM-4 (CD242), is red cell specific and belongs to the intercellular adhesion molecule family. ICAM-4 binds to several integrin receptors on blood and endothelial cells and is thus able to form large cellular complexes containing red cells. Its physiological function(s) has remained incompletely understood, but recent work shows that macrophage integrins can bind red cells through this ligand. In this article we discuss molecular properties of major blood group antigens, describe ICAM-4 in more detail, and show that phagocytosis of senescent red cells is in part ICAM-4/beta(2)-integrin dependent.

Effect of a simulation-based workshop on multidisplinary teamwork of newborn emergencies: an intervention study.

BACKGROUND: Video analyses of real-life newborn resuscitations have shown that Neonatal Resuscitation Program (NRP) guidelines are followed in fewer than 50% of cases. Multidisciplinary simulation is used as a first-rate tool for the improvement of teamwork among health professionals. In the study we evaluated the impact of the crisis resource management (CRM) and anesthesia non-technical skills instruction on teamwork during simulated newborn emergencies. METHODS: Ninety-nine participants of two delivery units (17 pediatricians, 16 anesthesiologists, 14 obstetricians, 31 midwives, and 21 neonatal nurses) were divided to an intervention group (I-group, 9 teams) and a control group (C-group, 6 teams). The I-group attended a CRM and ANTS instruction before the first scenario. After each scenario the I-group performed either self- or peer-assessment depending on whether they had acted or observed in the scenario. All the teams participated in two and observed another two scenarios. All the scenarios were video-recorded and scored by three experts with Team Emergency Assessment Measure (TEAM). SPSS software and nlme package were used for the statistical analyses. RESULTS: The total TEAM scores of the first scenario between the I- and C-group did not differ from each other. Neither there was an increase in the TEAM scoring between the first and second scenario between the groups. The CRM instruction did not improve the I-group's teamwork performance. Unfortunately the teams were not comparable because the teams had been allowed to self-select their members in the study design. The total TEAM scores varied a lot between the teams. Mixed-model linear regression revealed that the background of the team leader had an impact on differences of the total teamwork scores (D = 6.50, p = 0.039). When an anesthesia consultant was the team leader the mean teamwork improved by 6.41 points in comparison to specialists of other disciplines (p = 0.043). CONCLUSION: The instruction of non-technical skills before simulation training did not enhance the acquisition of teamwork skills of the intervention groups over the corresponding set of skills of the control groups. The teams led by an anesthesiologist scored the best. Experience of team leaders improved teamwork over the CRM instruction.

Assessment of newborn resuscitation skills of physicians with a simulator manikin.

OBJECTIVE: Education of medical staff according to Neonatal Resuscitation Program guidelines improves outcome of delivery room resuscitation. Regular assessment of skills is important for reliable performance of neonatal resuscitation. We assessed the practical resuscitation skills of clinicians in a standard scenario in a newborn simulation. DESIGN: Observational cohort study. MAIN OUTCOME MEASURES: The resuscitation skills of 6 consultant neonatologists, 11 paediatricians and 11 anaesthesiologists were assessed in a simulation. The standard test scenario was a newborn infant with asphyxia. A 30-item checklist was used for scoring technical skills, while non-technical skills were scored using a nine-item checklist. The pass/fail score was 18.66 for technical skills. Scoring was carried out by a neonatologist/anaesthesiologist team in real time. RESULTS: Two paediatricians and two anaesthesiologists failed the test. The average score was 25 for neonatologists, 22 for paediatricians and 20 for anaesthesiologists. Technical scores were compiled into four clusters for assessment of items in the same category. The scores in the ventilation cluster were lower the later the participants started ventilation, the longer they maintained pauses in ventilation, the older the baby at the time of intubation and the longer the time they used for intubation. The time intervals were checked from the video recordings. The neonatologists had better non-technical skills than the other groups. Good group-working skills correlated with high technical scores. CONCLUSIONS: Many clinicians exhibited inadequate skills to resuscitate a newborn infant in a standard scenario. The neonatologists, as clinical experts, performed best in both technical and non-technical skills testing.