2 research outputs found
Students take the lead for learning in practice: A process for building self-efficacy into undergraduate nursing education
© 2018 To prepare graduate nurses for practice, the curriculum and pedagogy need to facilitate student engagement, active learning and the development of self-efficacy. This pilot project describes and explores an initiative, the Check-in and Check-out process, that aims to engage students as active partners in their learning and teaching in their clinical preparation for practice. Three interdependent elements make up the process: a check-in (briefing) part; a clinical practice part, which supports students as they engage in their learning and practise clinical skills; and a check-out (debriefing) part. A student evaluation of this initiative confirmed the value of the process, which has subsequently been embedded in the preparation for practice and work-integrated learning courses in the undergraduate nursing programs at the participating university. The introduction of a singular learning process provides consistency in the learning approach used across clinical learning spaces, irrespective of their location or focus. A consistent learning process—including a common language that easily transfers across all clinical courses and clinical settings—arguably enhances the students’ learning experience, helps them to actively manage their preparation for clinical practice and to develop self-efficacy
Drug-induced blood pressure increase – recommendations for assessment in clinical and non-clinical studies
<p><b>Introduction:</b> Changes in blood pressure (BP) are now proactively examined throughout the drug development process as an integral aspect of safety monitoring. This is because hypertension is a very strong risk factor for cardiovascular events and drug-induced increases in BP have attracted increased regulatory attention. However, there is currently no guidance from regulatory agencies on the minimum BP data required for submissions, and there are no specific criteria for what constitutes a safety signal for increased BP in non clinical studies.</p> <p><b>Areas covered:</b> Evaluation of BP increases through the drug discovery and development process.</p> <p><b>Expert opinion:</b> Research into the effects of drugs should begin before clinical development is initiated and continue throughout the clinical trial program. Non clinical studies should inform a benefit–risk analysis that will aid decision-making of whether to enter the drug into Phase I development. The degree of acceptable risk will vary according to the therapy area, treatment indication and intended population for the new drug, and the approach to BP assessment and risk mitigation should be tailored accordingly. However, BP monitoring should always be included in clinical trials, and data collected from multiple studies, to convincingly prove or refute a suspicion of BP effects.</p