The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a complement to other forms of clinical study disclosure such as registry postings and scientific publications, lay summaries may aid in the transparency of a sponsor's clinical study results, thereby promoting trust, partnership, and patient engagement throughout the clinical study process. The data transparency field is changing rapidly; therefore, data owners should strive to stay abreast of the changes and deliver meaningful tools to their study participants and the public. Points to consider when developing lay summaries of clinical study results include regulatory drivers, the target audience, communication of complex data in a lay manner, and efficient processes for the development of lay summaries within one's company. Plain Language SummaryThere is a rule in Europe that clinical studies (experiments in humans) must have a summary written in plain language. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. People who participate in clinical studies, and others, may want to know information about clinical study results. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Lay summary writers must think about how they can help readers understand the information. It is hard to describe the results of clinical studies in a way that everyone can understand. This article gives some ideas to think about when writing lay summaries. * Amber Barnes amber.barnes@ucb.com 1 UCB Bioscience, RTP, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA Key PointsLay summaries of clinical study results are a complement to other forms of clinical study disclosure that aid in the understanding of complex clinical study results.The initial requirement for lay summaries began as a result of the EU Clinical Trial Regulation; however, evolving regulations and policies around the globe are shaping the future of clinical study disclosure.Ensuring patient value should be of paramount importance when developing lay summaries.
We conceptualize students’ opportunities to learn remotely during the initial school closures associated with the COVID-19 pandemic. We then examine variation in remote instruction using an original statewide survey of teachers in Tennessee, deployed just a few weeks into the closures. Using three-level logistic regression models, we explore potential predictors of regular remote instruction, including prepandemic measures of broadband access, the demographic composition of schools, and measures of district policy responses created from districts’ public COVID-19 plans. We find that teachers in schools serving more economically disadvantaged students and in rural districts are less likely to report regular remote instruction, especially via providing digital resources and holding virtual classes or tutoring. Fewer opportunities for Tennessee’s rural students appear driven in part by lower community access to high-speed broadband, but district policies to distribute technology may partially mitigate this gap in access.
PurposeLeadership coaching is an increasingly popular development tool for school principals. However, specific coaching behaviors are rarely conceptualized or examined in prior research. This study presents a coaching behavior framework and then analyzes actual coaching conversations between principals and coaches to illustrate how specific coaching behaviors create opportunities for principals to reflect and think critically about their leadership.Design/methodology/approachBuilding on theories of interpersonal learning, the authors develop a framework of coaching behaviors to distinguish coaching inquiries and assertions that facilitate critique and reflection and, therefore, activate opportunities for learning. The authors use this framework to code transcripts of 55 principal coaching sessions. The authors analyze the prevalence of certain coaching behaviors and then examine qualitative patterns in how the use of certain behaviors shapes the nature of coaching conversations.FindingsOnly about one-third of coded coaching behaviors in the analytic sample are categorized as coaching inquiries and assertions that activate opportunities for learning. In the qualitative comparisons of extracts from coaching conversations, the authors find coaches' use of these behaviors produced richer, more meaningful dialogue.Originality/valueUnlike much of the past research on leadership coaching, this analysis examines what happens in conversations between coaches and principals. This framework could be applied to a broad range of coaching programs intended to promote professional learning.
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