<b><i>Background:</i></b> Neonates with jaundice are usually managed according to their serum bilirubin despite an unclear overall correlation between bilirubin levels and patient-important outcomes (PIOs) such as kernicterus spectrum disorder (KSD). <b><i>Objectives:</i></b> We examined data from Cochrane Neonatal reviews to assess whether conditions that constituted KSD were included as key outcomes and how commonly they occurred in the population studied. <b><i>Methods:</i></b> We identified Cochrane reviews, published till November 2017 that evaluated interventions for neonatal jaundice (NNJ). We extracted the following information at the review and study levels: included population, outcomes assessed (in particular, whether PIOs such as KSD were listed as the primary outcomes), as well as their cumulative incidence in the reviews. <b><i>Results:</i></b> Out of 311 reviews, 11 evaluated interventions for NNJ with 78 randomized controlled trials (RCTs) included. Among the reviews, a total number of 148 outcomes were predefined and 30 (20.3%) were PIOs related to KSD, with 11 (36.7%) listed as primary outcomes. Among the 78 included RCTs (total participants = 8,232), 38 (48.7%) enrolled predominantly high-risk and 40 (51.3%) enrolled predominantly low-risk population. A total number of 431 outcomes were reported, and 40 (9.2%) were PIOs related to KSD (of which 37 were from studies with high-risk infants), with 13 (32.5%) listed as primary outcome. Cumulatively, no infant developed KSD across all studies. <b><i>Conclusions:</i></b> There is suboptimal representation of PIOs such as KSD in neonatal trials and Cochrane reviews on NNJ. Over half of the trials included populations with very low risk of KSD, which does not represent judicious use of resources. Amidst our continued search for a more reliable surrogate marker for NNJ, studies should evaluate the whole spectrum KSD alongside serum bilirubin in high-risk populations with sufficiently significant event rates, as this will make the trial methodologically feasible, with findings that will impact the population concerned.
<b><i>Introduction:</i></b> Composite outcomes are used to increase the power of a study by combining event rates. Many composite outcomes in adult clinical trials have components that differ substantially in patient importance, event rate, and effect size, making interpretation challenging. Little is known about the use of composite outcomes in neonatal randomized controlled trials (RCTs). <b><i>Methods:</i></b> We assessed the use of composite outcomes in neonatal RCTs included in Cochrane Neonatal reviews published till November 2017. Two authors reviewed the components of the composite outcomes to compare their patient importance and computed the ratios of effect sizes and event rates between the components, with an a priori threshold of 1.5, indicating a substantial difference. Descriptive statistics were presented. <b><i>Results:</i></b> We extracted 7,766 outcomes in 2,134 RCTs in 312 systematic reviews. Among them, 55 composite outcomes (0.7%) were identified in 46 RCTs. The vast majority (92.7%) of composite outcomes had 2 components, with death being the most common component (included 51 times [92.7%]). The components in nearly three-quarters of the composite outcomes (<i>n</i> = 40 [72.7%]) had different patient importance, while the effect sizes and event rates differed substantially between the components in 27 (49.1%) and 35 (63.6%) outcomes, respectively, with up to 43-fold difference in the event rates observed. <b><i>Conclusions:</i></b> The majority of composite outcomes in neonatal RCTs had different patient importance with contrasting effect sizes and event rates between the components. In patient communication, clinicians should highlight individual components, rather than the composites, with explanation on the relationship between the components, to avoid misleading impression on the effect of the intervention. Future trials should report the estimates of all individual components alongside the composite outcomes presented.
Introduction: Like most educational institutions, our medical school transitioned to online learning during the COVID-19 pandemic in March 2020. An initial survey of 192 undergraduate medical students conducted in June 2020 revealed a low acceptance of online assessments, lack of work-readiness, perception of online discussions as being inferior to face-to-face, and prevalent anxiety. Following this, we implemented pedagogic changes to encourage independent learning, improve patient contact, and increase social interactions between students. Methods: A follow-up study was conducted 12 months later in the same student population, excluding those who had graduated. The same 14-item anonymized survey questionnaire was administered, and comparisons were made between the follow-up and initial responses. Results: At follow-up, 45.6% of participants felt that online assessments can adequately and fairly assess students’ performance compared to the initial study (26.2%, p = 0.002). Participants at follow-up were generally more agreeable that discussion using an online learning platform was as effective as face-to-face learning compared to before (p = 0.017). Subgroup analysis showed that this was only true for Year 2 – 4 students. Year 5 students perceived online learning as less effective then face-to-face, reported lower confidence in their ability to apply their knowledge, and an increased in anxiety compared to before. Conclusion: While perception of online learning and assessment had improved at follow-up, the ramifications from restrictions to medical education over the past two years are now being felt most severely by the current final year students, emphasizing the importance of anticipating and addressing these concerns much earlier.
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