Influence of trial design,heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.     

Influence of a 2‐ to 6‐year physical education intervention on scholastic performance: The CHAMPS study‐DK

The aim of this study was to investigate the influence of a school‐based intervention with a tripling of physical education (PE ) lessons from two (90 minutes) to six lessons per week (270 minutes) on scholastic performance. This study is part of the CHAMPS study‐DK , a quasi‐experimental study that began in 2008. The intervention group consisted of six schools, and the control group consisted of four matched schools (mean age at baseline=8.4 years, kindergarten class fourth grade). Academic performance was extracted from the national test system from 2010 to 2014 (Math and Danish were measured at third and sixth, and second, fourth and sixth grades, respectively). Participants included 1888 students participating in at least one scholastic performance test. Linear mixed models were applied to test for differences between groups and adjusted for known confounders. No significant differences were observed between groups in the academic performance tests (control group reference); Danish second grade β=−1.34 (95% CI −9.90, 7.22), fourth grade β=0.22 (95% CI −6.12, 6.56), sixth grade β=1.03 (95% CI −5.02, 7.08), and all grades combined β=0.28 (95% CI −5.74, 6.31) and Math third grade β=−2.87 (95% CI −9.65, 3.90), sixth grade β=0.99 (95% CI −7.36, 9.34) and combined β=−1.20 (95% CI −8.10, 5.71). In conclusion, no significant differences were observed between intervention and control schools for scholastic performance. Importantly, there were no negative effects of additional PE on scholastic outcomes, despite more PE and longer school days for intervention children.     

The Genetic Link Between Diabetes and Atherosclerosis

Epidemiological studies have indicated that the risk of atherothrombotic coronary artery disease (CAD) is higher in patients with diabetes, but these results have not been consistently observed across clinical trials. To address this apparent discrepancy, we can apply the results of genome-wide association studies (GWAS) to provide a better understanding of the shared genetic architecture of diabetes and atherothrombotic CAD. For instance, a large GWAS has identified 16 novel loci that are associated with both diabetes and atherothrombotic CAD. These genetic variants may also be used to assess potential causal relationships reported in observational studies and clinical trials through Mendelian randomization analyses. For example, several Mendelian randomization analyses have shown that diabetes is associated with CAD independent of other risk factors (odds ratio [OR]: 1.63, 95% confidence interval [CI]: 1.23–2.07; P = 0.002). Furthermore, Mendelian randomization analyses can provide more insight into the perceived risk of diabetes among patients without diabetes receiving statin therapy. Here, genetically lower activity of HMG-CoA reductase (HMGCR) was associated with a modest increase in diabetes (OR per allele: 1.02, 95% CI: 1.00–1.05). These results highlight the biological mechanisms that link diabetes with the use of statins. In addition, this work illustrates the great potential value of genetic studies to clarify the mechanistic relationships among atherosclerotic vascular disease, dysglycemia, and diabetes. More research is needed to delineate and subsequently better understand the genetic links between diabetes and atherosclerosis.     

Effect of Life Review on Quality of Life For Older Adults Living in Nursing Homes

Aim: To examine the effects of life review on daily activities, social participation, outlook on life, and perceptions of living in a nursing home measured by life satisfaction and quality of life in older adults. Method: The study design was a two-phase quasi-experimental pre-post-tests including development and testing of a life review protocol. Nine residents, age ≥65, participated in a life review group once weekly for 6 weeks. Outcomes were analyzed using the Life Satisfaction Index-Z (LSI-Z) and pre-post surveys. Results: LSI-Z scores improved post-intervention and survey outcomes indicated participation in activities of daily living (ADLs), socialization, outlook on life, and living in a nursing home perceptions improved for all participants. Conclusion: The study demonstrates the effectiveness of a life review protocol to improve ADLs, social participation, and enhancing perceptions of outlook on life and living in a nursing home enhancing QOL and life satisfaction for older adult nursing home residents.