Objective. To evaluate the impact of an interprofessional blended learning course on medical and pharmacy students’ patient-centered interpersonal communication skills and to compare precourse and postcourse communication skills across first-year medical and second-year pharmacy student cohorts. Methods. Students completed ten 1-hour online modules and participated in five 3-hour group sessions over one semester. Objective structured clinical examinations (OSCEs) were administered before and after the course and were evaluated using the validated Common Ground Instrument. Nonparametric statistical tests were used to examine pre/postcourse domain scores within and across professions. Results. Performance in all communication skill domains increased significantly for all students. No additional significant pre/postcourse differences were noted across disciplines. Conclusion. Students’ patient-centered interpersonal communication skills improved across multiple domains using a blended learning educational platform. Interview abilities were embodied similarly between medical and pharmacy students postcourse, suggesting both groups respond well to this form of instruction.

Clinical trials are major and costly undertakings for researchers. Planning a clinical trial involves careful selection of the primary and secondary efficacy endpoints. The 2010 draft FDA guidance on adaptive designs acknowledges possible study design modifications, such as selection and/or order of secondary endpoints, in addition to sample size re-estimation. It is essential for the integrity of a double-blind clinical trial that individual treatment allocation of patients remains unknown. Methods have been proposed for re-estimating the sample size of clinical trials, without unblinding treatment arms, for both categorical and continuous outcomes. Procedures that allow a blinded estimation of the treatment effect, using knowledge of trial operational characteristics, have been suggested in the literature. Clinical trials are designed to evaluate effects of one or more treatments on multiple primary and secondary endpoints. The multiplicity issues when there is more than one endpoint require careful consideration for controlling the Type I error rate. A wide variety of multiplicity approaches are available to ensure that the probability of making a Type I error is controlled within acceptable pre-specified bounds. The widely used fixed sequence gate-keeping procedures require prospective ordering of null hypotheses for secondary endpoints. This prospective ordering is often based on a number of untested assumptions about expected treatment differences, the assumed population variance, and estimated dropout rates. We wish to update the ordering of the null hypotheses based on estimating standardized treatment effects. We show how to do so while the study is ongoing, without unblinding the treatments, without losing the validity of the testing procedure, and with maintaining the integrity of the trial. Our simulations show that we can reliably order the standardized treatment effect also known as signal-to-noise ratio, even though we are unable to estimate the unstandardized treatment effect. In order to estimate treatment difference in a blinded setting, we must define a latent variable substituting for the unknown treatment assignment. Approaches that employ the EM algorithm to estimate treatment differences in blinded settings do not provide reliable conclusions about ordering the null hypotheses. We developed Bayesian approaches that enable us to order secondary null hypotheses. These approaches are based on posterior estimation of signal-to-noise ratios. We demonstrate with simulation studies that our Bayesian algorithms perform better than existing EM algorithm counterparts for ordering effect sizes. Introducing informative priors for the latent variables, in settings where the EM algorithm has been used, typically improves the accuracy of parameter estimation in effect size ordering. We illustrate our method with a secondary analysis of a longitudinal study of depression. / Statistics

This thesis considers two related problems that has application in the field of experimental design for clinical trials: • fixed sample size determination for parallel arm, double-blind survival data analysis to test the hypothesis of no difference in survival functions, and • blinded sample size re-estimation for the same. For the first problem of fixed sample size determination, a method is developed generally for testing of hypothesis, then applied particularly to survival analysis; for the second problem of blinded sample size re-estimation, a method is developed specifically for survival analysis. In both problems, the exponential survival model is assumed. The approach we propose for sample size determination is Bayesian decision theoretical, using explicitly a loss function and a prior distribution. The loss function used is the intrinsic discrepancy loss function introduced by Bernardo and Rueda (2002), and further expounded upon in Bernardo (2011). We use a conjugate prior, and investigate the sensitivity of the calculated sample sizes to specification of the hyper-parameters. For the second problem of blinded sample size re-estimation, we use prior predictive distributions to facilitate calculation of the interim test statistic in a blinded manner while controlling the Type I error. The determination of the test statistic in a blinded manner continues to be nettling problem for researchers. The first problem is typical of traditional experimental designs, while the second problem extends into the realm of adaptive designs. To the best of our knowledge, the approaches we suggest for both problems have never been done hitherto, and extend the current research on both topics. The advantages of our approach, as far as we see it, are unity and coherence of statistical procedures, systematic and methodical incorporation of prior knowledge, and ease of calculation and interpretation. / Statistics

Background: Infant immunization pain is not currently well managed despite effective strategies. Objective: To determine the effectiveness of tactile stimulation when added to a combination of pain-reducing interventions in infants undergoing immunization. Methods: Healthy infants aged 4-6 months undergoing immunization in primary care were randomized to tactile stimulation or usual care. All infants also received pain-relieving interventions. A validated measure of acute pain in infants, the Modified Behavioral Pain Scale (MBPS), was the primary outcome. Results: Altogether, 120 infants participated. Characteristics did not differ (p > 0.05) between those allocated to tactile stimulation and usual care groups. Mean MBPS pain scores did not differ between groups: 8.2 (1.1) vs. 8.0 (1.3); p = 0.57, respectively. Conclusions: Parent-led tactile stimulation did not improve pain relief in infants when added to other interventions. Parental attention could have been focused on tactile stimulation, preventing parents from performing appropriate soothing activities. Additional investigation of the effectiveness of clinician-led tactile stimulation is recommended.

Background: Infant immunization pain is not currently well managed despite effective strategies. Objective: To determine the effectiveness of tactile stimulation when added to a combination of pain-reducing interventions in infants undergoing immunization. Methods: Healthy infants aged 4-6 months undergoing immunization in primary care were randomized to tactile stimulation or usual care. All infants also received pain-relieving interventions. A validated measure of acute pain in infants, the Modified Behavioral Pain Scale (MBPS), was the primary outcome. Results: Altogether, 120 infants participated. Characteristics did not differ (p > 0.05) between those allocated to tactile stimulation and usual care groups. Mean MBPS pain scores did not differ between groups: 8.2 (1.1) vs. 8.0 (1.3); p = 0.57, respectively. Conclusions: Parent-led tactile stimulation did not improve pain relief in infants when added to other interventions. Parental attention could have been focused on tactile stimulation, preventing parents from performing appropriate soothing activities. Additional investigation of the effectiveness of clinician-led tactile stimulation is recommended.