Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?

Background Most randomised clinical trials (RCTs) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach. Consequently, health professionals involved may feel insufficiently familiar or confident, or that new processes or systems that are integral to the service are insufficiently embedded in routine care prior to definitive evaluation in a RCT. This study aimed to determine the optimal run-in period for a new physiotherapy-led telephone assessment and treatment service known as PhysioDirect and whether a run-in was needed prior to evaluating outcomes in an RCT. Methods The PhysioDirect trial assessed whether PhysioDirect was as effective as usual care. Prior to the main trial, a run-in of up to 12 weeks was permitted to facilitate physiotherapists to become confident in delivering the new service. Outcomes collected from the run-in and main trial were length of telephone calls within the PhysioDirect service and patients’ physical function (SF-36v2 questionnaire) and Measure Yourself Medical Outcome Profile v2 collected at baseline and six months. Joinpoint regression determined how long it had taken call times to stabilise. Analysis of covariance determined whether patients’ physical function at six months changed from the run-in to the main trial. Results Mean PhysioDirect call times (minutes) were higher in the run-in (31 (SD: 12.6)) than in the main trial (25 (SD: 11.6)). Each physiotherapist needed to answer 42 (95% CI: 20,56) calls for their mean call time to stabilise at 25 minutes per call; this took a minimum of seven weeks. For patients’ physical function, PhysioDirect was equally clinically effective as usual care during both the run-in (0.17 (95% CI: -0.91,1.24)) and main trial (-0.01 (95% CI: -0.80,0.79)). Conclusions A run-in was not needed in a large trial testing PhysioDirect services in terms of patient outcomes. A learning curve was evident in the process measure of telephone call length. This decreased during the run-in and stabilised prior to commencement of the main trial. Future trials should build in a run-in if it is anticipated that learning would have an effect on patient outcome

Objective measures of situation awareness in a simulated medical environment

One major limitation in the use of human patient simulators is a lack of objective, validated measures of human performance. Objective measures are necessary if simulators are to be used to evaluate the skills and training of medical practitioners and teams or to evaluate the impact of new processes or equipment design on overall system performance. Situation awareness (SA) refers to a person's perception and understanding of their dynamic environment. This awareness and comprehension is critical in making correct decisions that ultimately lead to correct actions in medical care settings. An objective measure of SA may be more sensitive and diagnostic than traditional performance measures. This paper reviews a theory of SA and discusses the methods required for developing an objective measure of SA within the context of a simulated medical environment. Analysis and interpretation of SA data for both individual and team performance in health care are also presented

A Novel Multiplayer Screen-Based Simulation Experience for African Learners Improved Confidence in Management of Postpartum Hemorrhage

IntroductionPostpartum hemorrhage (PPH) remains a global challenge, affecting thirteen million women each year. In addition, PPH is a leading cause of maternal mortality in Asia and Africa. In the U.S.A., care of critically ill patients is often practiced using mannequin-based simulation. Mannequin-based simulation presents challenges in global health, particularly in low- or middle-income countries. We developed a novel multiplayer screen-based simulation in a virtual world enabling the practice of team coordination with PPH. We used this simulation with learners in Mulago, Uganda. We hypothesized that a multiplayer screen-based simulation experience would increase learner confidence in their ability to manage PPH.MethodsThe study design was a simple pre- and a post-intervention survey. Forty-eight interprofessional subjects participated in one of nine 1-h simulation sessions using the PPH software. A fifteen-question self-assessment administered before and after the intervention was designed to probe the areas of learning as defined by Bloom and Krathwohl: affective, cognitive, and psychomotor.ResultsCombined confidence scores increased significantly overall following the simulation experience and individually in each of the three categories of Bloom’s Taxonomy: affective, cognitive, and psychomotor.ConclusionWe provide preliminary evidence that multiplayer screen-based simulation represents a scalable, distributable form of learning that may be used effectively in global health education and training. Interestingly, despite our intervention being screen-based, our subjects showed improved confidence in their ability to perform psychomotor tasks. Although there is precedent for mental rehearsal improving performance, further research is needed to understand this finding

Toward Designing Information Display to Support Critical Care

The story within this article explores how narrative justice can be applied as a form of advocacy for persons seeking access to justice. The questions—what is narrative justice? How do we define it?—deserve a separate space, which will be shared in a forthcoming article. Meanwhile, in short, narrative justice is the power of the word—written, spoken, articulated with the emotion or experience of an individual or collective, to shape or express reaction to law and policy