OSCE best practice guidelines—applicability for nursing simulations

Background: Objective structured clinical examinations (OSCEs) have been used for many years within healthcare programmes as a measure of students’ and clinicians’ clinical performance. OSCEs are a form of simulation and are often summative but may be formative. This educational approach requires robust design based on sound pedagogy to assure practice and assessment of holistic nursing care. As part of a project testing seven OSCE best practice guidelines (BPGs) across three sites, the BPGs were applied to an existing simulation activity. The aim of this study was to determine the applicability and value of the OSCE BPGs in an existing formative simulation. Methods: A mixed methods approach was used to address the research question: in what ways do OSCE BPGs align with simulations. The BPGs were aligned and compared with all aspects of an existing simulation activity offered to first-year nursing students at a large city-based university, prior to their first clinical placement in an Australian healthcare setting. Survey questions, comprised of Likert scales and free-text responses, used at other sites were slightly modified for reference to simulation. Students’ opinions about the refined simulation activity were collected via electronic survey immediately following the simulation and from focus groups. Template analysis, using the BPGs as existing or a priori thematic codes, enabled interpretation and illumination of the data from both sources.Results: Few changes were made to the existing simulation plan and format. Students’ responses from surveys (n = 367) and four focus groups indicated that all seven BPGs were applicable for simulations in guiding their learning, particularly in the affective domain, and assisting their perceived needs in preparing for upcoming clinical practice. Discussion: Similarities were found in the intent of simulation and OSCEs informed by the BPGs to enable feedback to students about holistic practice across affective, cognitive and psychomotor domains. The similarities in this study are consistent with findings from exploring the applicability of the BPGs for OSCEs in other nursing education settings, contexts, universities and jurisdictions. The BPGs also aligned with other frameworks and standards often used to develop and deliver simulations. Conclusions: Findings from this study provide further evidence of the applicability of the seven OSCE BPGs to inform the development and delivery of, in this context, simulation activities for nurses. The manner in which simulation is offered to large cohorts requires further consideration to meet students’ needs in rehearsing the registered nurse role

OSCE Best Practice Guidelines – applicability for nursing simulations

Background: Objective structured clinical examinations (OSCEs) have been used for many years within healthcare programmes as a measure of students’ and clinicians’ clinical performance. OSCEs are a form of simulation and are often summative but may be formative. This educational approach requires robust design based on sound pedagogy to assure practice and assessment of holistic nursing care. As part of a project testing seven OSCE best practice guidelines (BPGs) across three sites, the BPGs were applied to an existing simulation activity. The aim of this study was to determine the applicability and value of the OSCE BPGs in an existing formative simulation. Methods: A mixed methods approach was used to address the research question: in what ways do OSCE BPGs align with simulations. The BPGs were aligned and compared with all aspects of an existing simulation activity offered to first-year nursing students at a large city-based university, prior to their first clinical placement in an Australian healthcare setting. Survey questions, comprised of Likert scales and free-text responses, used at other sites were slightly modified for reference to simulation. Students’ opinions about the refined simulation activity were collected via electronic survey immediately following the simulation and from focus groups. Template analysis, using the BPGs as existing or a priori thematic codes, enabled interpretation and illumination of the data from both sources.Results: Few changes were made to the existing simulation plan and format. Students’ responses from surveys (n = 367) and four focus groups indicated that all seven BPGs were applicable for simulations in guiding their learning, particularly in the affective domain, and assisting their perceived needs in preparing for upcoming clinical practice. Discussion: Similarities were found in the intent of simulation and OSCEs informed by the BPGs to enable feedback to students about holistic practice across affective, cognitive and psychomotor domains. The similarities in this study are consistent with findings from exploring the applicability of the BPGs for OSCEs in other nursing education settings, contexts, universities and jurisdictions. The BPGs also aligned with other frameworks and standards often used to develop and deliver simulations. Conclusions: Findings from this study provide further evidence of the applicability of the seven OSCE BPGs to inform the development and delivery of, in this context, simulation activities for nurses. The manner in which simulation is offered to large cohorts requires further consideration to meet students’ needs in rehearsing the registered nurse role

Gender Differences in Sleep Deprivation Effects on Risk and Inequality Aversion: Evidence from an Economic Experiment

Excessive working hours—even at night—are becoming increasingly common in our modern 24/7 society. The prefrontal cortex (PFC) is particularly vulnerable to the effects of sleep loss and, consequently, the specific behaviors subserved by the functional integrity of the PFC, such as risk-taking and pro-social behavior, may be affected significantly. This paper seeks to assess the effects of one night of sleep deprivation on subjects’ risk and social preferences, which are probably the most explored behavioral domains in the tradition of Experimental Economics. This novel cross-over study employs thirty-two university students (gender-balanced) participating to 2 counterbalanced laboratory sessions in which they perform standard risk and social preference elicitation protocols. One session was after one night of undisturbed sleep at home, and the other was after one night of sleep deprivation in the laboratory. Sleep deprivation causes increased sleepiness and decreased alertness in all subjects. After sleep loss males make riskier decisions compared to the rested condition, while females do the opposite. Females likewise show decreased inequity aversion after sleep deprivation. As for the relationship between cognitive ability and economic decisions, sleep deprived individuals with higher cognitive reflection show lower risk aversion and more altruistic behavior. These results show that one night of sleep deprivation alters economic behavior in a gender-sensitive way. Females’ reaction to sleep deprivation, characterized by reduced risky choices and increased egoism compared to males, may be related to intrinsic psychological gender differences, such as in the way men and women weigh up probabilities in their decision-making, and/or to the different neurofunctional substrate of their decision-making.The authors acknowledge financial support from the Spanish Ministry of Economic Competititveness (ECO2012-34928), Italian Ministry of University and Research MIUR (PRIN 20103S5RN3_002), Generalitat Valenciana (Research Projects Gruposo3/086), the Instituto Valenciano de Investigaciones Económicas (IVIE), and the Ministero della Salute (RF-2009-1528677)

Phase 3 evaluation of HP802-247 in the treatment of chronic venous leg ulcers

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Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial

Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial. Patients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group. There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively). In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs

Phase 3 evaluation of HP802-247 in the treatment of chronic venous leg ulcers

In 2012 we reported promising results from a phase 2 clinical trial of HP802-247, a novel spray-applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802-247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe. The primary endpoint was the proportion of ulcers with confirmed closure at the end of 12 weeks of treatment. An investigation into the root cause for the failure of HP802-247 to show efficacy in these two phase 3 trials was initiated immediately following the initial review of the North American trial results. Four hundred twenty-one patients were enrolled in the North American (HP802-247, 211; Vehicle 210) and 252 in the European (HP802-247, 131; Vehicle 121) trials. No difference in proportion of closed ulcers at week 12 was observed between treatment groups for either the North American (HP802-247, 61.1%; Vehicle 60.0%; p = 0.5896) or the European (HP802-247, 47.0%; Vehicle 50.0%; p = 0.5348) trials. Thorough investigation found no likelihood that design or execution of the trials contributed to the failure. Variability over time during the trials in the clinical response implicated the quality of the cells comprising HP802-247. Concordance between the two separate, randomized, controlled trials with distinct, nonoverlapping investigative sites and independent monitoring teams renders the possibility of a Type II error vanishingly small and provides strong credibility for the unexpected lack of efficacy observed. The most likely causative factors for the efficacy failure in phase 3 was phenotypic change in the cells (primarily keratinocytes) leading to batch to batch variability due to the age of the cell banks