Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms:a white paper from COMBACTE's STAT-Net

Innovations are urgently required for clinical development of antibacterials against multidrug-resistant organisms. Therefore, a European, public-private working group (STAT-Net; part of Combatting Bacterial Resistance in Europe [COMBACTE]), has reviewed and tested several innovative trials designs and analytical methods for randomized clinical trials, which has resulted in 8 recommendations. The first 3 focus on pharmacokinetic and pharmacodynamic modeling, emphasizing the pertinence of population-based pharmacokinetic models, regulatory procedures for the reassessment of old antibiotics, and rigorous quality improvement. Recommendations 4 and 5 address the need for more sensitive primary end points through the use of rank-based or time-dependent composite end points. Recommendation 6 relates to the applicability of hierarchical nested-trial designs, and the last 2 recommendations propose the incorporation of historical or concomitant trial data through Bayesian methods and/or platform trials. Although not all of these recommendations are directly applicable, they provide a solid, evidence-based approach to develop new, and established, antibacterials and address this public health challenge

Cooperating to commercialize technology: A dynamic model of fairness perceptions, experience, and cooperation

Technology entrepreneurship is an important driver of economic growth, although entrepreneurs must maintain cooperative ties with the owners of any technology they hope to bring to market. Existing studies show that fairness perceptions have a great influence on this cooperation, but no research investigates its precise mechanisms or dynamic patterns. This study explores the development of 17 ventures that cooperated with a university-owner of technology and thereby identifies different cooperation patterns in which fairness perceptions influence the degree of cooperation. These perceptions also change over time, partly as a function of accumulated experience and learning. A system dynamics model integrates insights from existing literature with the empirical findings to reveal which cooperation mechanisms relate to venture development over time; the combinations of individual experience, fairness perceptions, and market circumstances lead to four different patterns. This model can explain changes in entrepreneurial cooperation as a result of changes in fairness perceptions, which depend on learning effects and entrepreneurial experience. Each identified cooperation pattern has implications for research and offers insights for practitioners who need to manage relationships in practice

Transcending differences to study the transcendent: an exploratory study of researchers’ and chaplains’ reflections on interdisciplinary spiritual care research collaboration

Background: Despite recognition of the centrality of professional board-certified chaplains (BCC) in palliative care, the discipline has little research to guide its practices. To help address this limitation, HealthCare Chaplaincy Network funded six proposals in which BCCs worked collaboratively with established researchers. Recognizing the importance of interdisciplinary collaboration in the development of a new field, this paper reports on an exploratory study of project members’ reflections over time on the benefits and challenges of conducting inter-disciplinary spiritual care research. Methods: Data collection occurred in two stages. Stage 1 entailed two independent, self-reflective focus groups, organized by professional discipline, mid-way through the site projects. Stage 2 entailed end-of-project site reports and a conference questionnaire. Results: Eighteen professionals participated in the group discussions. Stage 1: researchers perceived chaplains as eager workers passionately committed to their patients and to research, and identified challenges faced by chaplains in learning to conduct research. Chaplains perceived researchers as passionate about their work, were concerned research might uncover negative findings for their profession, and sensed they used a dissimilar paradigm from their research colleagues regarding the ‘ways of relating’ to knowledge and understanding. Stage 2: researchers and chaplains noted important changes they ascribed to the interdisciplinary collaboration that were classified into six domains of cultural and philosophical understanding: respect; learning; discovery; creativity; fruitful partnerships; and learning needs. Conclusions: Chaplains and researchers initially expressed divergent perspectives on the research collaborations. During the projects’ lifespans, these differences were acknowledged and addressed. Mutual appreciation for each discipline’s strengths and contributions to inter-professional dialogue emerged

Effect of Lateralization on Motor and Mental Speed in Bipolar Disorder

Effect of lateralization on motor and mental speed in bipolar disorder Objective: The correspondence between the motor and mood regulation systems may shed light on the physiopathology of mood disorders. Handedness is a reliable proxy measure for cerebral lateralization for right handed subjects. In this study we have investigated the effects of lateralization on cognitive performance as well as motor and mental speed in bipolar disorder. Methods: Sixty-eight euthymic bipolar patients (mean age: 33.66 +/- 6.38, 33 female), and 65 healthy subjects (mean age: 33.65+7.11, 27 females) were enrolled. Participants with medical or psychiatric comorbidities were excluded. The Montreal Cognitive Assessment (MOCA), finger-tapping, peg-board test, Adult Memory and Information Processing battery (AMIPB), Edinburgh Handedness Inventory and reaction time tests were the measures utilized in our study. Results: The groups were similar in terms of age, gender and education. The bipolar patients were more lateralized than the controls (p=0.027), whereas eye and foot lateralization did not differ between the groups. The patients performed poorer than the controls on the MOCA (p=0.049), peg-board (right and left, p<0.001), finger-tapping (right p<0.001; left p=0.002), AMIPB (motor and A subtest, p<0.001 for both) and the visual and auditory (p<0.001 for both) reaction time tests. The degree of lateralization was correlated with the speed of processing in the bipolar group, but not in the control group. Conclusion: Right handed patients with bipolar disorder are more lateralized than healthy subjects and lateralization provides an advantage for processing speed in bipolar patients. This finding may indicate a relationship between lateralizing physiopathology and slowed interhemispheric communication and thus, an increase in lateralization might be a compensatory mechanism to use less interhemispheric communication in bipolar disorder