Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial

Introduction Congenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with standard care. Here, we describe the NITRIC trial protocol. Methods and analysis The NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants <2 years of age undergoing cardiac surgery with CPB will be randomly assigned to NO at 20 ppm administered into the CPB oxygenator for the duration of CPB or standard care (no NO) in a 1:1 ratio with stratification by age (<6 and ≥6 weeks), single ventricle physiology (Y/N) and study centre. The primary outcome will be VFD to day 28. Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs. Analyses will be conducted on an intention-to-treat basis. Preplanned secondary analyses will investigate the impact of NO on host inflammatory profiles postsurgery. Ethics and dissemination The study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial registration number ACTRN12617000821392.</p

Effects of the Active Choices Program on Self-Managed Physical Activity and Social Connectedness in Australian Defence Force Veterans: Protocol for a Cluster-Randomized Trial.

BACKGROUND: A stepped-down program is one in which clients transition from the care of a health professional to self-managed care. Very little is known about the effectiveness of stepped-down physical activity (PA) programs for military service veterans. OBJECTIVE: This study will test Active Choices, a stepped-down behavioral support program designed to help Australian Defence Force veterans and their dependents who are clients of the Department of Veterans' Affairs, transition from treatment by an exercise physiologist or physiotherapist to self-managed PA. METHODS: The study is a parallel-group, randomized trial, with city-based exercise physiology or physiotherapy practices that recruit eligible Department of Veterans' Affairs clients assigned to Active Choices or a comparison program. The study aims to recruit 52 participants (26 in each group). The Active Choices program will consist of 2 face-to-face (Weeks 1, 12) and 2 telephone (Weeks 4 and 8) consultations. During these sessions, the participant and Active Choices consultant will utilize an evidence-based resource booklet to review the key benefits of an active lifestyle, build an action plan for PA preferences, set and review goals, self-monitor progress relative to set goals, and discuss strategies to overcome PA barriers. Linking participants to local PA communities to overcome social isolation will be a program priority. The comparison program will consist of 2 consultations (Weeks 1 and 12) and use fewer behavioral support strategies (education, self-monitoring, and action planning only) than Active Choices. Outcome measures will be administered at baseline, end-intervention (12 weeks), and follow-up (24 weeks) to assess changes in moderate intensity self-managed PA, psychological well-being, and social connectedness. We will also measure health service utilization and costs as well as PA choices across the intervention period. End-intervention interviews will capture participant experiences. RESULTS: Due to the impacts of the COVID-19 pandemic on human research activities in Australia, participant recruitment will commence when it is safe and feasible to do so. CONCLUSIONS: Findings will provide valuable pilot data to support up-scaling of the program and larger effectiveness trials with regional and rural as well as city-based Australian Defence Force veterans and their dependents. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000559910; https://www.anzctr.org.au/ACTRN12620000559910.aspx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/21911

Chess databases as a research vehicle in psychology : modeling large data

The game of chess has often been used for psychological investigations, particularly in cognitive science. The clear-cut rules and well-defined environment of chess provide a model for investigations of basic cognitive processes, such as perception, memory, and problem solving, while the precise rating system for the measurement of skill has enabled investigations of individual differences and expertise-related effects. In the present study, we focus on another appealing feature of chess—namely, the large archive databases associated with the game. The German national chess database presented in this study represents a fruitful ground for the investigation of multiple longitudinal research questions, since it collects the data of over 130,000 players and spans over 25 years. The German chess database collects the data of all players, including hobby players, and all tournaments played. This results in a rich and complete collection of the skill, age, and activity of the whole population of chess players in Germany. The database therefore complements the commonly used expertise approach in cognitive science by opening up new possibilities for the investigation of multiple factors that underlie expertise and skill acquisition. Since large datasets are not common in psychology, their introduction also raises the question of optimal and efficient statistical analysis. We offer the database for download and illustrate how it can be used by providing concrete examples and a step-by-step tutorial using different statistical analyses on a range of topics, including skill development over the lifetime, birth cohort effects, effects of activity and inactivity on skill, and gender differences

Statistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial

Background: The NITric oxide during cardiopulmonary bypass (CPB) to improve Recovery in Infants with Congenital heart defects (NITRIC) trial, a 1320-patient, multicentre, randomised controlled trial, is aiming to improve survival free of ventilation after CPB by using nitric oxide delivered into the oxygenator of the CPB. Objective: To provide a statistical analysis plan before completion of patient recruitment and data monitoring. Final analyses for this study will adhere to this statistical analysis plan, which details all key pre-planned analyses. Stata scripts for analyses have been prepared alongside this statistical analysis plan. Methods: The statistical analysis plan was designed collaboratively by the chief investigators and trial statistician and builds on the previously published study protocol. All authors remain blinded to treatment allocation. Detail is provided on statistical analyses including cohort description, analysis of primary and secondary outcomes and adverse events. Statistical methods to compare outcomes are planned in detail to ensure methods are verifiable and reproducible. Results: The statistical analysis plan developed provides the trial outline, list of mock tables, and analysis scripts. The plan describes statistical analyses on cohort and baseline description, primary and secondary outcome analyses, process of care measures, physiological descriptors, and safety and adverse event reporting. We define the pre-specified subgroup analyses and the respective statistical tests used to compare subgroups. Conclusion: The statistical analysis plan for the NITRIC trial establishes detailed pre-planned analyses alongside Stata scripts to analyse the largest trial in the field of neonatal and paediatric heart surgery. The plan ensures standards for trial analysis validity aiming to minimise bias of analyses. Trial registration: ACTRN12617000821392

Does doctors' personality differ from those of patients, the highly educated and other caring professions? An observational study using two nationally representative Australian surveys

OBJECTIVES: Personality differences between doctors and patients can affect treatment outcomes. We examine these trait disparities, as well as differences across medical specialities. DESIGN: Retrospective, observational statistical analysis of secondary data. SETTING: Data from two data sets that are nationally representative of doctors and the general population in Australia. PARTICIPANTS: We include 23 358 individuals from a representative survey of the general Australian population (with subgroups of 18 705 patients, 1261 highly educated individuals and 5814 working in caring professions) as well as 19 351 doctors from a representative survey of doctors in Australia (with subgroups of 5844 general practitioners, 1776 person-oriented specialists and 3245 technique-oriented specialists). MAIN OUTCOME MEASURES: Big Five personality traits and locus of control. Measures are standardised by gender, age and being born overseas and weighted to be representative of their population. RESULTS: Doctors are significantly more agreeable (a: standardised score -0.12, 95% CIs -0.18 to -0.06), conscientious (c: -0.27 to -0.33 to -0.20), extroverted (e: 0.11, 0.04 to 0.17) and neurotic (n: 0.14, CI 0.08 to 0.20) than the general population (a: -0.38 to -0.42 to -0.34, c: -0.96 to -1.00 to -0.91, e: -0.22 to -0.26 to -0.19, n: -1.01 to -1.03 to -0.98) or patients (a: -0.77 to -0.85 to -0.69, c: -1.27 to -1.36 to -1.19, e: -0.24 to -0.31 to -0.18, n: -0.71 to -0.76 to -0.66). Patients (-0.03 to -0.10 to 0.05) are more open than doctors (-0.30 to -0.36 to -0.23). Doctors have a significantly more external locus of control (0.06, 0.00 to 0.13) than the general population (-0.10 to -0.13 to -0.06) but do not differ from patients (-0.04 to -0.11 to 0.03). There are minor differences in personality traits among doctors with different specialities. CONCLUSIONS: Several personality traits differ between doctors, the population and patients. Awareness about differences can improve doctor-patient communication and allow patients to understand and comply with treatment recommendations