Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

Objective: The purpose of this double-blind, randomised, controlled trial is to compare allergic outcomes in children following vaccination with acellular pertussis (aP) antigen (standard of care in Australia) given at 2 months of age versus whole cell pertussis (wP) in the infant vaccine schedule. Participants: Up to 3000 Australian infants 6 to <12 weeks of age born ≥32 weeks gestation. Interventions: The intervention is a wP containing vaccine as the first scheduled pertussis vaccine dose instead of an aP containing vaccine. Outcomes: The primary outcome is a binary indicator of history of IgE-mediated food allergy at the age of 12 months confirmed, where necessary, with an oral food challenge before 18 months of age. Secondary outcomes include (1) history of parent-reported clinician-diagnosed new onset of atopic dermatitis by 6 or 12 months of age with a positive skin prick test to any allergen before 12 months of age, (2) geometric mean concentration in pertussis toxin-specific IgG before and 21 to 35 days after a booster dose of aP at 18 months of age, and (3) sensitisation to at least one allergen by 12 months of age. Results: Operating characteristics of trial decision rules were evaluated by trial simulation. The selected rules for success and futility approximately maintain type I error of 0.05 and achieved power 0.85 for a reduction in the primary outcome from 10% in the control group to 7% in the intervention group. Discussion: A detailed, prospective statistical analysis plan (SAP) is presented for this Bayesian adaptive design. The plan was written by the trial statistician and details the study design, pre-specified adaptive elements, decision thresholds, statistical methods, and the simulations used to evaluate the operating characteristics of the trial. Application of this SAP will minimise bias and supports transparent and reproducible research. Trial registration: Australia & New Zealand Clinical Trials Registry, ACTRN12617000065392. Registered on 12 January 2017 Study protocol: https://doi.org/10.1136/bmjopen-2020-04283

Why Does Affect Matter in Organizations?

Interest in and research about affect in organizations have expanded dramatically in recent years. This article reviews what we know about affect in organizations, focusing on how employees ’ moods, emotions, and dispositional affect influence critical organizational outcomes such as job performance, decision making, creativity, turnover, prosocial behavior, teamwork, negotiation, and leadership. This review highlights pervasive and consistent effects, showing the importance of affect in shaping a wide variety of organizational behaviors, the knowledge of which is critical for researchers, managers, and employees. WhyDoesAffectMatter inOrganizations? Anorganizational vignette... I had just mentioned how small a raise I was going to give to Jerry, my top salesperson this year. I could see a subtle wave of anger and frustration wash over his usually calm features. I had been afraid this was going to happen. But what could I do? I was caught in the middle—the CEO wanted to cut our budget by 6%! Jerry’s voice had an edge to it, and I could tell that my explanations about th