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This project demonstrates the use of the IEEE 2791-2020 Standard (BioCompute Objects [BCO]) to enable the complete and concise communication of results from next generation sequencing (NGS) analysis. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data and then two independent analyses were performed. The first simulated a pharmaceutical regulatory submission to the US Food and Drug Administration (FDA) including analysis of results and a BCO. The second simulated an FDA review that included an independent analysis of the submitted data. Of the 118 simulated patient samples generated, 117 (99.15%) were in agreement in the two analyses. This process exemplifies how a template BCO (tBCO), including a verification kit, facilitates transparency and reproducibility, thereby reinforcing confidence in the regulatory submission process.

Importance Chronic, non-cancer pain affects approximately 20–30% of the population in North America, Europe, and Australia, with surgery and trauma frequently cited as inciting events. Prospective studies of fracture patients have demonstrated an association between somatic pre-occupation, poor coping, and low recovery expectations following surgery with persistent pain, functional limitations, and lower rates of return to work. Psychological interventions, such as cognitive behavioural therapy (CBT), that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients. Objective To determine whether online CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain among participants with an open or closed fracture of the appendicular skeleton. Design, setting, and participants The Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE) protocol will be followed to conduct a multi-centre randomized controlled trial. Participants undergoing surgical repair of a long bone fracture will be randomized to receive either (1) online CBT modules with asynchronous therapist feedback or (2) usual care. The primary outcome will be the prevalence of moderate to severe persistent post-surgical pain over 12 months post-fracture. Secondary outcomes include the Short Form-36 Physical and Mental Component Summary scores, return to function, pain severity and pain interference over 12 months post-fracture, and the proportion of patients prescribed opioid class medications (and average dose) at 6 and 12 months post-fracture. The COPE trial will enroll 1000 participants with open and closed fractures of the appendicular skeleton from approximately 10 hospitals in North America. Discussion If CBT is effective in improving outcomes among patients with traumatic fractures, our findings will promote a new model of care that incorporates psychological barriers to recovery. Trial registration ClinicalTrials.gov Identifier: NCT04274530. Registered on 14 February 2020.