Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom
Restarting planned surgery during the COVID-19 pandemic is a clinical and societal priority, but it is unknown whether it can be done safely and include high-risk or complex cases. We developed a Surgical Prioritization and Allocation Guide (SPAG). Here, we validate its effectiveness and safety in COVID-free sites. A multidisciplinary surgical prioritization committee developed the SPAG, incorporating procedural urgency, shared decision-making, patient safety, and biopsychosocial factors; and applied it to 1,142 adult patients awaiting orthopaedic surgery. Patients were stratified into four priority groups and underwent surgery at three COVID-free sites, including one with access to a high dependency unit (HDU) or intensive care unit (ICU) and specialist resources. Safety was assessed by the number of patients requiring inpatient postoperative HDU/ICU admission, contracting COVID-19 within 14 days postoperatively, and mortality within 30 days postoperatively.Aims
Methods