Randomized controlled trials reported in the literature are often affected by poor generalizability, and pragmatic trials have become an increasingly utilized workaround approach to overcome logistical limitations and explore routine interventions demonstrating equipoise in clinical practice. Intravenous albumin, for example, is commonly administered in the perioperative setting despite lacking supportive evidence. Given concerns for cost, safety, and efficacy, randomized trials are needed to explore the clinical equipoise of albumin therapy in this setting, and we therefore present an approach to identifying populations exposed to perioperative albumin to encourage clinical equipoise in patient selection and optimize study design for clinical trials.
Keywords: albumin; generalizability; pragmatic approach to clinical trials; randomized controlled trials.