Why Harmonizing Outcomes Matters in Procedural Innovation

In a correspondence piece published in The Lancet Gastroenterology & Hepatology, Dr. Zachary Smith, Founding Director of WIRE, examines how outcome selection shapes the interpretation and clinical value of procedural trials. Writing in response to three recent landmark randomized controlled trials on endoscopic ultrasonography-guided gastroenterostomy for malignant gastric outlet obstruction, Dr. Smith argues that rigorous methodology must advance in parallel with genuine attention to patient priorities.

The correspondence highlights a fundamental tension in early procedural innovation: while continuous and composite outcomes enhance trial efficiency and reduce sample size requirements, they risk diluting the connection between statistical significance and what actually matters to patients. For patients with advanced malignancy facing terminal illness, outcomes such as time to hospital discharge, resumption of chemotherapy, avoidance of readmission, and days spent at home with loved ones may be far more meaningful than the ability to quickly resume a semi-solid diet. Dr. Smith emphasizes that identifying these priorities requires direct engagement with patients and caregivers before trial design—and that harmonizing stakeholder-informed endpoints across studies will strengthen interpretability, generalizability, and applicability. This commitment to measuring what truly matters represents a core value of WIRE's research mission and reflects the kind of thoughtful, patient-centered science the institute was built to advance.

Citation: Smith ZL. Endoscopic palliation of malignant gastric outlet obstruction: harmonising around outcomes that matter. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):95-96. https://doi.org/10.1016/S2468-1253(25)00348-6