Standardizing endpoints in perioperative research

Standardized Renal Endpoints for Perioperative Clinical Trials: The Standardized Endpoints in Perioperative Medicine Initiative

“…Clinical trials seek to evaluate the impact of interventions on a variety of primary and secondary endpoints with the aim of implementing this knowledge to improve perioperative outcomes. However, the use of valid and relevant endpoints within such trials is pivotal to achieving this goal [5,6].…”

“…The current review describes the rationale, goals and the planned pathway of the StEP renal subgroup. Development of a set of standardized and core renal endpoints, valid and relevant for use in the perioperative Selected endpoints must be validated for the study population and clinical context under investigation [5] while also considering regulatory requirements for licensing novel therapeutic interventions as well as the values of patients whose outcomes we seek to improve [7,8]. Moreover, the consistent use of standardized and precisely defined endpoints is essential to facilitate the meaningful comparison of outcomes between studies as well as the pooling of results for subsequent meta-analysis [5].…”

“…This review describes a current, international collaboration whose goal is to identify and recommend a suite of clearly and precisely defined renal endpoints specifically suited for use in perioperative clinical trials [5]. The intent is to optimize the validity, reproducibility, comparability and utility of renal outcomes measured and reported in clinical trials from this evolving discipline.…”

The challenges in producing high-quality clinical evidence

“…This issue of the Journal documents the willingness for clinical trialists to adopt a core set of baseline characteristics and clinically meaningful and universally defined outcomes. 26 Future collaborations will be expected to produce increasingly accurate and homogeneous databases that can also be recycled in numerous ways. Current and evolving research designs and statistical methods will improve our ability to reduce biases.…”

“…Ce numéro du Journal documente le désir d'adopter, pour les essais cliniques, un ensemble de base des caractéristiques à l'inclusion et de critères d'évaluation cliniquement pertinents, avec une définition universelle. 26 De futures collaborations devront produire des bases de données de plus en plus précises et homogènes qui pourront être « recyclées » de nombreuses manières. Les plans actuels et évolutifs de la recherche et des méthodes statistiques amélioreront notre capacité à réduire les biais.…”