Inclusion of Patient-Reported Outcomes in Clinical Trials

Abstract

When evaluating the outcome of an operation, surgeons are traditionally focused on issues of morbidity and mortality. Although it is extremely important to know metrics such as the occurrence of a surgical site infection or death after surgery, measuring the patient perspective is also necessary for determining the success of an operation. A patient-reported outcome (PRO) is defined by the U.S. Food and Drug Administration as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” [1] An example of a PRO might include a patient’s characterization of postoperative fatigue or their physical function satisfaction after an operation, as both determinations are made by the patients themselves and cannot be directly measured or observed. Studies have shown that clinical or physical assessments are not always reflective of how the patient actually functions or feels, highlighting the importance of incorporating PROs into surgical practice [2].