Patient Acceptable Symptomatic State and Substantial Clinical Benefit Matter Most to Patients and Must Be Reported Correctly

Abstract

Despite a push for a focus on clinical rather than “statistical” significance and an emphasis on reporting of outcome thresholds such as the patient acceptable symptomatic state (PASS) and substantial clinical benefit (SCB), the PASS and SCB are rarely reported and, when reported, are often reported incorrectly. Yet, patients require satisfaction (PASS) as a result of our treatments, and patients desire to improve substantially (SCB). Determining whether patients are satisfied and/or substantially improved is simple . . . just ask them. The questions are known as anchor questions. Obviously, different patients have different PASS and SCB thresholds, and reliance on previously published literature for values of these thresholds can result in error—thus, the anchor questions. And, each patient must be assessed individually. Outcome thresholds are not group-level metrics, and they must be reported as the percentage of individuals who achieve the clinically significant outcome. Certain patients, such as athletes, have high baseline function and may demand maximum outcome improvement. In contrast, the minimal clinically important difference is a less-than-ideal measure; patients do not desire “minimal” improvement. Journals must do a better job of publishing patient-reported outcome measures that matter most to patients: satisfaction and substantial benefit.