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Editorial Commentary: Researchers Should Determine Study-Specific Thresholds for Substantial Clinical Benefit and
Mark P Cote1, Brandon J Allen1, Srish S Chenna1
1Boston, Massachusetts, U.S.A.
Abstract:
Patient-reported outcome measures capture a patient's health throughout the care process, but the scores do not provide direct information on whether there has been substantial improvement or whether the patient is satisfied with his or her current state of health. In contrast, metrics such as the substantial clinical benefit and patient acceptable symptomatic state are clinically relevant threshold scores that correspond to improvement and satisfaction. Various studies report varied thresholds because of differing anchor questions (used to establish improvement or satisfaction), lengths of follow-up, sample sizes, and patient demographic characteristics. This is unsurprising considering varied patient expectations, values, and goals, as well as surgeon practice patterns, setting, and interpersonal skills, that may influence patient perception. Such complexities will produce variation in threshold values from study to study, even studies using similar anchor questions, lengths of follow-up, and sample sizes. Thus, thresholds reported in the past literature may not well apply to current and future research, and researchers should determine study-specific thresholds, ideally by asking the patient whether he or she is substantially improved and/or satisfied, that is, asking 2"anchor questions." To fully appreciate metrics such as the substantial clinical benefit and patient acceptable symptomatic state, they need to be viewed as distributions of values.