The variability in minimal clinically important difference and patient acceptable symptomatic state values did not have an impact on treatment effect estimates

Abstract

The MCID or PASS value has a low impact on the difference in the success rate between the arms in a trial.

Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively

“…We have used MCII, which is similar to the minimal clinically important difference, except that MCII only addresses the direction of improvement and not worsening (Tubach et al 2009). We calculated MCII estimates by several approaches and the mean change approach was considered the primary approach, as this is robust and may seem more intuitive and more easy to interpret than the complex ROC approaches (de Vet et al 2007).…”

“…Since it can be problematic to interpret change in scores and absolute postoperative scores in a clinically meaningful way (Quintana et al 2012), different cut-points can be determined. One of these cut-points is the minimal clinically important improvement (MCII), a PRO change score value defined as the minimal change representing a clinically important improvement from the patient’s perspective (Tubach et al 2009). Another cut-point is the patient-acceptable symptom state (PASS), a value of the postoperative PRO score found acceptable by the patients, defined as the overall health state at which patients consider themselves to be feeling well (Maksymowych et al 2010).…”

Mind the MIC: large variation among populations and methods

“…Tubach et al [37] recently showed, based on hypothetical studies, that the MIC value has a low impact on the difference in the success rate between the arms in a trial.…”

Minimal change is sensitive, less specific to recovery: a diagnostic testing approach to interpretability

“…In recent years, groups, such as Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) have explored both MCID and defining LDAS [17,56]. Recently, this has evolved into the minimal clinically important improvement (MCII) and the PASS in the work of Tubach et al, , 2006Tubach et al, , 2009. These were not included in the current evaluation as our data collection overlapped with the publication, and we did not field the indicators needed for MCII and PASS.…”