Development of Multinational Definitions of Minimal Clinically Important Improvement and Patient Acceptable Symptomatic State in Osteoarthritis

Abstract

Objective. The ability to interpret scores from patient-reported outcome measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state attainment. The goal was to develop multinational estimates for minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS). Methods. A multinational sample of patients with osteoarthritis (OA) was evaluated before and 4 weeks after treatment with nonsteroidal antiinflammatory drugs. Patients completed either the Western Ontario and McMaster Osteoarthritis Index (WOMAC) numerical rating scale 3.1 (hip and knee OA) or the Australian/Canadian Index (AUSCAN) numerical rating scale 3.1 (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved, from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN indices. Results. A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (percentage) change for MCII ranged 6-9 (10% to 17%) for WOMAC and 4-9 (8% to 15%) for AUSCAN. PASS estimates ranged 39-48 for WOMAC and 38-45 for AUSCAN. Some between-country variation was observed in MCII and PASS. Conclusion. Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency, and age-and sex-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions, and other condition-specific outcome measures.

Peripheral and Central Sensitization of Pain in Individuals With Hand Osteoarthritis and Associations With Self‐Reported Pain Severity

“…A subgroup of 76 participants (26%) responded late (>14 days after clinical examination) to the pain questionnaires. Pain severity as rated on the NRS and AUSCAN was reported to be above the patient acceptable symptom state in 33% and 52% of our study population, respectively. Few participants received ≥1 oral and/or topical analgesic on a daily basis (41 of 282) (acetaminophen in 11, NSAIDs in 34, opioid/opioid‐like drugs in 5) (Table ).…”

Illness perceptions and their association with 2 year functional status and change in patients with hand osteoarthritis

“…Change equal to or above the minimal clinically important difference (MCID) was used for HAQ (0.22) to classify patients as progressed; changes below this value were regarded as not progressed 34 . For AUSCAN function, the retrograde of the minimal clinically important improvement (MCII) was used, i.e., 1.4 35 . Since, for FIHOA, no MCII or MCID is known, progression was defined as the minimal change potentially detectable, which is 1 unit (or 3.3%) 36 .…”

Defining and evaluating a novel outcome measure representing end-stage knee osteoarthritis: data from the Osteoarthritis Initiative

“…Many individuals with incident esKOA experienced a clinically meaningful change in pain. The development of esKOA corresponded to an average increase in WOMAC pain of 2.9 (out of 20), which is considered clinically meaningful and meant many participants were no longer in an acceptable state of knee pain [16,17]. Individuals who developed esKOA also reported an increase in global arthritis impact, which would translate to many of these participants reaching an unacceptable symptom state (3.2 on a 10-point scale) [18].…”