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Abstract

Patient Acceptable Symptom State (PASS) is an absolute threshold proposed for symptomatic variables in osteoarthritis (OA) to determine the point beyond which patients consider themselves well and, as such, are satisfied with treatment. Two large previously reported studies of knee OA have shown that both lumiracoxib and celecoxib were superior to placebo in terms of conventional outcome measures. To assess the clinical relevance of these results from the patient's perspective, the same data pooled from these two studies were analysed with respect to the PASS. In total, 3,235 patients were included in two multicentre, randomised, double-blind studies of identical design. Patients were randomly assigned to receive lumiracoxib 100 mg once daily (n = 811), lumiracoxib 100 mg once daily with an initial dose of lumiracoxib 200 mg once daily for the first 2 weeks (100 mg once daily with initial dose [n = 805]), celecoxib 200 mg once daily (n = 813), or placebo (n = 806) for 13 weeks. Treatments were compared with respect to the PASS criteria (for OA pain, patient's global assessment of disease activity, and the Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1 [WOMAC™ LK 3.1] Function [difficulty in performing daily activities] subscale score). At week 13, 43.3%, 45.3%, and 42.2% of patients in the lumiracoxib 100 mg once daily, lumiracoxib 100 mg once daily with initial dose, and the celecoxib 200 mg once daily groups, respectively, considered their current states as satisfactory versus 35.5% in the placebo group. Similar results were observed for patient's global assessment of disease activity and WOMAC™ LK 3.1 Function subscale score. This post hoc analysis suggests that the statistical significance of the results observed with lumiracoxib or celecoxib compared with placebo using conventional outcome variables is complemented by clinical relevance to the patient. Trial registration numbers: NCT00366938 and NCT00367315.

Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial

“…The PASS provides clinically meaningful information that can be expressed as a percentage of individuals who meet the threshold for PASS, regardless of the change from baseline in symptoms. 20 Success on the GROC was reported at a higher frequency in the manual therapy-plus-exercise group at the end of care (4 weeks) and at a 6-month longterm follow-up (FIGURE 2). The GROC is commonly utilized in clinical research to determine cutoff scores for patient-perceived changes in condition.…”

How to define responders in osteoarthritis

“…It has been suggested that PASS may be more robust than MCII, since it is not affected by initial level of symptoms 61 ; it also has the advantage of encompassing a notion of quality of life. 62 Further research is necessary, though the two techniques, MCII and PASS, do appear to be complementary.…”

Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) – a feasibility study in patients with knee osteoarthritis using a mixed method approach

“…Firstly, some of the psychological questionnaires (AAQ-II [ 47 ], CPAQ-8 [ 48 ], GIC [ 49 ]) were removed as all the patients had difficulty understanding resulting in completion difficulty. Other outcome measures such as the PAM, Global Perceived Effect (GPE) [ 49 ], Patient Acceptable Symptom State (PASS) and treatment failure [ 66 ] which are sensitive but simple questionnaires will be included for the subsequent RCT in place of the excluded questionnaires as these outcome measures have previously been used in musculoskeletal conditions of the knee [ 67 ]. The overall respondent burden would be reduced.…”