Thresholds of patient‐reported outcomes that define the patient acceptable symptom state in ankylosing spondylitis vary over time and by treatment and patient characteristics

Abstract

Objective. The patient acceptable symptom state (PASS) is a single-question outcome tool to assess the level of symptoms at which patients with rheumatic diseases consider themselves well. We evaluated whether ankylosing spondylitis (AS) patient characteristics were associated with attaining the PASS and whether these characteristics influenced PASS thresholds for patient-reported outcome (PRO) tools. Methods. The Adalimumab Trial Evaluating Long-term Efficacy and Safety for Ankylosing Spondylitis was a randomized, placebo-controlled study that evaluated the efficacy and safety of adalimumab in treating AS. The PASS and PROs were assessed over 24 weeks. PASS thresholds for PROs were set as either the 25th or 75th percentiles of the PRO response score. Logistic regression analyses were conducted to determine the associations of particular patient characteristics with the PASS and other response outcomes at 12 weeks (ASessment in Ankylosing Spondylitis International Working Group criteria for 20% improvement [ASAS20], ASAS40, ASAS5/6, ASAS partial remission, and Bath Ankylosing Spondylitis Disease Activity Index 50% improvement). Results. Age >40 years, disease duration >10 years, female sex, placebo treatment, and English-speaking site were consistently associated with greater PASS thresholds for PROs. Age, male sex, disease duration, and treatment were each independently associated with attainment of the PASS at 12 weeks. Only age and treatment were independently associated with other response outcomes. PASS thresholds also decreased over 24 weeks. Conclusion. PASS thresholds for PROs changed over time. These thresholds, as well as the attainment of the PASS, were affected by covariates unrelated to treatment. If confirmed in other studies, these results cast doubt on using the PASS to assess absolute health status in clinical research.

Evaluation of the Patient Acceptable Symptom State (PASS) in Italian Patients Affected by Systemic Lupus Erythematosus: Association with Disease Activity Indices

“…Similarly, a significantly higher frequency of patients with an acceptable status was achieved by AS patients treated with adalimumab compared with patients assuming placebo. Interestingly, patients treated with adalimumab had also lower disease activity [21,22,35]. …”

“…PASS was assessed in all patients by asking to answer yes or no to a single question [21] that was previously translated into Italian. In the linguistic validation process, two Italian translators, who are native speakers and are experienced in translating health questionnaires, independently translated the question.…”

“…The original question was "Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?” [21]. For this question patients could give a dichotomized answer (yes or no).…”

“…The patient acceptable symptom state (PASS) is a single-question outcome tool to evaluate the level of symptoms at which patients consider themselves well [21]. Data published in the literature report the application of PASS to patients affected by Ankylosing Spondylitis (AS), osteoarthritis (OA), and Rheumatoid Arthritis (RA).…”

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

“…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). Both MCII and PASS estimations will be of future importance in research and clinical practice because they focus on the patient perspective of total hip arthroplasty (THA).…”