Evaluation and validation of the patient acceptable symptom state (PASS) in patients with ankylosing spondylitis

Maksymowych, Walter P.; Richardson, Rhonda; Mallon, Catherine; Heijde, Desirée van der; Boonen, Annelies

doi:10.1002/art.22469

Cited by 122 publications

(120 citation statements)

References 16 publications

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“…For example, the ASQoL score of patients who satisfied the FM criteria (mean 13.1) indicated worse quality of life than the level deemed acceptable by patients (ASQoL score of 8.0) (31). Moreover, according to reference centile charts of the BASDAI, patients who met the criteria for FM had a mean BASDAI score between the 75th and 90th centiles (32).…”

Section: Discussionmentioning

confidence: 99%

Co‐Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia

Macfarlane

Barnish

Pathan

et al. 2017

Arthritis & Rheumatology

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Objective To estimate the proportion of patients with axial spondyloarthritis (SpA) in a UK national biologics registry who met criteria for fibromyalgia (FM), and to delineate the characteristics of these patients. Methods Two cohorts of patients are prospectively recruited from across 83 centers in the UK for the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR‐AS). All patients are required to meet Assessment of SpondyloArthritis international Society (ASAS) criteria for axial SpA. Patients are either newly starting biologic therapy (biologics cohort) or are naive to treatment with biologic agents (non‐biologics cohort) at the time of recruitment, and all patients are followed up prospectively. At recruitment and follow‐up, clinical information and measurements are recorded while patients complete the 2011 research criteria for FM and assessments of the level of disease activity and work impact. Results Of the patients registered in the BSRBR‐AS, 1,504 (68% male) were eligible for the current analysis, of whom 311 (20.7%) met the 2011 research criteria for FM. Prevalence of FM was similar between patients who fulfilled the modified New York criteria for AS (19.7%) and those who fulfilled ASAS imaging criteria but not the modified New York criteria (25.2%); however, among those who fulfilled only the ASAS clinical criteria, the prevalence of FM was lower (9.5%). Patients who met FM criteria reported significantly worse disease activity, function, global severity scores, and quality of life, and were more likely to have moderate or severe levels of mood disorder and clinically important fatigue. Patients who met FM criteria reported experiencing work impairment around half their working time. Meeting FM criteria was not related to elevated C‐reactive protein levels or most extraspinal manifestations, but was associated with a higher likelihood of having received biologic therapy. Conclusion Developing management approaches that would address the significant unmet clinical needs of the 1 in 5 patients with axial SpA who meet criteria for FM should be a research priority.

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Section: Discussionmentioning

confidence: 99%

Co‐Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia

Macfarlane

Barnish

Pathan

et al. 2017

Arthritis & Rheumatology

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“…This approach identifies the cut-off point corresponding to the 75th percentile of the scores for improvement in patients who report an important improvement by the anchoring question. Applying receiver operating characteristic (ROC) curves allows for choosing the threshold that is the best compromise between sensitivity and specificity for each outcome criterion 7 8…”

Section: The Concepts Of MCII and Mcidmentioning

confidence: 99%

Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean?

Kvien

Heiberg

Hagen

2007

Annals of the Rheumatic Diseases

268

273

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“…One cross-sectional study described the validation of the PASS in AS according to reported flare status, expressed need to see the physician, attainment of ASAS partial remission, and PASS contribution to QOL (5). A second study showed that more patients with active AS who were ASAS20 responders following treatment with adalimumab achieved the PASS compared with ASAS20 nonresponders to adalimumab (6).…”

Section: Introductionmentioning

confidence: 99%

“…Significantly more adalimumab-treated patients reported achievement in the PASS compared with placebo-treated patients, indicating excellent discriminant capacity. There has also been considerable interest in defining the PASS concept according to thresholds for the patient self-reported outcomes (PROs) in AS (5)(6)(7)(8). However, these estimates have varied in different reports and it is unclear whether these variations reflect study design variability (cross-sectional versus prospective) or other unknown factors.…”

Section: Introductionmentioning

confidence: 99%

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

Maksymowych

Gooch

Dougados

et al. 2010

Arthritis Care & Research

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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.

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Evaluation and validation of the patient acceptable symptom state (PASS) in patients with ankylosing spondylitis

Cited by 122 publications

References 16 publications

Co‐Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia

Co‐Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia

Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean?

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

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