Dataset Information

Comparing the Patient-Reported Physical Function Outcome Measures in a Real-Life International Cohort of Patients With Psoriatic Arthritis.

ABSTRACT:

Objective

We evaluated the psychometric properties of 3 patient-reported outcome measures to assess the physical function in psoriatic arthritis (PsA).

Methods

Data were available for the Health Assessment Questionnaire disability index (HAQ DI), the 12-item Short Form instrument physical component summary (SF-12 PCS), and the Psoriatic Arthritis Impact of Disease instrument functional capacity score (PsAID-FC). Data came from a longitudinal study in 14 countries of consecutive adults with definite PsA with ≥2 years of duration. The score distribution, construct validity, responsiveness, and thresholds of meaning of the patient-reported outcome measures were evaluated.

Results

At baseline, 414 subjects (52% male) were analyzed. The mean ± SD age was 52.4 ± 12.5 years and duration of illness was 10.9 ± 8.1 years. Ceiling effects were noted in 31% and 21% of patients for HAQ DI and PsAID-FC, respectively; floor effects were minimal. All 3 patient-reported outcome measures met a priori hypotheses for construct validity. After a median follow-up of 4.1 (interquartile range 2.7) months in 350 patients, 27%, 54%, and 18% of patients reported themselves improved, not changed, and worsened, respectively. Change scores were statistically different for groups for worsening versus no-change for all patient-reported outcome measures. PsAID-FC was more sensitive to change than the other 2 patient-reported outcome measures. Comparing groups with worsening condition to no-change, the standardized response mean square ratios were HAQ DI 29.9, SF-12 PCS 16.7, and PsAID-FC 40.1.

Conclusion

HAQ DI, SF-12 PCS, and PsAID-FC are valid measures of physical function for PsA. PsAID-FC, a single question, performed similarly to the other patient-reported outcome measures and may be an additional option to measure PsA-specific physical function.

SUBMITTER: Leung YY

PROVIDER: S-EPMC7371516 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Publications

Comparing the Patient-Reported Physical Function Outcome Measures in a Real-Life International Cohort of Patients With Psoriatic Arthritis.

Leung Ying Ying YY Orbai Ana-Maria AM de Wit Maarten M Balanescu Andra A Dernis Emmanuelle E Soubrier Martin M Eder Lihi L Smolen Josef S JS Coates Laura C LC Gossec Laure L

Arthritis care & research 20210313 4

<h4>Objective</h4>We evaluated the psychometric properties of 3 patient-reported outcome measures to assess the physical function in psoriatic arthritis (PsA).<h4>Methods</h4>Data were available for the Health Assessment Questionnaire disability index (HAQ DI), the 12-item Short Form instrument physical component summary (SF-12 PCS), and the Psoriatic Arthritis Impact of Disease instrument functional capacity score (PsAID-FC). Data came from a longitudinal study in 14 countries of consecutive ad ...[more]

PMID: 31961492

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Project description:ObjectiveThe objective was to investigate interplay and physical and mental component scores between change (Δ) in health-related quality of life (HRQoL) quantified by the physical component score (PCS) and mental component score (MCS) retrieved from short-form health survey (SF-36), change in disease activity (ΔDAS28CRP) and manifestations of PsA.MethodsPsA patients initiating new medical therapy were enrolled. Independent disease measures evaluating disease activity, enthesitis, psoriasis, pain and fatigue were collected at treatment initiation and after 4 months. Interplay between independent disease measures and dependent outcome measures, ΔPCS and ΔMCS, was described with univariate regression analyses. Multivariate regression analyses were applied to assess the impact of independent variables, such as individual disease outcome measures vs ΔDAS28CRP on ΔPCS and ΔMCS.ResultsOne hundred and eight PsA patients were included. In the univariate regression analyses, improvement in fatigue, pain and disability were associated with improvement in ΔPCS (β; -2.08, -0.18 and -13.00, respectively; all P < 0.001) and ΔMCS (β; -1.59, -0.12 and -6.07, respectively; P < 0.001, P < 0.001 and P = 0.003, respectively). When patient-reported outcomes were included in the final multivariate models, improvements in ΔPCS and ΔMCS were associated with improvements in pain, fatigue and disability (P < 0.001). Improvement in enthesitis impacted ΔPCS positively (β -0.31, P < 0.001). No association was found between change in skin psoriasis, ΔPCS and ΔMCS (β 0.15, P = 0.056 and β 0.05, P = 0.561, respectively).ConclusionIn this PsA patient cohort, diminishing pain, disability and fatigue improved PCS and MCS significantly. Changes in enthesitis and psoriasis did not grossly impact HRQoL compared with DAS28CRP. Individual PsA manifestations influence HRQoL differently, which is important clinically when targeting treatment.Trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT02572700.

Project description:BackgroundSDZ-ADL (GP2017; Sandoz GmbH, Austria) is an EMA-/FDA-approved adalimumab biosimilar. The effect of SDZ-ADL on quality of life (QoL) and patient-reported outcomes (PROs) was assessed as part of two phase III studies, one in patients with moderate-to-severe chronic plaque psoriasis (PsO; ADACCESS) and the other in patients with rheumatoid arthritis (RA; ADMYRA). Additionally, ADACCESS included patients with psoriatic arthritis (PsA).MethodsADACCESS included 465 patients with PsO, whereas ADMYRA included 353 patients with RA. Both studies evaluated and confirmed equivalent efficacy, similar safety, and immunogenicity of SDZ-ADL with reference adalimumab (ref-ADL). A third of patients underwent multiple (four) treatment switches between study treatments starting at Week 17 (ADACCESS); all patients switched from ref-ADL to SDZ-ADL at Week 24 (ADMYRA). Assessed PROs included Dermatology Life Quality Index (DLQI) and EuroQol five-dimension health status questionnaire (EQ-5D-5L) in ADACCESS, Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) score in ADMYRA, and Health Assessment Questionnaire-Disability Index (HAQ-DI) in both studies.ResultsIn both studies, baseline scores for all PRO assessments were comparable between the two treatment groups. In ADACCESS, mean DLQI decreased from baseline in both groups, and the mean (standard deviation [SD]) percent reductions from baseline in DLQI were comparable between groups at Week 17 (SDZ-ADL, - 64.5 [80.3]; ref-ADL, - 70.6 [41.7]), which were sustained after the switch at Week 51 ('continued SDZ-ADL,' - 79.7 [36.2]; 'continued ref-ADL,' - 80.8 [44.6]; 'switched to SDZ-ADL,' - 70.7 [32.2]; 'switched to ref-ADL,' - 69.3 [49.6]). In ADACCESS, the proportion of patients with an EQ-5D-5L score of 1 (no problems) increased from baseline for all five dimensions in all treatment groups and was comparable between treatment groups at Week 51. In ADACCESS, in patients with PsA at baseline, mean (SD) HAQ-DI scores decreased from baseline in both treatment groups, and scores were comparable between groups at Week 17 (SDZ-ADL, 0.5 [0.6]; ref-ADL, 0.5 [0.6]) and after switching at Week 51 ('continued SDZ-ADL,' 0.4 [0.5]; 'continued ref-ADL,' 0.4 [0.6]; 'switched to SDZ-ADL,' 0.5 [0.8]; 'switched to ref-ADL,' 0.7 [0.6]). In ADMYRA, proportion of patients achieving HAQ-DI in the normal range (≤ 0.5) was comparable between treatment groups at Week 24 (SDZ-ADL, 37.8%; ref-ADL, 36.3%) and after switching at Week 48 ('SDZ-ADL,' 41.6%; 'ref-ADL/switched to SDZ-ADL,' 40.0%). In ADMYRA, mean FACIT-Fatigue scores increased from baseline in both treatment groups. At Week 24, mean (SD) percent change from baseline in the FACIT-Fatigue scores was 75.4 (135.5) in SDZ-ADL and 73.0 (96.3) in ref-ADL groups; the scores were sustained after switching at Week 48.ConclusionTreatment with SDZ-ADL and ref-ADL resulted in comparable improvements in PROs as well as QoL scores across the three diseases, PsO, PsA, and RA. Switching between SDZ-ADL and ref-ADL had no negative impact on PROs across the reported period. CLINICAL TRIALS.Gov identifierNCT02744755, NCT02016105.

Project description:IntroductionOutcome assessments after surgery for degenerative lumbar disorders (DLDs) rely on subjective patient-reported outcomes (PROMs). New objective functional capacity tests, like the smartphone-based 6-min walking test (6WT), have been introduced but presumably also do not reflect the patient's real-life functional performance.Research questionPilot study to analyze changes in smartphone-based real-life activity data for physical performance outcome in patients undergoing surgery for DLD.Material and methodsProspective observational study of DLD patients. Objective functional capacity and subjective outcomes were measured using 6WT and PROMs. Real-life physical performance data were acquired retrospectively using Apple iPhone Health data and compared against objective capacity and subjective outcomes.ResultsEight patients (mean 46 years, 62% male) provided 286.858 smartphone mile counts. PROMs and physical capacity (6WT) significantly improved postoperatively. 6WT results increased from 352m pre-to 555/567m at 6/12 weeks postoperatively (p = 0.03). For physical performance a linear mixed effect models showed an increase in daily distance in the first 4 months after surgery (slope +0.178; p < 0.001). However, those increases reversed from 4 until 12 months postoperatively (negative slope estimate of -0.076; p < 0.001). Smartphone-derived physical performance measures showed a positive correlation with corresponding physical capacity in the 6WT (R = 0.57,p = 0.004) and negative correlations with PROMs (COMI: R = -0.62p = 0.001; ZCQ-Physical-Function: R = -0.68,p < 0.001; ZCQ-Symptom-Severity: R = -0.52,p = 0.009).Discussion and conclusionSmartphone-based real-life activity data allows for longitudinal physical performance assessment. Physical performance correlated with physical capacity and patient's subjective perception of disability. However, physical performance may be more resistant to postoperative longtime change which should consult a more cautious use as objective outcome measure.

Project description:BackgroundIn psoriatic arthritis (PsA), further understanding of the relationships between clinical measures and patient-reported outcomes (PROs) is needed. This post hoc analysis evaluated associations between minimal disease activity (MDA) as a continuous outcome (termed ScoreMDA) or Psoriatic Arthritis Disease Activity Score (PASDAS) with selected PROs not included in the composite measures.MethodsData from two phase 3 studies of tofacitinib in PsA (OPAL Broaden [NCT01877668; N = 422]; OPAL Beyond [NCT01882439; N = 394]) were included. MDA (binary outcome) was defined as meeting ≥5/7 criteria. For ScoreMDA, each criterion was assigned a value (1 = true; 0 = false; score range, 0-7; scores ≥5 indicated MDA). For PASDAS (score range, 0-10), higher scores indicated worse disease activity. PROs analyzed included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Patient's Assessment of Arthritis Pain visual analog scale (Pain VAS), and EuroQoL-Five Dimensions-Three Level Health Questionnaire visual analog scale (EQ-5D-3L VAS) and utility index. Relationships were evaluated using repeated measures regression models.ResultsSimilar, approximately linear relationships were confirmed between PASDAS or ScoreMDA and PROs in both studies. In OPAL Broaden and OPAL Beyond, a one-point difference in PASDAS was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (- 6.7 mm, - 6.9 mm), Pain VAS (9.9 mm, 10.7 mm), and FACIT-F (- 2.8, - 3.3). A one-point difference in ScoreMDA was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (5.0 mm, 5.5 mm) and FACIT-F (1.9, 2.7) in OPAL Broaden and OPAL Beyond, respectively.ConclusionsLinear associations between PASDAS or ScoreMDA and PROs provide interpretable and quantifiable metrics between composite clinical measures and PROs, highlighting the importance of these measures in understanding the relevance of treat-to-target goals in PsA.Trial registrationClinicalTrials.gov, NCT01877668 . Registered on June 12, 2013. ClinicalTrials.gov, NCT01882439 . Registered on June 18, 2013.

Dataset Information

Comparing the Patient-Reported Physical Function Outcome Measures in a Real-Life International Cohort of Patients With Psoriatic Arthritis.

Objective

Methods

Results

Conclusion

Publications

Comparing the Patient-Reported Physical Function Outcome Measures in a Real-Life International Cohort of Patients With Psoriatic Arthritis.

Similar Datasets

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