Dataset Information

Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group.

ABSTRACT:

Objective

Pain interference, fatigue, and impaired physical function are common features of idiopathic inflammatory myopathies (IIM). The objective of this study was to evaluate the construct validity and test-retest reliability of the Patient Reported Outcome Information System (PROMIS) Pain Interference 6av1.0, Fatigue 7av1.0, and Physical Function 8bv2.0 instruments.

Methods

Patient-Reported Outcome Measures (PROMs) were deployed to adult IIM patients from OMERACT Myositis Working Group (MWG) international clinic sites via two online surveys (2019, 2021). Internal consistency of each PROM was analyzed by Cronbach's α. Construct validity was determined by a priori hypotheses generated by the MWG with >75% agreement for each hypothesis and calculated with Pearson correlations. Test-retest reliability was assessed using intraclass correlation coefficient with PROMIS instruments administered at time zero and 7 days.

Results

Surveys were sent to 368 participants in total; participants who completed each questionnaire varied (n=65 to 263). For construct validity, 10 out of 13 a priori hypotheses were met supporting construct validity of PROMIS instruments (Pain Interference 3/4, fatigue 4/4, and Physical Function 3/5). Test-retest reliability was strong for all PROMIS instruments. All PROMIS instruments demonstrated excellent internal consistency. None of the measures demonstrated any ceiling or floor effects except for a ceiling effect in the Pain Interference instrument.

Conclusions

This study presents test-retest reliability and construct validity evidence supporting PROMIS Pain Interference (6a v1.0), Fatigue (7a v1.0), and Physical Function (8b v2.0) using a large international cohort of patients with IIM. Internal consistency of these instruments was excellent. A ceiling effect was noted in the Pain Interference instrument.

SUBMITTER: DiRenzo D

PROVIDER: S-EPMC10354786 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group.

DiRenzo Dana D Saygin Didem D de Groot Ingrid I Bingham Iii Clifton O CO Lundberg Ingrid E IE Needham Merrilee M Park Jin Kyun JK Regardt Malin M Sarver Catherine C Song Yeong Wook YW Maxwell Lara L Beaton Dorcas D de Visser Marianne M Christopher-Stine Lisa L Mecoli Christopher A CA Alexanderson Helene H

Seminars in arthritis and rheumatism 20221103

<h4>Objective</h4>Pain interference, fatigue, and impaired physical function are common features of idiopathic inflammatory myopathies (IIM). The objective of this study was to evaluate the construct validity and test-retest reliability of the Patient Reported Outcome Information System (PROMIS) Pain Interference 6av1.0, Fatigue 7av1.0, and Physical Function 8bv2.0 instruments.<h4>Methods</h4>Patient-Reported Outcome Measures (PROMs) were deployed to adult IIM patients from OMERACT Myositis Work ...[more]

PMID: 36410180

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Project description:BackgroundA series of qualitative studies conducted by the OMERACT Myositis Working Group identified pain interference, fatigue, and physical function as highly important life impact domains for adults with idiopathic inflammatory myositis (IIM). In this study, our goal was to assess the responsiveness and minimal important difference of PROMIS pain interference (6a), fatigue (7a), and physical function (8b).MethodsAdults with IIM from USA, Netherlands, Korea, Sweden, and Australia with two "clinical" visits were enrolled in this prospective study. Anchor questions on a Likert scale were collected at baseline, and manual muscle testing (MMT), physician and patient reported global disease activity, and PROMIS instruments were collected at both visits. Responsiveness was assessed with i) ANOVA, ii) paired t-test, effect size and standardized response mean, and iii) Pearson correlation. Minimal important difference (MID), minimal important change (MIC) and minimal detectable change (MDC) values were calculated.Results114 patients with IIM (median age 60, 60 % female) completed both visits. Changes in PROMIS instruments were significantly different among anchor categories. Patients who reported improvement had a significant improvement in their PROMIS scores with at least medium effect size, while patients who reported worsening and stability did not show a significant change with weak effect size. PROMIS instruments had weak to moderate correlations with MMT, patient and physician global disease activity. MID was approximately 2-3 points for Pain Interference and 3-4 points for Fatigue and Physical Function forms based on the method used. MIC was approximately 4-5 for improvement of all the instruments, while MDC was 1.7-2 points for Pain Interference and Physical Function and 3.2-3.9 for Fatigue.ConclusionThis study provides evidence towards the responsiveness of the PROMIS instruments in a large international prospective cohort of adults with IIM supporting their use as PROMs in adult myositis.

Project description:ImportanceIdiopathic inflammatory myopathies are heterogeneous in their pathophysiologic features and prognosis. The emergence of myositis-specific autoantibodies suggests that subgroups of patients exist.ObjectiveTo develop a new classification scheme for idiopathic inflammatory myopathies based on phenotypic, biological, and immunologic criteria.Design, setting, and participantsAn observational, retrospective cohort study was performed using a database of the French myositis network. Patients identified from referral centers for neuromuscular diseases were included from January 1, 2003, to February 1, 2016. Of 445 initial patients, 185 patients were excluded and 260 adult patients with myositis who had complete data and defined historical classifications for polymyositis, dermatomyositis, and inclusion body myositis were enrolled. All patients were tested for anti-histidyl-ARN-t- synthetase (Jo1), anti-threonine-ARN-t-synthetase (PL7), anti-alanine-ARN-t-synthetase (PL12), anti-complex nucleosome remodeling histone deacetylase (Mi2), anti-Ku, anti-polymyositis/systemic scleroderma (PMScl), anti-topoisomerase 1 (Scl70), and anti-signal recognition particle (SRP) antibodies. A total of 708 variables were collected per patient (eg, cancer, lung involvement, and myositis-specific antibodies).Main outcomes and measuresUnsupervised multiple correspondence analysis and hierarchical clustering analysis to aggregate patients in subgroups.ResultsAmong 260 participants (163 [62.7%] women; mean age, 59.7 years; median age [range], 61.5 years [48-71 years]), 4 clusters of patients emerged. Cluster 1 (n = 77) included patients who were male, white, and older than 60 years and had finger flexor and quadriceps weakness and findings of vacuolated fibers and mitochondrial abnormalities. Cluster 1 regrouped patients who had inclusion body myositis (72 of 77 patients [93.5%]; 95% CI, 85.5%-97.8%; P < .001). Cluster 2 (n = 91) regrouped patients who were women and had high creatine phosphokinase levels, necrosis without inflammation, and anti-SRP or anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies corresponding to immune-mediated necrotizing myopathy (53 of 91 [58.2%]; 95% CI, 47.4%-68.5%; P < .001). Cluster 3 (n = 52) regrouped patients who had dermatomyositis rash and anti-Mi2, anti-melanoma differentiation-associated protein 5 (MDA5), or anti-transcription intermediary factor-1γ (TIF1γ) antibodies, mainly corresponding with patients who had dermatomyositis (43 of 52 [82.7%]; 95% CI, 69.7%-91.8%; P < .001). Cluster 4 (n = 40) was defined by the presence of anti-Jo1 or anti-PL7 antibodies corresponding to antisynthetase syndrome (36 of 40 [90.0%]; 95% CI, 76.3%-97.2%; P < .001). The classification of an independent cohort (n = 50) confirmed the 4 clusters (Cohen κ light, 0.8; 95% CI, 0.6-0.9).Conclusions and relevanceThese findings suggest a classification of idiopathic inflammatory myopathies with 4 subgroups: dermatomyositis, inclusion body myositis, immune-mediated necrotizing myopathy, and antisynthetase syndrome. This classification system suggests that a targeted clinical-serologic approach for identifying idiopathic inflammatory myopathies may be warranted.

Project description:BackgroundUltrasound (US) can evaluate all joint components affected by knee osteoarthritis (KOA); however, standardized scoring of US-detected pathology is needed to improve its diagnostic and monitoring capabilities.ObjectivesTo examine the validity, reliability, and feasibility of the Outcome Measures in Rheumatology (OMERACT) ultrasound scoring for KOA, comparing with clinical and radiography measures, using predefined cutoff values.MethodsThis cross-sectional study included 75 Egyptian patients with primary KOA. All patients had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, bilateral knee radiography, and ultrasonography. Inter-observer reliability of ultrasound was evaluated in 30 knees by another newly trained operator.ResultsMost of the OMERACT-US KOA scores showed significant associations with WOMAC clinical scores, except for femoral cartilage damage and effusion. The synovitis score was significantly associated with WOMAC-pain score (p-value 0.046), while medial meniscus extrusion (MME) and medial osteophytes were significantly associated with WOMAC-stiffness score (p-value 0.009 and 0.023, respectively). MME and synovitis were significantly associated with WOMAC-physical score (p-value 0.035 and 0.020, respectively). The ultrasound scores also showed a strong correlation with radiographic scoring. Inter-observer reliability ranged from moderate to excellent agreement (k = 0.58 to k = 0.83); it was highest for lateral osteophytes (k = 0.83), good agreement for synovitis (k = 0.72), any osteophytes (k = 0.71), damage of femoral cartilage (k = 0.70), and moderate agreement for medial osteophytes (k = 0.58) and MME (k = 0.59).ConclusionOMERACT-US scoring system for KOA demonstrated validity, reliability, and feasibility for evaluating both structural and inflammatory components. Using cutoff values improved the scoring reliability for osteophytes and MME. Key Points • OMERACT-US scores provide a valid assessment of inflammatory and structural components of knee osteoarthritis. • The following changes may improve the performance of the OMERACT-US scores. a. The binary score for effusion and synovial hypertrophy can be omitted, as they have no added value. b. A semi-quantitative grading for effusion may capture the impact of effusion on clinical outcomes. c. Added cutoff values to score medial meniscal extrusion, osteophytes, and pathological effusion improved the respective scores' reliability. d. Applying the updated OMERACT definition of synovitis. • OMERACT-US scores are reliable to be used with a newly trained operator, particularly when cutoff values are included, and proper training time is provided. • The OMERACT-US score is feasible to be used in clinical practice, as the time taken to perform was short, even for a newly trained operator.

Dataset Information

Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group.

Objective

Methods

Results

Conclusions

Publications

Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group.

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