scholarly journals POS0248 PSYCHOMETRIC PROPERTIES OF OUTCOME MEASUREMENT INSTRUMENTS FOR ANCA-ASSOCIATED VASCULITIS: A SYSTEMATIC LITERATURE REVIEW

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 345.1-346
Author(s):  
A. Berti ◽  
G. Boleto ◽  
P. A. Merkel ◽  
G. Tomasson ◽  
S. Monti ◽  
...  
Keyword(s):  
Disease Activity ◽  
Psychometric Properties ◽  
Patient Reported Outcomes ◽  
Granulomatosis With Polyangiitis ◽  
Outcome Measurement ◽  
Patient Reported Outcome ◽  
Measurement Instruments ◽  
Anca Associated Vasculitis ◽  
Patient Reported ◽  
Disease Damage

Background:The OMERACT Vasculitis Working Group has defined a Core Domain Set of outcome measures for ANCA-associated vasculitis (AAV). However, the psychometric properties of available outcome measurement instruments in AAV, an essential consideration when choosing among instruments, have not been summarized.Objectives:To systematically review and summarize the psychometric properties of outcome measurement instruments used in AAV.Methods:A comprehensive search of several databases (Medline, EMBASE, Cochrane, Scopus, among others) from inception to July 14, 2020 and without language limitations was conducted. Articles were included if they covered psychometric properties of instruments used in AAV (granulomatosis with polyangiitis, GPA; microscopic polyangiitis, MPA; eosinophilic granulomatosis with polyangiitis, EGPA); articles encompassing other systemic vasculitides and not presenting the data for AAV separately were excluded. Following the COSMIN and OMERACT frameworks, different psychometric properties (validity, inter- and intra-observer reliability, sensitivity to change, and feasibility) of outcome measurement instruments used in AAV were assessed. Risk of bias was assessed according to the COSMIN checklist.Results:From 2505 articles identified, 20 met the predefined criteria. Three were identified as development studies, 14 were validation studies, and 3 pursued both objectives.These studies provided information on 16 instruments: 8 assessing disease activity, 1 assessing disease damage, 3 assessing patient-reported outcome, 4 assessing function (Figure 1). Overall, a few psychometric properties have been considered in each study, ranging from one to five. Most of the instruments were tested in GPA only (n=7), followed by AAV as a group (GPA, MPA and EGPA; n=5), MPA and GPA (n=3), and EGPA only (n=1). Sample sizes of the studies ranged between 27 and 626 patients. The studies with a higher risk of bias, according to COSMIN definitions, were those assessing RAPID3, MVIA, ENT/GPA DAS, and ODSS.There was a wide heterogeneity of the psychometric proprieties assessed for each instrument. Validity was the most frequently assessed domain in 88% of the instruments, and few properties other than construct validity were reported (Figure 1).Within each domain, BVAS/WG for activity, VDI for damage, AAV-PRO for patient-reported outcomes, and ODSS for function were the instruments with more psychometric features assessed. For the disease activity domain, BVAS/WG showed a good validity having the highest correlation with physician global assessment (r=0.90), a good reliability (intra-observer ICC=0.62; inter-observer ICC=0.97), and good feasibility and responsiveness. For disease damage, VDI showed moderate validity (correlations with BVAS/WG at 5-year with r=0.20 and BVAS/WG at 1-year with r=0.40) and good feasibility. Among patient-reported outcomes, AAV-PRO had the best performance in terms of validity (construct validity: correlations of the 6 disease domains and EQ-5D-5L, with r ranging between -0.78 and -0.55; discriminating validity between active disease versus remission of the 6 disease domains, p<0.0001 for all comparisons). The performance of instruments assessing function domain was low-to-moderate.Conclusion:Sixteen instruments covering the OMERACT domains of disease activity, damage, patient-reported outcome, and function had their psychometric properties assessed in the study of AAV. The majority were developed or validated for GPA only or AAV as a group. Overall, validity was the domain most frequently assessed. BVAS/WG, VDI, AAV-PRO, and ODSS were the instruments with more psychometric features assessed. More rigorous studies aimed at estimating a wider range of psychometric properties in larger numbers of patients with AAV are warranted.References:[1]Castrejon I, et al. Clin Exp Rheumatol. 2015[2]Merkel PA, Journal of Rheumatology, July 2011Disclosure of Interests:None declared

scholarly journals AB0373 PSYCHOMETRIC PROPERTIES OF OUTCOME MEASUREMENT INSTRUMENTS FOR LARGE VESSEL VASCULITIS: A SYSTEMATIC LITERATURE REVIEW

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1213.1-1213
Author(s):  
G. Boleto ◽  
A. Berti ◽  
P. A. Merkel ◽  
S. Aydin ◽  
H. Direskeneli ◽  
...  
Keyword(s):  
Disease Activity ◽  
Psychometric Properties ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
Measurement Instruments ◽  
Core Domain ◽  
Patient Reported ◽  
Disease Damage

Background:Giant cell arteritis (GCA) and Takayasu arteritis (TAK) are two forms of chronic progressive large-vessel vasculitis (LVV) of unknown etiology. In 2016, the OMERACT Vasculitis Working Group proposed the development of a Core Domain Set of outcome measures for LVV including organ and arterial function, fatigue, pain, biomarkers, and death (1). Understanding the psychometric properties of outcome measurement instruments is essential when selecting among instruments to use in research; a summary of such properties for measures of LVV has not been developed.Objectives:To systematically review and summarize the psychometric properties of outcome measurement instruments used to measure the domains of the OMERACT core domain set for LVV.Methods:A comprehensive search of several databases (Medline, EMBASE, Cochrane, among others) from inception to July 14, 2020 was conducted. Articles were included if they covered psychometric properties of instruments used in LVV. Following the COSMIN and OMERACT frameworks, different psychometric properties (validity, inter- and intra-observer reliability, sensitivity to change, and feasibility) of outcome measurement instruments used in LVV (GCA and TAK) were assessed. Risk of bias was assessed according to the COSMIN checklist.Results:Among the 3534 articles identified, 15 studies focusing on the development or validation of psychometric properties on LVV met the predefined criteria. Two were development studies and 13 were validation studies. These studies provided information on 13 instruments: 5 instruments specific to TAK, 2 specific to systemic vasculitides, and 6 general, non-disease-specific instruments. No instruments specific to GCA were identified.Of the main psychometric properties assessed in the included studies, 40% had a low, 47% had moderate, and 13% had high risk of bias. Construct validity was the property most frequently assessed (in 93% of the tools) (Figure 1).In TAK, the Indian Takayasu Clinical Activity Score 2010 (ITAS2010) showed good consistency (r=0.97), reliability (intra-observer, ICC=0.60; inter-observer, ICC=0.92) and validity (correlation with Physician Global Assessment (PGA) (r=0.73)) for disease activity. Regarding disease damage, the Disease Extent Index-Takayasu (DEI-Tak) showed good validity (correlation with NIH score 94%, k=0.85). Non-specific vasculitis instruments such as the Vasculitis Damage Index (VDI) and the Birmingham Vasculitis Activity Score (BVAS) showed moderate validity in the assessment of disease damage in GCA (cumulative glucocorticoid dose and disease duration, r=0.30 and r=0.29) and TAK (cumulative glucocorticoid dose and disease duration, r=0.29 and r=0.25) in the former and disease activity in GCA in the later (PGA, r=0.50).Six non-vasculitis-specific patient-reported outcomes (PROs) instruments were identified, all showing low to moderate validity in GCA/TAK.Conclusion:The psychometric properties of 13 outcome measures to study LVV covering the OMERACT domains of disease activity, damage, and patient-reported outcomes were assessed. ITAS2010, DEI-Tak, VDI, and BVAS were the instruments with better psychometric properties for disease activity and/or damage. Disease activity and/or damage instruments specific for GCA, and validated PROs for both GCA and TAK are needed.References:[1]Sreih GA, Alibaz-Oner F, Kermani TA, Aydin SZ, Cronholm PF, Davis T, et al. Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016 | The Journal of Rheumatology [Internet]. [cité 26 avr 2020]. Disponible sur: http://www.jrheum.org/content/44/12/1933.longDisclosure of Interests:None declared

scholarly journals POS0830 FACTORS INFLUENCING PATIENT-REPORTED OUTCOMES IN ANCA-ASSOCIATED VASCULITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 668.2-669
Author(s):  
S. Monti ◽  
P. Delvino ◽  
C. Klersy ◽  
G. Coppa ◽  
A. Milanesi ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Patient Reported Outcomes ◽  
Granulomatosis With Polyangiitis ◽  
Disease Duration ◽  
Eosinophilic Granulomatosis With Polyangiitis ◽  
Anca Associated Vasculitis ◽  
Organ Systems ◽  
Damage Accrual ◽  
Patient Reported

Background:Patient-reported outcomes (PROs) are currently poorly integrated in the clinical evaluation of disease activity in patients with ANCA-associated vasculitis (AAV).Objectives:To assess the distribution of the Patient Global Assessment (PtGA) in patients with AAV in stable remission, and to identify correlates of PtGA; to assess the discordance between PtGA score and PhGA.Methods:Patients with a diagnosis of AAV [eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, microscopic polyangiitis] in stable, complete remission (defined by a BVAS=0) and with a Physician Global Assessment (PhGA)=0 were included. A questionnaire including several aspects of disease captured by PROs was collected. PtGA on a 0-100 mm visual analogue scale (VAS) was assessed, with higher scores representing higher/worse levels of disease activity. Similarly, VAS for pain, chronic damage according to the patient’s opinion, general health (GH), fatigue, and sleep quality were collected. The worst symptom in the patient’s opinion affecting the overall assessment of disease activity was recorded. The Cragg Hurdle model was used to assess the predictors of PtGA.Results:65 patients were included, female 57%, mean age 61±12 years. Mean disease duration at enrollment was 8±6 years. Mean vasculitis damage index (VDI) was 4.4 ±2.3, with 45% of patients having a VDI ≥ 5. Despite having been classified as being in remission, PtGA was elevated in 37% of patients. We explored several correlates of PtGA. Higher degree of damage accrual (VDI) did not influence the patient’s evaluation of current disease activity. Similarly, we did not identify a correlation between older age, educational level, number of organ-systems involved, number of comorbidities, the number of previous major or minor relapses, higher disease duration, nor the type of AAV diagnosis (figure 1, panel A). Only sex significantly correlated with PtGA scores: 19 (51%) of female patients reported an elevated PtGA compared to only 5 (18%) of male (p=0.009). PtGA resulted to be significantly correlated with other (mostly modifiable) PROs including VAS pain, perception of the level of chronic damage accrual, GH, and fatigue (figure 1, panel B). The agreement between patients’ and physicians’ assessments of disease activity was 63%. Patients reported pain, followed by chronic respiratory symptoms to be the worst-experienced ongoing manifestations affecting their evaluation of disease activity.Conclusion:A significant proportion of patients with AAV considered to be in remission by the physician still declares to have persistent aspects of uncontrolled disease. PtGA is significantly influenced by persistent pain and fatigue, which warrant better assessment in the future.Disclosure of Interests:None declared

scholarly journals Which patient-reported outcomes shall we use in hand surgery?

2019 ◽  
Vol 45 (1) ◽  
pp. 5-11 ◽  
Author(s):  
Miriam Marks
Keyword(s):  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Hand Surgery ◽  
Daily Practice ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Instruments ◽  
Patient Reported ◽  
General Quality

Nowadays, the use of patient-reported outcome measures to monitor a treatment effect in daily practice or to quantify study outcomes is indispensable. In hand surgery, there is a wide variety available. This article provides an overview about the most common hand-specific, upper-extremity specific and general quality of life patient-reported outcome measurement instruments with adequate psychometric properties. A checklist and a decision tree are provided for choosing the appropriate instrument when evaluating patients with hand conditions.

scholarly journals Adaptação transcultural dos Bancos de Itens de Ansiedade e Depressão do Patient-Reported Outcomes Measurement Information System (PROMIS) para língua portuguesa

2014 ◽  
Vol 30 (4) ◽  
pp. 879-884 ◽  
Author(s):  
Natália Fontes Caputo de Castro ◽  
Carlos Henrique Alves de Rezende ◽  
Tânia Maria da Silva Mendonça ◽  
Carlos Henrique Martins da Silva ◽  
Rogério de Melo Costa Pinto
Keyword(s):  
Information System ◽  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Patient Reported Outcome ◽  
Measurement Information ◽  
Outcomes Measurement ◽  
Patient Reported ◽  
Measurement Information System

O Patient-Reported Outcome Measurement Information System (PROMIS), estruturado em domínios físicos e psicossociais, superou lacunas ao propor nova ferramenta de avaliação de resultados aplicáveis às doenças crônicas com base em técnicas avançadas de estatística (TRI) e testes adaptativos computadorizados (CAT). O objetivo do estudo foi adaptar culturalmente os Bancos de Itens de Ansiedade e Depressão do PROMIS para a língua portuguesa. O processo seguiu rigorosas recomendações do FACIT por meio da tradução avançada, reconciliação, retrotradução, revisão do FACIT, revisores independentes, finalização das etapas pelo FACIT, pré-teste e incorporação dos resultados do pré- teste. A versão traduzida foi pré-testada em dez pacientes, sendo necessária a modificação nos itens 3, 46 e 53 de Ansiedade e no item 46 de Depressão. As alterações alcançaram a equivalência de significado e a versão final foi compatível com as habilidades linguísticas e culturais da população brasileira. Concluiu-se que a versão traduzida é semântica e conceitualmente equivalente aos originais.

scholarly journals Patient-Reported Outcomes Measures: An Introduction for Clinicians

2019 ◽  
Vol 4 (1) ◽  
pp. 8-15 ◽  
Author(s):  
Kathryn Yorkston ◽  
Carolyn Baylor
Keyword(s):  
Instrument Development ◽  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Communication Disorders ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Centered ◽  
Outcomes Measures ◽  
Patient Reported ◽  
Measurement Tools

Patient-reported outcome measures contain information that comes directly from the patient without interpretation by anyone else. These measures are an important part of a clinicians' arsenal of assessment approaches and are critical in the development of patient-centered approaches to intervention. In this introduction to patient-reported outcome measurement tools, a history is provided of this approach to measurement and its place within the context of clinical research and practice. The process of instrument development and application will be reviewed, along with examples of measurement tools from the field of neurological communication disorders. This introduction is supplemented by references that provide interested readers with more detailed information.

scholarly journals Generic Patient-Reported Outcomes and Outcome Measures: A Systematic Review Study Protocol

2021 ◽  
Author(s):  
Yuki Seidler ◽  
Erika Mosor ◽  
Margaret R Andrews ◽  
Carolina Watson ◽  
Nick Bott ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Systematic Reviews ◽  
Patient Reported Outcomes ◽  
Outcome Measurement ◽  
Meta Analysis ◽  
Patient Reported Outcome ◽  
Cochrane Library ◽  
Screening Process ◽  
Patient Reported

Background: Patient-reported outcomes (PROs) are an essential part of health outcome measurement and vital to patient-centricity and valued-based care. Several international consortia have developed core outcome sets and many of them include PROs. PROs are measured by patient-reported outcome measures (PROMs). PROs and PROMs can be generic or specific to certain diseases or conditions. While the characteristics of generic PROs and PROMs are well recognised as widely relevant and applicable across different domains, diseases and conditions, there is a lack of knowledge on the types of PROs measured by generic PROMs. We also do not know in which disease areas generic PROs and PROMs are commonly used. To date, there has been no systematic review solely focusing on generic PROMs, what they measure and their areas of application. Objectives: This systematic review will identify core PROs measured by generic PROMs used in adult populations and the areas in which they are applied. Methods: We will conduct a systematic review of reviews. The screening process and the reporting will comply with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) 2020 Statement. We will use four databases, Medline [PubMed], CINHAL [Ebsco], Cochrane [Cochrane Library], and PsycINFO [Ovid], and reports from international consortia. Inclusion criteria are systematic reviews, meta-analysis or patient-reported outcome sets developed by international consortia reporting on generic PROMs in adult populations. Articles primarily focusing on patient-reported experience measures (PREMs), children or adolescents, or those not written in English will be excluded. Risk of bias will be assessed by checking if the included articles comply with established guidelines for systematic reviews such as the PRISMA statement. We will extract generic PROMs and PROs measured by these PROMs, and the areas applied from the selected articles and reports. Extracted data and information will be quantitatively and qualitatively synthesised without statistical interference. The quality of the synthesised evidences will be assessed by clarifying the strengths, limitations and possible biases in our review.

Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial

Lupus ◽  
2019 ◽  
Vol 28 (14) ◽  
pp. 1628-1639 ◽  
Author(s):  
M Jolly ◽  
N Annapureddy ◽  
L Arnaud ◽  
H Devilliers
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Sf 36 ◽  
Patient Reported ◽  
Outcome Scores ◽  
Activity Measures ◽  
Flare Index ◽  
The Mean

Objectives To quantify changes in generic patient-reported outcomes against clinically meaningful, disease activity measures in systemic lupus erythematosus (SLE). Methods Using BLISS-52 trial data (867 SLE patients), we estimated the mean difference in change of patient-reported outcome scores (Medical Outcomes Study SF-36 and FACIT-fatigue) in relation to disease activity (SELENA-SLEDAI, SELENA-SLEDAI flare index, SLE responder index and British Isles Lupus Assessment Group (BILAG)), considering all study visits by the mean of multivariate mixed models. Predefined disease activity criteria were used to define for improvement and worsening. Results Mean changes in physical component summary/mental component summary and FACIT-fatigue in response to changes in SELENA-SLEDAI and SELENA-SLEDAI flare index were significantly lower than 2.5. New SELENA-SLEDAI flare index flare led to a significant change in all patient-reported outcome scores, except role emotional. Mean improvement in patient-reported outcomes with achievement of SLE responder index ranged between +6.2 (physical function) and +11.3 (bodily pain) for SF-36 domains, + 3.4 and +3.3 for mental component summary and physical component summary, and was +4.2 for FACIT-fatigue. When considering disease activity changes by organ system, changes in BILAG (constitutional) was independently associated with significant changes in FACIT-fatigue and all SF-36 domains (except physical function), changes in BILAG (musculoskeletal and hematological) were independently associated with significant changes in patient-reported outcome scores, except for role emotional (musculoskeletal) and general health/mental health (hematological). Mean changes in every SF-36 domain varied (and was >5) with SLE responder index attainment. Conclusions Knowledge of changes in patient-reported outcomes, against clinically meaningful changes in SLE disease activity measures, is crucial for designing of clinical trials, interpretation of results and shared decision-making for patient care.

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