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      Correlación y concordancia de la autoclinimetría en artritis reumatoide: revisión sistemática de la literatura y metanálisis Translated title: Patients-reported outcomes correlation and concordance in rheumatoid arthritis: systematic literature review and metaanalysis

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          Abstract

          Introducción: Existe un interés mundial en la evaluación de la artritis reumatoide (AR) desde la perspectiva del paciente mediante la autoclinimetría [en inglés patient-reported out comes (PROs)], que busca evaluar la actividad de la enfermedad, calidad de vida, pronóstico y adherencia terapéutica. Objetivo: Evaluar y analizar de manera objetiva el grado de correlación o concordancia entre las herramientas de autoclinimetría implementadas en AR con las mediciones objetivas realizadas por el equipo de salud, a través de una revisión sistemática de la literatura mundial y metanálisis. Materiales y métodos: Se realizó revisión sistemática de la literatura acerca de autoclinimetría en AR en PubMed, LILACS, Embase, SciELO y Biblioteca Virtual de la Salud, utilizando términos MeSH y DeCS, con un solo limite utilizado: humanos. Posteriormente, se realizó el metanálisis utilizando el programa Comprehensive Meta-Analysis versión 2. Resultados: Se incluyeron 85 artículos, demostrando correlaciones de moderadas a altas, entre las medidas objetivas realizadas por profesionales de la salud [DAS28, CDAI, SDAI, conteo articular inflamatorio (CAI) y doloroso (CAD), entre otros],y de autoclinimetría (RAPIDs, RADAI, RADAR, HAQ y CAI y CAD), por medio de metanálisis utilizando modelo de efectos aleatorios (p<0.0001). Conclusiones: La autoclinimetría tiene correlación y concordancia adecuadas con las medidas objetivas realizadas por el médico y su equipo entrenado. Ésta puede ser administrada tanto en la práctica clínica cotidiana como en ensayos clínicos, sin pretender que remplace el juicio clínico, pero con el ánimo de facilitar y optimizar el tiempo de consulta y los desenlaces de los pacientes.

          Translated abstract

          Introduction: There is a worldwide interest about the evaluation of rheumatoid arthritis (RA) from the perspective of the patient, using patient-reported outcomes (PROs), in order to assess disease activity, quality of life, prognosis, and treatment adherence. Objective: To evaluate and analyze the instruments of PROs and the degree of correlation with the objective measures done by the health practitioners through a systematic review and metaanalysis. Materials and methods: A systematic review was done in PubMed, LILACS, Embase, SciELO y Virtual Library Health (Biblioteca Virtual de la Salud) databases, using the MeSH terms and DeCS, with limit: Humans. A metaanalysis was done using the software Comprehensive Meta-Analysis version 2. Results: 85 articles were included, finding high to moderate correlations between the objective measures performed by trained health care practitioners [DAS28, CDAI, SDAI, swollen joint count (SJC) and tender joint count (TJC) among others] and PROs (RAPIDs, RADAI, RADAR, HAQ, SJC and TJC) through metaanalysis applying the random effect models (p<0.0001). Conclusions: PROs have an adequate correlation and concordance with the objective measures done by the health care practitioners. It can be administrated in the clinical practice and clinical trials, without pretending to replace the clinical concept but with the aim to facilitate and optimize the clinical consult and the patient outcomes.

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          Epidemiological aspects of rheumatoid arthritis: the sex ratio.

          Many rheumatic diseases, including rheumatoid arthritis (RA) are more frequent in females than males. The objective of this article was to examine the female versus male perspective regarding prevalence/incidence, etiological factors, disease severity/outcomes, access to therapy and therapeutic responses. We also present results from some new analyses from the patient registers in Oslo to supplement existing literature in this area. We found that the prevalence of RA is higher in females than males, the incidence is 4-5 times higher below the age of 50, but above 60-70 years the female/male ratio is only about 2. Smoking is a consistent predictor of RA in males, but findings have been more inconsistent in females. We could not confirm that health status is worse in females than males when corrections were made for different disease duration and for the underlying tendency of healthy females to report worse subjective health status than males. Some studies and data presented here indicate that females have less access to health services. We also found that female sex reduces the likelihood of achieving treatment response with methotrexate and anti-tumor necrosis factor (anti-TNF) drugs by 30-50%. More research is needed to fully describe the differences between males and females regarding epidemiological data.
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            Survival in rheumatoid arthritis: a population-based analysis of trends over 40 years.

            To evaluate trends in and risk factors for mortality among patients with rheumatoid arthritis (RA) over a 40-year period. A population-based inception cohort was assembled from among all Rochester, Minnesota residents ages > or =18 years who were first diagnosed with RA (fulfilling the 1987 American College of Rheumatology criteria for RA) between January 1, 1955 and December 31, 1994. Patients were followed up longitudinally through their entire medical records (including all inpatient and outpatient care by any provider) until death or migration from the county. Survival was described using the Kaplan-Meier method. Observed and expected survival were compared using the log-rank test, and standardized mortality ratios (SMRs) with expected survival were based on the sex and age of the study population and death rates from the Minnesota life tables. Cox proportional hazards models were used to estimate the influence of extraarticular manifestations and comorbidities, controlling for age, sex, body mass index (BMI), smoking, and rheumatoid factor positivity. Survival in this RA cohort was significantly lower than that expected in the population (P or =1 extraarticular manifestation was the strongest predictor of mortality after adjusting for age, sex, BMI, smoking, and rheumatoid factor positivity. Survival in RA patients is significantly lower than expected. The strongest predictors of survival appear to be those related to RA disease complications, specifically, extraarticular manifestations of the disease and comorbidities. More attention should be paid to mortality as an outcome measure in RA.
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              PRO development: rigorous qualitative research as the crucial foundation

              Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                rcre
                Revista Colombiana de Reumatología
                Rev.Colomb.Reumatol.
                Asociación Colombiana de Reumatología (Bogotá )
                0121-8123
                January 2013
                : 20
                : 1
                : 30-57
                Affiliations
                [1 ] Universidad del Rosario Colombia
                [2 ] Universidad del Rosario Colombia
                [3 ] Universidad del Rosario Colombia
                Article
                S0121-81232013000100004
                10.1016/S0121-8123(13)70010-0
                dc91cfce-29a8-4edb-8d48-08c92bdaf869

                http://creativecommons.org/licenses/by/4.0/

                History
                Product

                SciELO Colombia

                Self URI (journal page): http://www.scielo.org.co/scielo.php?script=sci_serial&pid=0121-8123&lng=en
                Categories
                RHEUMATOLOGY

                Rheumatology
                Patient-reported outcomes,clinical assessment,rheumatoid arthritis,Autoclinimetría,clinimetría,artritis reumatoide

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