ABSTRACT
RESUMEN INTRODUCCIÓN un sistema de evaluación ética de las investigaciones en seres humanos es esencial para proteger los derechos de los participantes. Los desafíos impuestos por la pandemia de la COVID-19 para conducir investigaciones éticas que produzcan resultados con rapidez demuestran la necesidad de fortalecerlo. El objetivo de este estudio fue describir el estado de situación de los sistemas de evaluación ética de las provincias de Argentina y las adaptaciones realizadas por la pandemia. MÉTODOS se realizó una encuesta a los comités provinciales de ética en investigación o áreas similares de los ministerios de Salud que ejercen la vigilancia sobre la evaluación ética de las investigaciones de su jurisdicción. RESULTADOS respondieron 16 de las 17 provincias encuestadas. El 93,7% de los comités provinciales evalúa investigaciones en seres humanos y tiene procedimientos operativos estandarizados (POE). El 68,7% lleva un registro de los comités de ética en investigación (CEI) de su jurisdicción. Un 75% acredita a los CEI y un 68,7% los supervisa. El 100% tiene un registro de las investigaciones en salud; en 56,2% de los casos este registro es público. Del total, 81,2% realizan actividades de capacitación. El 100% adaptó los POE para evaluar estudios sobre la COVID-19. DISCUSIÓN los resultados muestran sistemas provinciales consolidados. Se requiere fortalecer la transparencia en la investigación mediante el registro público de las investigaciones. Se identificaron posibilidades de mejora para proponer acciones a futuro.
ABSTRACT INTRODUCTION a research ethics system is essential to protect the rights of research participants. The challenges posed by the COVID-19 pandemic to conduct research ethically to produce rapid results have demonstrated the need to strengthen this system. The objective of this study was to describe the state of the research ethics system of the Provinces of Argentina and the adaptations made due to the pandemic. METHOD: a survey was conducted with provincial research ethics committees or similar areas within the Ministries of Health of the provinces responsible for the oversight of research ethics review under their jurisdiction. RESULTS sixteen of the 17 provinces surveyed responded. 93.7% of the provincial committees review human research and have standard operating procedures (SOPs). 68.7% register the research ethics committees (REC) in their jurisdiction. Seventy-five percent accredit RECs and 68.7% supervise them. 100% have a registry of health research in the jurisdiction, only 56.2% have public access. 81.2% carry out training activities. 100% adapted the SOPs to evaluate studies on COVID-19. DISCUSSION the results show consolidated provincial systems. Transparency in research needs to be strengthened through public registration of research. Possibilities for improvement were identified to propose future actions.
ABSTRACT
INTRODUCCIÓN: un sistema de evaluación ética de las investigaciones en seres humanos es esencial para proteger los derechos de los participantes. Los desafíos impuestos por la pandemia de la COVID-19 para conducir investigaciones éticas que produzcan resultados con rapidez demuestran la necesidad de fortalecerlo. El objetivo de este estudio fue describir el estado de situación de los sistemas de evaluación ética de las provincias de Argentina y las adaptaciones realizadas por la pandemia. MÉTODOS: se realizó una encuesta a los comités provinciales de ética en investigación o áreas similares de los ministerios de Salud que ejercen la vigilancia sobre la evaluación ética de las investigaciones de su jurisdicción. RESULTADOS: respondieron 16 de las 17 provincias encuestadas. El 93,7% de los comités provinciales evalúa investigaciones en seres humanos y tiene procedimientos operativos estandarizados (POE). El 68,7% lleva un registro de los comités de ética en investigación (CEI) de su jurisdicción. Un 75% acredita a los CEI y un 68,7% los supervisa. El 100% tiene un registro de las investigaciones en salud; en 56,2% de los casos este registro es público. Del total, 81,2% realizan actividades de capacitación. El 100% adaptó los POE para evaluar estudios sobre la COVID-19. DISCUSIÓN: los resultados muestran sistemas provinciales consolidados. Se requiere fortalecer la transparencia en la investigación mediante el registro público de las investigaciones. Se identificaron posibilidades de mejora para proponer acciones a futuro
INTRODUCTION: a research ethics system is essential to protect the rights of research participants. The challenges posed by the COVID-19 pandemic to conduct research ethically to produce rapid results have demonstrated the need to strengthen this system. The objective of this study was to describe the state of the research ethics system of the Provinces of Argentina and the adaptations made due to the pandemic. METHOD: a survey was conducted with provincial research ethics committees or similar areas within the Ministries of Health of the provinces responsible for the oversight of research ethics review under their jurisdiction. RESULTS: sixteen of the 17 provinces surveyed responded. 93.7% of the provincial committees review human research and have standard operating procedures (SOPs). 68.7% register the research ethics committees (REC) in their jurisdiction. Seventy-five percent accredit RECs and 68.7% supervise them. 100% have a registry of health research in the jurisdiction, only 56.2% have public access. 81.2% carry out training activities. 100% adapted the SOPs to evaluate studies on COVID-19. DISCUSSION: the results show consolidated provincial systems. Transparency in research needs to be strengthened through public registration of research. Possibilities for improvement were identified to propose future actions.
Subject(s)
Argentina , Ethical Review , Ethics Committees, Research , Health Research Policy , BetacoronavirusABSTRACT
UNLABELLED: The objective of the study was to evaluate work disability and its main associated factors in patients with early arthritis. Argentine Consortium for Early Arthritis (CONAART) is the first early arthritis cohort in Argentina. Patients with one or more swollen joints and less than 2 years of symptoms duration were followed up prospectively in 13 departments of rheumatology. Social, demographic, familiar, clinical, and laboratory data were recollected. At first year and every year, X-rays of hands and feet were performed and working status and pharmaco-economic data were recollected. Work status (employed, unemployed, retired) and type of work were assessed by direct interview using a predesigned questionnaire. Eight hundred forty-eight patients were included, rheumatoid arthritis (RA) = 483 (57 %)and undifferentiated arthritis (UA) = 365 (43 %), 694 (81.8 %) were women, median age was 46 years (interquartile range (IQR) 35-55.7) and median symptoms duration 7 months (IQR 3-12). Patients with RA had significantly higher disease activity, worse functional capacity and quality of life, and more severe radiological damage compared to UA patients. However work disability (unemployed patient) was comparable between groups (RA = 21 % versus UA = 18.6 % p = NS). In both groups, unemployed patients had higher disease activity score of 28 joints (DAS28), worse Health Assessment Questionnaire (HAQ) values, and less years of formal education (p value <0.005 in all comparisons). Radiological damage was greater in unemployed patients but this difference did not reach statistical significance. In multivariate analysis, disease activity was the main variable associated with unemployment in both groups. Joint involvement was the main cause of work disability in this cohort of patients with early arthritis, independently of the final diagnosis. KEY MESSAGES: 1. Work disability is higher in patients with inflammatory arthritis as compared to the general population. 2. Prevalence of work disability is comparable among patients with undifferentiated and rheumatoid arthritis. 3. Disease activity is the main disease variable associated with work disability.
Subject(s)
Arthritis, Rheumatoid/epidemiology , Foot Joints/diagnostic imaging , Hand Joints/diagnostic imaging , Unemployment/statistics & numerical data , Adult , Argentina , Arthritis/diagnostic imaging , Arthritis/epidemiology , Arthritis, Rheumatoid/diagnostic imaging , Cohort Studies , Disability Evaluation , Educational Status , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Radiography , Severity of Illness Index , Surveys and QuestionnairesABSTRACT
OBJECTIVES: To assess patients' preferences for rheumatoid-arthritis treatments with biologic agents using a discrete-choice experiment. METHODS: A discrete-choice experiment was conducted with adult rheumatoid-arthritis patients who had never been treated with biological agents from two university hospitals-public and private-in Buenos Aires, Argentina. We evaluated preferences for seven treatment attributes (with two to three levels each): effectiveness, mode of administration, frequency of administration, local and systemic adverse events, severe infections, and out-of-pocket costs.A probit regression model was used to analyze the relative importance of rheumatoid-arthritis treatment attributes. We estimated attributes' relative importance and their 95% confidence intervals. RESULTS: Survey responses from 240 patients with rheumatoid arthritis receiving conventional disease-modifying antirheumatic drugs were included in the study. All tested biological agents' attributes significantly affected the choice of treatment. Attributes' relative importance in decreasing order was the following (mean, confidence interval 95%): cost, 0.81 (0.69-0.92); systemic adverse events, 0.66 (0.57-0.76); frequency of administration, 0.61 (0.52-0.71); efficacy, 0.42 (0.32-0.51); route of administration, 0.41 (0.30-0.52); local adverse events, 0.40 (0.31-0.49); and serious infections, 0.29 (0.22-0.37). CONCLUSIONS: Different treatment attributes had a significant and different influence in rheumatoid-arthritis patients' choice of biological agents. This type of study can not only inform about patients' preferences but also about the trade-offs among different possible treatments or process-related attributes.
