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1.
Coluna/Columna ; 19(2): 154-159, Apr.-June 2020. tab, graf
Article in English | LILACS | ID: biblio-1133562

ABSTRACT

ABSTRACT Objective Observational studies and register data provide researchers with ample opportunities to obtain answers to questions that randomized controlled trials cannot answer for organizational or ethical reasons. One of the most common tools for solving this problem is the use of propensity score matching (PSM) methods. The purposes of our study were to compare various models and algorithms for selecting PSM parameters, using retrospective clinical data, and to compare the results obtained using the PSM method with those of prospective studies. Methods The results of two studies (randomized prospective and retrospective) conducted at the Novosibirsk Research Institute of Traumatology and Orthopedics were used for comparative analysis. The trials aimed to study the effectiveness and safety of surgical treatment of degenerative dystrophic lesions in the lumbar spine. We compared the results using the recommended PSM parameters (caliper=0.2 and 0.6) the propensity score is the probability of assignment to one treatment conditional on a subject's measured baseline covariates. Propensity-score matching is increasingly being used to estimate the effects of exposures using observational data. In the most common implementation of propensity-score matching, pairs of treated and untreated subjects are formed whose propensity scores differ by at most a pre-specified amount (the caliper widthand the caliper values often used in real-life studies (0.05, 0.1, 0.25, 0.5, and 0.8) with the those obtained in a similar prospective study. Results After eliminating systematic selection bias, the results of the retrospective and randomized prospective studies were qualitatively comparable. Conclusion The results of this study provide recommendations for the use of PSM: when evaluating efficacy scores in neurosurgical studies (with a sample size < 150 patients), we recommend matching on the logit of the propensity score using calipers of width equal to 0.6 of the standard deviation of the logit of the propensity score. Level of evidence V; Type of study is expert opinion.


RESUMO Objetivos Estudos observacionais e dados de registro fornecem aos pesquisadores amplas oportunidades de obter respostas às perguntas que os estudos clínicos randomizados não podem responder por razões institucionais ou éticas. Uma das ferramentas mais comuns para resolver esse problema é o uso dos métodos de Propensity Score Matching (PSM, pareamento de escore de propensão). O objetivo do nosso estudo foi comparar vários modelos e algoritmos para a seleção de parâmetros de PSM, usando os dados clínicos retrospectivos e comparar os resultados obtidos com esse método com os de estudos prospectivos. Métodos Os resultados de dois estudos (randomizado prospectivo e retrospectivo), realizados no Instituto de Pesquisa de Traumatologia e Ortopedia de Novosibirsk, foram utilizados para análise comparativa. Os estudos visaram estudar a eficácia e a segurança do tratamento cirúrgico de lesões distróficas degenerativas na coluna lombar. Comparamos os resultados usando os parâmetros recomendados pelo PSM, isto é calibração (caliper) de 0,2 e 0,6 e os valores de calibração usados com frequência em estudos da vida real (0,05, 0,1, 0,25, 0,5 e 0,8) com os obtidos em um estudo prospectivo semelhante. Resultados Depois de eliminar o viés sistemático de seleção, os resultados de estudos randomizados prospectivos e retrospectivos foram qualitativamente comparáveis. Conclusões Os resultados deste estudo fornecem recomendações para o uso do PSM: ao avaliar os escores de eficácia em estudos neurocirúrgicos (com tamanho de amostra < 150 pacientes), recomendamos a correspondência do logit do escore de propensão com calibração de largura de 0,6 do desvio padrão do logit do escore de propensão. Nível de evidência V; Opinião do especialista.


RESUMEN Objetivos Los estudios de observación y los datos de registro brindan a los investigadores amplias oportunidades para obtener respuestas a preguntas que los estudios clínicos aleatorizados no pueden responder por razones institucionales o éticas. Una de las herramientas más comunes para resolver este problema es el uso de los métodos de Propensity Score Matching (PSM, emparejamiento de puntaje de propensión). El objetivo de nuestro estudio fue comparar varios modelos y algoritmos para la selección de parámetros de PSM, utilizando los datos clínicos retrospectivos y comparar los resultados obtenidos con ese método con los de estudios prospectivos. Métodos Los resultados de dos estudios (prospectivo aleatorizado y retrospectivo) realizados en el Instituto de Investigación de Traumatología y Ortopedia de Novosibirsk se utilizaron para el análisis comparativo. Los estudios tuvieron como objetivo estudiar la eficacia y seguridad del tratamiento quirúrgico de las lesiones distróficas degenerativas en la columna lumbar. Comparamos los resultados usando los parámetros recomendados por el PSM, esto es, calibración (caliper) de 0,2 y 0,6 y los valores de calibración usados con frecuencia en estudios de la vida real (0,05, 0,1, 0,25, 0,5 y 0,8) con los obtenidos en un estudio prospectivo semejante. Resultados Después de eliminar el sesgo sistemático de selección, los resultados de estudios prospectivos aleatorizados y retrospectivos fueron cualitativamente comparables. Conclusiones Los resultados de este estudio proporcionan recomendaciones para el uso del PSM: al evaluar los puntajes de eficacia en estudios neuroquirúrgicos (con tamaño de muestra <150 pacientes), recomendamos la correspondencia del logit del puntaje de propensión con calibración de ancho de 0.6 de la desviación estándar del logit de puntaje de propensión. Nivel de evidencia V; Opinión del especialista.


Subject(s)
Humans , Neurosurgery , Spinal Fusion , Spinal Stenosis , Bias
2.
Int Arch Allergy Immunol ; 174(3-4): 151-160, 2017.
Article in English | MEDLINE | ID: mdl-29212072

ABSTRACT

BACKGROUND: Expression levels of cytokine and growth factor receptors have been found to be important in the regulation of their action. Tumor necrosis factor-α (TNFα) is actively involved in inflammation processes in atopic dermatitis (AD), but the role of TNFα membrane receptors (TNFR) and their regulatory function in AD remains unclear. AIM: We aimed to determine the associations of parameters of TNFRα expression on immunocompetent cells with disease severity before and after therapy in AD patients. METHODS: TNFRα expression on T cells, B cells, and monocytes was evaluated by flow cytometry. To determine receptor numbers on the cells, Quantibrite PE beads were used. The content of soluble mediators was evaluated by ELISA. To reveal linear relationships between the index scoring AD (SCORAD) and the studied parameters, multiple linear regression model building was used. RESULTS: TNFR1 and TNFR2 expression in lymphocyte and monocyte populations of AD patients was higher than in healthy individuals (HI). At the same time an increased percentage of positive cells was not associated with high receptor density, and vice versa. Serum content of TNFα, both soluble receptors, the number of TNFR2/T cells, and the percentage of TNFR2+ monocytes were found to be strongly associated with the SCORAD index. CONCLUSION: AD patients had increased TNFR expression on immune cells. Changes in the parameters of TNFRα expression compared to HI were associated with the disease severity index SCORAD.


Subject(s)
B-Lymphocytes/immunology , Dermatitis, Atopic/immunology , Monocytes/immunology , Receptors, Tumor Necrosis Factor/metabolism , T-Lymphocytes/immunology , Adult , Cell Separation , Disease Progression , Female , Flow Cytometry , Humans , Immunocompetence , Male , Middle Aged , Receptors, Tumor Necrosis Factor/genetics , Severity of Illness Index , Up-Regulation , Young Adult
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