Tu1871 THE CONCORDANCE OF SHORT FORM-36 HEALTH SURVEY SCORES WITH MAYO SCORES IN THE TOFACITINIB ULCERATIVE COLITIS CLINICAL PROGRAM

2020 ◽  
Vol 158 (6) ◽  
pp. S-1197
Author(s):  
Marla C Dubinsky ◽  
Andrew G. Bushmakin ◽  
Joseph C. Cappelleri ◽  
John Woolcott ◽  
Puza Sharma ◽  
...  
2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S566-S567
Author(s):  
M C Dubinsky ◽  
A G Bushmakin ◽  
J C Cappelleri ◽  
J Woolcott ◽  
P Sharma ◽  
...  

Abstract Background The Short Form-36 Health Survey version 2 (SF-36v2) is a generic health-related quality-of-life (HRQoL) instrument [1]. Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). In these exploratory analyses the concordance between total and partial Mayo scores and SF-36v2 scores was evaluated in patients with UC in the Phase 3 tofacitinib 8-week OCTAVE Induction 1&2 (NCT01465763; NCT01458951) and 52-week OCTAVE Sustain (NCT01458574) studies. Methods A repeated measures regression model was used to evaluate the relationship between total and partial Mayo scores (as predictor) and SF-36v2 component and domain scores. A sensitivity analysis to assess the linearity assumption was performed using Mayo score as a categorical anchor (represented by integer values 0–12 [total] or 0–9 [partial]). Previous analyses identified clinically important differences (CIDs) in total and partial Mayo scores as changes of 3 points and 2.25 points, respectively [2]. Mean differences in SF-36v2 component and domain scores were compared with their recommended group-level CID thresholds [3]. Results Clinically meaningful differences of 3 points and 2.25 points in total and partial Mayo scores, respectively, were generally associated with clinically meaningful differences in SF-36v2 component and domain scores, with the exception of Role-Emotional with partial Mayo score in the pooled induction studies and with total Mayo score in the maintenance study. In the induction studies, a 3-point difference in total Mayo score was associated with a mean difference exceeding CIDs in both the SF-36v2 Physical Component Summary score (mean improvement 4.5; 95% confidence interval [CI] 4.2, 4.7) and Mental Component Summary score (mean improvement 5.0; 95% CI 4.6, 5.3). Results were closely aligned when Mayo score was used as a categorical or continuous anchor, supporting a linear relationship between Mayo score and SF-36v2 scores (Figure). Similar results were observed in the maintenance study, and when assessing the relationship of partial Mayo score with SF-36v2 scores. Conclusion Clinically meaningful decreases in disease activity, as measured by Mayo score, were associated with clinically meaningful benefits in HRQoL, as measured by SF-36v2 component and domain scores. These findings highlight the impact that disease activity has on HRQoL and may assist with articulating the treatment effect of tofacitinib on specific domains. References


Author(s):  
Marco Fredy Jaimes Laguado ◽  
Nelson Adolfo Mariño Landazabal ◽  
Carlos Gustavo Enciso Mattos

El presente trabajo de investigación tiene como fin determinar las mujeres con fibromialgia que laboran en la E.S.E Hospital San Juan de Dios de Pamplona a partir de la aplicación de los cuestionario estructurados Fibromialgia Impact Questionnaire (FIQ) Short Form 36 Health Survey (SF - 36). A su vez determinar el confort en Ellas, basado en el modelo de Katharine Kolcaba a través de la aplicación Del Instrumentos validados de la teoría de mediano rango, cuestionario general de comodidad (GCQ) identificando los tipos de confort (alivio, tranquilidad y trascendencia) desarrollado por la doctora Katherine Kolcaba. Para el logro de esta investigación se aplicaron los instrumentos a mujeres en rango de edad de 25 a 60 años que laboran en la E.S.E Hospital San Juan de Dios de Pamplona y que accedieron firmar el consentimiento informado durante, primer periodo académico del año 2012.


2018 ◽  
Vol 4 ◽  
pp. 233372141878281 ◽  
Author(s):  
Esmeralda Valdivieso-Mora ◽  
Mirjana Ivanisevic ◽  
Leslie A. Shaw ◽  
Mauricio Garnier-Villarreal ◽  
Zachary D. Green ◽  
...  

2007 ◽  
Vol 41 (2) ◽  
pp. 260-268 ◽  
Author(s):  
Ana Paula Mastropietro ◽  
Érika Arantes de Oliveira ◽  
Manoel Antônio dos Santos ◽  
Júlio César Voltarelli

OBJETIVO: Traduzir para o português e validar o questionário de qualidade de vida Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) em pacientes transplantados de medula óssea. OBJETIVO: O estudo foi realizado em Ribeirão Preto, SP, em 2005. O FACT-BMT (versão 3) traduzido e a versão em português do Short Form-36 Health Survey (SF-36) foram aplicados simultaneamente em 55 pacientes consecutivos com leucemia, submetidos ao transplante e em seguimento. Dois parâmetros clínicos foram utilizados para testar a sensibilidade do questionário: tempo decorrido do transplante e presença ou não de doença do enxerto contra o hospedeiro. Foi utilizada a análise de variância (ANOVA) com o teste post hoc de Tukey. Aplicou-se o coeficiente alfa de Cronbach, padronizado para todas as questões, escore final e domínios. RESULTADOS: A média de idade dos pacientes foi 34,8±8,1 anos, com escolaridade média de 10,8±4,7 anos, sendo 78,1% do sexo feminino. A duração média de tempo pós-transplante foi de 29,8±32,19 meses. Nenhuma alteração do formato original do questionário foi observada no final do processo de tradução e adaptação cultural. A consistência interna foi alta (0,88). A correlação entre o questionário traduzido e o SF-36 variou de 0,35 a 0,57, considerada de moderada a boa para a maioria dos domínios de qualidade de vida. A avaliação das validades de construto e concorrente foi satisfatória e estatisticamente significativa. CONCLUSÕES: A versão para o português do FACT-BMT foi validada satisfatoriamente para a aplicação em pacientes brasileiros de ambos os sexos submetidos ao transplante de medula óssea.


Surgery Today ◽  
2013 ◽  
Vol 44 (2) ◽  
pp. 264-270 ◽  
Author(s):  
Timuçin Alar ◽  
Kenan Can Ceylan ◽  
Seyda Ors Kaya ◽  
Serpil Sevinç ◽  
Deniz Sigirli ◽  
...  

2009 ◽  
Vol 16 (11) ◽  
pp. 1409-1413 ◽  
Author(s):  
Wolfram Scharbrodt ◽  
Marco Stein ◽  
Vanessa Schreiber ◽  
Dieter-Karsten Böker ◽  
Matthias F. Oertel

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