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1.
Artigo em Inglês | MEDLINE | ID: mdl-38571333

RESUMO

BACKGROUND: Post-publication handling of integrity concerns in randomized clinical trials (RCTs) is a contentious matter. OBJECTIVES: We undertook a scoping systematic review to map the literature regarding post-publication integrity issues in RCTs. SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/pgxd8) we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post-publication research integrity concerns in RCTs. DATA COLLECTION AND ANALYSIS: The study findings grouped within domains relating to issues concerning post-publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated. MAIN RESULTS: The initial search captured 3159 citations, of which 89 studies were included in the review. Cross-sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post-publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post-investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains. CONCLUSIONS: Various research integrity domains and issues covering post-publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post-publication integrity concerns in RCTs.

3.
Arch Esp Urol ; 61(1): 41-54, 2008.
Artigo em Espanhol | MEDLINE | ID: mdl-18405027

RESUMO

OBJECTIVES: To analyze the modifications induced by laparoscopic and open nephrectomies in living donor transplantation on cytokines, to evaluate operative trauma of different surgical techniques and the influence on ischemia/reperfusion syndrome and renal function. METHODS: Thirty pigs underwent left nephrectomy, 15 by laparoscopy and 15 by open approach in an experimental autotransplantation model. RESULTS: Serum level of IL-2, IL-6, IL-10 and tumor necrosis factor (TNF) were lower during laparoscopic than open nephrectomy: 6.8 +/- 0.6 vs 13.9 +/- 1.1 pg/ml for IL-2, 46.2 +/- 2.3 vs 84.4 +/- 2.5 pg/ml for IL-6, 26.1 +/- 2.4 vs 92.8 +/- 12.6 pg/ml for IL-10, and 17.6 +/- 2.1 vs 38.5 +/- 4.8 pg/ml for TNF. There was no association between renal blood flow (RBF) and cytokines levels during nephrectomy: IL-2 (p = 0.498), IL-6 (p = 0.117), IL-10 (p = 0.081) y TNF (p = 0.644). However, there was correlation between IL-10 and the decrease of RBF after transplantation: (R2 0.48; p = 0.02). Initial serum creatinine levels were correlated with RBF and IL-2 levels during nephrectomy (R = 0.831, R2 = 0.691, p = 0.025), and postransplantation RBF (R = 0.784, R2 = 0.614, p < 0.0001). Seventh day creatinine levels were correlated with postransplantation RBF (R = 0.537, R2 = 0.289, p = 0.002) and IL-2 levels during nephrectomy (R = 0.685, R2 = 0.469, p = 0.015). CONCLUSIONS: Cytokine levels were higher during the open approach than laparoscopic procedure. High levels of RBF during nephrectomy and transplantation improve early graft function while low levels of RBF and high levels ol IL-2 during nephrectomy induce delayed graft function.


Assuntos
Citocinas/sangue , Transplante de Rim/efeitos adversos , Transplante de Rim/métodos , Laparoscopia , Traumatismo por Reperfusão/sangue , Traumatismo por Reperfusão/etiologia , Animais , Suínos
4.
Arch. esp. urol. (Ed. impr.) ; 61(1): 41-54, ene.-feb. 2008. ilus, tab
Artigo em Es | IBECS | ID: ibc-059044

RESUMO

Objetivos: Analizar comparativamente los niveles de citocinas producidos durante la nefrectomía laparoscópica y abierta de donante vivo para trasplante, como marcadores de agresión tisular dependiendo del tipo de técnica quirúrgica empleada y su influencia sobre el síndrome de isquemia-reperfusión y la función del injerto. Métodos: Se realizó sobre un modelo de autotrasplante renal (TR) en 30 cerdos divididos en dos grupos de15 animales cada uno: a un grupo se le practicó nefrectomía abierta y al segundo grupo nefrectomía laparoscópica. Resultados: Los niveles de IL-2, IL-6, IL-10 y factor de necrosis tumoral (TNF) fueron significativamente menores durante la nefrectomía laparoscópica: 6,8±0,6 vs 13,9±1,1 pg/ml para IL-2, 46,2±2,3 vs 84,4±2,5 pg/ml para IL-6, 26,1±2,4 vs 92,8 ± 12,6 pg/ml para IL-10, y 17,6 ± 2,1 vs 38,5±4,8 pg/ml para TNF. No existió asociación entre el flujo sanguíneo renal (FSR) y los niveles de citocinas durante la fase de extracción: IL-2 (p= 0,498), IL-6 (p=0,117), IL-10 (p=0,081) y TNF (p=0,644). Sin embargo, existió correlación entre los niveles de IL-10 y el descenso de FSR al final del autoTR: (R2 0,48; p= 0,02). La función inicial del injerto se correlacionó con el FSR y los niveles de IL-2 levels durante la nefrectomía (R=0,831, R2= 0,691, p= 0,025), y el FSR de reperfusión (R= 0,784, R2= 0,614, p<0,0001). La función tardía del injerto se correlacionó con el FSR postTR (R= 0,537, R2 = 0,289, p= 0,002) y el nivel de IL-2 durante la extracción (R=0,685, R2= 0,469, p= 0,015). Conclusiones: Los niveles de citocinas fueron significativamente superiores en los animales sometidos a nefrectomía abierta que a nefrectomía laparoscópica. Los valores altos de FSR durante la extracción y el TR, y los niveles elevados de IL-10 durante el TR, mejoraron la función del injerto en el postTR inmediato. Valores de FSR bajos y niveles elevados de IL-2 durante la extracción afectaron negativamente a la función del injerto durante la primera semana postrasplante (AU)


Objectives: To analyze the modifications induced by laparoscopic and open nephrectomies in living donor transplantation on cytokines, to evaluate operative trauma of different surgical techniques and the influence on ischemia/reperfusion syndrome and renal function. Methods: Thirty pigs underwent left nephrectomy, 15 by laparoscopy and 15 by open approach in an experimental autotransplantation model. Results: Serum level of IL-2, IL-6, IL-10 and tumor necrosis factor (TNF) were lower during laparoscopic than open nephrectomy: 6,8±0,6 vs 13,9±1,1 pg/ml for IL-2, 46,2±2,3 vs 84,4±2,5 pg/ml for IL-6, 26,1±2,4 vs 92,8 ± 12,6 pg/ml for IL-10, and 17,6 ± 2,1 vs 38,5±4,8 pg/ml for TNF. There was no association between renal blood flow (RBF) and cytokines levels during nephrectomy: IL-2 (p= 0,498), IL-6 (p=0,117), IL-10 (p=0,081) y TNF (p=0,644). However, there was correlation between IL-10 and the decrease of RBF after transplantation: (R2 0,48; p= 0,02). Initial serum creatinine levels were correlated with RBF and IL-2 levels during nephrectomy (R=0,831, R2= 0,691, p= 0,025), and postransplantation RBF (R= 0,784, R2= 0,614, p< 0,0001). Seventh day creatinine levels were correlated with postransplantation RBF (R= 0,537, R2= 0,289, p= 0,002) and IL-2 levels during nephrectomy (R=0,685, R2= 0,469, p= 0,015). Conclusions: Cytokine levels were higher during the open approach than laparoscopic procedure. High levels of RBF during nephrectomy and transplantation improve early graft function while low levels of RBF and high levels ol IL-2 during nephrectomy induce delayed graft function (AU)


Assuntos
Animais , Citocinas/metabolismo , Traumatismo por Reperfusão/etiologia , Transplante de Rim/efeitos adversos , Citocinas/biossíntese , Nefrectomia/métodos , Transplante de Rim/métodos , Modelos Animais , Suínos , Laparoscopia/métodos , Laparoscopia/efeitos adversos
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