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.
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.
