scholarly journals Measurement of long-term outcomes in observational and randomised controlled trials

2007 ◽  
Vol 191 (S50) ◽  
pp. s78-s84 ◽  
Author(s):  
Richard Hodgson ◽  
Chris Bushe ◽  
Robert Hunter

BackgroundRandomised controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. However, the outcomes of RCTs often lackclinical utility and usually do not address real-world effectivenessAimsTo review how traditional RCTs may be triangulatedwith other methodologies such as observational studies and pragmatic trials by highlighting recently reported studies, outcomes used and their respective meritsMethodLiterature review focusing on drug treatmentResultsRecently reported observational and some pragmatic studies show a degree of consistency in reported results and use outcomes that have face validity for cliniciansConclusionsNo single experimental paradigm or outcome provides the necessary data to optimise treatment of mental illness in the clinical setting

BMJ ◽  
2013 ◽  
Vol 346 (jun18 3) ◽  
pp. f2820-f2820 ◽  
Author(s):  
J. A. Cook ◽  
P. McCulloch ◽  
J. M. Blazeby ◽  
D. J. Beard ◽  
D. Marinac-Dabic ◽  
...  

2020 ◽  
Vol 41 (6) ◽  
pp. 992-999
Author(s):  
Iria Dobarrio-Sanz ◽  
José Manuel Hernández-Padilla ◽  
María Mar López-Rodríguez ◽  
Cayetano Fernández-Sola ◽  
José Granero-Molina ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028430 ◽  
Author(s):  
Li Ding ◽  
Chuanjun Zhuo ◽  
Yuxin Fan ◽  
Yalan Zhang ◽  
Hui Li ◽  
...  

IntroductionBariatric surgeries are effective in treating obesity related comorbidities, including type 2 diabetes mellitus. More robust evidence is needed to facilitate choice of procedure. In this systemic review, we aim to investigate the comparative long-term effectiveness in inducing remission of type 2 diabetes, halting diabetic complications, reducing mortality and the safety of conventional and emerging bariatric surgeries.Methods and analysisDatabases including Cochrane Central Register, EMBASE, MEDLINE and clinical trial registries will be searched for randomised controlled trials with at least 3 years of follow-up, including direct and/or indirect evidence regarding primary bariatric surgeries in overweight or obese adults with type 2 diabetes mellitus, from inception of each database to 2019, with no language or publication type limits imposed. Dual selection of studies, data extraction and risk of bias assessments will be performed. Primary outcomes include full diabetes remission, composite outcome of full or partial diabetes remission and adverse event profiles. Secondary outcomes include anthropometric measurements, cardiovascular risk factor burden, medication burden, diabetic complications and all-cause mortality. Given sufficient homogeneity, network meta-analyses will be performed in a random-effects model based on the Bayesian framework, while assessing for consistency between direct and indirect estimates. Heterogeneities of studies will be explored through meta-regression analysis, and robustness of findings will be checked by sensitivity analysis, and an alternative method under a frequentist framework. All statistical analysis and graphical presentations will be conducted by R software V.3.3.3 (The R Project for Statistical Computing). The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation criteria for each outcome.Ethics and disseminationEthics approval is not required as individual patient data will not be included. This review will be subject for publication in a peer reviewed journal.PROSPERO registration numberCRD42018110775.


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