scholarly journals IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

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 ◽  
...  
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


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.


2020 ◽  
Vol 162 (12) ◽  
pp. 2939-2947
Author(s):  
Helen C. U. Ota ◽  
Brandon G. Smith ◽  
Alexander Alamri ◽  
Faith C. Robertson ◽  
Hani Marcus ◽  
...  

Abstract Background The Idea, Development, Exploration, Assessment and Long-term study (IDEAL) framework was created to provide a structured way for assessing and evaluating novel surgical techniques and devices. Objectives The aim of this paper was to investigate the utilization of the IDEAL framework within neurosurgery, and to identify factors influencing implementation. Methods A bibliometric analysis of the 7 key IDEAL papers on Scopus, PubMed, Embase, Web of Science, and Google Scholar databases (2009–2019) was performed. A second journal-specific search then identified additional papers citing the IDEAL framework. Publications identified were screened by two independent reviewers to select neurosurgery-specific articles. Results The citation search identified 1336 articles. The journal search identified another 16 articles. Following deduplication and review, 51 relevant articles remained; 14 primary papers (27%) and 37 secondary papers (73%). Of the primary papers, 5 (36%) papers applied the IDEAL framework to their research correctly; two were aligned to the pre-IDEAL stage, one to the Idea and Development stages, and two to the Exploration stage. Of the secondary papers, 21 (57%) explicitly discussed the IDEAL framework. Eighteen (86%) of these were supportive of implementing the framework, while one was not, and two were neutral. Conclusion The adoption of the IDEAL framework in neurosurgery has been slow, particularly for early-stage neurosurgical techniques and inventions. However, the largely positive reviews in secondary literature suggest potential for increased use that may be achieved with education and publicity.


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