scholarly journals Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review

2017 ◽  
Vol 42 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Laura E Diment ◽  
Mark S Thompson ◽  
Jeroen HM Bergmann
Keyword(s):  
Upper Limb ◽  
Randomised Controlled Trials ◽  
Three Dimensional ◽  
Controlled Trials ◽  
Long Term Effects ◽  
Three Dimensional Printing ◽  
Upper Limb Prostheses ◽  
Randomised Controlled ◽  
Dimensional Printing

Background: Three-dimensional printing provides an exciting opportunity to customise upper-limb prostheses. Objective: This review summarises the research that assesses the efficacy and effectiveness of three-dimensional printed upper-limb prostheses. Study design: Systematic review. Methods: PubMed, Web of Science and OVID were systematically searched for studies that reported human trials of three-dimensional printed upper-limb prostheses. The studies matching the language, peer-review and relevance criteria were ranked by level of evidence and critically appraised using the Downs and Black Quality Index. Results: After removing duplicates, 321 records were identified. Eight papers met the inclusion criteria. No studies used controls; five were case studies and three were small case-series studies. All studies showed promising results, but none demonstrated external validity, avoidance of bias or statistically significant improvements over conventional prostheses. The studies demonstrated proof-of-concept rather than assessing efficacy, and the devices were designed to prioritise reduction of manufacturing costs, not customisability for comfort and function. Conclusion: The potential of three-dimensional printing for individual customisation has yet to be fully realised, and the efficacy and effectiveness to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on quality of life remain unknown. Clinical relevance Initial studies suggest that three-dimensional printing shows promise for customising low-cost upper-limb prosthetics. However, the efficacy and effectiveness of these devices have yet to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on patient quality of life remain unknown.

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 ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Surgical Innovation ◽  
Term Study ◽  
Long Term Study ◽  
Randomised Controlled ◽  
Ideal Framework

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
Keyword(s):  
Gold Standard ◽  
Observational Studies ◽  
Randomised Controlled Trials ◽  
Face Validity ◽  
Controlled Trials ◽  
Experimental Paradigm ◽  
Pragmatic Trials ◽  
Long Term Outcomes ◽  
Randomised Controlled

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

Non-pharmacological interventions to improve constipation amongst older adults in long-term care settings: A systematic review of randomised controlled trials

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 ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Randomised Controlled Trials ◽  
Long Term Care ◽  
Controlled Trials ◽  
Pharmacological Interventions ◽  
Term Care ◽  
Randomised Controlled

scholarly journals Comparative long-term effectiveness and safety of primary bariatric surgeries in treating type 2 diabetes mellitus in adults: a protocol for systematic review and network meta-analysis of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028430 ◽  
Author(s):  
Li Ding ◽  
Chuanjun Zhuo ◽  
Yuxin Fan ◽  
Yalan Zhang ◽  
Hui Li ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Diabetic Complications ◽  
Randomised Controlled Trials ◽  
Diabetes Remission ◽  
Controlled Trials ◽  
Randomised Controlled

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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