scholarly journals Development and validation pathways of artificial intelligence tools evaluated in randomised clinical trials

2021 ◽  
Vol 28 (1) ◽  
pp. e100466
Author(s):  
George C M Siontis ◽  
Romy Sweda ◽  
Peter A Noseworthy ◽  
Paul A Friedman ◽  
Konstantinos C Siontis ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Significant Variation ◽  
External Validation ◽  
Clinical Effectiveness ◽  
Standard Of Care ◽  
Translation Process ◽  
Development Study ◽  
Randomised Controlled ◽  
Development And Validation ◽  
Evaluation Approaches

ObjectiveGiven the complexities of testing the translational capability of new artificial intelligence (AI) tools, we aimed to map the pathways of training/validation/testing in development process and external validation of AI tools evaluated in dedicated randomised controlled trials (AI-RCTs).MethodsWe searched for peer-reviewed protocols and completed AI-RCTs evaluating the clinical effectiveness of AI tools and identified development and validation studies of AI tools. We collected detailed information, and evaluated patterns of development and external validation of AI tools.ResultsWe found 23 AI-RCTs evaluating the clinical impact of 18 unique AI tools (2009–2021). Standard-of-care interventions were used in the control arms in all but one AI-RCT. Investigators did not provide access to the software code of the AI tool in any of the studies. Considering the primary outcome, the results were in favour of the AI intervention in 82% of the completed AI-RCTs (14 out of 17). We identified significant variation in the patterns of development, external validation and clinical evaluation approaches among different AI tools. A published development study was found only for 10 of the 18 AI tools. Median time from the publication of a development study to the respective AI-RCT was 1.4 years (IQR 0.2–2.2).ConclusionsWe found significant variation in the patterns of development and validation for AI tools before their evaluation in dedicated AI-RCTs. Published peer-reviewed protocols and completed AI-RCTs were also heterogeneous in design and reporting. Upcoming guidelines providing guidance for the development and clinical translation process aim to improve these aspects.

scholarly journals Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043370
Author(s):  
Ainsley Matthewson ◽  
Olena Bereznyakova ◽  
Brian Dewar ◽  
Alexandra Davis ◽  
Mark Fedyk ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Standard Of Care ◽  
Standards Of Care ◽  
Controlled Trials ◽  
Theory Approach ◽  
Reference Centre ◽  
Cochrane Database ◽  
Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

330 DEVELOPMENT AND VALIDATION OF AN ARTIFICIAL INTELLIGENCE SYSTEM TO OPTIMIZE CLINICIAN REVIEW OF PATIENT RECORDS

2021 ◽  
Vol 160 (6) ◽  
pp. S-64-S-65
Author(s):  
Ethan A. Chi ◽  
Gordon Chi ◽  
Cheuk To Tsui ◽  
Yan Jiang ◽  
Karolin Jarr ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Patient Records ◽  
Artificial Intelligence System ◽  
Intelligence System ◽  
Development And Validation

scholarly journals Oral splints for temporomandibular disorder or bruxism: a systematic review

BDJ ◽  
2020 ◽  
Vol 228 (3) ◽  
pp. 191-197 ◽  
Author(s):  
Philip Riley ◽  
Anne-Marie Glenny ◽  
Helen V. Worthington ◽  
Elisabet Jacobsen ◽  
Clare Robertson ◽  
...  
Keyword(s):  
Temporomandibular Disorder ◽  
Cochrane Review ◽  
Clinical Effectiveness ◽  
Tooth Wear ◽  
Sensitivity Analyses ◽  
Data Synthesis ◽  
Random Effects Models ◽  
Minimal Treatment ◽  
Mean Differences ◽  
Randomised Controlled

AbstractObjectives To evaluate the clinical-effectiveness of oral splints for patients with TMD or bruxism for the primary outcomes: pain (TMD) and tooth wear (bruxism).Data sources Four databases including MEDLINE and EMBASE were searched from inception until 1 October 2018.Data selection and extraction Randomised controlled trials comparing all types of splints versus no/minimal treatment for patients with TMD or bruxism were eligible. Standard Cochrane review methods were used. Standardised mean differences (SMD) were pooled for the primary outcome of pain, using random effects models in TMD patients.Data synthesis Thirty-seven trials were included and the evidence identified was of very low certainty using GRADE assessments. When all subtypes of TMD were pooled into one global TMD group, there was no evidence that splints reduced pain: SMD (up to 3 months) -0.18 (95% CI -0.42 to 0.06); 13 trials, 1,076 participants. There was no evidence that any other outcomes improved when using splints. There was no evidence of adverse events associated with splints, but reporting was poor regarding this outcome. No trials measured tooth wear in patients with bruxism. There was a large variation in diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these factors did not indicate a reduction in pain.Conclusions The very low-certainty evidence identified did not demonstrate that splints reduced pain in TMD as a group of conditions. There is insufficient evidence to determine whether splints reduce tooth wear in patients with bruxism.

An Artificial Intelligence System for the Detection of Bladder Cancer via Cystoscopy: A Multicenter Diagnostic Study

2021 ◽  
Author(s):  
Shaoxu Wu ◽  
Xiong Chen ◽  
Jiexin Pan ◽  
Wen Dong ◽  
Xiayao Diao ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Bladder Cancer ◽  
Diagnostic Accuracy ◽  
External Validation ◽  
Operation Time ◽  
Short Latency ◽  
Lesion Detection ◽  
Diagnostic Study ◽  
Internal Validation ◽  
Predictive Values

Abstract Background Cystoscopy plays an important role in bladder cancer (BCa) diagnosis and treatment, but its sensitivity needs improvement. Artificial intelligence has shown promise in endoscopy, but few cystoscopic applications have been reported. We report a Cystoscopy Artificial Intelligence Diagnostic System (CAIDS) for BCa diagnosis. Methods In total, 69,204 images from 10,729 consecutive patients from six hospitals were collected and divided into training, internal validation, and external validation sets. The CAIDS was built using a pyramid scene parsing network and transfer learning. A subset (n = 260) of the validation sets was used for a performance comparison between the CAIDS and urologists for complex lesion detection. The diagnostic accuracy, sensitivity, specificity, and positive and negative predictive values and 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Results The diagnostic accuracies of the CAIDS were 0.977 (95% CI = 0.974–0.979) in the internal validation set and 0.990 (95% CI = 0.979–0.996), 0.982 (95% CI = 0.974–0.988), 0.978 (95% CI = 0.959–0.989), and 0.991 (95% CI = 0.987–0.994) in different external validation sets. In the CAIDS versus urologists’ comparisons, the CAIDS showed high accuracy and sensitivity (accuracy = 0.939, 95% CI = 0.902–0.964; and sensitivity = 0.954, 95% CI = 0.902–0.983) with a short latency of 12 s, much more accurate and quicker than the expert urologists. Conclusions The CAIDS achieved accurate BCa detection with a short latency. The CAIDS may provide many clinical benefits, from increasing the diagnostic accuracy for BCa, even for commonly misdiagnosed cases such as flat cancerous tissue (carcinoma in situ), to reducing the operation time for cystoscopy.

scholarly journals The Effectiveness of Deep Oscillation Therapy on Reducing Swelling and Pain in Athletes With Acute Lateral Ankle Sprains

2019 ◽  
Vol 28 (8) ◽  
pp. 902-905
Author(s):  
Matt Hausmann ◽  
Jacob Ober ◽  
Adam S. Lepley
Keyword(s):  
Day Treatment ◽  
Athletic Trainers ◽  
Clinical Effectiveness ◽  
Standard Of Care ◽  
Return To Play ◽  
Ankle Sprains ◽  
Current Standard ◽  
Bottom Line ◽  
Lateral Ankle ◽  
Additional Loss

Clinical Scenario: Ankle sprains are the most prevalent athletic-related musculoskeletal injury treated by athletic trainers, often affecting activities of daily living and delaying return to play. Most of these cases present with pain and swelling in the ankle, resulting in decreased range of motion and strength deficits. Due to these impairments, proper treatment is necessary to avoid additional loss of play and prevent future injuries. Recently, there has been an increased use of deep oscillation therapy by clinicians to manage pain and swelling following a variety of injuries, including ankle sprains. However, very little evidence has been produced regarding the clinical effectiveness of deep oscillation therapy, limiting its application in therapeutic rehabilitation of acute lateral ankle sprains. Clinical Question: Is deep oscillation therapy effective in reducing pain and swelling in patients with acute lateral ankle sprains compared with the current standard of care protection, rest, ice, compression, and elevation? Summary of Key Findings: The literature was searched for studies of level 2 evidence or higher that investigated deep oscillation therapy on pain and inflammation in patients with lateral ankle sprains. Three randomized control trials were located and appraised. One of the 3 studies demonstrate a reduction in pain following 6 weeks of deep oscillation therapy compared with the standard of care or placebo interventions. The 2 other studies, 1 utilizing a 5-day treatment and the other a 1 time immediate application, found no differences in deep oscillation therapy compared with the standard of care. Clinical Bottom Line: There is inconclusive evidence to support the therapeutic use of deep oscillation therapy in reducing pain and swelling in patients with acute lateral ankle sprains above and beyond the current standard of care. In addition, the method of treatment application and parameters used may influence the effectiveness of deep oscillation therapy. Strength of Recommendation: Level B.

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