scholarly journals Gestational diabetes prevention and treatment: a protocol for developing core outcome sets

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030574 ◽  
Author(s):  
Aoife Maria Egan ◽  
Fidelma P Dunne ◽  
Linda M Biesty ◽  
Delia Bogdanet ◽  
Caroline Crowther ◽  
...  

IntroductionSelective reporting bias, inconsistency in the chosen outcomes between trials and irrelevance of the chosen outcomes for women, limit the efficiency and value of research for prevention and treatment of gestational diabetes mellitus (GDM). One way to address these challenges is to develop core outcome sets (COSs).Methods and analysisThe aim of this manuscript is to present a protocol for a study to develop COSs for GDM prevention and treatment. This is a three-phase project consisting of (1) a systematic review of the literature to create two lists of outcomes that have been reported in trials and systematic reviews of trials of interventions for the prevention and treatment of GDM, (2) a three-round, web-based e-Delphi survey with key stakeholders to prioritise these outcomes and (3) a consensus meeting to resolve any remaining disagreements and to agree on two COSs.Ethics and disseminationEthical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 13 December 2018 (Reference: C.A.2078). We will disseminate our research findings through peer-reviewed, open access publications and present at international conferences to reach a wide range of knowledge users.

2020 ◽  
Author(s):  
Oliver Maassen ◽  
Sebastian Fritsch ◽  
Julia Gantner ◽  
Saskia Deffge ◽  
Julian Kunze ◽  
...  

BACKGROUND The increasing development of artificial intelligence (AI) systems in medicine driven by researchers and entrepreneurs goes along with enormous expectations for medical care advancement. AI might change the clinical practice of physicians from almost all medical disciplines and in most areas of healthcare. While expectations for AI in medicine are high, practical implementations of AI for clinical practice are still scarce in Germany. Moreover, physicians’ requirements and expectations of AI in medicine and their opinion on the usage of anonymized patient data for clinical and biomedical research has not been investigated widely in German university hospitals. OBJECTIVE Evaluate physicians’ requirements and expectations of AI in medicine and their opinion on the secondary usage of patient data for (bio)medical research e.g. for the development of machine learning (ML) algorithms in university hospitals in Germany. METHODS A web-based survey was conducted addressing physicians of all medical disciplines in 8 German university hospitals. Answers were given on Likert scales and general demographic responses. Physicians were asked to participate locally via email in the respective hospitals. RESULTS 121 (39.9%) female and 173 (57.1%) male physicians (N=303) from a wide range of medical disciplines and work experience levels completed the online survey. The majority of respondents either had a positive (130/303, 42.9%) or a very positive attitude (82/303, 27.1%) towards AI in medicine. A vast majority of physicians expected the future of medicine to be a mix of human and artificial intelligence (273/303, 90.1%) but also requested a scientific evaluation before the routine implementation of AI-based systems (276/303, 91.1%). Physicians were most optimistic that AI applications would identify drug interactions (280/303, 92.4%) to improve patient care substantially but were quite reserved regarding AI-supported diagnosis of psychiatric diseases (62/303, 20.5%). 82.5% of respondents (250/303) agreed that there should be open access to anonymized patient databases for medical and biomedical research. CONCLUSIONS Physicians in stationary patient care in German university hospitals show a generally positive attitude towards using most AI applications in medicine. Along with this optimism, there come several expectations and hopes that AI will assist physicians in clinical decision making. Especially in fields of medicine where huge amounts of data are processed (e.g., imaging procedures in radiology and pathology) or data is collected continuously (e.g. cardiology and intensive care medicine), physicians’ expectations to substantially improve future patient care are high. However, for the practical usage of AI in healthcare regulatory and organizational challenges still have to be mastered.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016371 ◽  
Author(s):  
Louise Rose ◽  
Meera Agar ◽  
Lisa D Burry ◽  
Noll Campbell ◽  
Mike Clarke ◽  
...  

IntroductionDelirium is a common, serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials. Core outcome sets aim to standardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area. Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and/or treat delirium, irrespective of study population. We aim to identify additional core outcomes specific to the critically ill, acutely hospitalised patients, palliative care and older adults.Methods and analysisWe will conduct a systematic review of published and ongoing delirium trials (1980 onwards) and one-on-one interviews of patients who have experienced delirium and family members. These data will inform Delphi round 1 of a two-stage consensus process. In round 2, we will provide participants their own response, summarised group responses and those of patient/family participants for rescoring. We will randomise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses. We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion. We will repeat the Delphi process and consensus meeting to select measures for each core outcome. We will recruit 240 Delphi participants giving us 80% power to detect a 1.0–1.5 point (9-point scale) difference by feedback method between rounds. We will analyse differences for subsequent scores, magnitude of opinion change, items retained and level of agreement.Ethics and disseminationWe are obtaining research ethics approvals according to local governance. Participation will be voluntary and data deidentified. Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake. We will disseminate through peer-reviewed open access publications and present at conferences selected to reach a wide range of knowledge users.


2020 ◽  
Vol 3 ◽  
pp. 53 ◽  
Author(s):  
Karen Matvienko-Sikar ◽  
Kerry Avery ◽  
Jane Blazeby ◽  
Karen Hughes ◽  
Pamela Jacobson ◽  
...  

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.  Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.


Diabetologia ◽  
2020 ◽  
Vol 63 (6) ◽  
pp. 1120-1127 ◽  
Author(s):  
Aoife M. Egan ◽  
◽  
Delia Bogdanet ◽  
Tomás P. Griffin ◽  
Oratile Kgosidialwa ◽  
...  

2021 ◽  
Vol 3 ◽  
pp. 53
Author(s):  
Karen Matvienko-Sikar ◽  
Kerry Avery ◽  
Jane Blazeby ◽  
Karen Hughes ◽  
Pamela Jacobsen ◽  
...  

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.  Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.


2020 ◽  
Vol 25 (46) ◽  
pp. 4848-4860 ◽  
Author(s):  
Anisha Anand ◽  
Gopinathan Manavalan ◽  
Ranju Prasad Mandal ◽  
Huan-Tsung Chang ◽  
Yi-Ru Chiou ◽  
...  

: The prevention and treatment of various infections caused by microbes through antibiotics are becoming less effective due to antimicrobial resistance. Researches are focused on antimicrobial nanomaterials to inhibit bacterial growth and destroy the cells, to replace conventional antibiotics. Recently, carbon dots (C-Dots) become attractive candidates for a wide range of applications, including the detection and treatment of pathogens. In addition to low toxicity, ease of synthesis and functionalization, and high biocompatibility, C-Dots show excellent optical properties such as multi-emission, high brightness, and photostability. C-Dots have shown great potential in various fields, such as biosensing, nanomedicine, photo-catalysis, and bioimaging. This review focuses on the origin and synthesis of various C-Dots with special emphasis on bacterial detection, the antibacterial effect of CDots, and their mechanism.


2020 ◽  
Author(s):  
Julia Hegy ◽  
Noemi Anja Brog ◽  
Thomas Berger ◽  
Hansjoerg Znoj

BACKGROUND Accidents and the resulting injuries are one of the world’s biggest health care issues often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT aims to remedy this situation by offering a low-threshold web-based self-help intervention for psychological distress after an accident. OBJECTIVE The overall aim is to evaluate the efficacy and cost-effectiveness of the SelFIT program plus care as usual (CAU) compared to only care as usual. Furthermore, the program’s user friendliness, acceptance and adherence are assessed. We expect that the use of SelFIT is associated with a greater reduction in psychological distress, greater improvement in mental and physical well-being, and greater cost-effectiveness compared to CAU. METHODS Adults (n=240) showing adjustment problems due to an accident they experienced between 2 weeks and 2 years before entering the study will be randomized. Participants in the intervention group receive direct access to SelFIT. The control group receives access to the program after 12 weeks. There are 6 measurement points for both groups (baseline as well as after 4, 8, 12, 24 and 36 weeks). The main outcome is a reduction in anxiety, depression and stress symptoms that indicate adjustment problems. Secondary outcomes include well-being, optimism, embitterment, self-esteem, self-efficacy, emotion regulation, pain, costs of health care consumption and productivity loss as well as the program’s adherence, acceptance and user-friendliness. RESULTS Recruitment started in December 2019 and is ongoing. CONCLUSIONS To the best of our knowledge, this is the first study examining a web-based self-help program designed to treat adjustment problems resulting from an accident. If effective, the program could complement the still limited offer of secondary and tertiary psychological prevention after an accident. CLINICALTRIAL ClinicalTrials.gov NCT03785912; https://clinicaltrials.gov/ct2/show/NCT03785912?cond=NCT03785912&draw=2&rank=1


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