scholarly journals Community Consensus Guidelines to Support FAIR Data Standards in Clinical Research Studies in Primary Mitochondrial Disease

2021 ◽  
pp. 2100047
Author(s):  
Amel Karaa ◽  
Laura E. MacMullen ◽  
John C. Campbell ◽  
John Christodoulou ◽  
Bruce H. Cohen ◽  
...  
Keyword(s):  
Clinical Research ◽  
Mitochondrial Disease ◽  
Consensus Guidelines ◽  
Data Standards ◽  
Research Studies

scholarly journals A systematic review of criteria used to report complications in soft tissue and oncologic surgical clinical research studies in dogs and cats

2019 ◽  
Vol 49 (1) ◽  
pp. 61-69 ◽  
Author(s):  
Christelle M. Follette ◽  
Michelle A. Giuffrida ◽  
Ingrid M. Balsa ◽  
William T. N. Culp ◽  
Philipp D. Mayhew ◽  
...  
Keyword(s):  
Systematic Review ◽  
Soft Tissue ◽  
Clinical Research ◽  
Research Studies

scholarly journals THU0528 NAILFOLD VIDEOCAPILLAROSCOPY REPORTING IN CLINICAL RESEARCH: INTERNATIONAL DELPHI BASED CONSENSUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 503.1-504
Author(s):  
F. Ingegnoli ◽  
T. Schioppo ◽  
A. Herrick ◽  
A. Sulli ◽  
F. Bartoli ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Research ◽  
Rheumatic Diseases ◽  
Unmet Need ◽  
Future Research ◽  
Invasive Technique ◽  
Delphi Consensus ◽  
Research Support ◽  
The Impact ◽  
Research Studies

Background:Nailfold capillaroscopy (NVC), a non-invasive technique to assess microcirculation, is increasingly being incorporated into rheumatology routine clinical practice. Currently, the degree of description of NVC methods varies amongst research studies, making interpretation and comparison between studies challenging. In this field, an unmet need is the standardization of items to be reported in research studies using NVC.Objectives:To perform a Delphi consensus on minimum reporting standards in methodology for clinical research, based on the items derived from a systematic review focused on this topic.Methods:The systematic review of the literature on NVC methodology relating to rheumatic diseases was performed according to PRISMA guidelines (PROSPERO CRD42018104660) to July 22nd2018 using MEDLINE, Embase, Scopus. Then, a three-step web-based Delphi consensus was performed in between members of the EULAR study group on microcirculation in rheumatic diseases and the Scleroderma Clinical Trials Consortium. Participants were asked to rate each item from 1 (not appropriate) to 9 (completely appropriate).Results:In total, 3491 references were retrieved in the initial search strategy, 2862 were excluded as duplicates or after title/abstract screening. 632 articles were retrieved for full paper review of which 319 fulfilled the inclusion criteria. Regarding patient preparation before the exam, data were scarce: 38% reported acclimatization, 5% to avoid caffeine and smoking, 3% to wash hands and 2% to avoid manicure. Concerning the device description: 90% reported type of instrument, 77% brand/model, 72% magnification, 46% oil use, 40% room temperature and 35% software for image analysis. As regards to examination details: 76% which fingers examined, 75% number of fingers examined, 15% operator experience, 13% reason for finger exclusion, 9% number of images, 8% quality check of the images and 3% time spent for the exam. Then, a three-round Delphi consensus on the selected items was completed by 80 participants internationally, from 31 countries located in Australia, Asia, Europe, North and South America. Some items reached the agreement at the second round (85 participants), and other items were suggested as important to consider in a future research agenda (e.g. temperature for acclimatization, the impact of smoking, allergies at the application of the oil to the nailbed, significance of pericapillary edema, methods of reporting hemorrhages, ramified and giant capillaries). The final agreement results are reported below:Conclusion:On the basis of the available literature the description of NVC methods was highly heterogeneous and individual published studies differed markedly. These practical suggestions developed using a Delphi process among international participants provide a guidance to improve and to standardize the NVC methodology in future clinical research studies.Disclosure of Interests:Francesca Ingegnoli: None declared, Tommaso Schioppo: None declared, Ariane Herrick: None declared, Alberto Sulli Grant/research support from: Laboratori Baldacci, Francesca Bartoli: None declared, Nicola Ughi: None declared, John Pauling: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl

scholarly journals Quality of life in primary sclerosing cholangitis: a systematic review

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Elena Marcus ◽  
Paddy Stone ◽  
Anna-Maria Krooupa ◽  
Douglas Thorburn ◽  
Bella Vivat
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Clinical Research ◽  
Disease Progression ◽  
Primary Sclerosing Cholangitis ◽  
Sclerosing Cholangitis ◽  
Small Sample ◽  
Limited Evidence ◽  
Research Studies

Abstract Background Primary sclerosing cholangitis (PSC) is a rare bile duct and liver disease which can considerably impact quality of life (QoL). As part of a project developing a measure of QoL for people with PSC, we conducted a systematic review with four review questions. The first of these questions overlaps with a recently published systematic review, so this paper reports on the last three of our initial four questions: (A) How does QoL in PSC compare with other groups?, (B) Which attributes/factors are associated with impaired QoL in PSC?, (C) Which interventions are effective in improving QoL in people with PSC?. Methods We systematically searched five databases from inception to 1 November 2020 and assessed the methodological quality of included studies using standard checklists. Results We identified 28 studies: 17 for (A), ten for (B), and nine for (C). Limited evidence was found for all review questions, with few studies included in each comparison, and small sample sizes. The limited evidence available indicated poorer QoL for people with PSC compared with healthy controls, but findings were mixed for comparisons with the general population. QoL outcomes in PSC were comparable to other chronic conditions. Itch, pain, jaundice, severity of inflammatory bowel disease, liver cirrhosis, and large-duct PSC were all associated with impaired QoL. No associations were found between QoL and PSC severity measured with surrogate markers of disease progression or one of three prognostic scoring systems. No interventions were found to improve QoL outcomes. Conclusion The limited findings from included studies suggest that markers of disease progression used in clinical trials may not reflect the experiences of people with PSC. This highlights the importance for clinical research studies to assess QoL alongside clinical and laboratory-based outcomes. A valid and responsive PSC-specific measure of QoL, to adequately capture all issues of importance to people with PSC, would therefore be helpful for clinical research studies.

Proteomics of Human Milk: Definition of a Discovery Workflow for Clinical Research Studies

2021 ◽  
Author(s):  
Loïc Dayon ◽  
Charlotte Macron ◽  
Sabine Lahrichi ◽  
Antonio Núñez Galindo ◽  
Michael Affolter
Keyword(s):  
Human Milk ◽  
Clinical Research ◽  
Definition Of ◽  
Research Studies

scholarly journals Gap between real-world data and clinical research within hospitals in China: a qualitative study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038375
Author(s):  
Feifei Jin ◽  
Chen Yao ◽  
Xiaoyan Yan ◽  
Chongya Dong ◽  
Junkai Lai ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Clinical Research ◽  
Real World ◽  
Data Standards ◽  
Medical Record Data ◽  
Real World Data ◽  
World Data ◽  
Electronic Medical Record Data ◽  
Research Platform ◽  
Record Data

ObjectiveTo investigate the gap between real-world data and clinical research initiated by doctors in China, explore the potential reasons for this gap and collect different stakeholders’ suggestions.DesignThis qualitative study involved three types of hospital personnel based on three interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.SettingSix tertiary hospitals (three general hospitals and three specialised hospitals) in Beijing, China, were included.ParticipantsIn total, 42 doctors from 12 departments, 5 information technology managers and 4 clinical managers were interviewed through stratified purposive sampling.ResultsElectronic medical record data cannot be directly downloaded into clinical research files, which is a major problem in China. The lack of data interoperability, unstructured electronic medical record data and concerns regarding data security create a gap between real-world data and research data. Updating hospital information systems, promoting data standards and establishing an independent clinical research platform may be feasible suggestions for solving the current problems.ConclusionsDetermining the causes of gaps and targeted solutions could contribute to the development of clinical research in China. This research suggests that updating the hospital information system, promoting data standards and establishing a clinical research platform could promote the use of real-world data in the future.

scholarly journals Understanding the nature and scope of clinical research commentaries in PubMed

2019 ◽  
Vol 27 (3) ◽  
pp. 449-456
Author(s):  
James R Rogers ◽  
Hollis Mills ◽  
Lisa V Grossman ◽  
Andrew Goldstein ◽  
Chunhua Weng
Keyword(s):  
Clinical Research ◽  
Sentiment Analysis ◽  
Random Sample ◽  
Full Text ◽  
Topic Modeling ◽  
Critical Appraisal ◽  
Research Articles ◽  
Disease Specific ◽  
Research Studies

Abstract Scientific commentaries are expected to play an important role in evidence appraisal, but it is unknown whether this expectation has been fulfilled. This study aims to better understand the role of scientific commentary in evidence appraisal. We queried PubMed for all clinical research articles with accompanying comments and extracted corresponding metadata. Five percent of clinical research studies (N = 130 629) received postpublication comments (N = 171 556), resulting in 178 882 comment–article pairings, with 90% published in the same journal. We obtained 5197 full-text comments for topic modeling and exploratory sentiment analysis. Topics were generally disease specific with only a few topics relevant to the appraisal of studies, which were highly prevalent in letters. Of a random sample of 518 full-text comments, 67% had a supportive tone. Based on our results, published commentary, with the exception of letters, most often highlight or endorse previous publications rather than serve as a prominent mechanism for critical appraisal.

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