scholarly journals A Clinical Research on the Impact of Dexamethasone Versus Dexamethasone-Metoclopramide Combination in Reducing Postoperative Vomiting and Nausea After Cranial Surgery

Cureus ◽  
2021 ◽  
Author(s):  
Fahri Eryilmaz ◽  
Umar Farooque
Keyword(s):  
Clinical Research ◽  
Postoperative Vomiting ◽  
Cranial Surgery ◽  
The Impact

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 Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016

2017 ◽  
Vol 5 ◽  
pp. 153-159 ◽  
Author(s):  
C. Ohmann ◽  
S. Canham ◽  
J. Demotes ◽  
G. Chêne ◽  
J. Lauritsen ◽  
...  
Keyword(s):  
Clinical Research ◽  
Data Centre ◽  
Certification Programme ◽  
The Impact

Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24121-e24121
Author(s):  
Celeste Cagnazzo ◽  
Veronica Franchina ◽  
Giuseppe Toscano ◽  
Franca Fagioli ◽  
Tindara Franchina ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Cancer Patients ◽  
Experimental Therapy ◽  
Average Score ◽  
Trial Participation ◽  
Primary Role ◽  
Fake News ◽  
Patient Awareness ◽  
The Impact

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.

scholarly journals Barriers to symptom management care pathway implementation in pediatric Cancer

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
L. Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.

scholarly journals The Need for Shared Nomenclature on Racism and Related Terminology in Psychology

2021 ◽  
Vol 16 (5) ◽  
pp. 886-892
Author(s):  
Angela M. Haeny ◽  
Samantha C. Holmes ◽  
Monnica T. Williams
Keyword(s):  
Clinical Research ◽  
Negative Impact ◽  
Racial Microaggressions ◽  
The United States ◽  
Multiple Forms ◽  
Social Construct ◽  
Racial Hierarchy ◽  
The Social ◽  
The Many ◽  
The Impact

With the increased desire to engage in antiracist clinical research, there is a need for shared nomenclature on racism and related constructs to help move the science forward. This article breaks down the factors that contributed to the development and maintenance of racism (including racial microaggressions), provides examples of the many forms of racism, and describes the impact of racism for all. Specifically, in the United States, racism is based on race, a social construct that has been used to categorize people on the basis of shared physical and social features with the assumption of a racial hierarchy presumed to delineate inherent differences between groups. Racism is a system of beliefs, practices, and policies that operate to advantage those at the top of the racial hierarchy. Individual factors that contribute to racism include racial prejudices and racial discrimination. Racism can be manifested in multiple forms (e.g., cultural, scientific, social) and is both explicit and implicit. Because of the negative impact of racism on health, understanding racism informs effective approaches for eliminating racial health disparities, including a focus on the social determinants of health. Providing shared nomenclature on racism and related terminology will strengthen clinical research and practice and contribute to building a cumulative science.

scholarly journals The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

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