scholarly journals Primary systemic sclerosis heart involvement: A systematic literature review and preliminary data-driven, consensus-based WSF/HFA definition

2021 ◽  
pp. 239719832110532
Author(s):  
Cosimo Bruni ◽  
Maya H Buch ◽  
Daniel E Furst ◽  
Giacomo De Luca ◽  
Aleksandra Djokovic ◽  
...  

Introduction: Primary heart involvement in systemic sclerosis may cause morpho-functional and electrical cardiac abnormalities and is a common cause of death. The absence of a clear definition of primary heart involvement in systemic sclerosis limits our understanding and ability to focus on clinical research. We aimed to create an expert consensus definition for primary heart involvement in systemic sclerosis. Methods: A systematic literature review of cardiac involvement and manifestations in systemic sclerosis was conducted to inform an international and multi-disciplinary task force. In addition, the nominal group technique was used to derive a definition that was then subject to voting. A total of 16 clinical cases were evaluated to test face validity, feasibility, reliability and criterion validity of the newly created definition. Results: In total, 171 publications met eligibility criteria. Using the nominal group technique, experts added their opinion, provided statements to consider and ranked them to create the consensus definition, which received 100% agreement on face validity. A median 60(5–300) seconds was taken for the feasibility on a single case. Inter-rater agreement was moderate (mKappa (95% CI) = 0.56 (0.46–1.00) for the first round and 0.55 (0.44–1.00) for the second round) and intra-rater agreement was good (mKappa (95% CI) = 0.77 (0.47–1.00)). Criterion validity showed a 78 (73–84)% correctness versus gold standard. Conclusion: A preliminary primary heart involvement in systemic sclerosis consensus-based definition was created and partially validated, for use in future clinical research.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1574.1-1575
Author(s):  
C. Bruni ◽  
M. H. Buch ◽  
P. Seferovic ◽  
M. Matucci-Cerinic

Background:pSScHI may cause tissue, functional and conduction abnormalities with varied clinical manifestations. The absence of a clear definition of pSScHI impairs the significance and ability of focussed research, frequently not allowing the distinction between primary and secondary involvement.Objectives:We aimed to establish an expert consensus definition for pSScHI, to be used in clinical trials and everyday clinical practice, and to start its validation process.Methods:A SLR for cardiac manifestations and alterations in SSc was conducted using PubMed, Web of Science and Embase. Articles published from inception to December 31st, 2018 were identified. Inclusion criteria included papers in English on adult SSc patients, with heart involvement as outcome. We excluded non-human studies, secondary heart involvement (eg PAH, drugs, infections), reviews and case reports. PRISMA recommendations were followed where applicable. Extracted data were categorized into relevant domains (signs, symptoms, anatomical site involved, physiological abnormalities, pathological changes, prognostic outcomes), which informed the consensus definition. Sixteen senior experts (7 rheumatologists, 8 cardiologists, 1 pathologist) discussed the data and, using a nominal group technique, added expert opinion, provided statements to consider and ranked them. Consensus was attained for agreement >70%. Sixteen clinical cases were evaluated in two rounds to test for face validity, feasibility, inter- and intra-rater reliability and criterion validity (gold standard set by agreed evaluation between expert rheumatologist, cardiologist and methodologist).Results:2593 publications were identified and screened, 251 full texts were evaluated,172 met eligibility criteria. Data from the 7 domains were extracted and used to develop the World Scleroderma Foundation – Heart Failure Association (WSF-HFA) consensus-derived definition of pSSc-HI, as follows:“pSScHI comprises cardiac abnormalities that are predominantly attributable to SSc rather than other causes and/or complications*. pSScHI may be sub-clinical and must be confirmed through diagnostic investigation. The pathogenesis of pSScHI comprises one or more of inflammation, fibrosis and vasculopathy. *Non SSc-specific cardiac conditions (e.g. Ischaemic heart disease, arterial hypertension, drug toxicity, other cardiomyopathy, primary valvular disease) and/or SSc non cardiac conditions (e.g. PAH, Renal involvement, ILD).”Face validity was determined by a 100% agreement on credibility; application was feasible, with a median 60 (5-600) seconds taken per case; inter rater agreement was moderate [mKappa (95%CI) 0.56 (0.46-1.00) and 0.55 (0.44-1.00) for the two rounds] and intra rater agreement was good [mKappa (95%CI) 0.77 (0.47-1,00)]. Content validity was reached based on the wide variety of patients in the SLR, criterion validity was reached with 78 (73-84) % correctness.Conclusion:Using a SLR and modified nominal technique, we have developed a preliminary pSScHI consensus-based definition and started a validation process for it to be used in clinical research and clinical practice.Acknowledgments:Aleksandra Djokovic, Giacomo De Luca, Raluca B. Dumitru,Alessandro Giollo, Marija Polovina, Yossra Atef Suliman, Kostantinos Bratis, Alexia Steelandt, Ivan Milinkovic, Anna Baritussio, Ghadeer Hasan, Anastasia Xintarakou, Yohei Isomura, George Markousis-Mavrogenis, Silvia Bellando-Randone, Lorenzo Tofani, Sophie Mavrogeni, Luna Gargani, Alida L.P. Caforio, Carsten Tschoepe, Arsen Ristic, Karin Klingel, Sven Plein, Elijah Behr, Yannick Allanore, Masataka Kuwana, Christopher Denton, Daniel E. Furst, Dinesh Khanna, Thomas Krieg, Renzo Marcolongo.Disclosure of Interests:Cosimo Bruni Speakers bureau: Actelion, Eli Lilly, Maya H Buch Grant/research support from: Pfizer, Roche, and UCB, Consultant of: Pfizer; AbbVie; Eli Lilly; Gilead Sciences, Inc.; Merck-Serono; Sandoz; and Sanofi, Petar Seferovic: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim


2019 ◽  
Author(s):  
Putri Diana ◽  
Rusdinal ◽  
Hade Afriansyah

This article aims to describe how the technique should be used in decision making to get the right results and in accordance with the objectives to be achieved. The methodology used to arrange this article is Systematic Literature Review (SLR). First, researcher find relevant theories, and then make a conclusion about it, then analyzing, and finally make a new information based researcher analyzing. The result of this article base on the researcher analyzing is generally there are three techniques that can be used in decision making, such participatory technique, group decision making technique, and nominal group technique.


2016 ◽  
Vol 8 (2) ◽  
pp. 165-172 ◽  
Author(s):  
Sawsan Abdel-Razig ◽  
Halah Ibrahim ◽  
Hatem Alameri ◽  
Hossam Hamdy ◽  
Khaled Abu Haleeqa ◽  
...  

ABSTRACT  Medical professionalism has received increased worldwide attention, yet there is limited information on the applicability and utility of established Western professionalism frameworks in non-Western nations.Background  We developed a locally derived consensus definition of medical professionalism for the United Arab Emirates (UAE), which reflects the cultural and social constructs of the UAE and the Middle East.Objective  We used a purposive sample of 14 physicians working in the UAE as clinical and education leaders. This expert panel used qualitative methods, including the world café, nominal group technique, the Delphi method, and an interpretive thematic analysis to develop the consensus statement.Methods  The expert panel defined 9 attributes of medical professionalism. There was considerable overlap with accepted Western definitions, along with important differences in 3 aspects: (1) the primacy of social justice and societal rights; (2) the role of the physician's personal faith and spirituality in guiding professional practices; and (3) societal expectations for professional attributes of physicians that extend beyond the practice of medicine.Results  Professionalism is a social construct influenced by cultural and religious contexts. It is imperative that definitions of professionalism used in the education of physicians in training and in the assessment of practicing physicians be formulated locally and encompass specific competencies relevant to the local, social, and cultural context for medical practice. Our goal was to develop a secular consensus statement that encompasses culture and values relevant to professionalism for the UAE and the Arab region.Conclusions


2010 ◽  
Vol 15 (5) ◽  
pp. 445-466 ◽  
Author(s):  
Duarte B. Morais ◽  
Anthony C. Ogden

The purpose of this article is to report on the initial development of a theoretically grounded and empirically validated scale to measure global citizenship. The methodology employed is multi-faceted, including two expert face validity trials, extensive exploratory and confirmatory factor analyses with multiple datasets, and a series of three small-group interviews utilizing nominal group technique to verify the scope of the global citizenship construct. The findings provide support for a three-dimensional Global Citizenship Scale that encompasses social responsibility, global competence, and global civic engagement. Global competence and global civic engagement are both strong dimensions of global citizenship, and each has three reliable subdimensions that add further refinement to the construct. Social responsibility proves to be a dimension of global citizenship with a less clearly defined structure. The Global Citizenship Scale and its conceptual framework have important implications for education abroad outcomes research and practice.


2017 ◽  
Vol 2 (2) ◽  
pp. 115-120 ◽  
Author(s):  
Yossra Atef Suliman ◽  
Cosimo Bruni ◽  
Sindhu R. Johnson ◽  
Emanuela Praino ◽  
Mohamed Alemam ◽  
...  

2017 ◽  
Vol 27 (6) ◽  
pp. 627-639 ◽  
Author(s):  
Teresio Avitabile ◽  
Claudio Azzolini ◽  
Francesco Bandello ◽  
Francesco Boscia ◽  
Sandro De Falco ◽  
...  

Purpose To reach a consensus, among experts, on the role of aflibercept in diabetic macular edema (DME) through literature review. Methods Two round tables, involving 12 Italian experts, were organized: in the first one, 6 pharmacologic and clinical questions were selected and analyzed by a systematic literature review, using a population, intervention, control, and outcomes framework; in the second one, the nominal group technique was used to discuss relevant evidence related to each question. The consensus was assessed using the 5-point Delphi score. Results Agreement on statements was reached on 6/6 questions. The final statements were as follows: 1) High levels of both vascular endothelial growth factor (VEGF) and placental growth factor play an important role in the pathogenesis of DME. 2) The aflibercept pharmacologic profile is notably different from that of other anti-VEGF. 3) Aflibercept significantly improves functional and anatomical outcomes, and rapidly improves best-corrected visual acuity up to its peak; these results remain stable over time. 4) Diabetic macular edema aflibercept treatment requires a 5-monthly injection loading phase. Alternatively, a personalized pro re nata (PRN) regimen based on monthly monitoring and strict retreatment criteria can be used. 5) As an alternative to the bimonthly fixed regimen, in the maintenance phase the treatment schedule may be a PRN regimen with strict retreatment criteria or a treat and extend regimen. 6) No concerns on aflibercept ocular and systemic safety emerged from the literature. Conclusions Consensus was reached among experts on how to best treat patients with DME with aflibercept.


2014 ◽  
Vol 6 (6) ◽  
pp. 704-705
Author(s):  
Li-Qiong Wang ◽  
Wen-Yuan Li ◽  
Wen-Jing Xiong ◽  
Ning Liang ◽  
Yun-Jiao Zhang ◽  
...  

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