The first section of this thesis aims to provide an international perspective on the characterisation of patients with axial spondyloarthritis. Through different aspects of the classification... Show moreThe first section of this thesis aims to provide an international perspective on the characterisation of patients with axial spondyloarthritis. Through different aspects of the classification criteria, we review the importance of global applicability of these criteria. As classification criteria ensure the same patients are selected for participation in clinical trials worldwide, global applicability would allow for direct comparisons between studies executed in different geographical regions. Likewise, standardised assessment and reporting of results from clinical trials allows for direct comparisons between studies investigating different treatments, or identical treatments in populations from a different ethnicity or background, which is debated in the second part of this thesis. Herein, we describe the process of the development of the core set for axial spondyloarthritis, specifically by updating the domains of the ASAS-OMERACT core set for ankylosing spondylitis. In the final part of this thesis, we discuss health-related quality of life and work and activity impairments in patients with chronic back pain suspected of axial spondyloarthritis. Show less
Dip, F.; Boni, L.; Bouvet, M.; Carus, T.; Diana, M.; Falco, J.; ... ; Rosenthal, R.J. 2022
Background: In recent decades, the use of near-infrared light and fluorescence-guidance during open and laparoscopic surgery has exponentially expanded across various clinical settings. However,... Show moreBackground: In recent decades, the use of near-infrared light and fluorescence-guidance during open and laparoscopic surgery has exponentially expanded across various clinical settings. However, tremendous variability exists in how it is performed. Objective: In this first published survey of international experts on fluorescence-guided surgery, we sought to identify areas of consensus and nonconsensus across 4 areas of practice: fundamentals; patient selection/preparation; technical aspects; and effectiveness and safety. Methods: A Delphi survey was conducted among 19 international experts in fluorescence-guided surgery attending a 1-day consensus meeting in Frankfurt, Germany on September 8(th), 2019. Using mobile phones, experts were asked to anonymously vote over 2 rounds of voting, with 70% and 80% set as a priori thresholds for consensus and vote robustness, respectively. Results: Experts from 5 continents reached consensus on 41 of 44 statements, including strong consensus that near-infrared fluorescence-guided surgery is both effective and safe across a broad variety of clinical settings, including the localization of critical anatomical structures like vessels, detection of tumors and sentinel nodes, assessment of tissue perfusion and anastomotic leaks, delineation of segmented organs, and localization of parathyroid glands. Although the minimum and maximum safe effective dose of ICG were felt to be 1 to 2 mg and >10 mg, respectively, there was strong consensus that determining the optimum dose, concentration, route and timing of ICG administration should be an ongoing research focus. Conclusions: Although fluorescence imaging was almost unanimously perceived to be both effective and safe across a broad range of clinical settings, considerable further research remains necessary to optimize its use. Show less
Introduction: The aim of this study was to obtain expert consensus on the content of a curriculum for learning chorionic villus sampling (CVS) and amniocentesis (AC) and the items of an assessment... Show moreIntroduction: The aim of this study was to obtain expert consensus on the content of a curriculum for learning chorionic villus sampling (CVS) and amniocentesis (AC) and the items of an assessment tool to evaluate CVS and AC competence. Methods: We used a 3-round iterative Delphi process. A steering committee supervised all processes. Seven international collaborators were identified to expand the breadth of the study internationally. The collaborators invited fetal medicine experts to participate as panelists. In the first round, the panelists suggested content for a CVS/AC curriculum and an assessment tool. The steering committee organized and condensed the suggested items and presented them to the panelists in round 2. In the second round, the panelists rated and commented on the suggested items. The results were processed by the steering committee and presented to the panelists in the third round, where final consensus was obtained. Consensus was defined as support by more than 80% of the panelists for an item. Results: Eighty-six experts agreed to participate in the study. The panelists represented 16 countries across 4 continents. The final list of curricular content included 12 theoretical and practical items. The final assessment tool included 11 items, systematically divided into 5 categories: pre-procedure, procedure, post-procedure, nontechnical skills, and overall performance. These items were provided with behavioral scale anchors to rate performance, and an entrustment scale was used for the final overall assessment. Conclusion: We established consensus among international fetal medicine experts on content to be included in a CVS/AC curriculum and on an assessment tool to evaluate CVS/AC skills. These results are important to help transition current training and assessment methods from a time- and volume-based approach to a competency-based approach which is a key step in improving patient safety and outcomes for the 2 most common invasive procedures in fetal medicine. Show less
Boel, A.; Navarro-Compan, V.; Landewe, R.; Heijde, D. van der 2021
Objectives: There are two different approaches to involve participants in consecutive rounds of a Delphi survey: (1) invitation to every round independent of response to the previous round ("all... Show moreObjectives: There are two different approaches to involve participants in consecutive rounds of a Delphi survey: (1) invitation to every round independent of response to the previous round ("all-rounds'') and (2) invitation only when responded to the previous round ("respondents-only''). This study aimed to investigate the effect of invitation approach on the response rate and final outcome of a Delphi survey.Study Design and Setting: Both experts (N = 188) and patients (N = 188) took part in a Delphi survey to update the core outcome set (COS) for axial spondyloarthritis. A study with 1:1 allocation to two experimental groups (ie, "all-rounds'' [N = 187] and "respondents-only'' [N = 189]) was built-in.Results: The overall response rate was lower in the "respondents-only group'' (46%) compared to the "all-rounds group'' (61%). All domains that were selected for inclusion in the COS by the "respondents-only group'' were also selected by the "all-rounds group.'' Additionally, the four most important domains were identical between groups after the final round, with only minor differences in the other domains.Conclusion: Inviting panel members who missed a round to a subsequent round will lead to a better representation of opinions of the originally invited panel and reduces the chance of false consensus, while it does not influence the final outcome of the Delphi. (C) 2020 The Authors. Published by Elsevier Inc. Show less
