TY - JOUR
T1 - Thoracic outlet syndrome (TROTS) registry
T2 - A study protocol for the primary upper extremity deep venous thrombosis section
AU - Schropp, Ludo
AU - de Kleijn, Robert J. C. M. F.
AU - Westerink, Jan
AU - Nijkeuter, Mathilde
AU - Vonken, Evert-Jan
AU - van der Schaaf, Irene C.
AU - Goedee, H. Stephan
AU - Vrancken, Alexander F. J. E.
AU - van Hattum, Eline S.
AU - Petri, Bart-Jeroen
AU - de Borst, Gert J.
AU - Ünlü, Çağdaş
AU - Bemelmans, Remy H. H.
AU - Westerweel, Peter E.
AU - Lijkwan, Maarten
AU - Esselink, Anne C.
AU - Bode, Aron S.
AU - Msc, Hinke Nagtegaal
AU - ten Cate, Arina
AU - van Laanen, Jorinde
AU - van der Veer, Arian
AU - van Weel, Vincent
AU - Mol, Gerben C.
AU - Florie, Jasper
AU - Faber, Daniel R.
AU - de Vries, Jeroen K.
AU - van de Mortel, Robertus H. W.
AU - Molegraaf, Marijke
AU - Jongkind, Vincent
AU - Yeung, Kakkhee
AU - Coppens, Michiel
AU - van der Bogt, Koen E. A.
AU - Beishuizen, Edith D.
AU - van Ommen, C. Heleen
AU - Kruip, Marieke J. H. A.
AU - van Rijn, Marie Josee E.
AU - van Bemmel, Thomas
AU - Klemm, Peter L.
AU - Hovens, Marcel M. C.
AU - van Schaik, Paul M.
AU - Eefting, Matthijs
AU - van Well, Anne M. E.
AU - van Nieuwenhuizen, Roos C.
AU - van Wissen, Sanne
AU - Willems, Martine C. M.
AU - Post, Judith P.
AU - Kleijwegt, Fleur S.
AU - TROTS registry collaborators
AU - Suijker, Monique H.
N1 - Publisher Copyright: © 2023 Schropp et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Introduction There is a lack of comprehensive and uniform data on primary upper extremity deep venous thrombosis (pUEDVT). pUEDVT includes venous thoracic outlet syndrome related upper extremity deep venous thrombosis (UEDVT) and idiopathic UEDVT. Research on these conditions has been hampered by their rarity, lack of uniform diagnostic criteria, and heterogeneity in therapeutic strategies. To improve current research data collection using input of all various pUEDVT treating medical specialists, we initiated the ThoRacic OuTlet Syndrome (TROTS) registry. The aim of the TROTS registry is to a) collect extensive data on all pUEDVT patients through a predefined protocol, b) give insight in the long term outcome using patient reported outcome measures, c) create guidance in the diagnostic and clinical management of these conditions, and thereby d) help provide content for future research. Methods and analysis The TROTS registry was designed as an international prospective longitudinal observational registry for data collection on pUEDVT patients. All pUEDVT patients, regardless of treatment received, can be included in the registry after informed consent is obtained. All relevant data regarding the initial presentation, diagnostics, treatment, and follow-up will be collected prospectively in an electronic case report form. In addition, a survey containing general questions, a Health-related Quality of Life questionnaire (EQ-5D-5L), and Functional Disability questionnaire (Quick-DASH) will be sent periodically (at the time of inclusion, one and two years after inclusion, and every five years after inclusion) to the participant. The registry protocol was approved by the Medical Ethical Review Board and registered in the Netherlands Trial Register under Trial-ID NL9680. The data generated by the registry will be used for future research on pUEDVT and published in peer reviewed journals. Conclusion TROTS registry data will be used to further establish the optimal management of pUEDVT and lay the foundation for future research and guidelines.
AB - Introduction There is a lack of comprehensive and uniform data on primary upper extremity deep venous thrombosis (pUEDVT). pUEDVT includes venous thoracic outlet syndrome related upper extremity deep venous thrombosis (UEDVT) and idiopathic UEDVT. Research on these conditions has been hampered by their rarity, lack of uniform diagnostic criteria, and heterogeneity in therapeutic strategies. To improve current research data collection using input of all various pUEDVT treating medical specialists, we initiated the ThoRacic OuTlet Syndrome (TROTS) registry. The aim of the TROTS registry is to a) collect extensive data on all pUEDVT patients through a predefined protocol, b) give insight in the long term outcome using patient reported outcome measures, c) create guidance in the diagnostic and clinical management of these conditions, and thereby d) help provide content for future research. Methods and analysis The TROTS registry was designed as an international prospective longitudinal observational registry for data collection on pUEDVT patients. All pUEDVT patients, regardless of treatment received, can be included in the registry after informed consent is obtained. All relevant data regarding the initial presentation, diagnostics, treatment, and follow-up will be collected prospectively in an electronic case report form. In addition, a survey containing general questions, a Health-related Quality of Life questionnaire (EQ-5D-5L), and Functional Disability questionnaire (Quick-DASH) will be sent periodically (at the time of inclusion, one and two years after inclusion, and every five years after inclusion) to the participant. The registry protocol was approved by the Medical Ethical Review Board and registered in the Netherlands Trial Register under Trial-ID NL9680. The data generated by the registry will be used for future research on pUEDVT and published in peer reviewed journals. Conclusion TROTS registry data will be used to further establish the optimal management of pUEDVT and lay the foundation for future research and guidelines.
UR - http://www.scopus.com/inward/record.url?scp=85145932200&partnerID=8YFLogxK
U2 - https://doi.org/10.1371/journal.pone.0279708
DO - https://doi.org/10.1371/journal.pone.0279708
M3 - Article
C2 - 36608058
SN - 1932-6203
VL - 18
JO - PLOS ONE
JF - PLOS ONE
IS - 1 January
M1 - e0279708
ER -