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Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology
BACKGROUND: Pharmacological thromboprophylaxis in the peri-operative period involves a trade-off between reduction in venous thromboembolism (VTE) and an increase in bleeding. Baseline risks, in the absence of prophylaxis, for VTE and bleeding are known to vary widely between urological procedures,...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307154/ https://www.ncbi.nlm.nih.gov/pubmed/25540016 http://dx.doi.org/10.1186/2046-4053-3-150 |
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author | Tikkinen, Kari AO Agarwal, Arnav Craigie, Samantha Cartwright, Rufus Gould, Michael K Haukka, Jari Naspro, Richard Novara, Giacomo Sandset, Per Morten Siemieniuk, Reed A Violette, Philippe D Guyatt, Gordon H |
author_facet | Tikkinen, Kari AO Agarwal, Arnav Craigie, Samantha Cartwright, Rufus Gould, Michael K Haukka, Jari Naspro, Richard Novara, Giacomo Sandset, Per Morten Siemieniuk, Reed A Violette, Philippe D Guyatt, Gordon H |
author_sort | Tikkinen, Kari AO |
collection | PubMed |
description | BACKGROUND: Pharmacological thromboprophylaxis in the peri-operative period involves a trade-off between reduction in venous thromboembolism (VTE) and an increase in bleeding. Baseline risks, in the absence of prophylaxis, for VTE and bleeding are known to vary widely between urological procedures, but their magnitude is highly uncertain. Systematic reviews and meta-analyses addressing baseline risks are uncommon, needed, and require methodological innovation. In this article, we describe the rationale and methods for a series of systematic reviews of the risks of symptomatic VTE and bleeding requiring reoperation in urological surgery. METHODS/DESIGN: We searched MEDLINE from January 1, 2000 until April 10, 2014 for observational studies reporting on symptomatic VTE or bleeding after urological procedures. Additional studies known to experts and studies cited in relevant review articles were added. Teams of two reviewers, independently assessed articles for eligibility, evaluated risk of bias, and abstracted data. We derived best estimates of risk from the median estimates among studies rated at the lowest risk of bias. The primary endpoints were 30-day post-operative risk estimates of symptomatic VTE and bleeding requiring reoperation, stratified by procedure and patient risk factors. DISCUSSION: This series of systematic reviews will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding. Our work advances standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at best estimates of risk (including modeling of timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate certainty in estimates of risk. The results will be incorporated in the upcoming European Association Urology Guideline on Thromboprophylaxis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014010342. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/2046-4053-3-150) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4307154 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-43071542015-01-28 Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology Tikkinen, Kari AO Agarwal, Arnav Craigie, Samantha Cartwright, Rufus Gould, Michael K Haukka, Jari Naspro, Richard Novara, Giacomo Sandset, Per Morten Siemieniuk, Reed A Violette, Philippe D Guyatt, Gordon H Syst Rev Protocol BACKGROUND: Pharmacological thromboprophylaxis in the peri-operative period involves a trade-off between reduction in venous thromboembolism (VTE) and an increase in bleeding. Baseline risks, in the absence of prophylaxis, for VTE and bleeding are known to vary widely between urological procedures, but their magnitude is highly uncertain. Systematic reviews and meta-analyses addressing baseline risks are uncommon, needed, and require methodological innovation. In this article, we describe the rationale and methods for a series of systematic reviews of the risks of symptomatic VTE and bleeding requiring reoperation in urological surgery. METHODS/DESIGN: We searched MEDLINE from January 1, 2000 until April 10, 2014 for observational studies reporting on symptomatic VTE or bleeding after urological procedures. Additional studies known to experts and studies cited in relevant review articles were added. Teams of two reviewers, independently assessed articles for eligibility, evaluated risk of bias, and abstracted data. We derived best estimates of risk from the median estimates among studies rated at the lowest risk of bias. The primary endpoints were 30-day post-operative risk estimates of symptomatic VTE and bleeding requiring reoperation, stratified by procedure and patient risk factors. DISCUSSION: This series of systematic reviews will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding. Our work advances standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at best estimates of risk (including modeling of timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate certainty in estimates of risk. The results will be incorporated in the upcoming European Association Urology Guideline on Thromboprophylaxis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014010342. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/2046-4053-3-150) contains supplementary material, which is available to authorized users. BioMed Central 2014-12-23 /pmc/articles/PMC4307154/ /pubmed/25540016 http://dx.doi.org/10.1186/2046-4053-3-150 Text en © Tikkinen et al.; licensee BioMed Central. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Protocol Tikkinen, Kari AO Agarwal, Arnav Craigie, Samantha Cartwright, Rufus Gould, Michael K Haukka, Jari Naspro, Richard Novara, Giacomo Sandset, Per Morten Siemieniuk, Reed A Violette, Philippe D Guyatt, Gordon H Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology |
title | Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology |
title_full | Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology |
title_fullStr | Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology |
title_full_unstemmed | Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology |
title_short | Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology |
title_sort | systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (rotbus): introduction and methodology |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307154/ https://www.ncbi.nlm.nih.gov/pubmed/25540016 http://dx.doi.org/10.1186/2046-4053-3-150 |
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