1. Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology
- Author
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Riikka Aaltonen, Rufus Cartwright, Nadina Khamani, Linglong Huang, Ines Beilmann-Lehtonen, Chathura B B Ratnayake, Rachel Couban, Anna Luomaranta, Sanjay Pandanaboyana, Lauri I Lavikainen, Sanna M Oksjoki, Kari A.O. Tikkinen, Fang Zhou Ge, Paul J. Karanicolas, Aleksi R Raudasoja, Kirsi Joronen, Herney Andrés García-Perdomo, Yung Lee, Yingqi Xiao, Kaisa Ahopelto, Ville Sallinen, Carolina Nystén, Jovita L. Cárdenas, Borna Tadayon Najafabadi, Taina Nykänen, Tino Singh, Antti Kivelä, Päivi K. Karjalainen, Huda Gomaa, Riikka M. Tähtinen, Gordon H. Guyatt, Yuting Wang, Tuomas P. Kilpeläinen, Tapio Korhonen, Marco H. Blanker, Samantha Craigie, Anne K Mattila, Karoliina Aro, Ilkka Kalliala, Matthew L Izett-Kay, Hanna Lampela, Robin W.M. Vernooij, Liang Yao, Päivi J. Galambosi, Jari Haukka, and Negar Pourjamal
- Subjects
medicine.medical_specialty ,Baseline risk ,Surgical complications ,Medicine (miscellaneous) ,Hemorrhage ,Lower risk ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Gynecologic Surgical Procedures ,Randomized controlled trial ,law ,medicine ,Protocol ,Humans ,Hemorrhage/etiology ,030212 general & internal medicine ,Data reporting ,Grading (education) ,Thromboprophylaxis ,Gynecologic Surgical Procedures/adverse effects ,business.industry ,Incidence (epidemiology) ,Bleeding ,Modeling ,Anticoagulants ,Thrombosis ,Venous Thromboembolism ,medicine.disease ,Venous Thromboembolism/epidemiology ,Risk of bias ,3. Good health ,Surgery ,Systematic review ,Gynecology ,030220 oncology & carcinogenesis ,Medicine ,Observational study ,Female ,business ,Systematic Reviews as Topic - Abstract
Background Venous thromboembolism (VTE) and bleeding are serious and potentially fatal complications of surgical procedures. Pharmacological thromboprophylaxis decreases the risk of VTE but increases the risk of major post-operative bleeding. The decision to use pharmacologic prophylaxis therefore represents a trade-off that critically depends on the incidence of VTE and bleeding in the absence of prophylaxis. These baseline risks vary widely between procedures, but their magnitude is uncertain. Systematic reviews addressing baseline risks are scarce, needed, and require innovations in methodology. Indeed, systematic summaries of these baseline risk estimates exist neither in general nor gynecologic surgery. We will fill this knowledge gap by performing a series of systematic reviews and meta-analyses of the procedure-specific and patient risk factor stratified risk estimates in general and gynecologic surgeries. Methods We will perform comprehensive literature searches for observational studies in general and gynecologic surgery reporting symptomatic VTE or bleeding estimates. Pairs of methodologically trained reviewers will independently assess the studies for eligibility, evaluate the risk of bias by using an instrument developed for this review, and extract data. We will perform meta-analyses and modeling studies to adjust the reported risk estimates for the use of thromboprophylaxis and length of follow up. We will derive the estimates of risk from the median estimates of studies rated at the lowest risk of bias. The primary outcomes are the risk estimates of symptomatic VTE and major bleeding at 4 weeks post-operatively for each procedure stratified by patient risk factors. We will apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate evidence certainty. Discussion This series of systematic reviews, modeling studies, and meta-analyses will inform clinicians and patients regarding the trade-off between VTE prevention and bleeding in general and gynecologic surgeries. Our work advances the standards in systematic reviews of surgical complications, including assessment of risk of bias, criteria for arriving at the best estimates of risk (including modeling of the timing of events and dealing with suboptimal data reporting), dealing with subgroups at higher and lower risk of bias, and use of the GRADE approach. Systematic review registration PROSPERO CRD42021234119
- Published
- 2021