Systematic reviews of observational studies of Risk of Thrombosis and Bleeding in General and Gynecologic Surgery (ROTBIGGS): introduction and methodology.

Autor:	Lavikainen LI; Faculty of Medicine, University of Helsinki, Helsinki, Finland., Guyatt GH; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.; Department of Medicine, McMaster University, Hamilton, ON, Canada., Lee Y; Division of General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada., Couban RJ; Department of Anesthesia, McMaster University, Hamilton, ON, Canada., Luomaranta AL; Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Sallinen VJ; Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.; Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Kalliala IEJ; Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Karanicolas PJ; Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.; Department of Surgery, University of Toronto, Toronto, ON, Canada., Cartwright R; Department of Obstetrics and Gynaecology, LNWH NHS Trust, London, UK., Aaltonen RL; Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland., Ahopelto K; Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Aro KM; Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Beilmann-Lehtonen I; Department of Transplantation and Liver Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Blanker MH; Department of General Practice and Elderly Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Cárdenas JL; National Center for Health Technology Excellence (CENETEC) Direction of Health Technologies assessment, Mexico City, Mexico., Craigie S; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada., Galambosi PJ; Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Garcia-Perdomo HA; Division of Urology, Department of Surgery, School of Medicine, Universidad del Valle, Cali, Colombia., Ge FZ; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, L8S 4L8, Canada., Gomaa HA; High Institute of Public Health, Alexandria University, Alexandria, Egypt.; Tanta Chest Hospital, Ministry of Health and Population, Tanta, Egypt., Huang L; Faculty of Medicine, University of Helsinki, Helsinki, Finland., Izett-Kay ML; Urogynaecology Department, The John Radcliffe Hospital, Oxford University Hospitals, Oxford, UK., Joronen KM; Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland., Karjalainen PK; Department of Obstetrics and Gynecology, Central Finland Central Hospital, Jyväskylä, Finland.; Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland., Khamani N; Department of Obstetrics and Gynecology, Institute of Childrens' Health, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.; Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Kilpeläinen TP; Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Kivelä AJ; Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Korhonen T; Experts by Experience, Abdominal Center, Helsinki University Hospital, Helsinki, Finland., Lampela H; Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Mattila AK; Central Finland Central Hospital, Department of Surgery, Jyväskylä, Finland., Najafabadi BT; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada., Nykänen TP; Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland., Nystén C; Faculty of Medicine, University of Helsinki, Helsinki, Finland., Oksjoki SM; Felicitas Mehiläinen Turku, Turku, Finland., Pandanaboyana S; Department of HPB and Transplant Surgery, Freeman Hospital, Newcastle Upon Tyne, UK.; Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne, UK., Pourjamal N; Laboratory of Molecular Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland., Ratnayake CBB; Department of Surgery, The University of Auckland, Auckland, New Zealand.; Auckland City Hospital, Auckland, New Zealand., Raudasoja AR; Faculty of Medicine, University of Helsinki, Helsinki, Finland., Singh T; Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland., Tähtinen RM; Department of Obstetrics and Gynecology, Tampere University Hospital, Tampere, Finland., Vernooij RWM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.; Department of Nephrology & Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands., Wang Y; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada., Xiao Y; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.; West China School of Nursing/Department of Nursing, West China Hospital, Sichuan University, Chengdu, China., Yao L; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada., Haukka J; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.; Clinicum/Department of Public Health, University of Helsinki, Helsinki, Finland., Tikkinen KAO; Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. kari.tikkinen@helsinki.fi.; Department of Surgery, South Karelian Central Hospital, Lappeenranta, Finland. kari.tikkinen@helsinki.fi.
Jazyk:	angličtina
Zdroj:	Systematic reviews [Syst Rev] 2021 Oct 08; Vol. 10 (1), pp. 264. Date of Electronic Publication: 2021 Oct 08.
DOI:	10.1186/s13643-021-01814-2
Abstrakt:	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. (© 2021. The Author(s).)
Databáze:	MEDLINE
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