Abstract
Objective
The goal of this study was to develop an approach that can be used where baseline
risk estimates that are directly applicable to prioritized patient-important outcomes
are not available from published studies.
Study design
The McMaster University GRADE Centre and the ASH guideline panel for the prevention
of VTE in surgical patients developed a modeling approach based on explicit assumptions
about the distribution of symptoms, anatomical location, and severity of VTE events.
Results
We applied the approach to derive modeled estimates of baseline risk. These estimates
were used to calculated absolute measures of anticipated effects that informed the
discussion of the evidence and the formulation of 30 guideline recommendations.
Conclusion
Our approach can assist guideline developers facing a lack of information about baseline
risk estimates that directly apply to outcomes of interest. The use of modeled estimates
increases transparency in the process and makes the baseline risk used by guideline
experts explicit during their decision-making.
Keywords
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References
- GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.Journal of clinical epidemiology. 2011; 64: 383-394
- Analysing data and undertaking meta-analyses.Cochrane handbook for systematic reviews of interventions. 2019; : 241-284
- Interpreting results and drawing conclusions.(editors)in: Higgins JPT Thomas J Chandler J Cumpston M Li T Page MJ Welch VA Cochrane Handbook for Systematic Reviews of Interventions version 6 (updated July 2019). Cochrane, 2019
- GRADE guidelines: 12. Preparing summary of findings tables-binary outcomes.Journal of clinical epidemiology. 2013; 66: 158-172
- Systematic reviews of observational studies of risk of thrombosis and bleeding in urological surgery (ROTBUS): introduction and methodology.Syst Rev. 2014; 3: 150
- A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results.Trials. 2015; 16: 495
- Uncertainties in baseline risk estimates and confidence in treatment effects.BMJ. 2012; 345: e7401
- Approach to outcome measurement in the prevention of thrombosis in surgical and medical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.Chest. 2012; 141: 185-194https://doi.org/10.1378/chest.11-2289
- American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients.Blood Adv. 2019; 3: 3898-3944
- Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group.BMC Health Serv Res. 2004; 4: 38
- GRADE guidelines: 3. Rating the quality of evidence.Journal of clinical epidemiology. 2011; 64: 401-406
- Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise.CMAJ. 2014; 186: E123-E142
- GRADE guidelines: 2. Framing the question and deciding on important outcomes.Journal of clinical epidemiology. 2011; 64: 395-400
- A randomized multicenter trial to evaluate simple utility elicitation techniques in patients with gastroesophageal reflux disease.Med Care. 2004; 42: 1132-1142
- Development and use of health outcome descriptors: a guideline development case study.Health Qual Life Outcomes. 2020; 18: 167
- Rates of symptomatic venous thromboembolism in US surgical patients: a retrospective administrative database study.Journal of thrombosis and thrombolysis. 2009; 28: 458-464
- Expert Evidence in Guidelines G. Distinguishing opinion from evidence in guidelines.BMJ. 2019; 366: l4606
- Improving GRADE evidence tables part 3: detailed guidance for explanatory footnotes supports creating and understanding GRADE certainty in the evidence judgments.J Clin Epidemiol. 2016; 74 (Epub 6 Jan 12): 28-39https://doi.org/10.1016/j.jclinepi.2015.12.006
- Procedure-specific Risks of Thrombosis and Bleeding in Urological Cancer Surgery: Systematic Review and Meta-analysis.European urology. 2018; 73: 242-251
- Procedure-specific Risks of Thrombosis and Bleeding in Urological Non-cancer Surgery: Systematic Review and Meta-analysis.European urology. 2018; 73: 236-241
- Incidence of Venous Thromboembolism and Benefits and Risks of Thromboprophylaxis After Cardiac Surgery: A Systematic Review and Meta-Analysis.Journal of the American Heart Association. 2015; 4e002652
- Thromboembolic disease in spinal surgery: a systematic review.Spine. 2009; 34: 291-303
- The compliance of thromboprophylaxis affects the risk of venous thromboembolism in patients undergoing hip fracture surgery.SpringerPlus. 2016; 5: 1362
- The effect of aspirin and low-molecular-weight heparin on venous thromboembolism after knee replacement: a non-randomised comparison using National Joint Registry Data.J Bone Joint Surg Br. 2012; 94: 914-918https://doi.org/10.1302/0301-620X.94B7.29129
- The effect of aspirin and low-molecular-weight heparin on venous thromboembolism after hip replacement: a non-randomised comparison from information in the National Joint Registry.J Bone Joint Surg Br. 2011; 93 (10.302/0301-620X.93B11.27622): 1465-1470
- Venous thromboembolism after severe trauma: incidence, risk factors and outcome.Injury. 2010; 41: 97-101
- Incidence and timing of venous thromboembolism after surgery for gynecological cancer.Gynecol Oncol. 2011; 121 (Epub Dec 22): 64-69https://doi.org/10.1016/j.ygyno.2010.11.038
- Venous thromboembolism and use of prophylaxis among women undergoing laparoscopic hysterectomy.Obstet Gynecol. 2011; 117 (10.097/AOG.0b013e31821bdd16): 1367-1374
- Incidence and risk factors for symptomatic venous thromboembolism following cholecystectomy.Langenbeck's archives of surgery. 2015; 400: 463-469
- Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision?.Journal of clinical epidemiology. 2016; 75: 6-15
- Symptoms and clinical relevance: a dilemma for clinical trials on prevention of venous thromboembolism.Thromb Haemost. 2013; 109 (Epub 2013 Jan 24): 585-588https://doi.org/10.1160/TH12-08-0627
- Are asymptomatic DVTs relevant?: one measure for all.Chest. 2013; 143: 874https://doi.org/10.1378/chest.12-2510
- The COMET (Core Outcome Measures in Effectiveness Trials) Initiative.Maturitas. 2016; 91 (Epub Jun 9): 91-92https://doi.org/10.1016/j.maturitas.2016.06.007
Article info
Publication history
Published online: July 17, 2021
Accepted:
July 14,
2021
Footnotes
Conflict of interest: A.C. has served as a consultant for Synergy and his institution has received research support on his behalf from Alexion, Bayer, Novo Nordisk, Pfizer, Sanofi, Spark, and Takeda; all other authors declare no competing financial interests.
Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Identification
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© 2021 Elsevier Inc. All rights reserved.
