Ruor.uottawa.ca



TITLEProtocol for a scoping review of outcomes in clinical studies of interventions for venous thromboembolism in adults AUTHORSTobias Tritschler1,2, Nicole Langlois1, Brian Hutton1, Beverley J. Shea1, Risa Shorr1, Sara Ng1, Suzanne Dubois3, Carol West3, Alfonso Iorio4,5, Peter Tugwell1, Grégoire Le Gal1AFFILIATIONS1. Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada2. Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland3. Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network; Patient Partner Platform4. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada5. Department of Medicine, McMaster University, Hamilton, Ontario, Canada6. Division of Hematology and Hematological Malignancies, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, CanadaCORRESPONDING AUTHORGrégoire Le Gal, The Ottawa Hospital, General Campus, Box 201A, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada; E-mail address: glegal@ohri.caWORD COUNT1985KEY WORDSCore outcome set, Deep vein thrombosis, Pulmonary embolism, Outcome research, Venous thromboembolismABSTRACTIntroduction: Venous thromboembolism (VTE) is a common, potentially fatal yet treatable disease. Several advances in treatment of VTE have been made over the past decades, but definition and reporting of outcomes across those studies are inconsistent. Development of an international core outcome set for clinical studies of interventions for VTE addresses this lack of standardization. The first step in the development of a core outcome set is to conduct a scoping review which aims to generate an inclusive list of unique outcomes that have been reported in previous studies.Methods and analysis: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials will be searched with no language restriction for prospective studies reporting on interventions for treatment of VTE in adult non-pregnant patients. Records will be sorted in reverse chronologic order. Study screening and data extraction will be independently performed by 2 authors in blocks based upon date of publication, starting with 2015-2020 and subsequent 1-year periods, until no new outcome measures are identified from the set of included studies. After homogenizing spelling and combining outcomes with the same meaning, a list of unique outcomes will be determined. Those outcomes will be grouped into outcome domains. Qualitative analysis and descriptive statistics will be used to report results. Ethics and dissemination: Ethical approval is not required for this study. The results of this scoping review will be presented at scientific conferences, published in a peer-reviewed journal, and they will provide candidate outcome domains to be considered in subsequent steps in the development of a core outcome set for clinical studies of interventions for VTE.INTRODUCTIONRationaleVenous thromboembolism (VTE) is a common condition manifested as deep vein thrombosis (DVT) or pulmonary embolism (PE). If left untreated, the reported mortality of PE has varied widely in historical and more recent studies,PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaWV0bzwvQXV0aG9yPjxZZWFyPjIwMTg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [1,2] but timely and appropriate treatment with anticoagulant medications dramatically reduces fatal events to less than 1%. ADDIN EN.CITE <EndNote><Cite><Author>Carrier</Author><Year>2010</Year><RecNum>1</RecNum><DisplayText>[3]</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1572017808" guid="251fa1e1-5106-431f-9848-3d22ab7f6bc7">1</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Carrier, M.</author><author>Le Gal, G.</author><author>Wells, P. S.</author><author>Rodger, M. A.</author></authors></contributors><auth-address>University of Ottawa, Ottawa Hospital Research Institute, Ontario, Canada.</auth-address><titles><title>Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism</title><secondary-title>Ann Intern Med</secondary-title><alt-title>Annals of internal medicine</alt-title></titles><periodical><full-title>Ann Intern Med</full-title><abbr-1>Annals of internal medicine</abbr-1></periodical><alt-periodical><full-title>Ann Intern Med</full-title><abbr-1>Annals of internal medicine</abbr-1></alt-periodical><pages>578-89</pages><volume>152</volume><number>9</number><edition>2010/05/05</edition><keywords><keyword>Anticoagulants/*adverse effects</keyword><keyword>Hemorrhage/*chemically induced/mortality</keyword><keyword>Humans</keyword><keyword>Recurrence</keyword><keyword>Risk Assessment</keyword><keyword>Venous Thromboembolism/*drug therapy/*mortality</keyword></keywords><dates><year>2010</year><pub-dates><date>May 4</date></pub-dates></dates><isbn>1539-3704 (Electronic)&#xD;0003-4819 (Linking)</isbn><accession-num>20439576</accession-num><work-type>Research Support, Non-U.S. Gov&apos;t&#xD;Review</work-type><urls><related-urls><url>;[3] In addition to PE-related death, most VTE treatment studies incorporate recurrent VTE or bleeding as primary or secondary outcomes. However, it has been noted that the list, definition and reporting of outcomes is inconsistent across studies and discrepancies in how these outcomes are defined and measured have led to important challenges in comparing and synthesizing the results of trials.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaXR0PC9BdXRob3I+PFllYXI+MjAxODwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [4] Lack of valid and standardized definitions of domains and measures for certain outcomes has also compromised the ability to demonstrate clinically meaningful effects. For example, how severe a bleeding event should be to count as an outcome has been a matter of debate. ADDIN EN.CITE <EndNote><Cite><Author>Schulman</Author><Year>2005</Year><RecNum>809</RecNum><DisplayText>[5]</DisplayText><record><rec-number>809</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1572017811" guid="42d68b12-6f9e-452b-9551-52ceaa965835">809</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Schulman, S.</author><author>Kearon, C.</author><author>Subcommittee on Control of Anticoagulation of the Scientific Standardization Committee of the International Society on Thrombosis Haemostasis,</author></authors></contributors><auth-address>Coagulation Unit, Karolinska University Hospital, Stockholm, Sweden. schulms@mcmaster.ca</auth-address><titles><title>Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients</title><secondary-title>J Thromb Haemost</secondary-title></titles><periodical><full-title>J Thromb Haemost</full-title><abbr-1>Journal of thrombosis and haemostasis : JTH</abbr-1></periodical><pages>692-4</pages><volume>3</volume><number>4</number><edition>2005/04/22</edition><keywords><keyword>Anticoagulants/*adverse effects/pharmacology</keyword><keyword>Fibrinolytic Agents/*adverse effects/pharmacology</keyword><keyword>Hematology/standards</keyword><keyword>Hemorrhage/*chemically induced/mortality/therapy</keyword><keyword>*Hemostasis</keyword><keyword>Humans</keyword><keyword>Platelet Aggregation Inhibitors/*adverse effects/pharmacology</keyword><keyword>Postoperative Complications</keyword></keywords><dates><year>2005</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1538-7933 (Print)&#xD;1538-7836 (Linking)</isbn><accession-num>15842354</accession-num><urls><related-urls><url>;[5] The definition of PE-related death is variable between studies, ADDIN EN.CITE <EndNote><Cite><Author>Kraaijpoel</Author><Year>2019</Year><RecNum>1097</RecNum><DisplayText>[6]</DisplayText><record><rec-number>1097</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1572017813" guid="cfa13c1a-c458-4845-af62-44876c7b036e">1097</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kraaijpoel, N.</author><author>Tritschler, T.</author><author>Guillo, E.</author><author>Girard, P.</author><author>Le Gal, G.</author></authors></contributors><auth-address>Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.&#xD;Department of Medicine, University of Ottawa, Ottawa, ON, Canada.&#xD;Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.&#xD;Institut du Thorax Curie-Montsouris, Paris, France.&#xD;Institut Mutualiste Montsouris, Paris, France.&#xD;Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada.</auth-address><titles><title>Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review</title><secondary-title>J Thromb Haemost</secondary-title></titles><periodical><full-title>J Thromb Haemost</full-title><abbr-1>Journal of thrombosis and haemostasis : JTH</abbr-1></periodical><pages>1590-1607</pages><volume>17</volume><number>10</number><edition>2019/07/14</edition><keywords><keyword>cause of death</keyword><keyword>mortality</keyword><keyword>outcome assessment (health care)</keyword><keyword>pulmonary embolism</keyword><keyword>venous thromboembolism</keyword></keywords><dates><year>2019</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1538-7836 (Electronic)&#xD;1538-7836 (Linking)</isbn><accession-num>31301689</accession-num><urls><related-urls><url>;[6] and within a single study the outcome adjudicators demonstrated poor reproducibility (50% discordant results) for unexplained sudden death adjudicated as PE-related.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HaXJhcmQ8L0F1dGhvcj48WWVhcj4yMDE3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [10,11] The first step in the development of a COS includes a scoping review of the literature to identify outcomes and domains that have been used previously. The results of the scoping review will help to determine the heterogeneity of reported outcomes and establish a list of unique outcomes. The results of this scoping review, considered together with the findings of other planned qualitative work involving multiple stakeholders (including patients, caregivers, clinicians, researchers, clinical practice guideline developers, health technology assessors, payers, policy makers, public research funding agencies, and drug developers), will inform candidate outcomes and domains for the final consensus process to determine the COS for clinical studies of interventions for VTE.ObjectivesPrimary objectiveThe primary objective of the scoping review is to generate an inclusive list of unique outcome domains that have been reported in previous VTE treatment studies.Secondary objectivesThe secondary objectives are to assess the number of unique outcome domains and measures reported (i.e., outcome reporting heterogeneity),PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Zb3VuZzwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [12] to assess the number of unique outcomes reported per study, to assess the presence of different wording for the same outcomes, to assess different timepoints at which unique outcomes are measured, to assess the number of patient-reported unique outcomes, and to capture outcome definitions.METHODS AND ANALYSISThis protocol was developed following guidance in the COMET and Outcome Measures in Rheumatology (OMERACT) handbooks and reporting adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) Statement (supplementary appendix 1).PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb2hlcjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [14] Eligibility criteriaParticipantsWe will seek studies that enrolled adults diagnosed with VTE, either DVT of the legs, PE, or both. We will exclude VTE studies which included only pregnant women, comprising the ante-partum, peri-partum and post-partum periods, because an ongoing systematic review already assesses reported outcomes in this specific population (PROSPERO registration number CRD42019111479).InterventionsWe are interested in 9 categories of interventions for treatment of VTE: 1. anticoagulation; 2. aspirin and other nonsteroidal anti-inflammatory drugs; 3. statins; 4. thrombolysis; 5. surgery; 6. venous filters; 7. pharmacomechanical catheter-directed thrombolysis; 8. venous angioplasty and stenting; and 9. compression stockings. Studies involving the evaluation of other therapies will be excluded. Because of the wide range of treatment options for VTE, some outcome domains may only be relevant to certain therapies or subpopulation of patients. While these may not be mandatory domains in the final core outcome set, they may represent important but optional domains or research agenda domains according to the OMERACT onion schema ADDIN EN.CITE <EndNote><Cite><Author>OMERACT Initiative</Author><RecNum>1138</RecNum><DisplayText>[11]</DisplayText><record><rec-number>1138</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1574133074" guid="1568b9d6-27a3-4645-a7b8-63b005784dda">1138</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>OMERACT Initiative,</author></authors></contributors><titles><title>The OMERACT Handbook. 2018. Available at Accessed 21 April, 2020.</title></titles><dates></dates><urls></urls></record></Cite></EndNote>[11]. As such, the categorization of interventions will not only be collected to characterize included studies but also considered in study selection and data extraction (see “data management and selection process”).OutcomeThis review will capture all outcomes reported in the included studies.Study designRandomized controlled trials and prospective cohort studies will be eligible.Search strategyAn experienced information specialist developed the strategy for structured database searches in consultation with the review team. The search strategy was peer reviewed according to the Peer Review of Electronic Search Strategies (PRESS) guideline statement by a second independent information specialist before being finalized.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0dvd2FuPC9BdXRob3I+PFllYXI+MjAxNjwvWWVhcj48

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ADDIN EN.CITE.DATA [15] Databases to be searched will include MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. No language restrictions will be in place. The search strategy for MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for the first block of studies to be screened (i.e., 2014-2020; see “data management and selection process”) is provided in the supplementary appendix 2.Data management and selection processScreening of studies at both the title/abstract level (Level 1 screening) and the full text level (Level 2 screening) will be implemented in Covidence, an online software management program for the performance of systematic reviews. ADDIN EN.CITE <EndNote><Cite><RecNum>1008</RecNum><DisplayText>[16]</DisplayText><record><rec-number>1008</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1572017812" guid="be19506b-78db-4581-9498-b5722c8d8507">1008</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia. Available at </title></titles><dates></dates><urls></urls></record></Cite></EndNote>[16] All documents will be reviewed independently by two team members. Disagreement will be resolved by discussion or by involving a third reviewer, if needed. A flow diagram summarizing the process of study selection will be prepared.To maximize efficiency of the study selection process, titles/abstracts for Level 1 screening will be sorted in reverse chronologic order and will be screened in blocks based upon date of publication. To begin, studies published between 2015-2020 will be screened at both abstract and full text level to establish a full set of included studies for this time period. Data extraction from these studies (methods described below) will be performed in full to establish a complete ‘map’ of all the outcomes measured in the set of included studies. Subsequently, in one-year intervals (i.e. 2014, 2013, 2012, etc.), the same approach will be taken; selection of additional studies for inclusion will be halted when, for a one-year period, no new outcome measures are identified from the set of included studies (commonly referred to as ‘saturation’ in terms of outcome measures). This approach is recommended by COMET and OMERACT guidance and results in a robust source of information for the review while offering efficiencies in both study selection and data extraction.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaWxsaWFtc29uPC9BdXRob3I+PFllYXI+MjAxNzwvWWVh

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ADDIN EN.CITE.DATA [10,11] Because studies assessing different categories of interventions may be variably represented over time, saturation will be assessed for each of the 9 above-defined intervention categories. If a certain category is not represented by at least 1 study within one of the assessment periods (i.e., 2015-2020 and subsequent 1-year periods), selection of additional studies will not be halted for this particular category.Data extractionFor all included studies identified using the above approach, extracted data from each report will include the characteristics of the study (design, year, country, interventions, follow-up duration), as well as the set of reported outcomes, outcome definitions, outcome measurement tools, timing of measurement and metrics. Outcome descriptions will be extracted verbatim. All data of interest will be extracted from the source publications by 2 authors independently.Outcomes and prioritizationThe primary outcome of the study is a list of unique outcomes reported in the included studies. A unique outcome will be defined as one that has original meaning and context.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Zb3VuZzwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [12] Outcomes differing only in timing of the outcome assessment (e.g., 10-day versus 30-day all-cause mortality) will not be considered unique. We will extract outcomes verbatim and also record each outcome’s definition, timing of assessment, measurement and metrics. The selection process of unique outcomes will follow the proposal of Young et al.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Zb3VuZzwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [12] First, duplicate verbatim outcomes will be removed after homogenizing spelling (e.g., bleeding and bleed, rates and rate, etc.). Second, outcomes meaning the same will be re-written by 2 reviewers independently to develop non-verbatim outcomes. The re-writing process will be documented. Finally, outcomes remaining after removal of duplicate non-verbatim outcomes will define the list of unique outcomes.Risk of bias (quality) assessmentGiven that the purpose of this review is to develop an inclusive set of outcome domains in order to inform subsequent steps in the VTE-COS development, no risk of bias assessment will be performed. This is consistent with recommendations in the PRISMA extension for scoping reviews.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UcmljY288L0F1dGhvcj48WWVhcj4yMDE4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [14]Data synthesisWe will use descriptive statistics to report the number of verbatim outcomes reported overall and in each individual study and the number of terms used to describe a single unique outcome. Furthermore, we will report the number of unique outcomes overall and per study, definitions of unique outcomes including timepoints of assessment, as well as the number of physician-reported and patient-reported unique outcomes.Similar unique outcomes will be grouped into domains. A domain is defined as a component or concept of “an aspect of health or health condition that needs to be measured to appropriately assess the effects of a health intervention”. ADDIN EN.CITE <EndNote><Cite><Author>OMERACT Initiative</Author><RecNum>1138</RecNum><DisplayText>[11]</DisplayText><record><rec-number>1138</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1574133074" guid="1568b9d6-27a3-4645-a7b8-63b005784dda">1138</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>OMERACT Initiative,</author></authors></contributors><titles><title>The OMERACT Handbook. 2018. Available at Accessed 21 April, 2020.</title></titles><dates></dates><urls></urls></record></Cite></EndNote>[11] Once several domains have been identified, outcomes within domains will be checked for internal homogeneity (i.e., coherence of outcomes within domain) and external heterogeneity (i.e., distinction to outcomes in other domains). ADDIN EN.CITE <EndNote><Cite><Author>Patton</Author><Year>2014</Year><RecNum>1156</RecNum><DisplayText>[17]</DisplayText><record><rec-number>1156</rec-number><foreign-keys><key app="EN" db-id="axx02z0p8pdzwcexar7v5zrnrs2aed9efrrw" timestamp="1575661428" guid="25b67cc9-5e93-48fe-bc2a-9f354f5575df">1156</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Patton, M.Q.</author></authors></contributors><titles><title>Qualitative Research and Evaluation Methods</title></titles><edition>4</edition><dates><year>2014</year></dates><publisher>SAGE</publisher><urls></urls></record></Cite></EndNote>[17] As per OMERACT filter 2.1, the final list of domains will be categorized into 4 core areas including manifestations/abnormalities, life impact, death/lifespan, and societal/resource use.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb2VyczwvQXV0aG9yPjxZZWFyPjIwMTk8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [18]We will use descriptive statistics to report the number of domains and core areas covered in each individual study and vice versa. In subgroup analyses, we will assess differences related to above-mentioned descriptive statistics between randomized controlled trials and prospective cohort studies, and between different locations of initial VTE (i.e., studies for which patients were eligible if they had DVT vs. PE vs. VTE).Confidence in cumulative evidenceBecause we aim to capture and describe what outcomes have been reported in previous VTE studies, determination of the strength of evidence is not applicable.Patient and public involvementPatient partners of the Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network contributed to the concept and protocol of this scoping review and will be involved in the dissemination of the results.ETHICS AND DISSEMINATIONEthical approval is not required for this study because this is a scoping review of published studies. In this scoping review, we aim to generate a list of unique outcome domains reported in previous studies of VTE treatment. This list will serve to define core domains to be considered in the development of a COS for VTE treatment studies. Subsequent steps of the COS development project include 1) individual interviews and focus groups of different stakeholders to identify additional candidate domains which are important for patients and other stakeholders and to increase understanding of stakeholder-relevant outcomes; 2) a Delphi survey to add additional previously not identified outcomes and to prioritize outcomes; 3) a consensus meeting among the study researchers and key stakeholders to define the final COS; and 4) the dissemination of the final COS.The findings of this scoping review will be disseminated through a peer-reviewed journal publication and presentations at scientific conferences. As part of the VTE-COS project, the study is endorsed by the International Society on Thrombosis and Haemostasis (ISTH), the CanVECTOR network and the International Network of VENous Thromboembolism Clinical Research Networks (INVENT). In addition to publication and presentation of the study findings, we will use their platforms to foster dissemination of results to researchers, knowledge users and patients in form of audience-specific summary reports.FUNDINGThe VTE-COS project is funded by the Canadian Institutes of Health Research (PJT-165897) and is supported by the CanVECTOR Network; the Network receives grant funding from the Canadian Institutes of Health Research (CDT-142654). The funder played no role in developing the protocol.ACKNOWLEDGEMENTTobias Tritschler holds an Early Postdoc. Mobility Award from the Swiss National Science Foundation (SNSF P2ZHP3_177999) and a Fellowship Award from the CanVECTOR Network. Grégoire Le Gal holds an Early Researcher Award from the Province of Ontario, a mid-career clinician scientist award from the Heart and Stroke Foundation of Ontario, and the Chair on the Diagnosis of Venous Thromboembolism, Department of Medicine, University of PETING INTERESTSThe authors state that they have no competing interests.AUTHOR CONTRIBUTIONSAll authors contributed to concept and design of the study. TT, NL, BH and GLG wrote the manuscript. All authors reviewed and revised the manuscript. All authors approved the final version of the manuscript.REFERENCES ADDIN EN.REFLIST 1. Nieto JA, Vicente JA, Prieto LM, et al. Thirty-day outcomes in patients with acute pulmonary embolism who discontinued anticoagulant therapy before 90 days. Am Heart J 2018;206:1-10. doi: 10.1016/j.ahj.2018.08.014 [published Online First: 2018/10/03]2. Barritt DW, Jordan SC. Anticoagulant drugs in the treatment of pulmonary embolism. A controlled trial. Lancet 1960;1(7138):1309-12. doi: 10.1016/s0140-6736(60)92299-63. Carrier M, Le Gal G, Wells PS, et al. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med 2010;152(9):578-89. doi: 10.7326/0003-4819-152-9-201005040-00008 [published Online First: 2010/05/05]4. Witt DM, Nieuwlaat R, Clark NP, et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy. Blood Adv 2018;2(22):3257-91. doi: 10.1182/bloodadvances.2018024893 [published Online First: 2018/11/30]5. Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific Standardization Committee of the International Society on Thrombosis Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x [published Online First: 2005/04/22]6. Kraaijpoel N, Tritschler T, Guillo E, et al. Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review. J Thromb Haemost 2019;17(10):1590-607. doi: 10.1111/jth.14570 [published Online First: 2019/07/14]7. Girard P, Penaloza A, Parent F, et al. Reproducibility of clinical events adjudications in a trial of venous thromboembolism prevention. J Thromb Haemost 2017;15(4):662-69. doi: 10.1111/jth.13626 [published Online First: 2017/01/17]8. Klok FA, Barco S, Siegerink B. Measuring functional limitations after venous thromboembolism: A call to action. Thromb Res 2019;178:59-62. doi: 10.1016/j.thromres.2019.04.003 [published Online First: 2019/04/14]9. Kahn SR, Houweling AH, Granton J, et al. Long-term outcomes after pulmonary embolism: current knowledge and future research. Blood Coagul Fibrinolysis 2014;25(5):407-15. doi: 10.1097/MBC.0000000000000070 [published Online First: 2014/01/29]10. Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials 2017;18(Suppl 3):280. doi: 10.1186/s13063-017-1978-4 [published Online First: 2017/07/07]11. OMERACT Initiative. The OMERACT Handbook. 2018. Available at Accessed 21 April, 2020. 12. Young AE, Brookes ST, Avery KNL, et al. A systematic review of core outcome set development studies demonstrates difficulties in defining unique outcomes. J Clin Epidemiol 2019;115:14-24. doi: 10.1016/j.jclinepi.2019.06.016 [published Online First: 2019/07/06]13. Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1. doi: 10.1186/2046-4053-4-1 [published Online First: 2015/01/03]14. Tricco AC, Lillie E, Zarin W, et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med 2018;169(7):467-73. doi: 10.7326/M18-0850 [published Online First: 2018/09/05]15. McGowan J, Sampson M, Salzwedel DM, et al. PRESS Peer Review of Electronic Search Strategies: 2015 Guideline Statement. J Clin Epidemiol 2016;75:40-6. doi: 10.1016/j.jclinepi.2016.01.021 [published Online First: 2016/03/24]16. Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia. Available at . 17. Patton MQ. Qualitative Research and Evaluation Methods. 4 ed: SAGE 2014.18. Boers M, Beaton DE, Shea BJ, et al. OMERACT Filter 2.1: Elaboration of the Conceptual Framework for Outcome Measurement in Health Intervention Studies. J Rheumatol 2019;46(8):1021-27. doi: 10.3899/jrheum.181096 [published Online First: 2019/02/17]SUPPLEMENTARY MATERIALSupplementary appendix 1. PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist.Section and topicItem NoChecklist itemPageADMINISTRATIVE INFORMATIONTitle:?Identification1aIdentify the report as a protocol of a systematic review1?Update1bIf the protocol is for an update of a previous systematic review, identify as suchN/ARegistration2If registered, provide the name of the registry (such as PROSPERO) and registration number6Authors:?Contact3aProvide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of corresponding author2?Contributions3bDescribe contributions of protocol authors and identify the guarantor of the review13Amendments4If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes; otherwise, state plan for documenting important protocol amendmentsN/ASupport:?Sources5aIndicate sources of financial or other support for the review13?Sponsor5bProvide name for the review funder and/or sponsor13?Role of sponsor or funder5cDescribe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol13INTRODUCTIONRationale6Describe the rationale for the review in the context of what is already known4-5Objectives7Provide an explicit statement of the question(s) the review will address with reference to participants, interventions, comparators, and outcomes (PICO)5METHODSEligibility criteria8Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years considered, language, publication status) to be used as criteria for eligibility for the review6-8Information sources9Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other grey literature sources) with planned dates of coverage7Search strategy10Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be repeated19-22Study records:Data management11aDescribe the mechanism(s) that will be used to manage records and data throughout the review7-8Selection process11bState the process that will be used for selecting studies (such as two independent reviewers) through each phase of the review (that is, screening, eligibility and inclusion in meta-analysis)7-8Data collection process11cDescribe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any processes for obtaining and confirming data from investigators8-9Data items12List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data assumptions and simplifications9Outcomes and prioritization13List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale9Risk of bias in individual studies14Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the outcome or study level, or both; state how this information will be used in data synthesis10Data synthesis15aDescribe criteria under which study data will be quantitatively synthesised915bIf data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and methods of combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)1015cDescribe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)10-1115dIf quantitative synthesis is not appropriate, describe the type of summary planned10-11Meta-bias(es)16Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies)N/AConfidence in cumulative evidence17Describe how the strength of the body of evidence will be assessed (such as GRADE)11* It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0. From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349(jan02 1):g7647.Supplementary appendix 2. Electronic search strategy.Database: Embase Classic+Embase <1947 to current>, Ovid MEDLINE(R) ALL <1946 to current>, EBM Reviews - Cochrane Central Register of Controlled Trials <Current>Search Strategy:--------------------------------------------------------------------------------1 *thrombosis/dt, th, su or *thromboembolism/dt, th, su or *venous thromboembolism/dt, th, su or *venous thrombosis/dt, th, su2 *Pulmonary Embolism/dt, th, su3 ((pulmonary or lung) and embol*).ti.4 ((vein or venous) and thromb*).ti.5 (pe or dvt or vte).ti.6 (pulmonary embol* or lung embol*).kw.7 (venous thrombo* or vein thrombo*).kw.8 (pe or dvt or vte).kw.9 exp *Thrombophlebitis/dt, su, th [Drug Therapy, Surgery, Therapy]10 Thrombophlebitis.ti,kw.11 (superficial and thrombosis).ti.12 (superficial and thrombosis).kf.13 or/1-1214 Anticoagulants/ or exp Anticoagulants/tu15 exp Factor Xa Inhibitors/16 (rivaroxaban or apixaban or edoxaban or betrixaban or danaproid or darexaban).mp.17 Antithrombins/18 (dabigatran or ximelagatra).mp.19 exp Vitamin K/ai [Antagonists & Inhibitors]20 (Coumadin or warfarin or phenprocoumon or marcoumar or acenocoumaro).mp.21 exp Heparin, Low-Molecular-Weight/22 (dalteparin or fragmin or enoxaparin or clexane or lovenox or nadroparin or fraxiparin or fondaparinux or arixtra or bemiparin or semuloparin or sulodexide).mp.23 Heparin/24 (heparin or liquemin or liquaemin).mp.25 exp Anti-Inflammatory Agents, Non-Steroidal/26 aspirin.tw,kw.27 exp Hydroxymethylglutaryl-CoA Reductase Inhibitors/28 (Atorvastatin or fluvastatin or lovastatin or pravastatin or rosuvastatin or simvastatin or pitavastatin).mp.29 exp Thrombolytic Therapy/30 Mechanical Thrombolysis/31 fibrinolytic agents/ or streptokinase/ or tissue plasminogen activator/32 Urokinase-Type Plasminogen Activator/33 (streptokinase or urokinase or recombinant tissue plasminogen activator or rt-PA or alteplase).mp.34 exp Thrombectomy/35 (thrombectom* or Thrombolysis).tw,kw.36 Vena Cava Filters/37 vena cava filter*.tw,kw.38 (Catheter-directed adj2 (treatment or management or therapy)).tw.39 Ultrasound-assisted thrombolysis.tw,kw.40 stents/ or angioplasty/41 ((vein or venous) adj3 (stent* or angioplast*)).tw. or (stent* or angioplast*).ti.42 Stockings, Compression/43 Compression stocking*.tw,kw.44 or/14-4345 13 and 4446 randomized controlled trial.pt.47 controlled clinical trial.pt.48 random*.tw.49 placebo.ab.50 clinical trials as topic.sh.51 trial.ti. (824446)52 cohort studies/ or prospective studies/53 prospective*.tw.54 or/46-5355 45 and 5456 limit 55 to yr="2014 -Current"57 56 use medall58 45 use cctr59 limit 58 to yr="2014 -Current"60 *deep vein thrombosis/dm, dt, th, su61 *lung embolism/dm, dt, th, su62 *vein thrombosis/dm, dt, th, su63 *thrombosis/dm, dt, th, su64 *thromboembolism/dm, dt, th, su65 *venous thromboembolism/dm, dt, th, su66 *vein thrombosis/dm, dt, th, su67 ((pulmonary or lung) and embol*).ti.68 ((vein or venous) and thromb*).ti.69 (pe or dvt or vte).ti.70 *thrombophlebitis/dm, dt, su, th71 *superficial thrombophlebitis/dm, dt, su, th72 *leg thrombophlebitis/dm, dt, su, th73 thrombophlebitis.ti.74 (superficial and thrombosis).ti.75 or/60-7476 exp *anticoagulant agent/dt, th or anticoagulant agent/77 exp blood clotting factor 10a inhibitor/78 (rivaroxaban or apixaban or edoxaban or betrixaban or danaproid or darexaban).tw.79 antithrombin/80 (dabigatran or ximelagatra).mp.81 antivitamin K/82 (Coumadin or warfarin or phenprocoumon or marcoumar or acenocoumaro).mp.83 exp low molecular weight heparin/84 (dalteparin or fragmin or enoxaparin or clexane or lovenox or nadroparin or fraxiparin or fondaparinux or arixtra or bemiparin or semuloparin or sulodexide).tw.85 heparin/86 (heparin or liquemin or liquaemin).tw.87 exp nonsteroid antiinflammatory agent/88 aspirin.tw.89 exp hydroxymethylglutaryl coenzyme A reductase inhibitor/90 (Atorvastatin or fluvastatin or lovastatin or pravastatin or rosuvastatin or simvastatin or pitavastatin).tw.91 fibrinolytic therapy/92 exp mechanical thrombectomy/93 fibrinolytic agent/ or exp plasminogen activator/94 (streptokinase or urokinase or recombinant tissue plasminogen activator or rt-PA or alteplase).tw.95 (thrombectom* or Thrombolysis).tw.96 vena cava filter/97 vena cava filter*.tw.98 (Catheter-directed adj2 (treatment or management or therapy)).tw.99 blood clot lysis/100 vascular stent/ or venous stent/101 angioplasty/102 ((vein or venous) adj3 (stent* or angioplast*)).tw.103 (stent* or angioplast*).ti.104 compression stocking/105 Compression stocking*.tw.106 or/76-105107 75 and 106108 random*.tw. or placebo*.mp. or double-blind*.tw.109 prospective study/110 cohort analysis/ and prospective*.tw.111 (prospective* adj5 (stud* or analysis)).tw.112 or/108-111113 107 and 112114 limit 113 to yr="2014 -Current"115 114 use emczd116 57 or 59 or 115117 116 use medall Medline118 116 use emczd Embase119 116 use cctr Cochrane ................
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