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      Risk Factors for Surgical Site Infection After Lower Limb Revascularization Surgery in Adults With Peripheral Artery Disease: Protocol for a Systematic Review and Meta-analysis


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          Surgical site infections (SSIs) are common, costly, and associated with increased morbidity and potential mortality after lower limb revascularization surgery (ie, arterial bypass, endarterectomy, and patch angioplasty). Identifying evidence-informed risk factors for SSI in patients undergoing these surgeries is therefore important.


          The aim of this study is to conduct a systematic review and meta-analysis of prognostic studies to identify, synthesize, and determine the certainty in the cumulative evidence associated with reported risk factors for early and delayed SSI after lower limb revascularization surgery in adults with peripheral artery disease.


          We will search MEDLINE, Embase, the seven databases in Evidence-Based Medicine Reviews, review articles identified during the search, and included article bibliographies. We will include studies of adults (aged ≥18 years) with peripheral artery disease that report odds ratios, risk ratios, or hazard ratios adjusted for the presence of other risk factors or confounding variables and relating the potential risk factor of interest to the development of SSI after lower limb revascularization surgery. We will exclude studies that did not adjust for confounding, exclusively examined certain high-risk patient cohorts, or included >20% of patients who underwent surgery for indications other than peripheral artery disease. The primary outcomes will be early (in-hospital or ≤30 days) SSI and Szilagyi grade I (cellulitis involving the wound), grade II (infection involving subcutaneous tissue), and grade III (infection involving the vascular graft) SSI. Two investigators will independently extract data and evaluate the study risk of bias using the Quality in Prognosis Studies tool. Adjusted risk factor estimates with similar definitions will be pooled using DerSimonian and Laird random-effects models. Heterogeneity will be explored using stratified meta-analyses and meta-regression. Finally, we will use the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to determine certainty in the estimates of association between reported risk factors and the development of SSI.


          The protocol was registered in PROSPERO (International Prospective Register of Systematic Reviews). We will execute the peer-reviewed search strategy on June 30, 2021, and then complete the review of titles and abstracts and full-text articles by July 30, 2021, and September 15, 2021, respectively. We will complete the full-text study data extraction and risk of bias assessment by November 15, 2021. We anticipate that we will be able to submit the manuscript for peer review by January 30, 2022.


          This study will identify, synthesize, and determine the certainty in the cumulative evidence associated with risk factors for early and delayed SSI after lower limb revascularization surgery in patients with peripheral artery disease. The results will be used to inform practice, clinical practice statements and guidelines, and subsequent research.

          Trial Registration

          PROSPERO International Prospective Register of Systematic Reviews CRD42021242557; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=242557

          International Registered Report Identifier (IRRID)


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          Most cited references53

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          Measuring inconsistency in meta-analyses.

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            Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

            Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
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              Quantifying heterogeneity in a meta-analysis.

              The extent of heterogeneity in a meta-analysis partly determines the difficulty in drawing overall conclusions. This extent may be measured by estimating a between-study variance, but interpretation is then specific to a particular treatment effect metric. A test for the existence of heterogeneity exists, but depends on the number of studies in the meta-analysis. We develop measures of the impact of heterogeneity on a meta-analysis, from mathematical criteria, that are independent of the number of studies and the treatment effect metric. We derive and propose three suitable statistics: H is the square root of the chi2 heterogeneity statistic divided by its degrees of freedom; R is the ratio of the standard error of the underlying mean from a random effects meta-analysis to the standard error of a fixed effect meta-analytic estimate, and I2 is a transformation of (H) that describes the proportion of total variation in study estimates that is due to heterogeneity. We discuss interpretation, interval estimates and other properties of these measures and examine them in five example data sets showing different amounts of heterogeneity. We conclude that H and I2, which can usually be calculated for published meta-analyses, are particularly useful summaries of the impact of heterogeneity. One or both should be presented in published meta-analyses in preference to the test for heterogeneity. Copyright 2002 John Wiley & Sons, Ltd.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                September 2021
                16 September 2021
                : 10
                : 9
                : e28759
                [1 ] Department of Surgery Faculty of Medicine University of Ottawa Ottawa, ON Canada
                [2 ] The O'Brien Institute for Public Health, University of Calgary Calgary, AB Canada
                [3 ] Department of Critical Care Medicine Faculty of Medicine University of Calgary Calgary, AB Canada
                [4 ] Department of Medicine University of Ottawa Ottawa, ON Canada
                [5 ] Department of Surgery Western University London, ON Canada
                [6 ] Department of Anesthesia and Pain Medicine University of Ottawa Ottawa, ON Canada
                Author notes
                Corresponding Author: Derek J Roberts Derek.Roberts01@ 123456gmail.com
                Author information
                ©Derek J Roberts, Sudhir K Nagpal, Henry T Stelfox, Tim Brandys, Vicente Corrales-Medina, Luc Dubois, Daniel I McIsaac. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.09.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 13 March 2021
                : 21 June 2021
                : 22 June 2021
                : 23 June 2021

                lower limb revascularization surgery,peripheral artery disease,risk factors,surgical site infection,systematic review


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