Publications by authors named "Holger J Schünemann"

471 Publications

Bringing two worlds closer together: a critical analysis of an integrated approach to guideline development and quality assurance schemes.

BMC Health Serv Res 2021 Feb 24;21(1):172. Epub 2021 Feb 24.

Department of Health Research Methods, Evidence, and Impact, McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street West, Hamilton, ON, L8N 4K1, Canada.

Background: Although quality indicators are frequently derived from guidelines, there is a substantial gap in collaboration between the corresponding parties. To optimise workflow, guideline recommendations and quality assurance should be aligned methodologically and practically. Learning from the European Commission Initiative on Breast Cancer (ECIBC), our objective was to bring the key knowledge and most important considerations from both worlds together to inform European Commission future initiatives.

Methods: We undertook several steps to address the problem. First, we conducted a feasibility study that included a survey, interviews and a review of manuals for an integrated guideline and quality assurance (QA) scheme that would support the European Commission. The feasibility study drew from an assessment of the ECIBC experience that followed commonly applied strategies leading to separation of the guideline and QA development processes. Secondly, we used results of a systematic review to inform our understanding of methodologies for integrating guideline and QA development. We then, in a third step, used the findings to prepare an evidence brief and identify key aspects of a methodological framework for integrating guidelines QA through meetings with key informants.

Results: Seven key themes emerged to be taken into account for integrating guidelines and QA schemes: (1) evidence-based integrated guideline and QA frameworks are possible, (2) transparency is key in clearly documenting the source and rationale for quality indicators, (3) intellectual and financial interests should be declared and managed appropriately, (4) selection processes and criteria for quality indicators need further refinement, (5) clear guidance on retirement of quality indicators should be included, (6) risks of an integrated guideline and QA Group can be mitigated, and (7) an extension of the GIN-McMaster Guideline Development Checklist should incorporate QA considerations.

Discussion: We concluded that the work of guideline and QA developers can be integrated under a common methodological framework and we provided key findings and recommendations. These two worlds, that are fundamental to improving health, can both benefit from integration.
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http://dx.doi.org/10.1186/s12913-020-05819-wDOI Listing
February 2021

Guideline-based quality assurance: a conceptual framework for the definition of key elements.

BMC Health Serv Res 2021 Feb 24;21(1):173. Epub 2021 Feb 24.

Department of Health Research Methods, Evidence, and Impact McMaster University Health Sciences Centre, Room 2C16, 1280 Main Street, West Hamilton, ON, L8N 4K1, Canada.

Background: In 2017, the European Commission's Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC).

Methods: A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance.

Results: Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations.

Conclusions: The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.
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http://dx.doi.org/10.1186/s12913-021-06148-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903784PMC
February 2021

Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative.

Br J Cancer 2021 Feb 18. Epub 2021 Feb 18.

Michael G. DeGroote Cochrane Canada and McGRADE Centres; Department of Health Research Methods, Evidence and Impact, McMaster University Health Sciences Centre, Hamilton, Ontario, Canada.

Background: Predicting the risk of recurrence and response to chemotherapy in women with early breast cancer is crucial to optimise adjuvant treatment. Despite the common practice of using multigene tests to predict recurrence, existing recommendations are inconsistent. Our aim was to formulate healthcare recommendations for the question "Should multigene tests be used in women who have early invasive breast cancer, hormone receptor-positive, HER2-negative, to guide the use of adjuvant chemotherapy?"

Methods: The European Commission Initiative on Breast Cancer (ECIBC) Guidelines Development Group (GDG), a multidisciplinary guideline panel including experts and three patients, developed recommendations informed by systematic reviews of the evidence. Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Four multigene tests were evaluated: the 21-gene recurrence score (21-RS), the 70-gene signature (70-GS), the PAM50 risk of recurrence score (PAM50-RORS), and the 12-gene molecular score (12-MS).

Results: Five studies (2 marker-based design RCTs, two treatment interaction design RCTs and 1 pooled individual data analysis from observational studies) were included; no eligible studies on PAM50-RORS or 12-MS were identified and the GDG did not formulate recommendations for these tests.

Conclusions: The ECIBC GDG suggests the use of the 21-RS for lymph node-negative women (conditional recommendation, very low certainty of evidence), recognising that benefits are probably larger in women at high risk of recurrence based on clinical characteristics. The ECIBC GDG suggests the use of the 70-GS for women at high clinical risk (conditional recommendation, low certainty of evidence), and recommends not using 70-GS in women at low clinical risk (strong recommendation, low certainty of evidence).
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http://dx.doi.org/10.1038/s41416-020-01247-zDOI Listing
February 2021

Use of GRADE in evidence syntheses published in high-impact-factor nutrition journals: a methodological survey.

J Clin Epidemiol 2021 Feb 12. Epub 2021 Feb 12.

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.. Electronic address:

Objective: To identify and describe the use of the GRADE approach for rating the certainty of evidence in nutrition systematic reviews (SRs).

Study Design And Setting: We systematically searched for SRs using GRADE and were published between 2015 and 2019 in the 10 "nutrition" journals with the highest impact factor according to the JCR 2018.

Results: Out of 800 SRs, 55 SRs of randomized control trials (RCTs) and/or non-randomized studies (NRSs) used GRADE. Forty-seven SRs (5.9%) rated the outcome specific certainty of evidence (n=36 in 2018/2019). We identified a total of 465 certainty of evidence outcome ratings (n=335 RCT ratings), ranging from very-low (28.8%) to low (41%), moderate (26.5%), and high (3.7%). Very-low and high certainty of evidence ratings accounted for 61.4% and 0.8% of ratings in SRs of NRSs, compared to 16.1% and 4.8% in SRs of RCTs. Certainty of evidence was downgraded mostly for risk of bias (37.8%) and imprecision (33%) in SRs of RCTs and for imprecision (32.7%), risk of bias (29.4%) and inconsistency (29%) in SRs of NRSs.

Conclusion: Our study suggests a need for directing more attention towards strengthening acceptance of GRADE as well as building knowledge of the GRADE methodology in nutrition evidence synthesis.
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http://dx.doi.org/10.1016/j.jclinepi.2021.02.010DOI Listing
February 2021

American Society of Hematology 2021 guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19.

Blood Adv 2021 02;5(3):872-888

Michael G. DeGroote Cochrane Canada Centre.

Background: Coronavirus disease 2019 (COVID-19)-related critical illness and acute illness are associated with a risk of venous thromboembolism (VTE).

Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation for thromboprophylaxis for patients with COVID-19-related critical illness and acute illness who do not have confirmed or suspected VTE.

Methods: ASH formed a multidisciplinary guideline panel and applied strict management strategies to minimize potential bias from conflicts of interest. The panel included 3 patient representatives. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic evidence reviews (up to 19 August 2020). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including GRADE Evidence-to-Decision frameworks, to assess evidence and make recommendations, which were subject to public comment.

Results: The panel agreed on 2 recommendations. The panel issued conditional recommendations in favor of prophylactic-intensity anticoagulation over intermediate-intensity or therapeutic-intensity anticoagulation for patients with COVID-19-related critical illness or acute illness who do not have confirmed or suspected VTE.

Conclusions: These recommendations were based on very low certainty in the evidence, underscoring the need for high-quality, randomized controlled trials comparing different intensities of anticoagulation. They will be updated using a living recommendation approach as new evidence becomes available.
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http://dx.doi.org/10.1182/bloodadvances.2020003763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869684PMC
February 2021

Challenges in applying the GRADE approach in public health guidelines and systematic reviews: A concept paper from the GRADE Public Health Group.

J Clin Epidemiol 2021 Jan 18. Epub 2021 Jan 18.

MRC/CSO Social and Public Health Sciences Unit, Berkeley Square, 99 Berkeley Street, University of Glasgow, G3 7HR, United Kingdom.

Objective: This paper explores the need for conceptual advances and practical guidance in the application of the GRADE approach within public health contexts.

Study Design And Setting: We convened an expert workshop and conducted a scoping review to identify challenges experienced by GRADE users in public health contexts. We developed this concept paper through thematic analysis and an iterative process of consultation and discussion conducted with members electronically and at three GRADE Working Group meetings.

Results: Five priority issues can pose challenges for public health guideline developers and systematic reviewers when applying GRADE: (1) incorporating the perspectives of diverse stakeholders; (2) selecting and prioritising health and 'non-health' outcomes; (3) interpreting outcomes and identifying a threshold for decision-making; (4) assessing certainty of evidence from diverse sources, including non-randomised studies; and (5) addressing implications for decision-makers, including concerns about conditional recommendations. We illustrate these challenges with examples from public health guidelines and systematic reviews, identifying gaps where conceptual advances may facilitate the consistent application or further development of the methodology, and provide solutions.

Conclusion: The GRADE Public Health Group will respond to these challenges with solutions that are coherent with existing guidance and can be consistently implemented across public health decision-making contexts.
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http://dx.doi.org/10.1016/j.jclinepi.2021.01.001DOI Listing
January 2021

Managing conflicts of interest in the development of health guidelines.

CMAJ 2021 Jan;193(2):E49-E54

Centre for Communicable Diseases and Infection Control (Traversy, Rodin), Public Health Agency of Canada, Ottawa, Ont.; Department of Medicine, University of Calgary (Barnieh, Tonelli), Calgary, Alta.; Department of Internal Medicine (Akl), American University of Beirut, Beirut, Lebanon; Department of Family Medicine (Allan), University of Alberta, Edmonton, Alta.; School of Epidemiology and Public Health (Brouwers), University of Ottawa, Ottawa, Ont.; Institut national d'excellence en santé et en services sociaux (Ganache), Montréal, Que.; Lawrence S. Bloomberg Faculty of Nursing (Grundy), University of Toronto, Toronto, Ont.; Department of Health Research Methods, Evidence and Impact (Guyatt, Schünemann), McMaster University Faculty of Health Sciences, Hamilton, Ont.; CMAJ (Kelsall), Ottawa, Ont.; National Institute for Health and Care Excellence (NICE) (Leng), London, UK; Department of Family Medicine (Moore), McMaster University, Hamilton, Ont.; Department of Family and Community Medicine (Persaud) and Li Ka Shing Knowledge Institute (Straus), St. Michael's Hospital, Toronto, Ont.; Lady Davis Institute and Department of Psychiatry (Thombs), Jewish General Hospital and McGill University, Montréal, Que.; Institut für Evidence in Medicine (Schünemann), Medical Center & Faculty of Medicine, University of Freiburg, Freiburg, Germany.

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http://dx.doi.org/10.1503/cmaj.200651DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7773042PMC
January 2021

"AI's gonna have an impact on everything in society, so it has to have an impact on public health": a fundamental qualitative descriptive study of the implications of artificial intelligence for public health.

BMC Public Health 2021 Jan 6;21(1):40. Epub 2021 Jan 6.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Background: Our objective was to determine the impacts of artificial intelligence (AI) on public health practice.

Methods: We used a fundamental qualitative descriptive study design, enrolling 15 experts in public health and AI from June 2018 until July 2019 who worked in North America and Asia. We conducted in-depth semi-structured interviews, iteratively coded the resulting transcripts, and analyzed the results thematically.

Results: We developed 137 codes, from which nine themes emerged. The themes included opportunities such as leveraging big data and improving interventions; barriers to adoption such as confusion regarding AI's applicability, limited capacity, and poor data quality; and risks such as propagation of bias, exacerbation of inequity, hype, and poor regulation.

Conclusions: Experts are cautiously optimistic about AI's impacts on public health practice, particularly for improving disease surveillance. However, they perceived substantial barriers, such as a lack of available expertise, and risks, including inadequate regulation. Therefore, investment and research into AI for public health practice would likely be beneficial. However, increased access to high-quality data, research and education regarding the limitations of AI, and development of rigorous regulation are necessary to realize these benefits.
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http://dx.doi.org/10.1186/s12889-020-10030-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7787411PMC
January 2021

Next-Generation Allergic Rhinitis Care in Singapore: 2019 ARIA Care Pathways.

Ann Acad Med Singap 2020 11;49(11):885-896

Department of Otolaryngology, Head and Neck Surgery, Sengkang General Hospital, Singapore.

Allergic rhinitis (AR) is prevalent in Singapore, with a significant disease burden. Afflicting up to 13% of the population, AR impairs quality of life, leads to reduced work productivity and is an independent risk factor for asthma. In the last 2 decades, local studies have identified patient and physician behaviours leading to suboptimal control of the disease. Yet, there is an overall lack of attention to address this important health issue. Allergic Rhinitis and its Impact on Asthma (ARIA) is a European organisation aimed at implementing evidence-based management for AR worldwide. Recent focus in Europe has been directed towards empowering patients for self-management, exploring the complementary role of mobile health, and establishing healthcare system-based integrated care pathways. Consolidation of these ongoing efforts has led to the release of the 2019 ARIA care pathways. This review summarises the ARIA update with particular emphasis on the current status of adult AR in Singapore. In addition, we identify unmet needs and future opportunities for research and clinical care of AR in the local context.
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November 2020

Improving the trustworthiness of findings from nutrition evidence syntheses: assessing risk of bias and rating the certainty of evidence.

Eur J Nutr 2020 Dec 30. Epub 2020 Dec 30.

Faculty of Medicine, Institute for Evidence in Medicine, Medical Center, University of Freiburg, Freiburg, Germany.

Suboptimal diet is recognized as a leading modifiable risk factor for non-communicable diseases. Non-randomized studies (NRSs) with patient relevant outcomes provide many insights into diet-disease relationships. Dietary guidelines are based predominantly on findings from systematic reviews of NRSs-mostly prospective observational studies, despite that these have been repeatedly criticized for yielding potentially less trustworthy results than randomized controlled trials (RCTs). It is assumed that these are a result of bias due to prevalent-user designs, inappropriate comparators, residual confounding, and measurement error. In this article, we aim to highlight the importance of applying risk of bias (RoB) assessments in nutritional studies to improve the credibility of evidence of systematic reviews. First, we discuss the importance and challenges of dietary RCTs and NRSs, and provide reasons for potentially less trustworthy results of dietary studies. We describe currently used tools for RoB assessment (Cochrane RoB, and ROBINS-I), describe the importance of rigorous RoB assessment in dietary studies and provide examples that further the understanding of the key issues to overcome in nutrition research. We then illustrate, by comparing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach with current approaches used by United States Department of Agriculture Dietary Guidelines for Americans, and the World Cancer Research Fund, how to establish trust in dietary recommendations. Our overview shows that the GRADE approach provides more transparency about the single domains for grading the certainty of the evidence and the strength of recommendations. Despite not increasing the certainty of evidence itself, we expect that the rigorous application of the Cochrane RoB and the ROBINS-I tools within systematic reviews of both RCTs and NRSs and their integration within the GRADE approach will strengthen the credibility of dietary recommendations.
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http://dx.doi.org/10.1007/s00394-020-02464-1DOI Listing
December 2020

Minimal important difference estimates for patient-reported outcomes: A systematic survey.

J Clin Epidemiol 2020 Dec 13;133:61-71. Epub 2020 Dec 13.

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario L8S 4L8, Canada; Department of Medicine, McMaster University, 1280 Main St East, Hamilton, Ontario L8S 4L8, Canada.

Objectives: The objective of the study was to develop an inventory summarizing all anchor-based minimal important difference (MID) estimates for patient-reported outcome measures (PROMs) available in the medical literature.

Study Design And Setting: We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database internal library (January 1989-October 2018). We included primary studies empirically calculating an anchor-based MID estimate for any PROM in adults and adolescents. Pairs of reviewers independently screened and selected studies, extracted data, and evaluated the credibility of the MIDs.

Results: We identified 585 eligible studies, the majority conducted in Europe (n = 211) and North America (n = 179), reporting 5,324 MID estimates for 526 distinct PROMs. Investigators conducted their studies in the context of patients receiving surgical (n = 105, 18%), pharmacological (n = 85, 15%), rehabilitation (n = 65, 11%), or a combination of interventions (n = 194, 33%). Of all MID estimates, 59% (n = 3,131) used a global rating of change anchor. Major credibility limitations included weak correlation (n = 1,246, 23%) or no information regarding the correlation (n = 3,498, 66%) between the PROM and anchor and imprecision in the MID estimate (n = 2,513, 47%).

Conclusion: A large number of MIDs for assisting in the interpretation of PROMs exist. The MID inventory will facilitate the use of MID estimates to inform the interpretation of the magnitude of treatment effects in clinical research and guideline development.
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http://dx.doi.org/10.1016/j.jclinepi.2020.11.024DOI Listing
December 2020

Validating the "feasibility, acceptability, cost, and equity" instrument using stakeholder perceptions of feasibility, acceptability, cost, and equity in guideline implementation.

J Clin Epidemiol 2020 Dec 1;131:133-140. Epub 2020 Dec 1.

Department of Family Medicine, University of Ottawa, Ottawa, Canada.

Background And Objective: To present a structured approach for assessing stakeholder perceptions and implementing the approach in guideline development.

Methods: This work was carried out by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Equity and Stakeholder Engagement Project Groups through brainstorming and iterative frameworks, stakeholder engagement, pilot testing, refinement of ideas, using input from workshops, and discussions at GRADE Working Group meetings to produce this document, which constitutes a GRADE conceptual article on implementation.

Results: We introduce the FACE implementation criteria, feasibility, acceptability, cost, and equity; priority; and "intent to implement" criterion. We outline the implementation importance of networks and approaches to patient and other stakeholder engagement. Implementation is often highly contextual and can benefit from stakeholder engagement and other assessments. Our FACE approach provides stakeholder questions and language to inform guideline implementation and tools.

Conclusion: The FACE criteria propose a series of knowledge translation questions to guide the assessment of implementation for evidence-based guidelines. It is desirable for guideline developers to use a conceptual approach, such as FACE, to tailor implementation and inform end of guideline dissemination and knowledge translation activities.
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http://dx.doi.org/10.1016/j.jclinepi.2020.11.018DOI Listing
December 2020

Ventilation Techniques and Risk for Transmission of Coronavirus Disease, Including COVID-19.

Ann Intern Med 2020 11;173(10):860

American University of Beirut Medical Center, Beirut, Lebanon (E.A.A.).

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http://dx.doi.org/10.7326/L20-1179DOI Listing
November 2020

GRADE approach to drawing conclusions from a network meta-analysis using a minimally contextualised framework.

BMJ 2020 11 11;371:m3900. Epub 2020 Nov 11.

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4L8, Canada.

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http://dx.doi.org/10.1136/bmj.m3900DOI Listing
November 2020

GRADE approach to drawing conclusions from a network meta-analysis using a partially contextualised framework.

BMJ 2020 11 10;371:m3907. Epub 2020 Nov 10.

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4L8, Canada.

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http://dx.doi.org/10.1136/bmj.m3907DOI Listing
November 2020

Guidelines rarely used GRADE and applied methods inconsistently: A methodological study of Australian guidelines.

J Clin Epidemiol 2021 Feb 29;130:125-134. Epub 2020 Oct 29.

Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, Australia; Adelaide GRADE Centre, Adelaide, Australia.

Objectives: The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is accepted methodology to assess the certainty of the evidence included in systematic reviews and clinical practice guidelines. The GRADE approach is endorsed globally, in Australia, the National Health and Medical Research Council advocated for the use of the GRADE approach in 2011. The purpose of this methodological review was to assess how GRADE has been adopted for Australian practice guidelines.

Study Design And Setting: This methodological review searched of the National Health and Medical Research Council Clinical Practice Guidelines Portal from 2011 to 2018, in an effort to retrieve all practice guidelines available via this medium.

Results: 240 guidelines were retrieved authored by 51 different organizations. 15 guidelines followed GRADE methodology. Application of GRADE methods varied between guidelines, some misreported and altered aspects of the GRADE process. Guidelines that closely adhered to the guidance from the GRADE Working Group scored higher in domain 3 (rigor of development) of the Appraisal of Guidelines for Research and Evaluation II tool, indicating a positive linear relationship between GRADE adherence and rigor of development scores.

Conclusion: The results of our project suggest that the use of GRADE in Australian guidelines is increasing, however, strategies to increase uptake and reporting within the guideline community need to be explored.
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http://dx.doi.org/10.1016/j.jclinepi.2020.10.017DOI Listing
February 2021

Using GRADE evidence to decision frameworks to choose from multiple interventions.

J Clin Epidemiol 2021 Feb 28;130:117-124. Epub 2020 Oct 28.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada; Institut für Evidence in Medicine, Medical Center & Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address:

Background And Objective: Guideline development groups or other health care decision makers frequently encounter situations that require a simultaneous comparison of multiple interventions. This sometimes becomes apparent either when they identify questions of interest, before they formulate recommendations, or it may surface only when recommendations have already been formulated based on pairwise comparisons.

Methods: Using examples from the World Health Organization, the European Commission, and a professional society, we developed a flexible approach to developing recommendations when a multiple-intervention comparison (MC) is needed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence to decision (EtD) frameworks. We iteratively refined this approach through user testing and then included a module in GRADE's official software GRADEpro to test the approach in two real and one theoretical guideline recommendations.

Results: We found the approach feasible and that all EtD criteria should be considered in an MC approach. We judged that guideline development groups and other decision makers will benefit from the availability of a network meta-analyses (NMA) of intervention effects to support decisions; however, NMA supports only one of many criteria, that is, the balance of health benefits and harms, and is therefore helpful, but not essential to the approach we propose. When similar but not identical comparators are used to address MC, challenges may arise with intransitivity and the relative rankings of interventions.

Conclusion: We successfully applied the MC approach and software module in generating recommendations across different scenarios and identified challenges. The MC approach allows guideline groups and other decision makers to transparently and critically assess multiple options for a given health question. Application of the approach by others may lead to refinement and allow for better understanding of its impact in developing recommendations and making choices.
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http://dx.doi.org/10.1016/j.jclinepi.2020.10.016DOI Listing
February 2021

Risk-assessment models for VTE and bleeding in hospitalized medical patients: an overview of systematic reviews.

Blood Adv 2020 Oct;4(19):4929-4944

Department of Health Research Methods, Evidence, and Impact, Michael G. DeGroote Cochrane Canada, McMaster GRADE Centres, McMaster University, Hamilton, ON, Canada.

Multiple risk-assessment models (RAMs) for venous thromboembolism (VTE) in hospitalized medical patients have been developed. To inform the 2018 American Society of Hematology (ASH) guidelines on VTE, we conducted an overview of systematic reviews to identify and summarize evidence related to RAMs for VTE and bleeding in medical inpatients. We searched Epistemonikos, the Cochrane Database, Medline, and Embase from 2005 through June 2017 and then updated the search in January 2020 to identify systematic reviews that included RAMs for VTE and bleeding in medical inpatients. We conducted study selection, data abstraction and quality assessment (using the Risk of Bias in Systematic Reviews [ROBIS] tool) independently and in duplicate. We described the characteristics of the reviews and their included studies, and compared the identified RAMs using narrative synthesis. Of 15 348 citations, we included 2 systematic reviews, of which 1 had low risk of bias. The reviews included 19 unique studies reporting on 15 RAMs. Seven of the RAMs were derived using individual patient data in which risk factors were included based on their predictive ability in a regression analysis. The other 8 RAMs were empirically developed using consensus approaches, risk factors identified from a literature review, and clinical expertise. The RAMs that have been externally validated include the Caprini, Geneva, IMPROVE, Kucher, and Padua RAMs. The Padua, Geneva, and Kucher RAMs have been evaluated in impact studies that reported an increase in appropriate VTE prophylaxis rates. Our findings informed the ASH guidelines. They also aim to guide health care practitioners in their decision-making processes regarding appropriate individual prophylactic management.
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http://dx.doi.org/10.1182/bloodadvances.2020002482DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556144PMC
October 2020

Erratum to "Controversy and debate series on core outcome sets. Paper 3:debate on paper 1 from the perspective of GRADE [Grading of Recommendations Assessment, Development and Evaluation]" [Journal of Clinical Epidemiology 125C (2020) 216-221].

J Clin Epidemiol 2020 Dec 9;128:162. Epub 2020 Oct 9.

Department of Health Research Methods, Evidence, and Impact, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres, McMaster University, Hamilton, ON, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2020.09.014DOI Listing
December 2020

Assessing the process and outcome of the development of practice guidelines and recommendations: PANELVIEW instrument development.

CMAJ 2020 Oct;192(40):E1138-E1145

Department of Health Research Methods, Evidence, and Impact (Wiercioch, Akl, Santesso, Zhang, Morgan, Baldeh, Mustafa, Etxeandia-Ikobaltzeta, Carrasco-Labra, Ventresca, Brignardello-Petersen, Morgano, Brożek, Schünemann), McMaster University, Hamilton, Ont.; Department of Internal Medicine (Akl), American University of Beirut, Beirut, Lebanon; School of Medicine (Yepes-Nuñez), Universidad de los Andes, Bogotá, Colombia; Department of Internal Medicine (Kowalski), Federal University of Paraná, Curitiba, Brazil; Division of Nephrology and Hypertension (Mustafa), Department of Medicine, University of Kansas Medical Center, Kansas City, Kan.; Guideline Development Group (Laisaar), Faculty of Medicine, Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia; Ministry of Social Affairs (Raid), Tallinn, Estonia; Department of Internal Medicine (Neumann), Pontificia Universidad Católica de Chile, Santiago, Chile; Federal University of Rio Grande do Sul (Falavigna), Institute for Health Technology Assessment, Porto Alegre, Brazil; Department of Medicine (Brożek, Schünemann), McMaster University, Hamilton, Ont.; Department of Innovation in Medical Education (McConnell), University of Ottawa, Ottawa, Ont.

Background: Guideline recommendations may be affected by flaws in the process, inappropriate panel member selection or conduct, conflicts of interest and other factors. To our knowledge, no validated tool exists to evaluate guideline development from the perspective of those directly involved in the process. Our objective was to develop and validate a universal tool, the PANELVIEW instrument, to assess guideline processes, methods and outcomes from the perspective of the participating guideline panellists and group members.

Methods: We performed a systematic literature search and surveys of guideline groups (identified through contacting international organizations and convenience sampling of working panels) to inform item generation. Subsequent groups of guideline methodologists and panellists reviewed items for face validity and missing items. We used surveys, interviews and expert review for item reduction and phrasing. For reliability assessment and feedback, we tested the PANELVIEW tool in 8 international guideline groups.

Results: We surveyed 62 members from 13 guideline panels, contacted 19 organizations and reviewed 20 source documents to generate items. Fifty-three additional key informants provided feedback about phrasing of the items and response options. We reduced the number of items from 95 to 34 across domains that included administration, training, conflict of interest, group dynamics, chairing, evidence synthesis, formulating recommendations and publication. The tool takes about 10 minutes to complete and showed acceptable measurement properties.

Interpretation: The PANELVIEW instrument fills a gap by enabling guideline organizations to involve clinicians, patients and other participants in evaluating their guideline processes. The tool can inform quality improvement of existing or new guideline programs, focusing on insight into and transparency of the guideline development process, methods and outcomes.
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http://dx.doi.org/10.1503/cmaj.200193DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546748PMC
October 2020

American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism.

Blood Adv 2020 Oct;4(19):4693-4738

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs in ∼1 to 2 individuals per 1000 each year, corresponding to ∼300 000 to 600 000 events in the United States annually.

Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support patients, clinicians, and others in decisions about treatment of VTE.

Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and adult patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment.

Results: The panel agreed on 28 recommendations for the initial management of VTE, primary treatment, secondary prevention, and treatment of recurrent VTE events.

Conclusions: Strong recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range of 2.0 to 3.0 over a lower INR range for patients with VTE who use a vitamin K antagonist (VKA) for secondary prevention, and use of indefinite anticoagulation for patients with recurrent unprovoked VTE. Conditional recommendations include the preference for home treatment over hospital-based treatment for uncomplicated DVT and PE at low risk for complications and a preference for direct oral anticoagulants over VKA for primary treatment of VTE.
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http://dx.doi.org/10.1182/bloodadvances.2020001830DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7556153PMC
October 2020

Supporting effective participation in health guideline development groups: The Guideline Participant Tool.

J Clin Epidemiol 2021 Feb 25;130:42-48. Epub 2020 Sep 25.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Michael G DeGroote Cochrane Canada and McMaster GRADE Centres, McMaster University, Hamilton, Ontario, Canada; Institute for Evidence in Medicine, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany; Department of Medicine, McMaster University, Hamilton, Canada. Electronic address:

Objectives: Health guidelines are a key knowledge translation tool produced and used by numerous stakeholders worldwide. Effective participation in guideline development groups or development groups is crucial for guideline success, yet little guidance exists for members of these groups. In this study, we present the Guideline Participant Tool (GPT) to support effective participation in guideline groups, in particular those using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

Study Design And Setting: We used a mixed methods and iterative approach to develop a tool to support guideline participation. We used the findings of a published systematic review to develop an initial list of items for considerations for guideline participants. Then, we refined this list through key informant interviews with guideline chairs, sponsors, and participants. Finally, we validated the GPT in three guideline groups with 26 guideline group members.

Results: The initial list of items based on 37 articles from the existing systematic review included 15 themes and 61 items for a draft tool. Ten key informant interviews helped us refine the list to include the following themes: selection of participants, guideline group process, and tool format. 26 respondents completed the validation survey from three guideline groups. Refinement of the tool ultimately generated a GPT with 33 items for participant consideration before, during, and in follow-up to guideline group meetings.

Conclusion: The GPT contains helpful guidance for all guideline participants, particularly those without previous guideline experience. Future research should further explore the need for additional tools to support guideline participants and identify and develop strategies for improving guideline members' participation in guideline groups. This work will be incorporated into INGUIDE.org guideline training and credentialing efforts by the Guidelines International Network and McMaster University.
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http://dx.doi.org/10.1016/j.jclinepi.2020.07.022DOI Listing
February 2021

GRADE Guidelines 30: the GRADE approach to assessing the certainty of modeled evidence-An overview in the context of health decision-making.

J Clin Epidemiol 2021 Jan 24;129:138-150. Epub 2020 Sep 24.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; McMaster GRADE Centre & Michael DeGroote Cochrane Canada Centre, McMaster University, Hamilton, Ontario, Canada.

Objectives: The objective of the study is to present the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) conceptual approach to the assessment of certainty of evidence from modeling studies (i.e., certainty associated with model outputs).

Study Design And Setting: Expert consultations and an international multidisciplinary workshop informed development of a conceptual approach to assessing the certainty of evidence from models within the context of systematic reviews, health technology assessments, and health care decisions. The discussions also clarified selected concepts and terminology used in the GRADE approach and by the modeling community. Feedback from experts in a broad range of modeling and health care disciplines addressed the content validity of the approach.

Results: Workshop participants agreed that the domains determining the certainty of evidence previously identified in the GRADE approach (risk of bias, indirectness, inconsistency, imprecision, reporting bias, magnitude of an effect, dose-response relation, and the direction of residual confounding) also apply when assessing the certainty of evidence from models. The assessment depends on the nature of model inputs and the model itself and on whether one is evaluating evidence from a single model or multiple models. We propose a framework for selecting the best available evidence from models: 1) developing de novo, a model specific to the situation of interest, 2) identifying an existing model, the outputs of which provide the highest certainty evidence for the situation of interest, either "off-the-shelf" or after adaptation, and 3) using outputs from multiple models. We also present a summary of preferred terminology to facilitate communication among modeling and health care disciplines.

Conclusion: This conceptual GRADE approach provides a framework for using evidence from models in health decision-making and the assessment of certainty of evidence from a model or models. The GRADE Working Group and the modeling community are currently developing the detailed methods and related guidance for assessing specific domains determining the certainty of evidence from models across health care-related disciplines (e.g., therapeutic decision-making, toxicology, environmental health, and health economics).
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.018DOI Listing
January 2021

Evaluating prophylactic heparin in ambulatory patients with solid tumours: a systematic review and individual participant data meta-analysis.

Lancet Haematol 2020 Oct;7(10):e746-e755

Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.

Background: Study-level meta-analyses provide high-certainty evidence that heparin reduces the risk of symptomatic venous thromboembolism for patients with cancer; however, whether the benefits and harms associated with heparin differ by cancer type is unclear. This individual participant data meta-analysis of randomised controlled trials examines the effect of heparin on survival, venous thromboembolism, and bleeding in patients with cancer in general and by type.

Methods: In this systematic review and meta-analysis we searched MEDLINE, Embase, and The Cochrane Library for randomised controlled trials comparing parenteral anticoagulants with placebo or standard care in ambulatory patients with solid tumours and no indication for anticoagulation published from the inception of each database to January 14, 2017, and updated it on May 14, 2020, without language restrictions. We calculated the effect of parenteral anticoagulant administration on all-cause mortality, venous thromboembolism occurrence, and bleeding related outcomes through multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect, adjusting for age, cancer type, and metastatic status. Interaction terms were tested to investigate effects in predefined subgroups. This study is registered with PROSPERO, CRD42013003526.

Findings: We obtained individual participant data from 14 of 20 eligible randomised controlled trials (8278 [79%] of 10 431 participants; 4139 included in the low-molecular-weight heparin group and 4139 in the control group). Meta-analysis showed an adjusted relative risk (RR) of mortality at 1 year of 0·99 (95% CI 0·93-1·06) and a hazard ratio of 1·01 (95% CI 0·96-1·07). The number of patients with venous thromboembolic events was 158 (4·0%) of 3958 with available data in the low-molecular-weight heparin group compared with 279 (7·1%) of 3957 in the control group. Major bleeding events occurred in 71 (1·7%) of 4139 patients in the control population and 88 (2·1%) in the low-molecular-weight heparin group, and minor bleeding events in 478 (12·1%) of 3945 patients with available data in the control group and 652 (16·6%) of 3937 patients in the low-molecular-weight heparin group. The adjusted RR was 0·58 (95% CI 0·47-0·71) for venous thromboembolism, 1·27 (0·92-1·74) for major bleeding, and 1·34 (1·19-1·51) for minor bleeding. Prespecified subgroup analysis of venous thromboembolism occurrence by cancer type identified the most certain benefit from heparin treatment in patients with lung cancer (RR 0·59 [95% CI 0·42-0·81]), which dominated the overall reduction in venous thromboembolism. Certainty of the evidence for the outcomes ranged from moderate to high.

Interpretation: Low-molecular-weight heparin reduces risk of venous thromboembolism without increasing risk of major bleeding compared with placebo or standard care in patients with solid tumours, but it does not improve survival.

Funding: Canadian Institutes of Health Research.
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http://dx.doi.org/10.1016/S2352-3026(20)30293-3DOI Listing
October 2020

Approaches of integrating the development of guidelines and quality indicators: a systematic review.

BMC Health Serv Res 2020 Sep 16;20(1):875. Epub 2020 Sep 16.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Background: Guidelines and quality indicators (for example as part of a quality assurance scheme) aim to improve health care delivery and health outcomes. Ideally, the development of quality indicators should be grounded in evidence-based, trustworthy guideline recommendations. However, anecdotally, guidelines and quality assurance schemes are developed independently, by different groups of experts who employ different methodologies. We conducted an extension and update of a previous systematic review to identify, describe and evaluate approaches to the integrated development of guidelines and related quality indicators.

Methods: On May 24th, 2019 we searched in Medline, Embase and CINAHL and included studies if they reported a methodological approach to guideline-based quality indicator development and were published in English, French, or German.

Results: Out of 16,034 identified records, we included 17 articles that described a method to integrate guideline recommendations development and quality indicator development. Added to the 13 method articles from original systematic review we included a total 30 method articles. We did not find any evaluation studies. In most approaches, guidelines were a source of evidence to inform the quality indicator development. The criteria to select recommendations (e.g. level of evidence or strength of the recommendation) and to generate, select and assess quality indicators varied widely. We found methodological approaches that linked guidelines and quality indicator development explicitly, however none of the articles reported a conceptual framework that fully integrated quality indicator development into the guideline process or where quality indicator development was part of the question formulation for developing the guideline recommendations.

Conclusions: In our systematic review we found approaches which explicitly linked guidelines with quality indicator development, nevertheless none of the articles reported a comprehensive and well-defined conceptual framework which integrated quality indicator development fully into the guideline development process.
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http://dx.doi.org/10.1186/s12913-020-05665-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493171PMC
September 2020

Systematic review and meta-analysis of test accuracy for the diagnosis of suspected pulmonary embolism.

Blood Adv 2020 Sep;4(18):4296-4311

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.

Pulmonary embolism (PE) is a common, potentially life-threatening yet treatable condition. Prompt diagnosis and expeditious therapeutic intervention is of paramount importance for optimal patient management. Our objective was to systematically review the accuracy of D-dimer assay, compression ultrasonography (CUS), computed tomography pulmonary angiography (CTPA), and ventilation-perfusion (V/Q) scanning for the diagnosis of suspected first and recurrent PE. We searched Cochrane Central, MEDLINE, and EMBASE for eligible studies, reference lists of relevant reviews, registered trials, and relevant conference proceedings. 2 investigators screened and abstracted data. Risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. We pooled estimates of sensitivity and specificity. The review included 61 studies. The pooled estimates for D-dimer sensitivity and specificity were 0.97 (95% confidence interval [CI], 0.96-0.98) and 0.41 (95% CI, 0.36-0.46) respectively, whereas CTPA sensitivity and specificity were 0.94 (95% CI, 0.89-0.97) and 0.98 (95% CI, 0.97-0.99), respectively, and CUS sensitivity and specificity were 0.49 (95% CI, 0.31-0.66) and 0.96 (95% CI, 0.95-0.98), respectively. Three variations of pooled estimates for sensitivity and specificity of V/Q scan were carried out, based on interpretation of test results. D-dimer had the highest sensitivity when compared with imaging. CTPA and V/Q scans (high probability scan as a positive and low/non-diagnostic/normal scan as negative) both had the highest specificity. This systematic review was registered on PROSPERO as CRD42018084669.
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http://dx.doi.org/10.1182/bloodadvances.2019001052DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509887PMC
September 2020

Potential impact of missing outcome data on treatment effects in systematic reviews: imputation study.

BMJ 2020 08 26;370:m2898. Epub 2020 Aug 26.

Department of Internal Medicine, American University of Beirut Medical Center, PO Box 11-0236, Riad-El-Solh Beirut 1107 2020, Beirut, Lebanon

Objective: To assess the risk of bias associated with missing outcome data in systematic reviews.

Design: Imputation study.

Setting: Systematic reviews.

Population: 100 systematic reviews that included a group level meta-analysis with a statistically significant effect on a patient important dichotomous efficacy outcome.

Main Outcome Measures: Median percentage change in the relative effect estimate when applying each of the following assumption (four commonly discussed but implausible assumptions (best case scenario, none had the event, all had the event, and worst case scenario) and four plausible assumptions for missing data based on the informative missingness odds ratio (IMOR) approach (IMOR 1.5 (least stringent), IMOR 2, IMOR 3, IMOR 5 (most stringent)); percentage of meta-analyses that crossed the threshold of the null effect for each method; and percentage of meta-analyses that qualitatively changed direction of effect for each method. Sensitivity analyses based on the eight different methods of handling missing data were conducted.

Results: 100 systematic reviews with 653 randomised controlled trials were included. When applying the implausible but commonly discussed assumptions, the median change in the relative effect estimate varied from 0% to 30.4%. The percentage of meta-analyses crossing the threshold of the null effect varied from 1% (best case scenario) to 60% (worst case scenario), and 26% changed direction with the worst case scenario. When applying the plausible assumptions, the median percentage change in relative effect estimate varied from 1.4% to 7.0%. The percentage of meta-analyses crossing the threshold of the null effect varied from 6% (IMOR 1.5) to 22% (IMOR 5) of meta-analyses, and 2% changed direction with the most stringent (IMOR 5).

Conclusion: Even when applying plausible assumptions to the outcomes of participants with definite missing data, the average change in pooled relative effect estimate is substantive, and almost a quarter (22%) of meta-analyses crossed the threshold of the null effect. Systematic review authors should present the potential impact of missing outcome data on their effect estimates and use this to inform their overall GRADE (grading of recommendations assessment, development, and evaluation) ratings of risk of bias and their interpretation of the results.
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http://dx.doi.org/10.1136/bmj.m2898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448113PMC
August 2020

Use of facemasks during the COVID-19 pandemic.

Lancet Respir Med 2020 10 3;8(10):954-955. Epub 2020 Aug 3.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8N 3Z5, Canada; Department of Medicine, McMaster University, Hamilton, ON L8N 3Z5, Canada.

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http://dx.doi.org/10.1016/S2213-2600(20)30352-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7398656PMC
October 2020

Recommendations for the conduct of systematic reviews in toxicology and environmental health research (COSTER).

Environ Int 2020 10 9;143:105926. Epub 2020 Jul 9.

Lancaster Environment Centre, Lancaster University, Lancaster LA1 4YQ, UK. Electronic address:

Background: There are several standards that offer explicit guidance on good practice in systematic reviews (SRs) for the medical sciences; however, no similarly comprehensive set of recommendations has been published for SRs that focus on human health risks posed by exposure to environmental challenges, chemical or otherwise.

Objectives: To develop an expert, cross-sector consensus view on a key set of recommended practices for the planning and conduct of SRs in the environmental health sciences.

Methods: A draft set of recommendations was derived from two existing standards for SRs in biomedicine and developed in a consensus process, which engaged international participation from government, industry, non-government organisations, and academia. The consensus process consisted of a workshop, follow-up webinars, email discussion and bilateral phone calls.

Results: The Conduct of Systematic Reviews in Toxicology and Environmental Health Research (COSTER) recommendations cover 70 SR practices across eight performance domains. Detailed explanations for specific recommendations are made for those identified by the authors as either being novel to SR in general, specific to the environmental health SR context, or potentially controversial to environmental health SR stakeholders.

Discussion: COSTER provides a set of recommendations that should facilitate the production of credible, high-value SRs of environmental health evidence, and advance discussion of a number of controversial aspects of conduct of EH SRs. Key recommendations include the management of conflicts of interest, handling of grey literature, and protocol registration and publication. A process for advancing from COSTER's recommendations to developing a formal standard for EH SRs is also indicated.
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http://dx.doi.org/10.1016/j.envint.2020.105926DOI Listing
October 2020

Pharmacologic thromboprophylaxis in adult patients undergoing neurosurgical interventions for preventing venous thromboembolism.

Blood Adv 2020 06;4(12):2798-2809

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

The impact of pharmacologic prophylaxis for venous thromboembolism in patients undergoing neurosurgical intervention remains uncertain. We reviewed the efficacy and safety of pharmacologic compared with nonpharmacologic thromboprophylaxis in neurosurgical patients. Three databases were searched through April 2018, including those for randomized controlled trials (RCTs) and for nonrandomized controlled studies (NRSs). Independent reviewers assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Seven RCTs and 3 NRSs proved eligible. No studies reported on symptomatic proximal and distal deep vein thrombosis (DVT). Two RCTs reported on screening-detected proximal and distal DVTs. We used the findings of these 2 RCTs as the closest surrogate outcomes to inform the proximal and distal DVT outcomes. These 2 RCTs suggest that pharmacologic thromboprophylaxis may decrease the risk of developing asymptomatic proximal DVT (relative risk [RR], 0.50; 95% confidence interval [CI], 0.30-0.84; low certainty). Findings were uncertain for mortality (RR, 1.27; 95% CI, 0.57-2.86; low certainty), symptomatic pulmonary embolism (PE) (RR, 0.84; 95% CI, 0.03-27.42; very low certainty), asymptomatic distal DVT (RR, 0.54; 95% CI, 0.27-1.08; very low certainty), and reoperation (RR, 0.43; 95% CI, 0.06-2.84; very low certainty) outcomes. NRSs also reported uncertain findings for whether pharmacologic prophylaxis affects mortality (RR, 0.72; 95% CI, 0.46-1.13; low certainty) and PE (RR, 0.18; 95% CI, 0.01-3.76). For risk of bleeding, findings were uncertain in both RCTs (RR, 1.57; 95% CI, 0.70-3.50; low certainty) and NRSs (RR, 1.45; 95% CI, 0.30-7.12; very low certainty). In patients undergoing neurosurgical procedures, low certainty of evidence suggests that pharmacologic thromboprophylaxis confers benefit for preventing asymptomatic (screening-detected) proximal DVT with very low certainty regarding its impact on patient-important outcomes.
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http://dx.doi.org/10.1182/bloodadvances.2020002195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322965PMC
June 2020