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Item Hypertension Pharmacological Treatment in Adults: A World Health Organization Guideline Executive Summary(Wolters Kluwer, 2022) Al-Makki, Akram; DiPette, Donald; Whelton, Paul K.; Murad, M. Hassan; Mustafa, Reem A.; Acharya, Shrish; Beheiry, Hind Mamoun; Champagne, Beatriz; Connell, Kenneth; Cooney, Marie Therese; Ezeigwe, Nnenna; Gaziano, Thomas Andrew; Gidio, Agaba; Lopez-Jaramillo, Patricio; Khan, Unab I.; Kumarapeli, Vindya; Moran, Andrew E.; Silwimba, Margaret Mswema; Rayner, Brian; Sukonthasan, Apichard; Yu, Jing; Saraffzadegan, Nizal; Reddy, K. Srinath; Khan, Taskeen; Medicine, School of MedicineHypertension is a major cause of cardiovascular disease and deaths worldwide especially in low- and middle-income countries. Despite the availability of safe, well-tolerated, and cost-effective blood pressure (BP)-lowering therapies, <14% of adults with hypertension have BP controlled to a systolic/diastolic BP <140/90 mm Hg. We report new hypertension treatment guidelines, developed in accordance with the World Health Organization Handbook for Guideline Development. Overviews of reviews of the evidence were conducted and summary tables were developed according to the Grading of Recommendations, Assessment, Development, and Evaluations approach. In these guidelines, the World Health Organization provides the most current and relevant evidence-based guidance for the pharmacological treatment of nonpregnant adults with hypertension. The recommendations pertain to adults with an accurate diagnosis of hypertension who have already received lifestyle modification counseling. The guidelines recommend BP threshold to initiate pharmacological therapy, BP treatment targets, intervals for follow-up visits, and best use of health care workers in the management of hypertension. The guidelines provide guidance for choice of monotherapy or dual therapy, treatment with single pill combination medications, and use of treatment algorithms for hypertension management. Strength of the recommendations was guided by the quality of the underlying evidence; the tradeoffs between desirable and undesirable effects; patient’s values, resource considerations and cost-effectiveness; health equity; acceptability, and feasibility consideration of different treatment options. The goal of the guideline is to facilitate standard approaches to pharmacological treatment and management of hypertension which, if widely implemented, will increase the hypertension control rate world-wide.Item Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation(BMC, 2020-02-01) Petkovic, Jennifer; Riddle, Alison; Akl, Elie A.; Khabsa, Joanne; Lytvyn, Lyubov; Atwere, Pearl; Campbell, Pauline; Chalkidou, Kalipso; Chang, Stephanie M.; Crowe, Sally; Dans, Leonila; Jardali, Fadi El; Ghersi, Davina; Graham, Ian D.; Grant, Sean; Greer-Smith, Regina; Guise, Jeanne-Marie; Hazlewood, Glen; Janet, Janet; Katikireddi, S. Vittal; Langlois, Etienne V.; Lyddiatt, Anne; Maxwell, Lara; Morley, Richard; Mustafa, Reem A.; Nonino, Francesco; Pardo, Jordi Pardo; Pollock, Alex; Kevin, Kevin; Riva, John; Schünemann, Holger; Simeon, Rosiane; Smith, Maureen; Stein, Airton T.; Synnot, Anneliese; Tufte, Janice; White, Howard; Welch, Vivian; Concannon, Thomas W.; Tugwell, Peter; Social and Behavioral Sciences, School of Public HealthStakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS: This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION: We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health.Item PROTOCOL: Barriers and facilitators to stakeholder engagement in health guideline development: A qualitative evidence synthesis(Wiley, 2022-04-25) Magwood, Olivia; Riddle, Alison; Petkovic, Jennifer; Lytvyn, Lyubov; Khabsa, Joanne; Atwere, Pearl; Akl, Elie A.; Campbell, Pauline; Welch, Vivian; Smith, Maureen; Mustafa, Reem A.; Limburg, Heather; Dans, Leonila F.; Skoetz, Nicole; Grant, Sean; Concannon, Tom; Tugwell, Peter; Epidemiology, Richard M. Fairbanks School of Public HealthBackground: There is a need for the development of comprehensive, global, evidence-based guidance for stakeholder engagement in guideline development. Stakeholders are any individual or group who is responsible for or affected by health- and healthcare-related decisions. This includes patients, the public, providers of health care and policymakers for example. As part of the guidance development process, Multi-Stakeholder Engagement (MuSE) Consortium set out to conduct four concurrent systematic reviews to summarise the evidence on: (1) existing guidance for stakeholder engagement in guideline development, (2) barriers and facilitators to stakeholder engagement in guideline development, (3) managing conflicts of interest in stakeholder engagement in guideline development and (4) measuring the impact of stakeholder engagement in guideline development. This protocol addresses the second systematic review in the series. Objectives: The objective of this review is to identify and synthesise the existing evidence on barriers and facilitators to stakeholder engagement in health guideline development. We will address this objective through two research questions: (1) What are the barriers to multi-stakeholder engagement in health guideline development across any of the 18 steps of the GIN-McMaster checklist? (2) What are the facilitators to multi-stakeholder engagement in health guideline development across any of the 18 steps of the GIN-McMaster checklist? Search methods: A comprehensive search strategy will be developed and peer-reviewed in consultation with a medical librarian. We will search the following databases: MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, PsycInfo, Scopus, and Sociological Abstracts. To identify grey literature, we will search the websites of agencies who actively engage stakeholder groups such as the AHRQ, Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR), INVOLVE, the National Institute for Health and Care Excellence (NICE) and the PCORI. We will also search the websites of guideline-producing agencies, such as the American Academy of Pediatrics, Australia's National Health Medical Research Council (NHMRC) and the WHO. We will invite members of the team to suggest grey literature sources and we plan to broaden the search by soliciting suggestions via social media, such as Twitter. Selection criteria: We will include empirical qualitative and mixed-method primary research studies which qualitatively report on the barriers or facilitators to stakeholder engagement in health guideline development. The population of interest is stakeholders in health guideline development. Building on previous work, we have identified 13 types of stakeholders whose input can enhance the relevance and uptake of guidelines: Patients, caregivers and patient advocates; Public; Providers of health care; Payers of health services; Payers of research; Policy makers; Program managers; Product makers; Purchasers; Principal investigators and their research teams; and Peer-review editors/publishers. Eligible studies must describe stakeholder engagement at any of the following steps of the GIN-McMaster Checklist for Guideline Development. Data collection and analysis: All identified citations from electronic databases will be imported into Covidence software for screening and selection. Documents identified through our grey literature search will be managed and screened using an Excel spreadsheet. A two-part study selection process will be used for all identified citations: (1) a title and abstract review and (2) full-text review. At each stage, teams of two review authors will independently assess all potential studies in duplicate using a priori inclusion and exclusion criteria. Data will be extracted by two review authors independently and in duplicate according to a standardised data extraction form. Main results: The results of this review will be used to inform the development of guidance for multi-stakeholder engagement in guideline development and implementation. This guidance will be official GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group guidance. The GRADE system is internationally recognised as a standard for guideline development. The findings of this review will assist organisations who develop healthcare, public health and health policy guidelines, such as the World Health Organization, to involve multiple stakeholders in the guideline development process to ensure the development of relevant, high quality and transparent guidelines.Item PROTOCOL: Guidance for stakeholder engagement in guideline development: A systematic review(Wiley, 2022-05-11) Petkovic, Jennifer; Riddle, Alison; Lytvyn, Lyubov; Khabsa, Joanne; Akl, Elie A.; Welch, Vivian; Magwood, Olivia; Atwere, Pearl; Graham, Ian D.; Grant, Sean; John, Denny; Vittal Katikireddi, Srinivasa; Langlois, Etienne; Mustafa, Reem A.; Todhunter‐Brown, Alex; Schünemann, Holger; Smith, Maureen; Stein, Airton T.; Concannon, Tom; Tugwell, Peter; Epidemiology, Richard M. Fairbanks School of Public HealthThis is the protocol for a Campbell systematic review. The objectives are as follows: to identify, describe, and summarize existing guidance and methods for multistakeholder engagement throughout the health guideline development process.Item Systematic review and meta-analysis of outcomes in patients with suspected pulmonary embolism(American Society of Hematology, 2021-04-27) Patel, Parth; Patel, Payal; Bhatt, Meha; Braun, Cody; Begum, Housne; Nieuwlaat, Robby; Khatib, Rasha; Martins, Carolina C.; Zhang, Yuan; Etxeandia-Ikobaltzeta, Itziar; Varghese, Jamie; Alturkmani, Hani; Bahaj, Waled; Baig, Mariam; Kehar, Rohan; Mustafa, Ahmad; Ponnapureddy, Rakesh; Sethi, Anchal; Thomas, Merrill; Wooldridge, David; Lim, Wendy; Bates, Shannon M.; Lang, Eddy; Le Gal, Grégoire; Haramati, Linda B.; Kline, Jeffrey A.; Righini, Marc; Wiercioch, Wojtek; Schünemann, Holger; Mustafa, Reem A.; Emergency Medicine, School of MedicinePrompt evaluation and therapeutic intervention of suspected pulmonary embolism (PE) are of paramount importance for improvement in outcomes. We systematically reviewed outcomes in patients with suspected PE, including mortality, incidence of recurrent PE, major bleeding, intracranial hemorrhage, and postthrombotic sequelae. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for eligible studies, reference lists of relevant reviews, registered trials, and relevant conference proceedings. We included 22 studies with 15 865 patients. Among patients who were diagnosed with PE and discharged with anticoagulation, 3-month follow-up revealed that all-cause mortality was 5.69% (91/1599; 95% confidence interval [CI], 4.56-6.83), mortality from PE was 1.19% (19/1597; 95% CI, 0.66-1.72), recurrent venous thromboembolism (VTE) occurred in 1.38% (22/1597; 95% CI: 0.81-1.95), and major bleeding occurred in 0.90% (2/221%; 95% CI, 0-2.15). In patients with a low pretest probability (PTP) and negative D-dimer, 3-month follow-up revealed mortality from PE was 0% (0/808) and incidence of VTE was 0.37% (4/1094; 95% CI: 0.007-0.72). In patients with intermediate PTP and negative D-dimer, 3-month follow-up revealed that mortality from PE was 0% (0/2747) and incidence of VTE was 0.46% (14/3015; 95% CI: 0.22-0.71). In patients with high PTP and negative computed tomography (CT) scan, 3-month follow-up revealed mortality from PE was 0% (0/651) and incidence of VTE was 0.84% (11/1302; 95% CI: 0.35-1.34). We further summarize outcomes evaluated by various diagnostic tests and diagnostic pathways (ie, D-dimer followed by CT scan).Item Systematic review and meta-analysis of test accuracy for the diagnosis of suspected pulmonary embolism(Silverchair, 2020-09-11) Patel, Parth; Patel, Payal; Bhatt, Meha; Braun, Cody; Begum, Housne; Wiercioch, Wojtek; Varghese, Jamie; Wooldridge, David; Alturkmani, Hani; Thomas, Merrill; Baig, Mariam; Bahaj, Waled; Khatib, Rasha; Kehar, Rohan; Ponnapureddy, Rakesh; Sethi, Anchal; Mustafa, Ahmad; Lim, Wendy; Le Gal, Grégoire; Bates, Shannon M.; Haramati, Linda B.; Kline, Jeffrey A.; Lang, Eddy; Righini, Marc; Kalot, Mohamad A.; Husainat, Nedaa M.; Jabiri, Yazan Nayif Al; Schünemann, Holger J.; Mustafa, Reem A.; Emergency Medicine, School of MedicinePulmonary 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.